cyrilzakka/clinical-trials huggingface dataset:
Effect of an Exercise Program on Risk of Fall in a Community Dwelling Older Adults

Background: Falls are a problem among the elderly population, it is known that currently about 30% of people over 65 years falls every year. The European Union estimates a cost of € 281 per inhabitant per year and a cost of € 25 billion per year for health care1 which translates into a significant economic impact. The World Health Organization2 argues that it is possible to reduce these costs through prevention and health promotion strategies. For this, it is important to raise awareness, evaluate risk factors and identify and implement intervention programs. Objective: To test the effect of an exercise program on the prevention of risk of fall. Methods: This study, which lasted 4 months, was experimental, prospective. The experimental group (EG) performed an exercise program and the control group (CG) maintained their usual routine. For the measurement and evaluation of the variables under study, were used: sociodemographic data questionnaire, self-efficacy for exercise scale, Portuguese version of the falls efficacy scale (FES), 10m walking speed (WS), Timed Up \& Go test (TUG), step test and Hercules® Force Platform (static balance). A significance level of 5% (p ≤ 0.05) was considered for all comparisons.


Eligibility Criteria:
Inclusion Criteria:

* age equal or superior to 55
* community dwelling individuals

Exclusion Criteria:

* comprehension deficit
* significative heart disease
* restrictive breath disease
Cystatin D Fibrinogen Like Protein 1

to detect role of cystatin D and fibrinogen like protein 1 in rheumatoid arthritis asses relationship between disease activity and cystatin D and fibrinogen like protein 1


Eligibility Criteria:
Inclusion Criteria:

* adult patient diagnosed for rheumatoid arthritis

Exclusion Criteria:

* patient with overlap syndrome indiviuals with other auto immune diseases
A Prospective, Randomized Trial of Early Versus Late Tracheostomy in Trauma Patients With Severe Brain Injury

The purpose of this study is to evaluate the efficacy of early conversion tracheostomy from endotracheal intubation (ET) to percutaneous, dilatational tracheostomy (PDT) in traumatic brain-injured patients requiring prolonged mechanical ventilation.

This is a prospective, randomized trial to evaluate the efficacy of early (less than or equal to 72 hours) versus late (10 to 14 days) conversion from endotracheal intubation to percutaneous, dilatational, translaryngeal tracheostomy for mechanical ventilation of traumatic brain injured patients.

The primary efficacy parameter will be the number of days on mechanical ventilation.

Secondary objectives include:

* Number of days in the hospital
* To assess the incidence of ventilator-acquired pneumonia in each group
* To assess the incidence of accidental extubation in each group
* To assess the incidence of death in each group

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* TBI defined as penetrating or blunt brain injury including 1)subarachnoid hemorrhage, 2)subdural hemorrhage, 3) epidural hemorrhage, 4)brain contusion, 5)diffuse axonal injury
* mechanically ventilated by endotracheal intubation
* projected to need ventilation support for more than 14 days according to: GCS measured in field less than or equal to 8 and a GCS on day 3 which remains less than or equal to 8
* informed consent obtained from patient or legal representative

Exclusion Criteria:

* less than 18 years of age
* projected to need ventilation support for less than 14 days
* anatomical deformity of the neck, including thyromegaly and cervical tumors
* previous tracheostomy
* uncontrolled coagulopathy
* existence of platelet count less than 50,000/mm2
* anti-platelet agents
* clinical evidence of ongoing infection at the proposed tracheostomy site as per physician
* mechanical ventilation with a positive end-expiratory pressure greater than 12 cm H20
* intubated more than 72 hours
* patient has undergone cricothyroidotomy
* cricoid cartilage, trachea, or sternal notch not palpable with neck in position
The Impact of a Personalized Care Intervention on 90-day Post-Discharge Care

The purpose of this 90 day study is to demonstrate the extent to which participants with cardiovascular conditions can improve their recovery at home through a mobile app, support and resources made available to them after hospitalization. The study will evaluate the effectiveness of personal care intervention support, including one-on-one guidance, educational information, check-ins, and Laguna's mobile app to help participants recover better after hospitalization.

