cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients

BACKGROUND: Mediterraneans have traditionally a low cardiovascular risk, although emerging lifestyles might change the trend. The aim of this study is to assess if hypercholesterolemic patient involvement in the preventive decision with the help of a decision aid has an impact on cardiovascular (CV) risk reduction superior to usual care.

METHOD: The design is a cluster randomised clinical trial. Participants are hypercholesterolemic patients (\>200 mg/dl or c-LDL\>130) from four primary care teams of Barcelona. Patients with previous CV events, age over 75 years or cognitive impairment are excluded. It is expected to create two cohorts of 139 patients each one. The randomisation is by doctor. Intervention group will receive information about their CV risk and the risk and benefits of different preventive measures. They will have access to a decission aid that will help them in the choice of the preventive measures.The material (printed and software) is adapted to the Catalan Population using local CV risk tables and will meet the CREDIBLE and DISCERN criteria. STUDY VARIABLES: Sociodemographic variables, CV risk factors, subjective health (SF 12), decisional conflict, anxiety/depression, analytic controls, treatment, treatment adherence, compliance and resources use. Basal evaluation and 3, 6, 12 month assessment. The study, financed by FIS, will begin the 01-07-2007.

RESULTS: The expected results are a higher reduction on the CV risk factors in the intervention group versus regular care.

CONCLUSIONS Study will provide a tool to be used in Spanish and Catalan population.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 14 and 75 years old having the inclusion criteria and consulting for cardiovascular risk diseases (CVD) in these centers.
* Patients who allow to participate in this study

Exclusion Criteria:

* Patients with mental disorders.
* Secundary cardiovascular risk patients
Sofosbuvir Plus Daclatasvir With or Without Ribavirin and Chronic HCV Genotype (GT) 4

This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.

Egyptian participants infected with HCV GT4 were classified into two groups: group 1 (easy to treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult to treat) was treated with a triple therapy of SOF/DCV/RBV daily for 12 weeks.

SOF dose was 400 mg/day given orally DCV was given in a dose of 60 mg/day, orally. RBV was given as oral tablets in the morning and in the evening based on patient's weight and tolerability (starting dose 600 mg/day to reach 1200 mg/day.

Eligibility Criteria:
Inclusion Criteria:

* Non-cirrhotic treatment-naïve participants
* FIB-4 \< 3.25
* albumin \> 3.5
* total bilirubin \< 1.2 mg/dl
* international normalized ratio (INR) \< 1.2
* platelet count \> 150,000 mm3.
* experienced participants who had previously failed treatment with peg-IFN-α-/RBV, SOF/peg-IFN-α +RBV, or SOF/SMV
* Naïve cirrhotic participants were confirmed by ultrasonographic features of cirrhosis

Exclusion Criteria:

* liver disease of non-HCV etiology
* hepatitis B or human immune-deficiency virus (HIV) infection
* poorly controlled diabetic (HbA1C \> 9) participants
* hepatocellular carcinoma
* a history of extra-hepatic malignancy within 5 years prior to the study
* pregnant or breast feeding
* renal disease; serum creatinine \> 2.5 mg/dl or eGFR \< 30 ml/min
* evidence of hepatic decompensation; INR \> 1.7, serum albumin \< 2.8 g/dl, total bilirubin \> 3 mg/dl
* blood picture abnormalities such as anemia (hemoglobin concentration of 10 g/dl or less) and thrombocytopenia (platelet count \< 50,000 cells/mm3)
* major severe illnesses such as congestive heart failure and respiratory failure.
NIV and CPAP Failure Predictors in COVID-19 Associated Respiratory Failure

Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure in patients with COVID-19 associated respiratory failure.

Propose adaptations to HACOR score based on the "state of art" of COVID-19

Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure in patients with COVID-19 associated respiratory failure.

