cyrilzakka/clinical-trials huggingface dataset:
A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease

The primary purpose of study is to estimate the incidence and comparative effect on health outcomes: 1) hospitalization for heart failure, 2) below knee lower extremity amputation. The date of first exposure to the particular drug(s) in the database, where the exposure start is between 1-April-2013 to 15-May-2017 and outcome data for these participants will be analyzed and reported in this study.


Eligibility Criteria:
Inclusion Criteria:

* First exposure to the particular drug(s) in database (index date)
* Exposure start is between 1 April 2013 and 15 May 2017
* At least 365 days of continuous observation time prior to index
* At least 1 condition occurrence of 'Type II diabetes' any time in the prior continuous observation time (which is at least 365 days long) before or on the index date (first exposure to the particular drug(s) in database)

For cohort with 'established cardiovascular disease - At least 1 occurrence of 'conditions indicating established cardiovascular disease' on or any time in the prior continuous observation time (which is at least 365 days long) prior to the index date

Exclusion Criteria:

- Participants with type 1 diabetes or secondary diabetes prior to or on the index date of exposure were excluded from the study
Arabic Version Of Henry Ford Hospital Headache Disability Inventory Questionnaire : Validity, And Reliability

ARABIC VERSION OF HENRY FORD HOSPITAL HEADACHE DISABILITY INVENTORY QUESTIONNAIRE: CROSS-CULTURAL ADAPTATION, VALIDITY, AND RELIABILITY

This questionnaire will be developed to assess the impact of headache on functional and emotional aspects of daily life. The Alpha version of HDI (alpha-HDI) included 40 items, but the newest Beta version (beta-HDI) contains 25 items. The Beta version of HDI, developed by Jacobson (1994) in English, is a generic headache disability questionnaire widely administered in the related research studies.

This questionnaire measures the effect of different medical and rehabilitation treatments on the physical and emotional disabilities in patients with different types of headaches. This generic headache questionnaire is not specific to any headache type. Therefore, HDI will be applied to follow the general consequences of different headache types and to compare different aspects of disability for a variety of headaches. Based on the literature, the original HDI has strong internal consistency/reliability and construct validity. The results of test-retest showed that HDI has an acceptable level of reliability considering the total questionnaire and its subscale scores.

The validity and reliability of the non-English versions of HDI, such as Spanish, have been previously investigated and confirmed. The Arabic researchers and practitioners need valid and reliable tools to measure the emotional and functional states of patients with different headache disorders.

So, This study will be carried out to translate and culturally adapt the HDI questionnaire for administration among the Egyptian patients with headaches. Moreover, This study will assess the validity and reliability of the developed Arabic version of this questionnaire. Creation of questionnaires in different languages must pass through many steps. Questionnaires must be translated, then culturally adapted to the environment in which they will be used.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic primary headache to enter the study.
2. Patients having chronic daily headaches at least 15 days a month.

Exclusion Criteria:

1. Patients with secondary headaches who has underlying serious problems (infection, trauma, tumors, and brain bleedings)
2. Severe psychotic and mental dysfunctions
Treatment of Wounds Utilizing Light

The Qray device is emitting broad light energy that is intended for diabetic ulcer healing. The study is double blinded.


Eligibility Criteria:
Inclusion Criteria:

* Patient has 8 weeks venus leg ulcer.
* The ulcer was not better on prior treatment of various medical clinics.
* The patient has diabetic ulcer grade 1 or 2

Exclusion Criteria:

* Patient has severe infection.
* Patient is taking antibiotic
* Patient has ankle brachial index less than 0.7
* Patient is schedule to undergone revascularization surgery 10 weeks before the study
* Patient has photosensitive disease
* Patient has cancer
* Creatinine level is more than 2 mg%
* Patient is taking immunosuppressive medication.
* Pregnant women
* Dialysis patient
* Anaemic patients(less than 9 gr)
* Patient has Albumin level less than 3 mg%
Handball-based Exercise and Type 2 Diabetes

This single-arm pilot study aims to investigate the feasibility of a handball-based intervention to people diagnosed with type 2 diabetes, including monitoring aerobic intensities and movement strategies during the intervention, and monitoring recruitment, adherence, and adverse events.

Furthermore, the study aims to investigate the feasibility of a test battery including both physiological and patient-reported outcomes, and to investigate preliminary exercise effects.

Physical activity and exercise are known to be beneficial for increasing insulin sensitivity in skeletal muscle in healthy as well as in individuals with type 2 diabetes. But many patients who recently have been diagnosed with type-2 diabetes is often living a sedentary lifestyle and have poor adherence to physical interventions.

