cyrilzakka/clinical-trials huggingface dataset:
Angiotensin Converting Enzyme Inhibitors & Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization

The purpose of this study is to determine if patients should stop taking their angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) around the time of their angiogram in order to prevent contrast induced nephropathy (CIN).

There are approximately 4000 coronary angiograms performed annually at the Hamilton General Hospital to diagnose and treat coronary artery disease. Many of the patients undergoing this procedure have mild kidney disease. Exposure to the contrast dye used in the procedure puts them at risk of worsening kidney function, a condition called contrast induced nephropathy (CIN) which is associated with significant morbidity and mortality. Many of these patients are also on an antihypertensive drug called an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). Their effects on the kidney during contrast exposure are not known. Our understanding of how the drug works leads us to believe that the use of these drugs around the time of contrast exposure may have detrimental effects on the kidney.

The purpose of this study is to determine if patients should continue taking or stop taking their ACE inhibitor or ARB around the time of their angiogram in order to prevent CIN.

Patients undergoing an elective coronary angiogram with mild kidney disease and currently taking an ACE inhibitor or ARB will be randomly divided into two groups. One group will continue taking their ACE inhibitor or ARB while the other group will stop taking their ACE inhibitor or ARB for at least 24 hours before and will resume their ACE inhibitor or ARB 48 to 96 hours after their angiogram. In both groups, kidney function will be assessed by means of a simple blood test both before and 48 to 96 hours after the angiogram. By doing this, we can determine which group had more kidney damage and which group had less kidney damage from the contrast exposure. We suspect that patients who do not take their ACE inhibitor around the time of their angiogram will have less kidney damage. All patients will receive the accepted measures for preventing kidney disease from contrast dye exposure.

CIN is associated with significant morbidity and mortality. If the use of ACEIs during coronary angiograms are associated with an increased risk of CIN, then these patients may benefit from holding their ACEI around the time of their procedure potentially improving their outcomes. This is a low cost intervention that could potentially change practice, reduce morbidity, save lives and pave the way for larger clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for Angiography in \>= 24hrs from enrolment
* Documented Cr \>= 150 within 3 months before cardiac catheterization AND/OR documented Cr \>= 132umol/L within 1 week Before Cardiac Catheterization
* Currently Taking an ACE Inhibitor

Exclusion Criteria:

* Patients with end stage renal disease (for example, patient on dialysis)
* Emergency Cardiac Catheterization with insufficient time to hold the ACEI
* Acute Pulmonary Edema
Non-caloric Sweeteners Levels in Breast Milk and Newborn's Blood and Effect on Microbiota's Composition.

This study evaluates the presence and quantity of non-caloric sweeteners in newborns umbilical cord blood, and in their mother's breast milk at delivery, at 2 months, 4 months and 6 months of age. Microbiota composition will be evaluated in milk and in feces of both mother and child.

The consumption of non-caloric sweeteners (ENC) is increasingly common in our country due to its wide use in all types of food and beverages, even those not labeled as "diet". Despite its widespread use and being an alternative to the consumption of sugars, several studies have shown that frequent ENC users are also at risk of excessive weight gain, type II diabetes, and cardiovascular diseases. In addition to this, the consumption of ENC in the early stages of life may predispose to the development of metabolic disorders later in life.The ENC have been shown to have effects on the health of those who consume them, causing metabolic disorders, weight gain and changes in the microbiota. The newborns, in whom gut microbiota is in the process of being established, influenced by the vaginal and intestinal microbiota of the mother, as well as by the mother's milk, are a vulnerable population in whom the effect of ENC consumption has not been investigated. This makes it relevant to study the prevalence of ENC in breast milk and umbilical cord blood of their newborns and to evaluate the composition of the intestinal and milk microbiota in order to identify changes attributable to the consumption of ENC.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years old
* Women in labor
* Consent to participate in the study

Exclusion Criteria:

* Pre-term delivery (\<30 weeks)
* Metabolic diseases (insulin resistance, diabetes, gestational diabetes)
* Hypertension
* Thyroid disease
* Cancer
Exploring the Role of Adipocyte Fatty Acid Binding Protein in the Association of Obstructive Sleep Apnea and Metabolic Dysfunction

Adipocyte fatty acid binding protein (A-FABP) is a member of the FABP super family, is abundant in adipocytes and macrophages. Regulatory functions of A-FABP in lipid and glucose metabolism have been described, and it is suggested to play an important role in the pathogenesis of metabolic syndrome.We hypothesize that obstructive sleep apnea (OSA) may upregulate A-FABP production and thus causally contribute to metabolic dysfunction. Our group has recently demonstrated that A-FABP, expressed and secreted from adipocytes, is present in the blood stream .The levels of A-FABP correlated with various metabolic variates in the metabolic syndrome. Furthermore, we have obtained novel data in men with a range of sleep disordered breathing showed that the duration of oxygen desaturation correlated with circulating levels of A-FABP, independent of age and waist/body mass index. The current proposal aims to pursue this finding and further explore the role of A-FABP in the association of OSA and metabolic dysfunction.

