cyrilzakka/clinical-trials huggingface dataset:
S-ICD Electrode Registry

The subcutaneous implantable cardioverter defibrillator (S-ICD) is established in the prevention of sudden cardiac death, but recently a defect of the electrode's Sense-B component was reported in some patients. This lead to inadequate shocks due to noise. The cause and incidence of this defect are unknown. The manufacturer issued a warning regarding this defect and a possible premature depletion of the battery in some device. Independent data on the incidence of these issues is limited. Further data is needed to better understand the risk of these complications.

The S-ICD therapy is an established treatment for primary and secondary prevention of sudden cardiac death. Recently, a report was published about a previously described complication of the electrode, in which a defect of the so-called Sense-B component is reported in a few affected patients. The defect of this component of the electrode leads to electrode noise and subsequent inadequate shocks. The cause of the defect and the incidence are currently unknown. The manufacturer Boston Scientific has issued a warning and advisory.

In addition to this advisory regarding the electrode of the S-ICD, there is also an active warning from the manufacturer regarding the possible premature exhaustion of the S-ICD battery. This is caused by an error in the manufacturing process of approximately 40,000 devices produced in 2018. The manufacturer estimates the incidence of premature battery exhaustion to be 4-15% within 5 years. Independent data on the incidence of premature exhaustion of these devices were initially scarce. The investigators conducted a retrospective data query in 2021 to capture the incidence of battery exhaustion at that time. The incidence was 3.7% after 5 years. The average follow-up time was only 3 years. The incidence of premature exhaustion increased significantly after 3 years, so data with a longer follow-up period is urgently needed.

Given that these data already show that the incidence of premature exhaustion increases significantly after 3 years and the observation period in the retrospective data was on average slightly under 3 years, a further query of the existing clinical data on the battery as part of this register is also planned. This would allow for a more accurate estimate of the risk of premature battery depletion.

Eligibility Criteria:
Inclusion Criteria:

- status post S-ICD insertion

Exclusion Criteria:

- no available follow-up data beyond 2 weeks after insertion
Long Term Results of 450 Percutaneous Closures of PDA in a Single Center

Percutaneous closure is one of the methods used to treat, among other congenital heart disorder, Persistent Ductus Arteriosus (PDA) in children and adults. During the years 1998-2013 four hundred and fifty patients were catheterized in the department of pediatric cardiology and congenital heart diseases in Rambam health care campus, using various devices.

In this retrospective research, the investigators analyze data from patients' medical files, to estimate and define the correlation between the patients' demographic and morphologic data to the type and size of chosen closure device.

Aim of study:

To create an algorithm that can be used to choose the proper device for percutaneous closure of the PDA, based on the characteristics of the patient and the PDA type.

The investigators analyze the demographic characteristics of patients before the procedure (Age, gender, weight, height, co-morbidities etc.), the type and characteristics of PDA and the chosen device, success and failure rates of the procedure, and adverse effects.

The data is taken from patients' medical files - based on medical reports regarding physical examination, blood tests and imaging studies including cineangiograms and echo-doppler studies.

Eligibility Criteria:
Inclusion Criteria:

* All the patients that underwent percutaneous closure of PDA between January 1998 and august 2013 in the department of pediatric cardiology and congenital heart diseases in Rambam health care campus

Exclusion Criteria:

* None
RX-5902 Treatment of Subjects With Triple Negative Breast Cancer

The purpose of this Phase 2 portion of the study is to use the dose and schedule of RX-5902 identified in the phase 1 to treat subjects with triple negative breast cancer.

In this dose-finding, open-label, single-agent study of RX-5902, subjects will be treated for up to 6 cycles of therapy. RX-5902 will be administered orally daily for 3 weeks followed by 1 week of rest in each cycle. All subjects will be followed for at least 30 days after the last dose of study agent for safety.