High intensity interval training as well as team-based interventions has proven to be effectful in regulation of physiological parameters related to type 2 diabetes. The aim of this study is to investigate the feasibility of a handball-based intervention to people diagnosed with type 2 diabetes

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* Understands and speaks danish

Exclusion Criteria:

* If General Practitioner do not recommend participation in the intervention
Fluoride Varnish Community Trial

This cluster-randomized controlled community trial aimed to assess the efficacy and costs of fluoride varnish application for caries prevention in a high-risk population in South Africa.

Despite advances in oral health, dental caries remains a significant problem - particularly in disadvantaged communities in low- and middle-income countries. A study in the Western Cape Region, which was conducted between 2001 and 2015, reported for example a caries prevalence of 84% for 6-years-old (Smit 2017), highlighting the need for oral health programs and cost-effective interventions. Fluoride varnish offers hereby a feasible possibility to supplement toothbrushing programs in order to improve fluoride delivery and consequently caries prevention. However, many studies failed to confirm the benefits of fluoride varnish for caries prevention, which may partially be explained by the fact that many of these studies were conducted in high-income countries, in which the caries increment is low due to a wide access to fluoride.

This study, thus aimed to further validate the benefits of fluoride varnish application specifically in a primary school setting within a peri-urban, low socio-economic, high-caries risk community in South Africa.

Eligibility Criteria:
Inclusion Criteria:

* Reception grad or grade 1 (age 4-8)
* Signed consent form
* Good general health

Exclusion Criteria:

* Any allergies (especially sticking plaster)
* History of asthma
* Chronic Ulcerated gums
* Chronic Stomatis
* Participation in other study (except LifeSmart)
A New Treatment of Retinitis Pigmentosa

This study is designed to assess and to evaluate the therapeutic effect of retrobulbar injection of autoserum in the treatment of retinitis pigmentosa.

The retinitis pigmentosa(RP) is an hereditary disease which causes visual deficiency leading to blindness. The methods of treatment include gene therapy, stem cell therapy and visual prothesis, etc. But all these methods own limitations can not be conquered in a short period. It was proved that vascular endothelial growth factor (VEGF) and pigment epithelium derived factor (PEDF) decreased in the aqueous humor of patients of RP. But the traditional exogenous nerve growth factors (NGFs) were immunogenic proteins and may cause inflammation. Autoserum contain a large amount of active factors and will not cause exclusive reaction. In this study we aim to assess and to evaluate the therapeutic effect and the safety of retrobulbar injection of autoserum in the treatment of retinitis pigmentosa.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of retinitis pigmentosa

Exclusion Criteria:

* Suspected glaucoma, suspected optic nerve disease, blindness due to other ocular disease
* Combined with serious systemic disease
* Can not cooperate with the interventions and examinations.
Natural Killer(NK) Cell Therapy for Acute Myeloid Leukemia

This is an open-label, Phase I study of QN-023a (allogeneic CAR-NK cells targeting CD33) in relapsed/refractory Acute Myeloid Leukemia (AML).

The clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-023a in patients with relapsed/refractory AML,where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.


Eligibility Criteria:
Key Inclusion Criteria:

* Provision of signed and dated informed consent form (ICF)
* ≥18 years old
* Diagnosis of r/r AML
* Subjects with CD33 positive leukemia cells
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Adequate organ function as defined in the protocol
* Donor specific antibody (DSA) to QN-023a: MFI \<= 2000

Key Exclusion Criteria:

* Allergic to drug used in this study
* Accept other anti-tumor drug within certain time of day 0 (first QN-023a dose infusion), time window and drug defined in the protocol.
* received systemic immunosuppressive therapy within 7 days of day 0, or likely to require systemic immunosuppressive therapy
* Acute Promyelocytic Leukemia (APL)
* Active central nervous system Leukemia.
* Uncontrolled, active clinically significant infection
* Clinically significant cardiovascular disease as defined in the protocol
* Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection
* History of central nervous system (CNS) disease such as stroke, epilepsy.
* Females are pregnant or lactating
* Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
Model-informed Individualized Treatment of Anti-infective Drugs

The study aims to optimize individualized treatment of anti-infective drugs in osteoarticular infections by analyzing drug exposure in patients blood and/or tissues using population pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected/confirmed osteoarticular infections who are undergoing anti-infective drug therapy.

Exclusion Criteria:

* Pregnant/lactating women.
* There are other factors that the researchers think are not suitable for inclusion.
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System

The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce pain following total knee replacement (or total knee arthroplasty (TKA)). This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the leg that received the knee replacement. The SPRINT System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).