We hypothesize that there are changes in circulating A-FABP level which can be mitigated by effective treatment of OSA.

The aim is to investigate the effect of CPAP treatment of OSA on circulating A-FABP, and other metabolic biomarkers and cardiovascular parameters

Eligibility Criteria:
Inclusion Criteria:

* Subjects between 18 - 65 years old
* Able to understand and give informed written consent

Exclusion Criteria:

* BMI \> 35 kg/m2, and features of obesity hypoventilation syndrome
* known diabetes mellitus or hyperlipidemia on treatment
* known cardiovascular disease except hypertension stable on treatment
* unstable medical illness
* need for starting treatment for OSA or other medical conditions immediately
Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With VL

This is a phase II/III open, comparative dose trial to find the lowest single dose of AmBisome for the treatment of primary, symptomatic visceral leishmaniasis(VL), in HIV negative patients. In this trial, the minimum effective dose will be determined in a sequential step, dose escalation design, which minimises the number of patients exposed to low, potentially inadequate doses and provides contemporaneous comparative data against the manufacturer's recommended dose schedule in this indication.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults and children aged 4 years or older with no upper age limit (in accordance with manufacturer's instructions)
* Acute, symptomatic, VL proven by parasitological examination of splenic aspirate (or bone marrow aspirate) with initial parasite index of at least 2+
* Haemoglobin \>4g/dL
* Fever for more than 2 weeks
* Living within reachable distance of the trial site to enable attendance for follow-up visits
* Written informed consent to participate (for children, by parent or guardian)
* HIV negative status

Exclusion Criteria:

* Patients 'in extremis' with signs/symptoms indicative of severe VL
* Patients who have received any anti-leishmanial treatment within the last 6 months
* Patients who have received any investigational (unlicensed) drugs during 6 months before recruitment
* Known underlying chronic disease, such as severe cardiac, pulmonary, renal, or hepatic impairment.
* Renal function tests (serum creatinine) outside the normal range
* Liver function tests more than 3 times the normal range at study entry
* Platelet count less than 40,000/ mm3
* Known alcohol abuse
* Pregnancy or lactation
* Concomitant acute drug usage for malaria and bacterial infection, pneumonia within last 7 days
* Known hypersensitivity to AmBisome or amphotericin B
* Any other condition which may invalidate the trial
An Adherence Study of Antipsychotic Medication in Outpatients With Schizophrenia or Schizoaffective Disorder

This prospective study examines the differences among several measures of adherence to antipsychotic medications in outpatients with schizophrenia. Adherence is assessed by using self-report, physician report, pill count and electronic monitoring. The rates of adherence/non-adherence with various tools will be manifested. The association between antipsychotic adherence/non-adherence and various clinical status, including psychotic symptoms, depressive symptoms, side effects, neurocognitive function and insight are analyzed. Participants are assessed at baseline during a visit to their outpatient clinic and followed up for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent
2. Male or female, aged from 20 to 65 years
3. Clinician rendered diagnosis of schizophrenia or schizoaffective disorder documented by a checklist of Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) criteria
4. Currently taking a single oral antipsychotic (e.g., Quetiapine, Risperidone, Olanzapine, or Amisulpride).
5. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropine (HCG) test at enrolment
6. Outpatient status, with psychiatric hospitalization or psychiatric emergency room visit within the previous 2 years and no hospitalizations within 3 months
7. mild to moderate symptom checked by CGI-S (less than score 4)
8. Able to understand and comply with the requirements of the study

Exclusion Criteria:

1. Any DSM-IV Axis I disorder not defined in the inclusion criteria
2. Presence of a co-morbid diagnosis that might influence outcome measures (e.g., mental retardation)
3. Alcohol or substance dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
4. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
5. Pregnancy or lactation
6. Evidence of hypersensitivity to Quetiapine or other antipsychotics used in the study
7. Use of any cytochrome P450 inhibitors or inducers in the 14 days preceding enrolment
8. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
9. use of pillbox
10. Treatment with Clozapine (because of its unique monitoring guidelines)
11. Administration of electroconvulsive therapy (ECT) in the last 6 months
12. Unstable or inadequately treated medical condition such as heart, liver, kidney, or lung disease, or a seizure disorder
13. Involvement in the planning and conduct of the other study.
14. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements.
Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide

The study will evaluate the safety and tolerability, optimal biologic dose, and pharmacokinetics of eltrombopag for patients with advanced sarcoma who have a low platelet count and are receiving ADRIAMYCIN and ifosfamide (AI) chemotherapy.