Eligibility Criteria:
Inclusion Criteria:

* Male and female who are 18 yrs or older
* Histologically confirmed triple negative breast cancer that are refractory, intolerant, or ineligible to receive approved standard therapies
* Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
* Life expectancy of at least 3 months
* Able to swallow capsules
* Provide written informed consent

Exclusion Criteria:

* Primary brain tumor or active brain metastasis
* Not recovered to less than or equal to Grade 1 toxicities (except Grade 2 alopecia or neuropathy) associated with previous cancer therapies
* Any other cancer treatments within 2 weeks of planned study treatment
* History of any medical or psychiatric condition or addictive disorder, or lab abnormality that in the opinion of the investigator, may increase risks or may interfere with study participation or interpretation of study results
* History of clinically significant GI bleed, intestinal obstruction, or GI perforation within 6 months of study dose
* Uncontrolled diabetes
* History of long QT syndrome or clinically significant cardiac arrhythmias (except stable atrial fibrillation)
* Myocardial infarction within 6 months of study dose
* Active infection requiring IV antibiotics within 2 weeks of study dose
* History of Hepatitis B, C, or HIV
* Use of potent inhibitor or inducer of CYP3A4/3A5 within 14 days of planned study treatment or expected requirement for use of such a drug during study
* Use of a potent inhibitor or inducer of drug transporters or conjugating enzymes within 14 days prior to planned study treatment or expected requirement for use of such a drug during study
* Receiving other investigational agents or not yet completed 30 days since completion of an investigational study
* Pregnant, planning a pregnancy, or breast feeding
* Male or female not willing to use adequate contraceptive precautions during the study period. Females must either be surgically sterile, post-menopausal for 12 months, or use a contraceptive approved by sponsor.
* Unwilling or unable to provide written informed consent, comply with study requirements, or be available for follow-up assessments
Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women

Aim of this study was to observe

The study was adjusted in two parts:

PART 1 is a crossectional study in which the prevalance, risk factors and etiology of nocturia among postmenopausal women is assessed.

PART 2 is a cohort study observing the impact of 10 different hormonal substitution therapies on nocturia.


Eligibility Criteria:
Inclusion Criteria:

* Women with postmenopausal symptoms (hot flushes, atrophy, ..)
* All women were 'early' postmenopausal stages +1a,+1b or +1c as defined by the 'Stages of Reproductive Aging Workshop' (STRAW) criteria

Exclusion Criteria:

* Intake of HRT on the moment of inclusion
* women with thyroid dysfunction
* women using antihypertensive agents
* women with a history of psychiatric or neurological disorders
* women with a history of alcohol or drug addiction.
Intervention for Men Who Batter Women

It was realized a case study in a batterer intervention program, where 86 men accepted to participate. It was used the Centers for Disease Control and Prevention - Follow up questionnaire, adapted to be used in Brazil.

The intimate partner violence is one of the most common forms of violence. Although man is the main author of violence, it is essential include actions to help him in order to produce a more effective result, because it is believed that he is able to recognize and take responsibility for the violence, using different forms of express. However, these actions have difficulties in evaluating its results. These research aims to analyze the relapse of violence after participation in a batterer intervention program. The investigators realized a case study in a batterer intervention program in the city of Brasília, capital of Brazil, 167 men were invited and 86 accepted to participate of the research. It was used the Centers for Disease Control and Prevention - Follow up questionnaire, adapted to be used in Brazil. All the participants answered the same questionnaire, and the participant exclusion criteria was less or more than 3 months of participation at the program or committed other types of violence. The participants were recruited and interviewed by the investigators, during the year of 2015 (from March until December), in the Center for Assistance to Family and perpetrators of Domestic Violence (NAFAVD). The participants answered questions about socioeconomic characteristics, the relapse of violence, use of drugs, and about the batterer program. The benefit of participate of the study is help to improve the programs to prevent intimate partner violence, and public policy about this issue, and the risk is to remember something that happened during the interview, so the participants could stop the participate when they want.

Eligibility Criteria:
Inclusion Criteria:

* men who participate of the program for 3 months, because committed intimate partner violence

Exclusion Criteria:

* men with less or more than 3 months of participation at the program, or committed other types of violence
Music Distraction Strategy in Children Dental Care

Music plays an important role reassuring helping reduce anxiety. Anxiety can be an interference factor in promoting oral health for children with high levels of anxiety tend to have negative behavior at the dentist. High oxygen levels and heart and respiratory frequencies are associated with high levels of anxiety. The objective of this study was to test the use of music in decreased cardiac and respiratory frequency of treated patients listening to music and being treated without hearing music.