This study was designed to provide support to a select group of participants by supplementing the hospital-provided discharge instructions. Laguna integrated hospital provided clinical guidance and Laguna's personalized contextual care protocols, with the goal of improving health outcomes and reducing readmissions within 90 days post-discharge.

Particiants in the intervention group received support from Laguna Health via Laguna's mobile app, phone, video, text, or web chat. Laguna provided contextual support to remove recovery barriers to these intervention participants.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the hospital with a diagnosis of a cardiovascular disorder as defined by the coded diagnoses for that admission
* Discharged to home
* Converse in English
* Uses a telephone (landline or cell phone)

Exclusion Criteria:

* Participant unable to provide informed consent
* Participant lacks cognitive ability to participate in the study interventions as judged by the individual initiating the consenting process
Ivermectin vs Combined Hydroxychloroquine and Antiretroviral Drugs (ART) Among Asymptomatic COVID-19 Infection

This is an open label randomised controlled study of oral ivermectin (600 mcg/kg/d\* 3 day) versus combined of hydroxychloroquine plus darunavir/ ritonavir for 5 days treatment among asymptomatic carrier of SAR-CoV2 adult Thai population. Both study treatment regimens will have oral zinc sulfate combination treatment ( 200mg. twice daily). Outcomes include safety and duration of detectable of SAR-CoV2 in nasopharyngeal/ throat (NP) swab by polymerase chain reaction amplification (PCR) after treatment. 40-50 patients in each treatment arm is planned, with an interim analysis when approximately 50% of cases is enrolled.

* Study procedure will be carried out after informed consent is obtained.
* Baseline physical exam and laboratory investigations will be performed.
* Eligible patients will be randomized to one of the two treatment arms.
* Symptoms and signs will be monitored daily.
* NP swab will be done at day5-7, and prior to discharge.
* Complete blood counts, blood chemistries, electrocardiography will be performed for adverse event monitoring within 5 days after end of study drugs' administration.
* Patients will be discharged at 2- 4 weeks after hospitalization, according to PCR results.
* There will be 1-2 follow up visit at out patient clinic for NP swab (patients with +ve last NP swab before discharge), and blood tests.
* Additional 5-8 ml. of EDTA blood will be taken at baseline and weekly for antibody detection.
* Interim analysis of both safety and efficacy will be performed when approximately 50% of enrollment is achieved.
* Intention to treat analysis is planned at the completion of enrollment.

Eligibility Criteria:
Inclusion Criteria:

* SAR-CoV2 detected by PCR from NP swab
* Asymptomatic or upper respiratory symptoms such as runny noses
* No history of fever or oral Temp \<37.8 degree celsius
* informed consent obtained

Exclusion Criteria:

* Fever or respiratory rate \>24/minute or oxygen saturation at room air\< 94%
* Any serious co-morbidity such as chronic lung disease, chronic kidney disease, cardiovascular diseases, arrythmia, diabetes mellitus with HbA1C \> 8%, chronic liver disease, lymphocyte count \<1,000cell/cu.mm.
* History of ivermectin or any of the study drug allergy.
* Concomitant medication with potential drug interaction with any of the study drugs such as alfuzosin, colchicine, ergot derivatives, cisapride, simvastatin and rifampicin
* Pregnant or lactating woman
LET Optimized IMPT in Treating Pediatric Patients With Ependymoma

This phase I trial studies the side effects of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) in treating pediatric patients with ependymoma. Radiation therapy such as LET optimized IMPT, uses proton beams to kill tumor cells and shrink tumors without damaging surrounding normal tissues.

PRIMARY OBJECTIVES:

I. To evaluate the safety of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) (bio-IMPT) for pediatric patients with ependymoma.

