cyrilzakka/clinical-trials huggingface dataset:
Integration of Follow-up by First and Second Line Practitioners by Telemonitoring in Heart Failure.

The aim of this study is to evaluate this model of telemonitoring-assisted close supervision and interaction between first and second line health professionals versus a model of telemonitoring without this integrated approach.

The incidence of acute decompensated heart failure is increasing. Patients with severe heart failure are rehospitalised for decompensation several times each year, increasing the cost for health care. In these cases of recurrent decompensation, the medical intervention in hospital is often limited to increasing the dosage of diuretics or vasodilators until the patient reaches a compensated state. After discharge, a readmission can be expected within a few months. A multidisciplinary approach by primary physician, heart failure nurse, rehabilitation team and cardiologist has been shown to decrease rehospitalisation rate and increase quality of life.

Very recently, our study group showed that an intense collaboration between first line practitioner and heart failure clinic, facilitated by the use of telemonitoring, can reduce mortality and hospitalisation rate. This study was a RIZIV sponsored trial of 6 months follow-up in patients with chronic heart failure. However, a large randomised multicentre trial investigating the use of telemonitoring in a population of heart failure (NYHA II-III) patients did not find any difference between telemonitoring and usual care (Chaudry et al NEJM 2010). In contradiction with this study, a Cochrane meta-analysis (Ingliss 2010) in more than 5000 patients confirmed our finding with a reduction in mortality and morbidity. The question therefore remains which factors are responsible for success or failure of the use of telemonitoring. Based on our previous experience, the approach of close monitoring by telemonitoring, with first line intervention by the patient's general practitioner (GP) and supervision by the heart failure clinic, might be the critical success factor.

Therefore, the aim of this study is to evaluate this model of telemonitoring-assisted close supervision and interaction between first and second line health professionals versus a model of telemonitoring without this integrated approach.

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized for decompensation of systolic heart failure
* LVEF \< 40% during hospitalization.

Exclusion Criteria:

* reversible forms of acute heart failure (acute ischemia, myocarditis,..)
* heart failure due to severe aortic stenosis
* participation in cardiac rehabilitation after discharge
* previous or actual residency in a nursing home
* creatinine clearance \<15 ml/min
* planned dialysis in the next 6 months
* planned biventricular pacemaker or cardiac surgery
* life expectancy of less than 1 year due to other diseases
* severe obstructive pulmonary disease (Gold III)
* significant mental or cognitive problems interfering with the daily measurements or intake of medication.
The Use of Sun Protection After Hamam (Turkish Bath)

Hamam is a common spa treatment. During a Hamam, some of the outermost layer of the skin is removed. The investigators believe that partly removing a protective skin layer might increase the risk of sun burn, especially for skin that has not been exposed to sun for a long time.

The aim with this study is to assess if Hamam-treated skin is more susceptible to sun burn compared with untreated skin.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* Healthy volunteers
* Skin types 1,2,3- Fitzpatrick scale
* Provided informed consent

Exclusion Criteria:

* Regular medication for a condition/disease
* Active skin disease
* Sun exposure on the back within four weeks prior to the start of the study
* History of premalignant or malignant skin lesions
* Tattoo covering more than half of the back
Functional Communicative Profile of Children With Down Syndrome

The aim of this study was to verify the use of communicative functions by children with DS in two interaction conditions: interaction with therapist and interaction with parent.

Parents and caregivers' engagement on therapeutic process of children with Down syndrome (DS) is important for language and communication development. The identification of the communicative skills presented by these children as well as the context influence in their performance as interlocutors, will contribute to the design of therapeutic interventions.

Pragmatics theories are helpful to language use studies, since it takes into account social and environmental aspects and considers adult-child interaction as a determinant factor for its occurrence.