Propose adaptations to HACOR score based on the "state of art" of COVID-19

- this adaptations may include radiologic aggravation and monitoring of CRF, ferritin, LDH, d-dimers, NT-proBNP, troponin I, GOT, GPT, blood count

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute respiratory failure due to COVID-19 who have initiated NIV or CPAP based on assistant clinician decision

Exclusion Criteria:

* Patients with imediate indication to invasive mechanical ventilation
* Patients with any formal contraindication to noninvasive respiratory support
Vision Loss Impact on Navigation in Virtual Reality

The purpose of this research is to better understand the impact of cortically-induced blindness (CB) and the compensatory strategies subjects with this condition may develop on naturalistic behaviors, specifically, driving. Using a novel Virtual Reality (VR) program, the researchers will gather data on steering behavior in a variety of simulated naturalistic environments. Through the combined use of computer vision, deep learning, and gaze-contingent manipulations of the visual field, this work will test the central hypothesis that changes to visually guided steering behaviors in CB are a consequence of changes to the visual sampling and processing of task-related motion information (i.e., optic flow).


Eligibility Criteria:
Cortically Blind Group:

Inclusion Criteria:

* Residents of the United States or Canada
* Presence of one-sided stroke or stroke-like damage to primary visual cortex or its immediate afferent white matter sustained within the specified age range of 21 - 75 years (verified by MRI and/or CT scans)
* Reliable visual field defects in both eyes (homonymous defects) as measured by Humphrey or equivalent perimetry.
* Willing, able, and competent to provide their own informed consent
* Cognitively able, responsible to understand written and oral instructions in English
* Emmetropic or else wear corrective contact lenses inside the virtual reality headset

Exclusion Criteria:

* Those who have never driven or earned a drivers' license
* Past or present ocular disease interfering with visual acuity
* Best corrected visual acuity (BCVA) worse than 20/40 in either eye
* Sustained damage to the dorsal lateral geniculate nucleus
* Presence of diffuse, whole-brain degenerative processes
* Presence of brain damage deemed by study staff to potentially interfere with outcome measures
* History of traumatic brain injury
* Documented history of drug/alcohol abuse
* Diagnosis of cognitive or seizure disorders
* Diagnosis of one-sided attentional neglect

Control Group:

Inclusion Criteria:

* Normal or corrected-to-normal vision, who are between the ages of 21 and 75 years of age, roughly matched to the age of CB subjects enrolled above
* Competent and responsible, as determined by the Principal Investigator
* Willing, able, and competent to provide their own informed consent
* Normal cognitive abilities, be able to understand written and oral instructions in English
* Emmetropic or else wear corrective contact lenses inside the virtual reality headset

Exclusion Criteria:

* Subjects who have never driven or earned a drivers' license
* BCVA worse than 20/40 in either eye
* Presence of vision loss from ocular diseases or disorders
* Presence of a visual field defect
* Inability to wear corrective contact lenses inside the virtual reality helmet if required to see clearly
* Subjects with a history of neurological disorders
* Subjects with a history of TBI
* Persons who lack the competence or are otherwise unable to perform the visual testing as directed.
The Effects of Diode Laser as an Adjunct to Non-surgical Periodontal Treatment on Periodontal Status in Patients With Stage III-IV Periodontitis

Periodontal disease is serious and global chronic disease. The prevalence of periodontal diseases in United Arab Emirates is not clear but data from Dubai Health Authority showed that one in five patients has received periodontal treatment in recent years.

Several studies reported the additional benefits provided by the use of diode laser in combination with ultrasonic debridement in the treatment of gum disease. The use of diode laser may debridement of deep pocketing areas while improving healing of gum tissues.

The aim of the study is to compare the effect of removing bacterial deposit (biofilm) from deep tooth pocket using combined diode laser and conventional pocket debridement versus conventional pocket debridement alone on tooth supporting tissue parameters in patients with advanced gum disease (periodontitis).

Methodology: A total of 22 patients with advanced gum disease will be randomly allocated to two groups: a control group, which will receive conventional pocket debridement and a test group which will receive ultrasonic debridement with diode laser. Gum measurements will be recorded by a masked calibrated examiner at six points for each tooth and patients' postoperative experience and satisfaction will be assessed using special forms.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over.
* Diagnosed with unstable generalised periodontitis, stage III-IV and grade B or C.
* Good compliance and commitment to attend follow-up review appointments.
* Willing to provide informed consent.

Exclusion Criteria:

* Received periodontal treatment in the last 12 months.
* Received systemic antibiotic in the last 6 months.
* Pregnancy or lactating participants
Trop2-targeted immunoPET Imaging of Solid Tumors

This study aims to establish and optimize the trophoblast cell surface antigen 2 (Trop2)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) will be evaluated.