Eligibility Criteria:
Key Inclusion Criteria:

* At least 21 years old
* Scheduled to undergo a primary unilateral total knee replacement procedure

Key Exclusion Criteria:

* Body Mass Index (BMI) \> 40 kg/m2
* Compromised immune system based on medical history
* History of valvular heart disease
* Implanted electronic device
* Joint or overlying skin infection of the affected limb
* History of recurrent skin infections
* Bleeding disorder
* Allergy to skin surface electrodes and/or medical-grade adhesive tapes
* Pregnant
Effect of Sodium Concentration of Priming and Rinsing Fluids on Weight Gain

Sodium loading during hemodialysis treatment is common and may contribute to increased interdialytic weight gain and hypertension. Excessive use of isotonic saline (containing 0.9% sodium chloride) is one of the factors that may cause sodium loading. During each hemodialysis session, approximately 400 mL of isotonic saline fluid, representing 1.4 grams of sodium, is used to prime and rinse the extracorporeal circuit, and is often administered to the patient. Switching to a non sodium-containing priming and rinsing fluid could allow for removal of the equivalent amount of sodium.

Switching to a non sodium-containing solution for the priming and rinsing of the extracorporeal circuit can contribute to increased sodium removal during the dialysis treatment and allow for reduced interdialytic weight gain, reduced thirst, and improved blood pressure control.

This 12 week study consists of 3 phases:

Phase 1 (4 weeks): Observation only. Standard priming/rinsing procedure with isotonic saline Phase 2 (4 weeks): Intervention. Switch to a 5% dextrose solution for priming/rinsing procedure Phase 3 (4 weeks): Switch back to standard priming/rinsing procedure with isotonic saline During the study, blood pressures will be measured in a standardized manner at 2 week intervals, a thirst questionnaire will be completed at the end of each phase, and interdialytic weight gain, in-center pre/post-HD blood pressure and intradialytic symptoms will be recorded, apart for routinely measured parameters.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory, clinically stable maintenance HD patients on a thrice weekly HD regimen.
* Willing and able to provide written, signed informed consent after the nature of the study has been explained.
* Willing and able to comply with all study procedures.
* Age ≥18 years.

Exclusion Criteria:

* Diabetes mellitus
* Considerable residual renal function (diuresis \> 500 mL/day)
* Simultaneous participation in another clinical study except observational trials
* Any psychological condition which could interfere with the patient's ability to comply with the study protocol
* Expectation that native kidney function will recover
* Impossibility to perform a blood pressure measurement on the upper limb
* Unable to verbally communicate in English
* Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period.
* Life expectancy \< 6 months
Pediatric Physical Activity for Children With Cancer

The goal of this pilot study is to test the feasibility and participant adherence (pediatric patients diagnosed with childhood cancer) to a virtual, 12-week physical activity program.

The aims of this project are to:

1. Determine the feasibility of administering the program and patient acceptability.
2. Report program adherence and completion rates.
3. Explore trends on the impact of a virtual PA intervention on psychosocial health and physical fitness.

Participants will undergo pre- and post-assessments including measurements of fitness, self-reported fatigue and depression symptoms, social support, and current amount of physical activity. Patients will then be invited to participate in two consecutive, 12-week virtual physical activity interventions with similar-aged peers (2x/week, 60 minutes/session) over 2 rounds.

It is critical for childhood cancer patients to maintain a physical activity (PA) regime as they are at an increased risk of developing co-morbidities. PA engagement is associated with positive psychosocial outcomes, and it has the potential to improve cardiopulmonary and musculoskeletal function. Patients will be enrolled and will undergo baseline assessments of fitness and quality of life as part of their standard care, and additional measures that include fatigue, depression, social support, and PA volume will be measured. Patients will be invited to participate in a 12-week virtual PA intervention with similar-aged peers (2x/week, 60 minutes/session). Patients will be led through activities that are culturally relevant and age-appropriate. At the end of the 12-week intervention, the same tests will be completed. The patients will have an opportunity to receive 2 interventions. A mixed method design will be used, where quantitative data will include information related to feasibility, PA volume, physical fitness, and psychosocial health measures, and qualitative data will be collected from the patients during the focus groups.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with cancer
* Ability to connect to virtual sessions 2x/week
* English literacy
* Having guardian consent and patient assent.
* Eligible patients will be those who do not require physical therapy (i.e., able to dress, ambulate) and will be physically able to participate, as determined by therapy staff.

Exclusion Criteria:

* Not having been diagnosed with cancer.
* Inability to communicate in English
* Requires physical or occupational therapy.
Clinical Evaluation of Monolithic Zirconia FPDs

The objectives of the present study are to compare the survival rates and possible biological and technical complications of metal-ceramic, veneered and monolithic zirconia posterior three-unit fixed partial dentures. The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.