SECONDARY OBJECTIVES:

I. To utilize advanced multiparametric magnetic resonance (MR) imaging to identify imaging biomarkers of structural and biological changes after proton therapy in pediatric ependymoma patients.

II. To compare quantitative image biomarkers in patients treated with bio-IMPT and standard proton therapy using a voxel level analysis.

III. To test and evaluate the validity of relative biological effectiveness (RBE) models and enhance their precision based on prospectively collected clinical image biomarkers.

IV. To evaluate acute and late toxicities, including pseudoprogression and symptom burden, in patients treated with bio-IMPT.

V. To estimate progression-free survival (PFS) and overall survival (OS). VI. To evaluate disease outcomes following the use of a simultaneous integrated boost (SIB) for pediatric ependymoma patients with gross residual disease following surgery.

OUTLINE:

Patients receive LET optimized IMPT for up to 6 weeks.

After completion of study treatment, patients are followed up at 1 month, then every 3 months for up to 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Previous pathologic confirmation of ependymoma, World Health Organization (WHO) grade II or III
* Disease must be confined to the brain (no evidence of spread on MR imaging of the spine or on staging lumbar puncture)
* Patient may not receive chemotherapy concurrent with radiation
* Signed informed consent by patient and/or parents or legal guardian
* Lansky performance status score of 50 -100

Exclusion Criteria:

* Patients with previous radiation therapy to the brain
* Ependymoma of the spine
* Disseminated ependymoma requiring craniospinal radiation therapy
* Pregnancy
* Inability to undergo MR imaging
* Inability to receive gadolinium-based contrast agent
Study Comparing BoneMaster Hydroxyapatite Coating With Plasma-sprayed Hydroxyapatite Coating on Acetabular Cups

The randomised controlled trial will be carried out on patients that require a total hip replacement (THR) to reduce pain and restore their function. One way of fixing the hip joint to the bone is by coating the implant to encourage the body to grow bone onto the replacement hip. This study is aiming to find out whether the new (Bonemaster) coating allows increased bony growth onto the cup when compared to the usual (plasma-sprayed) coating. This may reduce the incidence of early failures due to poor bony attachment, which is a well known complication for early failure of total hip replacements.

The study will compare two different types of coating (BoneMaster and Plasma-sprayed) on the cup of the replacement hip. Density of the bone immediately surrounding the cup will be observed to see if there are differences between the two groups. The density of bone will be measured using standard x-ray assessment and in a smaller sample of 14 patients, using a special scan called Dual Energy X-ray Absorptiometry (DEXA Scan). Functional comparisons will be assessed through clinical scores.

The patients will be identified by the orthopaedic surgeon in the orthopaedic clinic and deemed suitable for the study if all inclusion and exclusion criteria are met. 210 patients will be recruited to the study and each patient will be randomised into either of the groups allowing 105 patients into each group. Patients will be followed up at 6 months, 1 year and 2 years after the surgery. All patients will have radiographic assessments at these follow-up intervals, as well as Harris Hip, Oxford Hip and Womac scores. This will allow comparison of the two groups.

The BoneMaster coating has been extensively tested in cell and animal studies and has been evaluated in one previous clinical study and showed favorable results. Further investigation is required to ensure the new coating may enhance bony growth allowing better fixation of the hips in the early period after the operation and also over a longer period of time. The growth needs to be measured using a more sensitive scan than radiographic assessment alone, called DEXA which was also used in the previous study.