Feelings like anxiety can alter the levels of blood oxygenation from individuals in different situations, like during dental treatment. This cross over trial aimed to analyze the use of music as a distraction resource during children dental treatment, evaluating their cardiac and respiratory frequency. Thirty-four children took part in this study, 16 boys and 18 girls, from 4 to 6 years old, with no previous dental experience, who had two carious lesions on occlusal surfaces of molars, from the 2 municipalities of southeast Brasil. Children were selected through oral clinical exams, conducted in public schools. After parents signed a written consent; children were allocated in two groups: treatment with music (G1) and treatment without music (G2). Children acted as controls of themselves: the cross between groups allowed all children to be treated with and without music. Three dental visits were, scheduled in a weekly basis, the first for anamnesis and clinical examination; the second and third for the modified atraumatic restorative treatment (ARTm). The Mozart Symphony No 40 in G minor K550 was played in headphones. Cardiac and respiratory frequencies were obtained using a pulse oximeter, with the measures being taken in three moments: in the beginning of the treatment, during the intervention (use of a rotating device) and at the end of the treatment. Data were compiled and analyzed through the statistic software Statistical Analyse. The Wilcoxon test was used for inter and intra groups comparison (p\<0,050).

Music worked as a reassuring instrument during children dental treatment.

Eligibility Criteria:
Inclusion Criteria:

* Without children experience provided at the dentist
* Healthy children and without syndromes
* Children with normal hearing
* Children with two occlusal carious lesions with loss of enamel and dentin to 2/3 wherever possible to carry out the treatment technique Atraumatic Restorative adapted.

Exclusion Criteria:

* Children with syndromes
* Children without normal hearing
* Children thal not collaborated with the dentist
* Children with hospital and/or dental experience
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation

The research objective is to characterize the risk of a major adverse cardiovascular event (MACE) among new users of naldemedine versus new users of lubiprostone and new users of naloxegol as comparator opioid induced constipation (OIC) medications.

This is a prevalent new user cohort study conducted using multiple databases linkable to medical records and the National Death Index (NDI) to assess MACE risk among adult patients with chronic non-cancer pain receiving naldemedine or a comparator OIC medication. The uptake of naldemedine and comparator OIC medications will be monitored for each database annually until a sufficient number of patients to support the comparative analyses in the safety assessment phase is accrued. The safety assessment phase will commence at the conclusion of the monitoring phase.

Eligibility Criteria:
Inclusion Criteria:

* At least one dispensing of naldemedine or lubiprostone or naloxegol without prior use in the database of either medication (index date)
* At least two dispensings of opioids within six months prior to and including the index date, with at least a combined 31 cumulative days supply
* At least 18 years of age or older on the index date
* At least six months of continuous health plan coverage that includes medical and pharmacy benefits prior to and including the index date

Exclusion Criteria:

* Any acute MACE (non-fatal MI or non-fatal stroke) within six months before or on the index date
* Any cancer treatment or cancer pain diagnosis within six months before or on the index date
* Prior use of methylnaltrexone, alvimopan or naloxegol within six months before or on the index date
Portal Hypertension in Non-alcoholic Fatty Liver Disease: Association With Cardiovascular Risk and Identification of Non-invasive Biomarkers (THESIS)

Non-alcoholic fatty liver disease (NAFLD) is the most frequent cause of chronic liver disease in our environment. Preliminary data suggest that portal hypertension may exist in the initial phases of NAFLD due to mechanisms that have not yet been elucidated. The clinical relevance of its development in these initial phases is unknown, while in more advanced phases new data are required to confirm the close relationship between portal hypertension and the risk of decompensation described in other etiologies. Likewise, the influence of fibrosis and portal hypertension on the cardiovascular risk of patients with NAFLD is unknown. The aim of the present multicenter project is to characterize the presence of portal hypertension and the mechanisms involved in its development in the different stages of NAFLD, to assess the association between the degree of portal hypertension and the development of portal hypertension-related complications, to know the early cardiovascular risk in the different stages of the disease, and to identify noninvasive biomarkers of the presence and severity of portal hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* Clinical suspicion of NAFLD.
* Severe (controlled attenuation parameter (CAP) ≥330 dB/m) or mild steatosis (CAP: 298-317 dB / m), and FibroScan® grade 2 fibrosis (M probe: 7-9 kpa; XL probe: 5-7.5 kpa) in patients with grade 1 or 2 obesity and insulin resistance (HOMA index\> 2.6) or diabetes mellitus.
* Fibroscan® grade 3 or 4 fibrosis (M probe:\> 9 kpa; XL probe:\> 7.5 kpa).
* Decompensated NAFLD cirrhosis (i.e. development of ascites, variceal hemorrhage, and/or hepatic encephalopathy) up to Child B (9 points).
* Signature of informed consent.