Eligibility Criteria:
Inclusion Criteria:

* genetic diagnosis of Down syndrome
* good health conditions
* normal results on audiologic evaluation
* pediatric and ear, nose and throat periodic check ups.
* attend speech-language therapy at the Speech Language Pathology Laboratory in Syndromes and Sensorimotor Deficits (SLPL-SSD) of the School of Medicine of the University of São Paulo.

Exclusion Criteria:

* submission to long term hospitalizations due to heart diseases and major respiratory airway infections, that may interfere in the child's global development
* presence of visual or auditory important deficits
Study of Safety and Efficacy of a Probiotic and Postbiotic in Overweight Individuals

Investigate the effect of a probiotic (live bacteria) and postbiotic (heat-treated bacteria) strains in overweight individuals.

This study aims to investigate the safety and efficacy of live and heat treated bacteria on body composition of overweight individuals. The trial will be run in a single research centre and will recruit adult men and women, with BMI of 25-33kg/m2 with abdominal obesity.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index 25-33kg/m2
* Abdominal obesity (female waist circumference\>85cm; male waist circumference\>90cm)
* written informed consent

Exclusion Criteria:

* Taking the following medication within 1 month before starting the study: appetite stimulants/suppressants, lipid lowering drug, contraceptive
* taking antibiotics within 2 months before starting the study
* secondary obesity or secondary hypertension, diabetes type 1, GI disease, dyslipidaemia, type 2diabetes, hypertension
* consumption of pre- and probiotic-enriched products or dietary supplement for at least 4 weeks prior to the first screening visit
* nicotine, drug or alcohol abuse,
* other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit or confound the Study's results
A Multiple Dose Study Investigating Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Participants With Type 1 Diabetes Pharmacokinetics and Pharmacodynamics: How Insulin NNC0363-0845 is Transported Throughout the Body and How It Works

This study is designed to investigate the movement of insulin NNC0363-0845 throughout the body and how it works for the treatment of type 1 diabetes mellitus.

The aim of the study is to improve clinical outcomes for patients with type 1 diabetes mellitus by better controlling the blood sugar levels.

Participants will get insulin NNC0363-0845 as well as insulin detemir (Levemir®). NNC0363-0845 is a new insulin molecule designed to provide blood sugar-dependent insulin action, while insulin detemir is commonly used and prescribed by doctors.

Participants will get subcutaneous (under your skin) injections of insulin NNC0363-0845 (study medicine) up to 6 times daily for 3 days, and of insulin detemir up to 6 times daily for another 3 days. Which medication participants receive first and which second, insulin NNC0363-0845 or insulin detemir, is decided by chance.

The study will last for about 6 weeks up to a maximum of 14 weeks. Participants will have 2 in-house visits (where participants will stay at the site for 4 nights) and 5 outpatient visits with the study doctor. Participants will have frequent contact with the study doctor during the study.

During the in-house visits, two intravenous catheters (a thin tube inserted into a vein) will be inserted for blood sampling and infusions.

Interested parties may not participate in the study if the study doctor believes it will affect their health negatively.

Women cannot take part if they are of childbearing potential.


Eligibility Criteria:
Key inclusion criteria:

* Male participant or female participant of non-childbearing potential. Non-child-bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
* Aged 18-64 years (both inclusive) at the time of signing informed consent.
* Diagnosed with type 1 diabetes mellitus 1 year or more before screening.
* Current daily basal insulin treatment greater than 0.2 and below or equal to 0.5 (I)U/kg/day.
* Current total daily insulin treatment between 0.4 and 0.8 (I)U/kg/day (both inclusive).
* Body mass index between 18.5-29.9 kg/m\^2 (both inclusive).
* HbA1c (glycated haemoglobin) below or equal to 8.0%.

Key exclusion criteria:

* Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). Adequate contraceptive measures include that the male participant uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%). In addition, participants must not donate sperm for the duration of the study.
ER Niacin/Laropiprant Impact on Cardiovascular Markers and Atheroprogression in HIV-infected Individuals on cART

HIV-infected patients are at increased risk for cardiovascular disease. Large investigations support an inverse correlation between HDL-C levels and coronary heart disease. Therefore a treatment lowering HDL-C such as niacin could reduce the risk of atheroprogression not only through its benefit in terms of lipid profile, but also by reducing atherosclerotic inflammation.