Histologically confirmed solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer), or patients with suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) indicated by conventional diagnostic imaging will be included. Patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation.

Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.05-0.1 mCi/kg). The uptake of imaging tracers in tumors and normal organs/tissues will be scored visually and quantitatively.

Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to assess the diagnostic efficacy. The correlation between lesion uptake and Trop2 expression level determined by immunohistochemistry staining will be further analyzed. The primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18F-FDG PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 year-old and of either sex
* Histologically confirmed diagnosis of solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) or suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) by diagnostic imaging;
* Capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (ICF) and this protocol.

Exclusion Criteria:

* Pregnancy；
* Severe hepatic and renal insufficiency;
* Allergic to single-domain antibody radiopharmaceuticals.
XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults

XW004 is an acylated human glucagon-like peptide 1 (GLP-1) analogue and is being developed for type 2 diabetes mellitus (T2DM) and obesity management.

This is a single centre, double-blind, randomised, multiple-dose, placebo-controlled study, including six cohorts (Cohorts 1A/1B, 2, 3, 4, 5, 6) with a semi-parallel design. The study is designed to evaluate the safety, tolerability, PK, and PD of oral ecnoglutide tablet in healthy participants. Participants will undergo a Screening period beginning up to 28 days (Cohort 1 to 4) and 42 days (Cohort 5 and 6 ) prior to randomisation/dose administration and will be required to sign an informed consent form (ICF) before undertaking any study specific procedures or assessments. Participants who meet all of the inclusion and none of the exclusion criteria will be enrolled. Eligible participants will be admitted to the CRU on Day -1 for review of inclusion and exclusion criteria prior to the start of study procedures on Day 1. A Safety Review Committee (SRC) will be established to monitor the progress of this trial and to make recommendations on whether to continue, modify or stop the trial for safety or ethical reasons.

Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male or female participants, aged 18 to 55 years (inclusive at the time of informed consenting);
* Participants must be in good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before administration of study drug;
* Stable body weight for at least 3 months prior to Screening (i.e., \<5% change) by self-declaration;
* Participants must have a Body Mass Index (BMI) ≥22.0 kg/m2 and \<32.0 kg/m2 and weigh ≥55 kg at Screening (Cohorts 1A/1B to 3), or participants must have a BMI ≥30.0 kg/m2 and \<40.0 kg/m2 and weigh ≥75 kg at Screening (Cohort 4, 5 and 6 only);

Key Exclusion Criteria:

* Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product (IP) or procedures or interfere with study assessments;
* Confirmed diagnosis of diabetes mellitus type 1, type 2, or of any other forms at any time, and/or occurrence of documented or suspected hypoglycaemic episodes within 12 months prior to Screening;
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2;
GORE Glaucoma Drainage Implant Clinical Study Dominican Republic

The objective of this early feasibility clinical study is to evaluate the safety and effectiveness of the GORE Glaucoma Drainage Implant (2 configurations) in subjects with primary open-angle glaucoma that is uncontrolled by hypotensive medications or for which conventional incisional glaucoma surgery would be more likely to fail due to scarring.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, age 18 to 85 years, inclusive at screening visit
* A diagnosis of primary open-angle glaucoma (Shaffer angle ≥ 3 as seen on gonioscopy) at screening visit
* Medicated intraocular pressure at screening visit and the mean medicated diurnal IOP at baseline visit ≥ 18 mmHg and ≤ 40 mmHg by Goldmann Applanation Tonometry

Exclusion Criteria:

* Expected inability to implant the study device in the superotemporal quadrant (e.g., a lack of freely mobile conjunctiva to cover the entire implanted device in the superotemporal quadrant)
* Diagnosis of any active ocular disease or disorder (other than glaucoma) that requires treatment, where the disease or treatment could be reasonably expected to affect the vision or IOP during the duration of the study
* Prior corneal transplant surgery (full or partial thickness transplants) or clinically significant corneal dystrophy, e.g., Fuchs' dystrophy (\> 12 confluent guttae) in the study eye
* Concurrent cataract surgery or anticipated need for cataract surgery (i.e., clinically significant cataract) in the study eye during the 12 months following implantation
* BCDVA worse than 20/200 in the fellow (non-study) eye at the screening visit and BCDVA of the fellow eye cannot be worse than that of the study eye.
Value of Amphotericin B Inhalation for Prophylaxis of Invasive Pulmonary Aspergillosis After Renal Transplantation

The purpose of this study is to determine whether inhalation with aerosolized amphoterin B 10mg/d is more effective than aerosolized amphoterin B 2mg/d to reduce the incidence of invasive pulmonary aspergillosis.