Exclusion Criteria:

* Concomitant liver disease and patients with acute on chronic liver failure.
* Excessive alcohol consumption (≥ 30 grams per day in men and ≥ 20 grams per day in women).
* Comorbidities (HIV infection, connective diseases, prothrombotic disorders) and/or drugs (didanosine, azathioprine, oxaliplatin) associated with the presence of idiopathic non-cirrhotic portal hypertension.
* Clinical history of cardiovascular disease (ischemic cardiomyopathy, atrial fibrillation, valvular defects, severe arterial hypertension, previous hospitalizations secondary to heart failure, cerebrovascular disease).
* Severe renal impairment, defined by creatinine clearance \<15 ml/min/1.73m2.
* Any previous or current thrombosis in any venous territory.
* Uncontrolled psychiatric illness
* Contraindication to liver biopsy or any of the complementary tests included in the project.
* Hepatocellular carcinoma that does not meet Milan criteria.
* Pregnancy or breastfeeding
* Significant comorbidities that entail a functional limitation and/or a life expectancy of less than 12 months.
Microflare Protocol in Poor Responders

The effect of use of the microflare down regulation protocol on the outcome of the IVF/ICSI cycles in poor responders

The microflare as a method of down regulation protocol can be used to prepare the females suffering from poor ovarian reserve to undergo IVF/ICSI cycles. In this study we are trying to outline its effect on the clinical pregnancy rate as a main primary outcome, and to compare its use with the addition of growth hormone to the same protocol.

Eligibility Criteria:
Inclusion Criteria:

* females fulfilling the criteria of the ESHRE consensus 2011:

At least two of the following three features must be present:

(i) Advanced maternal age (≥40 years) or any other risk factor for POR; (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol); (iii) An abnormal ovarian reserve test (i.e. AFC ,5-7 follicles or AMH ,0.5 -1.1 ng/ml).

Exclusion Criteria:

* women who suffer from any other cause of infertility other than poor ovarian reserve
* refusal of the patient to consent for using her data in the study.
A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjects

This is a Phase 1, open-label, randomized, parallel design study to evaluate the PK and safety/tolerability of CC 90001 in Japanese and Caucasian healthy adult subjects.

The study will consist of multiple oral doses of IP (QD x 7 days) in 3 planned dose level cohorts of 100 mg, 200 mg, and 400 mg. Each cohort will have 20 subjects (10 Japanese subjects and 10 Caucasian subjects, with a minimum of 8 subjects to complete in each group) who will receive IP (see below).


Eligibility Criteria:
Inclusion Criteria:

Subjects must satisfy all of the following criteria to be enrolled in the study:

1. Healthy, adult, male and female subjects.
2. Japanese subjects who were born in Japan and not have lived outside of Japan for more than 10 years, have both parents and grandparents of Japanese origin, and have not significantly modified their diets since leaving Japan.
3. Caucasian subjects who have age and body mass index matched with Japanese subjects.

Exclusion Criteria:

1. Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study or place the subject at unacceptable risk if he/she were to participate in the study.
2. Use of any prescribed systemic or topical medication within 30 days of the first dose administration.
3. Has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion.
Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures

The goal of this study is to prove that intramuscular midazolam is more effective than buccal midazolam in cessation of seizure activity with comparable side effects.

Both buccal and intramuscular midazolam have been used to control seizures with variable succuss rates and side effects.

In this study the investigators are going to assign patient randomly to receive either buccal or intramuscular midazolam. Then will compare both efficacy and side effect in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Children 6 month to 14 years who will be presented to the pediatric emergency or attended by emergency medical service who have active seizure and had no intravenous access would be eligible for the study.

Exclusion Criteria:

* Cardiac arrest
* Head trauma
* Drowning
* Congenital heart disease
* Inborn errors of metabolism
* Electrolyte imbalance (hypocalcaemia, hyponatremia and hypoglycemia)
* Hemodynamic instability
* Allergy to benzodiazepines
* Focal seizures with preserved level of consciousness
Trial of Rifaximin in the Treatment of Tropical Enteropathy

The purpose of this study is to determine whether rifaximin is effective in the treatment of tropical enteropathy in a population of African children at high risk for this disease.


Eligibility Criteria:
Inclusion Criteria:

* live in single village

Exclusion Criteria:

* acutely malnourished
* acutely ill
* chronic disease