The study aims at showing that a therapy targeting HDL-C increase in HIV-infected patients on suppressive cART has the potential for reducing subclinical atherosclerotic inflammation associated with HIV itself in HIV-individuals on cART.

NILACH is a randomised, multicenter, double blind, placebo controlled, 48 weeks trial to test the effect of the newly marketed niacin/laropiprant on carotid intima-media thickness (IMT) in 90 subjects.

* Regimen 1: ER niacin/laropiprant 1g/20 mg for the first 4 weeks and 2g/40mg from week 5 to the end of the study (the titration aims to reduce adverse reactions)
* Regimen 2: ER niacin/laropiprant placebo p.m.

The primary end point is the change in mean common carotid intima-media thickness from baseline and 48 weeks, compared between the niacin/laropiprant group and the placebo group.

The proposed in vivo experiments should provide insights on the potential benefits of niacin treatment of cardiovascular disease in HIV patients. In addition, we will be able to further clarify the role of systemic inflammatory mediators in the development of early atherosclerosis of HIV-infected patients on antiretroviral therapy. Detection and treatment of non-infectious co-morbidities such as cardiovascular diseases have become essential for HIV-infected individuals exposed to lifelong antiretroviral therapy and go beyond mere management of opportunistic infections or virologic suppression.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \> 40 years;
* Women of childbearing potential must use two reliable contraceptive methods during the entire trial, from day 1 to one month after the end of the trial.
* Signing the study consent form;
* Stable cART since at least 3 months (ie no recent drug change);
* HIV-RNA below 100 copies for at least 6 months;
* HDL-cholesterol \<1.29 mmol/l for men; \<1.42 mmol/l for women

Exclusion Criteria:

* Pregnancy or lactation;
* Congestive Heart Failure;
* Malignant Hypertension;
* Acute or chronic coronary artery diseases;
* Any known cardiac arrhythmias;
* Diabetes;
* Concomitant cancer, rheumatologic disease or inflammatory bowel diseases;
* Concomitant renal or hepatic disease:

  * Creatinine above 150 micromol/L
  * Transaminases above 5 times upper normal limit
  * Prothrombin time (Quick) value below 50%;
* Prior intolerance to niacin therapy (reported in a medical report);
* Cyclosporine, anti-inflammatory drugs (other than aspirin) or cytokine therapy in concomitant intake;
* Abnormal thyroid function;
* Excessive consumption of alcohol;
* Known severe lactose intolerance.
Uterocervical Angle in Patients With Preterm Premature Rupture of the Membranes

To evaluate the performance of uterocervical angle (UCA) in the prediction of labor timing in patients with preterm premature rupture of the membranes


Eligibility Criteria:
Inclusion Criteria:

* no previous systemic illnesses
* Preterm Premature Rupture of the Membranes

Exclusion Criteria:

* abnormal Pap smear
* previous cesarean section
* history of dilatation and curettage (D\&C)
* history of loop electrosurgical excision procedure (LEEP) and cervical conization
Office-Based Superior Laryngeal Nerve Block for Treatment of Neurogenic Cough

The purpose of this study is to evaluate if office-based injection of a local anesthetic/steroid combination at the area of one superior laryngeal nerve can decrease cough frequency and alleviate symptoms of chronic cough in patients with neurogenic cough.