Eligibility Criteria:
Inclusion Criteria:

* 65ys≥age≥18ys
* renal transplant recipients

Exclusion Criteria:

* subjects with hypersensitivity to amphotericin B
* receipt of inhalational or intravenous amphotericin B within last 30 days
* subjects with known invasive fungal infection before renal transplant
* subjects with pneumonia
Triheptanoin Treatment Trial for Patients With Adult Polyglucosan Body Disease

The purpose of the study is to determine if triheptanoin is an effective treatment for the symptoms of Adult Polyglucosan Body Disease.

Adult polyglucosan disease is a progressive neurogenetic disorder characterized by neurogenic bladder, progressive difficulty with walking, and sensory abnormalities in the lower extremities which typically present in the 4th or 5th decade of life. The pathogenesis of the disease includes the accumulation of intracellular polyglucosan bodies (amylopectin-like polysaccharides) in the peripheral nerves as well as the central nervous system cells and is often associated with brancher enzyme deficiency which causes improper glycogen formation. It is hypothesized that decreased glycogen degradation leads to energy deficit in the nervous system cells. Therefore, anaplerotic therapy may supply needed substrate to the citric acid cycle to correct the energy deficit. This intervention may slow, halt or reverse the progression of the disease, for which there is no effective treatment. The trial involves 18 subjects ingesting a diet supplemented with triheptanoin, a 7 carbon triglyceride or a placebo of vegetable oil at a dose of 1-2 g/kg/24 hours in a randomized crossover controlled double blind study. The study lasts one year with patients receiving triheptanoin for 6 mo and the placebo oil for 6 mo. Safety monitoring includes urine organic acids and acyl carnitine profile.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of APBD by the presence of mutations of the GBE1 gene in both alleles or brancher enzyme deficiency
* Willing and able to travel to Dallas TX
* Able to tolerate dietary oil
* Able to provide informed consent

Exclusion Criteria:

* Intercurrent medical conditions that would confound the assessment of efficacy, such as HIV or diabetes
* Patients who are wheelchair bound
* Patients deemed unsuitable for the study by the investigator
The Efficacy of Melatonin in the Burning Mouth Syndrome

Burning mouth ( BMS) syndrome is the oral disorder characterized by an intraoral burning sensation for which no medical or dental cause can be found. The Headache Classification Committee of the International Headache Society (IHS) defines (BMS) as an ''intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3 months, without clinically evident causative lesions''. (BMS) is a common, chronic problem that has a negative impact on quality of life.

A wide variety of medications have been proposed for treating (BMS) both topical and systemic. Unfortunately, no treatment seems to offer assured results. Melatonin is a naturally occurring hormone secreted by the pineal gland. It has soporific effects with oral administration and is well tolerated. It enhances sleep Melatonin also may help sleep disturbances associated with (BMS) ; however, this remains to be proven.

The purpose of this study is to establish whether melatonin can aid in reducing pain improve sleep quality in (BMS)

Eligibility Criteria:
Inclusion Criteria:

* Intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3 months, without clinically evident causative lesions

Exclusion Criteria:

* Previous or current therapy with melatonin
* Allergy or hypersensitivity to melatonin
* Less than 18 years old.
* Pregnant
Physiotherapy in Postpartum After a Cesarean

The purpose of this study is to promote a prevention of the complications using an elaborate guide effective and easy to understand.

The puerperium consists the period of pregnancy and postpartum cycle that the alterations provoked for pregnancy and delivery on the women organism return to your state before pregnancy. The physiotherapist can follow the puerperium since hospital phase until women has been recovered of pregnancy physiologist alterations.

Eligibility Criteria:
Inclusion Criteria:

* have between 15 and 35 yeas old
* has realize an emergency or elective cesarean
* being in immediate puerperium and did not have receive any orientation

Exclusion Criteria:

* complications in delivery and postpartum
* complications with the baby
* physicologics disease