Eligibility Criteria:
Inclusion Criteria

* Patients suitable for THR surgery with a diagnosis of Osteoarthritis
* Patients aged 40 -85 years old.
* Patients with limited co-morbidity - ASA I - III (low risk for surgery)
* Patients must be able to understand instructions and be willing to return for follow up

Exclusion Criteria

* Rheumatoid arthritis
* Patients requiring supplemental screw fixation
* Previous hip surgery to the affected hip
* Patients with significant co-morbidity - ASA IV - V (high risk for surgery)
* Dementia
* Neurological conditions affecting everyday functional ability and hip movement
* The patient is unable to give informed consent
* Patients who have suffered from cancer
* The patient is currently part of another research study
* Patients who need to take Non Steroidal Anti-inflammatory Drugs (NSAIDs) in the first 6 weeks after surgery
Maxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia

The purpose of this prospective clinical data collection is to compare the outcomes of two different tibial bearings: the Maxim® Pop-Top® Tibia and Maxim® Modular Tibia.

The purpose of this prospective clinical data collection is to document and compare the performance and clinical outcomes between the Maxim® Knee System with Removable Molded Poly Tibia and the Maxim® Knee System with Modular Tibial Bearing as two treatment groups.

FDA has cleared these devices via Premarket Notification 510(k)'s K991753, K984623, K993159, K010027. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts and answer potential questions from reimbursement agencies.

Eligibility Criteria:
Inclusion Criteria:

Identical to the indications stated in the FDA approved labeling for the device (cleared in 510(k) K991753,

K984623, K993159, K010027). These indications are stated below:

* Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
* Correction of varus, valgus, or posttraumatic deformity.
* Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Patient selection factors to be considered include:

* need to obtain pain relief and improve function,
* ability and willingness of the patient to follow instructions, including control of weight and activity level,
* a good nutritional state of the patient,
* the patient must have reached full skeletal maturity.
* Porous coated knee joint replacement prostheses have not been approved for non-cemented applications in the United States.

Exclusion Criteria:

Identical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K991753, K984623, K993159, K010027's). These contraindications are stated below:

Absolute contraindications include:

* infection,
* sepsis
* osteomyelitis.

Relative contraindications include:

* uncooperative patient or patient with neurologic disorders who are incapable of following directions,
* Osteoporosis,
* metabolic disorders which may impair bone formation,
* osteomalacia,
* distant foci of infections which may spread to the implant site,
* rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
* vascular insufficiency, muscular atrophy, neuromuscular disease,
* incomplete or deficient soft tissue surrounding the knee.
Genetic Epidemiology of Blood Lipids and Obesity - Ancillary to NGHS

To conduct a genetic epidemiologic study of the coronary heart disease (CHD) risk factors of blood lipids and obesity in Black and white girls who participated in the NHLBI-supported National Growth and Health Study (NGHS). The study was ancillary to NGHS.

BACKGROUND:

The National Growth and Health Study, NGHS, was an epidemiologic study of 2,379 black and white girls, ages 9-10 years at entry, who were followed annually. The ancillary study had the potential for identifying those genes involved in determining Black/white differences in lipid metabolism and obesity. This was an exciting area in which there was virtually no available information. Finally, the study permitted an examination of the effects of gene variation on changes in quantitative levels of blood lipids as well as in body fat during different stages of pubescence since the NGHS protocol included annual anthropometric and maturation assessments and biannual blood lipid determinations along with extensive environmental measures which included dietary, household, and psychosocial information. The study was unique because of the rare opportunity to do genetic analyses in a large cohort of two ethnic groups of children on whom a very rich data base was available.

DESIGN NARRATIVE:

The study was an independent research project ancillary to the NGHS and utilized the extensive biological and environmental information available from the NGHS core data base. Blood samples were obtained from 1,133 girls seen at their followup examinations in Year 7 in order to determine genotypes at those loci known to be implicated in lipid metabolism and obesity. Both protein \[apolipoproteins C-II, D, and E and LP(a)\] and DNA \[apolipoprotein B, lipoprotein lipase (LPL), and LDL receptor\] were analyzed. The distribution of genetic variation within each ethnic group was determined. At each candidate gene locus, the genotype effects were estimated on quantitative level of apolipoproteins and lipoproteins, and also on the degree and distribution of body fat after adjusting for concomitant variables (such as age, biologic maturation stage adiposity) within each ethnic group. By comparing the frequencies of genotypes at candidate loci, their allelic effects were assessed as well as their impact on blood lipids and obesity development in Black and white females.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Amino Acid and Intestinal Protein Metabolism : Working Study