Neurogenic cough is a chronic cough without a clear cause. It is thought to be related to irritation of a nerve that goes to the larynx (voice box). This can happen after a viral upper respiratory infection. Current treatment uses therapy or medications taken by mouth. Those medications can be sedating and not well tolerated. An alternative approach would be to perform an injection "nerve block", which is commonly done for other nerve disorders such as around the spine. This may help people with neurogenic cough also. We studied this recently in a small group of patients and found that patients had improvement in their cough symptoms (Simpson 2018). It would be helpful to study this in a larger group of patients using more methods of evaluating cough symptom severity.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Ability of patients to speak and understand English
* Ability for patients to consent for themselves
* Cough for 8 weeks or greater, with suspected sensory neuropathic etiology of the cough. Inclusion based on history of preceding upper respiratory infection or other symptoms suggestive of irritable larynx such as cough in response to temperature changes, odors, scents/perfumes, tickle, irritation in the throat/paralaryngeal region, or talking.
* Persistent cough despite treatment of ALL the major contributors of cough (items listed below would be done as part of a standard clinical workup for chronic cough and are not done specific to this study):

  * Reflux disease treatment with one of the following: failure of two months of PPIs OR negative pH study
  * Asthma: lack of response to at least one month of steroid inhaler/bronchodilator OR normal PFTs/negative methacholine challenge + negative CXR/CT
  * Upper airway cough syndrome/Allergic disease: lack of response to at least one month of antihistamines/decongestants/nasal steroids OR negative allergy testing (skin or serum) OR lack of response to at least one year of immunotherapy/allergy shots

Exclusion Criteria:

* Age less than 18 years
* Patients unable or unwilling to provide informed consent
* Known etiology to cough other than sensory neuropathy (e.g., reflux disease, asthma, allergic rhinitis, chronic obstructive pulmonary disease)
* Addition of new neuromodulators at the time of the injection. Patients who were already being treated with neuromodulators for their cough (e.g., gabapentin, amitriptyline) will not be excluded provided their dose remains constant.
* Nissen fundoplication within the last year
* Smoking history within last 5 years
* Allergy to bupivacaine or Kenalog-40
Efficacy and Safety of SPD465 in Adults With ADHD

The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects sleep and how the participants perceive their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of ADHD
* Baseline ADHD-RS-IV score \>= 24
* Non-pregnant females of childbearing potential must comply with contraceptive restrictions

Exclusion Criteria:

* Significantly underweight or morbidly obese
* Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders
* History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder
Impact of SGLT2 Inhibitors in Heart Transplant Recipients

The goal of this clinical trial is to test if SGLT2 inhibitors could prevent or delay the development of Cardiac Allograft Vasculopathy (CAV) post-heart transplantation (TxC). The main questions it aims to answer are:

Primary outcome: CAV, according to ISHLT grading system diagnosed by CCTA; Secondary outcomes: cardiovascular death, all-cause mortality, hospitalization, worsening glomerular filtration rate, fasting glucose, weight, and blood pressure.

Exploratory and safety outcomes: Rejection, hypoglycemia, urinary tract infection, hypovolemia, and limb amputation.

HYPOTHESIS The null hypothesis is that SGLT2 inhibitors do not reduce the incidence of CAV in transplanted patients.

The alternative hypothesis is that SGLT2 inhibitors reduce the incidence of CAV in transplanted patients.METHODOLOGY Study Design A randomized clinical trial of superiority with active control (2 arms), with central randomization and blinded evaluation of outcomes, to evaluate the efficacy and safety of adding dapagliflozin or empagliflozin 10 mg once daily to conventional post-TxC treatment compared with the treatment of isolated conventional post-TxC for 6-8 months.

Study Sample Sample: All adult patients undergoing a heart transplant between January 2017 and December 2023 at Hospital de Messejana.

Inclusion Criteria Included: Patients of both sexes, aged ≥ 18 years, who have undergone heart transplantation between January 2017 and December 2023 and are under the care of the Heart Transplant and Heart Failure Unit at Hospital de Messejana.


Eligibility Criteria:
Inclusion Criteria:

Patients of both sexes, aged ≥ 18 years, who have undergone heart transplantation between January 2017 and December 2023 and are under the care of the Heart Transplant and Heart Failure Unit at Hospital de Messejana.