Ninety patients requiring at least one 3-unit Fixed partial denture (FPD) in the posterior region of the maxilla or mandible were included in this study. All subjects were recruited from the Master in Buccofacial Prostheses and Occlusion (Faculty of Odontology, University Complutense of Madrid, Spain). Before treatment, patients were informed of the study objectives, clinical procedures, materials used, advantages and possible risks of the ceramic material, and other therapeutic alternatives. Prior to the study, participants were asked to provide written informed consent. Ninety posterior FPDs were produced and allocated in parallel and randomly to either monolithic zirconia, veneered zirconia or MC restorations. The clinical procedures were performed by two experienced clinicians. All participants received oral hygiene instructions and a professional tooth cleaning prior to prosthetic treatment. The abutment teeth were prepared with a 0.8- to 1-mm-wide circumferential chamfer, an axial reduction of 1 mm and an occlusal reduction of 1.5- to 2.0-mm. A 10- to 15- degree angle of convergence was achieved for the axial walls. Tooth preparations were scanned with an intraoral scanner and the FPDs were designed using specific software. The restorations were then cemented using a resin self-adhesive cement. After cementation, occlusal contacts were evaluated, and the adjusted surfaces were polished using a porcelain polishing kit. The 90 FPDs were examined at 1week (baseline),1, 2 and 2 years by 2 researchers who were not involved in the restorative treatment.

Eligibility Criteria:
Inclusion Criteria:

* One posterior tooth (molar or premolar) to be replaced
* Vital abutments or abutments with an adequate endodontic treatment
* Abutment not crowned previously
* Periodontally healthy abutments with no signs of bone resorption or periapical disease
* Adequate occlusogingival height for an appropiate connector area of at least 9 mm2
* Stable occlusion and the presence of natural dentition in the antagonist arch.

Exclusion Criteria:

* Patients who require a Fixed Dental Prosthesis of more than three units
* Patients who present reduced crown length (less than 3 mm occlusogingival heigth)
* Poor oral hygiene, high caries activity, or active periodontal disease
Performance of Diuretic Stress Test in Predicting Short Term Renal Recovery in Oliguric Critically-ill Patients Recovery in the Short Term

Acute kidney injury (AKI) is a common disorder and associated with high morbidity and mortality. However, distinguishing transient AKI from persistent AKI may help in individualizing treatment and limit short and long term consequences of AKI. Previous studies suggested usual urinary indices to perform poorly for separating transient from persistent AKI in an unselected population of critically ill patients. The recent KDIGO (Kidney Disease Improving Global Outcomes) guidelines underlined the need for additional strategies in estimating renal short term prognosis.

Recently, a Furosemide stress test (FST) was validated in a cohort of unselected critically ill patients. This stress test performance was found to be good in predicting capacity to identify those patients that will progress to advanced stage AKI. Additionally, FST performance was higher than those of usual renal biomarker. The limited sample size of this preliminary study however precluded adjustment for usual confounders including oliguria.

The primary objective of this study is to assess diagnostic performance of FST in differentiating transient and persistent AKI. Secondary objectives are to assess diagnostic performance of FST in predicting need for renal replacement therapy, and to confirm FST results after adjustment for confounders.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \> 18 y.o)
* AKI stage 1 or more according to KDIGO
* Oliguria as defined by an oliguria lower than 0.5 mL/Kg
* Affiliation to the National Medical Insurance

Exclusion Criteria:

* Pregnancy
* Chronic kidney disease stage 4 or more
* Need for fluid bolus (\>1000 mL crystalloids or equivalent) or need for vasopressors increases or introduction in the 2 hours preceding inclusion
* Evidence of obstructive renal failure
Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF)

This is an interventional, double blind, randomized (2:1), and placebo-controlled study of 2 infusions of a 1 dose regimen of HepaStem in patients recently diagnosed (≤1 week) with ACLF grade 1 or 2 on top of Standard of Care (SoC), and for whom the diagnosis is not resolved on the day of infusion.


Eligibility Criteria:
Inclusion Criteria:

1. Are adults aged between 18 and 75 years old.
2. Have an initial diagnosis of ACLF at the investigational site.
3. Have ACLF grade 1 or 2 according to the EASL-CLIF Consortium definition.
4. Have a total bilirubin ≥ 5 mg/dL.
5. Are able to read, understand and give written informed consent.

Main Exclusion Criteria:

1. Have a MELD-Na score \> 35.
2. Have underlying cirrhosis due to biliary disease.
3. Have underlying cirrhosis due to autoimmune hepatitis.
4. Have active bleeding at a non-compressible site or at a compressible site that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study.
5. Have received treatment for bleeding complications during the current hospitalization and has a persistent high risk for re-bleeding that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study.
6. Have a complete portal vein thrombosis.
7. Have coagulation disturbances defined as:

   * fibrinogen \< 80 mg/dL
   * platelets \< 50 x 10³/mm³
8. Are requiring chronic dialysis therapy.
9. Have had a cerebrovascular, myocardial, limb arterial thrombotic event, or history for both thrombotic and hemorrhagic cerebrovascular events within 12 months prior to the Screening and not considered stabilized by the investigator.
10. Have a previous history of myocardial infarction and/or cardiac failure, with an ejection fraction rate (EFR) ≤ 40%.