Gut protein metabolism that could be influenced by protein supply is involved in the regulation of several physiological functions such as gut barrier function and represents a major contribution in the whole-body protein turnover. Intracellular pathways implicated in the transduction of amino acids effects remained unknown in the human gut. Thus, the aim of the present project is to evaluate and to understand the effects of amino acids (glutamine, leucine) on gut protein metabolism (synthesis and degradation) in young healthy humans.


Eligibility Criteria:
Inclusion Criteria:

* volunteers with seronegativity for HIV1 and HIV2 and HCV and HVB
* good nutritional state with physical indication mass included between 18,5 and 25kg/m2
* non-smoking volunteers
* volunteers without digestive, allergic or haemorrhagic history
* volunteers without progressive disease
* digestive endoscopy tolerance
* age \>=18 and \<= 50years
* consent obtained from volunteers

Exclusion Criteria:

* smoking volunteers
* volunteers with digestive, or allergic history
* volunteers with haemorrhagic sign
* pregnancy
* progressive digestive disease
* significant progressive disease
* volunteers with therapeutic treatment (aspirin)
* digestive endoscopy intolerance
* volunteers with neurological disorder or with delicate psychological state
Possible New Therapy for Advanced Cancer

IL-13-PE is a chemical similar to one made by the body that is connected to a toxin to specifically attack cancer cells. Researchers want to look at different doses of IL-13-PE to find one that may be safe and effective against cancer that has returned, spread to other organs, or that cannot be surgically removed.

Participants will receive physical exams and report side effects. Blood and urine samples will be collected. Imaging studies, tissue samples, and other tests will be used to study the tumor before the start of treatment and during the study. IL-13-PE therapy will be given to each participant on days 1, 3 and 5 of each monthly cycle for up to 4 monthly cycles.

The study will be done in two parts, with a six-month period between them. If the cancer continues to grow, participants will stop taking IL-13-PE. If the cancer continues to shrink or not grow the study will continue, even into a follow-up period after the second part of the study.

The first part of this study will determine how much IL-13-PE can be tolerated. For this part, the study is recruiting adult patients with various types of cancer. After six participants have taken the lowest dose with no more than one experiencing dose-limiting toxicity, two participants may begin the study taking the medium dose. If they tolerate the medium dose for a month, up to four more may begin at that dose. When at least three participants have tolerated the medium dose, two may attempt the highest dose. When they have tolerated the highest dose for one monthly cycle, 1-4 more may begin the study, receiving the highest dose.

Adrenal cortex cancer (ACC) is a rare tumor in the gland above the kidney. It affects only 1-2 people per million each year and causes hormone problems. This tumor affects children under age 5 and adults aged 30-40, causing death within five years for up to 80% of them. During the second part of the study, all participants will be ACC patients. They will receive the highest dose tolerated during Part 1 on days 1, 3, and 5 of each monthly cycle for up to four months.


Eligibility Criteria:
Inclusion Criteria:

* Has measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria at presentation
* Has failed standard treatment
* Has met protocol-specified criteria for qualification and contraception
* Has voluntarily consented to participate and provided written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* Has history or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
* the safety or well-being of the participant or study staff
* the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
* the analysis of results
5% Topical Ibuprofen (IBU) for Ankle Sprain

This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical placebo for the relief of pain associated with a first or second degree ankle sprain. Both twice daily and three times daily regimens will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* First or second degree ankle sprain within 48 hours of first dose of study medication
* Medically cleared to participate

Exclusion Criteria:

* Similar injury of same joint within last 6 months
* Requires bed rest, surgery, or over-the-counter or prescription analgesics