Eligibility Criteria:
Inclusion criteria:

* Adult subjects, 18 years or older
* Adequate liver and kidney function
* Prior history of ≥grade 2 thrombocytopenia (platelet nadir ≤ 75,000/microliters)
* Ability to ingest and retain oral medication
* Practice acceptable birth control
* Ability to understand and follow study requirements
* Life expectancy of at least 3 months

Exclusion criteria:

* History of platelet disorders, dysfunction, or a bleeding disorder
* Anti-coagulant used within 2 weeks prior to study start
* Females who are lactating or expecting
* History of thromboembolic events or drug induced thrombocytopenia
* History of central nervous system, brain and/or leptomeningeal metastases
* Prior surgery within 2 weeks or radiotherapy within 4 weeks of study start
* Pre-existing cardiac disease
Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO

The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS) patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).

This study will evaluate patient-reported outcomes for adults initiating telotristat ethyl (XERMELO) for carcinoid syndrome diarrhea (CSD) not adequately controlled by somatostatin analogs in US clinical practice. The primary objective is satisfaction with overall CS symptom control 6 months after starting XERMELO. Secondary objectives will evaluate satisfaction with control of CSD and flushing, CS symptoms, work productivity and activity impairment, SSA use, and weight. This study will provide real-world patient-reported outcomes in CS with XERMELO treatment for at least 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult, ≥18 years of age at the time of informed consent
* A new, valid prescription for XERMELO
* Initiating XERMELO for the treatment of carcinoid syndrome
* Able and willing to provide informed consent prior to participation in the study

Exclusion Criteria:

* Unable to understand and read English
* Unable to access the internet
* Prior exposure to XERMELO
Factors Associated With Physical Inactivity Among Adolescents

Despite the acknowledgment that physical activity is important for health, there are still few population-based or school-based studies that uses the current physical activity guidelines for adolescents.

Physical inactivity was defined a less than 300 min/w of moderate to vigorous-intensity physical activity practice.

Previous research has shown very high prevalence rates of physically inactive adolescents and a strong association with demographic, socioeconomic and biological factors.

Based on this information, the investigators are elaborating a systematic review of literature to obtain and provide more accurate information in this context.

The objectives of this study were to (i) review extant literature on the prevalence of physical inactivity (PI) in adolescents of both sex (10-18 years old); (ii) compare its prevalence between developed and developing countries.

The search was carried out using online databases (Biomed Central, CINAHL, EMBASE, ERIC, MEDLINE, PsycInfo, Scopus, SPORTDiscus), references cited by retrieved articles and by contact with the authors, considering articles published from the establishment of the databanks until April 29th, 2010.

Eligibility Criteria:
Inclusion Criteria:

* Cross-sectional studies.
* Original studies showed that physical inactivity is evaluated through a questionnaire.
* Studies which ranked 300\> inactivity min/wk.

Exclusion Criteria:

* Studies did not assess physical inactivity through a questionnaire.
* Studies in which the participants were only overweight/obese, diabetics or suffering from another disease.
Evaluation of Response to Two Schedules of Capecitabine in Patients With Metastatic Breast Cancer

The purpose of this study is to compare the efficacy of a novel schedule of an oral anticancer drug, capecitabine, in patients with metastatic breast cancer.

Mathematical models have predicted that 7 days of capecitabine followed by 7 days of rest is an optimal dosing schedule for this drug and previous studies done al Memorial Sloan Kettering Cancer Center support the tolerability of this scheme.

This definitive, randomized trial comparing the efficacy of the new dosage with the conventional dosing schedule in patients with metastatic breast cancer is necessary and we hypothesize it will be superior in terms of efficacy.

Dosing schedules based on mathematical predictions for optimal drug delivery based on efficacy rather than toxicity could facilitate more rapid and economical drug development. This trial is a proof of principle trial of the highest priority.


Eligibility Criteria:
Inclusion Criteria:

* 1 Subject Inclusion Criteria

  * Informed consent has been obtained.
  * Metastatic breast cancer.
  * Measurable or non-measurable disease per RECIST criteria.
  * Pathologic confirmation of breast cancer.
  * No limit to the number of prior chemotherapy regimens permitted for metastatic disease.
  * At least 3 weeks since prior chemotherapy. Patients should have recovered from all acute toxicity from such therapy (excluding alopecia).
  * Age ≥18.
  * ECOG 0-2
  * Absolute Neutrophil Count (ANC )≥1.0; hemoglobin ≥9, platelets

    ≥75.000
  * AST, ALT and Alkaline phosphatase \<2.5x upper limit of normal (or \<5x upper limit of normal in the case of liver metastases). Total bilirubin \<1.5x upper limit of normal.
  * Estimated creatinine clearance \>50ml/min.
  * If female of childbearing potential, pregnancy test is negative and the patient agrees to use an effective method to avoid pregnancy during the study.