Exclusion Criteria:

Patients who refuse to participate in the study, those with known hypersensitivity or intolerance to iSGLT2, individuals with type 1 diabetes mellitus, symptoms of hypotension, or systolic blood pressure below 80 mm Hg, an estimated glomerular filtration rate (eGFR) below 20 ml per minute per 1.73 m2 of body surface area, and pregnant women
Comparative Study Between the Effect of Diclofanic and Ketorolac in Post Tonsillectomy Pain Management

Compare between the analgesic efficacy of diclofenac sodium and ketorolac tromethamine in post-tonsillectomy pain management.and Compare between the effect of diclofenac sodium and ketorolac tromethamine on post-tonsillectomy bleeding

patients will be randomly allocated to two groups of 50 patients each Group (A): will receive intra-operative diclofenac sodium at dose of 0.3 mg/kg intravenously.

Group (B): will receive intra-operative ketorolac tromethamine at dose of 0.5 mg/kg intravenously.

Then the two groups will continue postoperatively on the same drug received intra-operative

I. Intra-operative data:

Bleeding score will be assessed by the surgeon at the end of the operation using the following Scale for bleeding assessment (0 = no bleeding, 1 = bleeding as usual, 2 = bleeding more than usual, 3 = profuse, 4 = excessive, and lastly 5 = excessive and continuous).

II. Early Post-operative data:

1. Post- tonsillectomy bleeding assessments;

   * Bleeding score will be recorded immediately postoperative and 3, 6, 12 and 24h postoperatively.
   * Hospital re-admission because of bleeding.
   * Re-operation because of bleeding.
2. Post- tonsillectomy pain assessments; Pain intensity will be assessed postoperatively by the verbal rating scale (VRS; 0 = no pain, 1 = mild pain, 2 = moderate pain, 3= severe pain, and lastly 4= excruciating pain). VRS assessment will be performed immediately postoperative and 3, 6, 12 and 24h postoperatively. Analgesia will be given if requested or if the VRS≥3. Patients in Group A will receive diclofenac sodium 0.3 mg/kg iv, while patients in Group B will receive ketorolac tromethamine 0.5 mg/kg.

The total consumption of analgesics used in each group in the first 24 h postoperative will be calculated and the time of the first request for analgesia will be recorded.

- Time needed to restore normal dietary habits.

IV. Late Post-operative data:

As aweekly follow up for 2 weeks :

1. bleeding tendency
2. Dysphagia.

   * Time needed to restore normal dietary habits

Eligibility Criteria:
Inclusion Criteria:

* Children scheduled for elective tonsillectomy\\adenotnsillectomy for chronic or recurrent tonsillitis and aged between 6 to 12 years

Exclusion Criteria:

* Known hypersensitivity to medication drugs.
* Coagulation disorders, thrombocytopenia or active bleeding for any cause.
* Bronchial asthma.
* Significant cardiac, renal, pulmonary, hepatic disease or peptic ulcer.
* The use of any analgesic medications within 24h preoperative or antiplatelet medication within the past 2 weeks.
Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery

The primary study objective is to compare the effectiveness of the combination of phacoemulsification with intraocular lens implant with ELIOS or competitor device in reducing IOP at 12 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects.
2. 40 years old or older.
3. Diagnosis of mild to moderate primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma:
4. Visually significant cataract eligible for phacoemulsification.

Exclusion Criteria:

1. All forms of angle closure glaucoma
2. Secondary glaucoma, including traumatic, neovascular, uveitic, lens-induced, steroid-induced, angle-recession, glaucoma associated with vascular disorders, and glaucoma associated with increased episcleral venous pressure
3. Congenital or developmental glaucoma
4. Prior incisional glaucoma surgery, intraocular surgery or ocular laser treatment of any type with the exception of selective laser trabeculoplasty (SLT) occurring a minimum of 6 months prior to the Screening visit