Exclusion Criteria:

* HER2 over-expression and/or amplification as determined by immunohistochemistry (3+) or FISH (\>2.0).

  * No prior fluoropyrimidine in the metastatic setting. Adjuvant fluoropyrimidine is permitted if \>12 months have elapsed since treatment.
  * No restriction for prior hormonal therapy.
  * GI malabsorption syndrome which could impair oral drug absorption.
  * Concurrent use of warfarin is discouraged as drug interactions may make management of INR more difficult.
  * Central nervous system metastases are permitted if previously treated or clinically stable for at least 3 months.
  * Pregnant or nursing patients.
  * Life expectancy \<3 months.
Prevalence of Self-medication for Dental Conditions by Parents for Their Children

To evaluate prevalence of self-medication for dental conditions by parents for their children.

Self-medications practices.

According to the World Health Organization, self-medication is the act of medicating oneself, either on their own initiative or on the advice of a close person, to treat self-recognized conditions or symptoms without supervision by a healthcare professional.

The growth and dissemination of self-medication practice represents a serious global public health issue, with increased risks of adverse drug reactions, non-beneficial drug interactions, drug abuse, and the emergence of drug-resistant pathogens.

Parents are the primary caregivers to whom children report their symptoms. But due to the presence of economic and time constraints, some parents seek the practice of self-medication for their children . However, children have a growing body reacting differently to the drugs (need of dose adjustment, choice of the proper route of administration and the need of taking in consideration the pharmacokinetics and pharmacodynamics particularities of medicines) and therefore the inappropriate and unguided use of medications may lead to fatal complications.

Eligibility Criteria:
Inclusion Criteria:

* Parents of healthy children up to 10 years.
* Parents who accept to participate in the study

Exclusion Criteria:

* Guardians other than parents (child's father or mother).
Influence of Short-term Vojta Therapy on the Gait in Healthy Adult Subjects.

The patterns of reflex locomotion described by Vojta contain all the basic patterns necessary for gait, which can be observed as partial patterns during normal postural ontogenesis in the first year of life. These patterns are triggered throughout life regardless of age, so they can be activated both in healthy subjects and in the presence of neurological pathology in adult patients.

In reflex locomotion, there is a coordinated and rhythmic activation of the entire skeletal muscles and different circuits of the central nervous system are stimulated. The motor reactions that are triggered regularly and cyclically due to pressure stimuli, from certain starting positions, are completely reproducible and as often as desired, even in the newborn child.

All the movements that appear in the development of the human being in grasping, turning, crawling, standing up and walking, are therefore visibly stimulated. They are, according to Prof. Vojta, present even in children of a developmental stage, in which they do not spontaneously yet possess these capacities.

Through the therapeutic application of reflex locomotion, those muscular functions used unconsciously and necessary for spontaneous daily motor skills are activated in the patient, especially in the spine, but also in the arms and legs, hands and feet and in the face.

Eligibility Criteria:
Inclusion Criteria:

* To be over 18 years old.

Exclusion Criteria:

* Present limitations or permanent or temporary injuries to the locomotor system.
Respiratory Drive Response in COPD Patients During Exercise With Non Invasive Ventilation (NIV).

A constant load exercise during 10 minutes will be performed in a group of Chronic Obstructive Pulmonary Disease patients, in a basal condition (spontaneous breathing); under noninvasive mask ventilation and with high flow nasal cannula. With the aim of reducing dyspnea, increasing exercise tolerance, and unload respiratory muscles, three exercises will be compared in terms of use of respiratory muscles and neural drive measured with paraesternal electromyography.

Exercise in chronic obstructive pulmonary disease is limited by dynamic hyperinflation and respiratory muscle overloadleading to severe dyspnea. During exercise, the increase in neural respiratory drive is notable to match ventilatory demand, correlated with breathlessness. Non-Invasive Ventilation may improve neural respiratory drive uncoupling and exercise tolerance. The aim of this study will be prove if Non-Invasive Ventilation and High flow nasal cannula during exercise reduces neural respiratory drive and improves dyspnea, measured with paraesternal electromyography

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe COPD or cystic fibrosis (with an obstructive pattern and air trapping) on the waiting list for a lung transplant, assessed by the Lung Transplant Unit of the 12 de Octubre University Hospital.
* Diagnostic criteria for COPD according to the GOLD and residual volume greater than 120% of theoretical
* Evidence of developing dynamic air trapping by analyzing flow / volume curves during physical exercise.
* Patients already adapted to home noninvasive mechanical ventilation (NIV) waiting for transplantation.

Exclusion Criteria:

* Presence of comorbidities that limit the patient's physical effort capacity (uncontrolled ischemic heart disease, severe pulmonary hypertension, neuromuscular disease).
* Refusal of treatment with NIV, or inclusion in the study.
* Inability to perform the proposed exercise in basal conditions and with ventilation.