cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Rate Response Performance in Pacemaker Patients With an Indication of Sinus Node Dysfunction

Providing ideal rate response to patients should improve their quality of life and ability to execute activities of daily living.

Medtronic pacemakers provide rate response pacing by utilizing dual zone programming to specify an "activities of daily living" (ADL) response rate and an "exertion" response rate. There is much data to support the target heart rate for an exercise response but the data to support the programming of the ADL rate is lacking.

Medtronic pacemakers provide rate response pacing by utilizing dual zone programming to specify an "activities of daily living" (ADL) response rate and an "exertion" response rate. There is much data to support the target heart rate for an exercise response but the data to support the programming of the ADL rate is lacking.

Unpublished Holter data from our center indicates that the ADL rate for most patients in our practice is between 50-70bpm rather than 95bpm. Moreover, this increased ADL rate may impact diastolic filling times and adversely impact cardiac output.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hypertension
* Sinus node dysfunction
* New implantation of a dual chamber pacemaker due to symptomatic sinus dysfunction or chronotropic incompetence defined as exercise heart rate less than 100 beats per minute

Exclusion Criteria:

* Second or Third degree AV block
* Age less than 60 or greater than 95 years
* EF less than 45%
* Patients that are not ambulatory
* Persistent atrial fibrillation (atrial fibrillation lasting greater than 7 days)
* Permanent atrial fibrillation (atrial fibrillation lasting great than 1 year)
Study Evaluating Genotypes Using Lucentis

The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms

Treatment naive exudative AMD patients will receive Lucentis treatment as standard of care, and followed monthly for 12 months. Standard ophthalmologic exams will be performed, along with ETDRS visual acuity and optical coherence tomography (OCT). A blood sample will be obtained for DNA analysis. The primary outcome measure is change in visual acuity at 4 months after initial Lucentis treatment. Secondary outcomes are change in visual acuity and retinal thickness at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Treatment naive AMD patients;
* At least 50 years of age;
* Visual acuity between 20/40 and 20/320

Exclusion Criteria:

* Pregnancy;
* Prior enrollment in a ranibizumab clinical trial;
* Previous therapy in either eye for AMD;
* Concurrent eye disease that could compromise visual acuity
Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopia

Presbyopia is a condition in which the eye exhibits a diminished ability to focus on near objects with increasing age. This study will assess the safety and exploratory efficacy of AGN-190584 is in treating participants with pseudophakic presbyopia.

AGN-190584 is approved (in the United States) for use in adults with presbyopia (including those who are pseudophakic) and this study is being conducted to better understand the safety and efficacy in the pseudophakic presbyopia population. This study is double-masked meaning that neither the participants nor the study doctors will know who will be given AGN-190584 and who will be given vehicle (does not contain treatment drug). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to vehicle. Approximately 150 participants aged 40-80 years with pseudophakic presbyopia will be enrolled in approximately 30 sites in the US.

Participants will receive eye drops of AGN-190584 or vehicle once daily in the morning in each eye for 14 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study. The effect of the treatment will be evaluated by medical assessments, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* History of bilateral pseudophakia with monofocal intraocular lenses corrected for distance (noncomplicated cataract surgery), with identifiable intraocular lens type/brand, at least 3 months after surgery (prior to baseline), and be in stable condition.
* If a participant has had neodymium-doped yttrium aluminum garnet (Nd:YAG) laser capsulotomy, it needs to be done bilaterally at least 1 month prior to baseline.
* Subjective complaints of poor near vision that impacts activities of daily living, as defined by at least a moderate impact (score \>= 3) on at least 1 question on 25-Item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) Questions 5 to 7 in the main questionnaire or Near Vision Subscale, Questions A3 to A5 in the Appendix of Optional Additional Questions at the screening visit.
* Best distance correction at screening in the range of spherical -1.50 D to +1.00 D inclusively and cylinder \<= ±2.00 D with photopic high contrast binocular corrected distance visual acuity (CDVA) of 20/25 or better at the screening and baseline visits.
* Mesopic, high contrast binocular distance-corrected near visual acuity (DCNVA) no better than 20/40 (J3) at screening and baseline visits.

Exclusion Criteria:

- Presence of any ocular condition that, in the opinion of the investigator, could affect the safety of the participant or interpretation of efficacy parameters (e.g., uveitis, acute iritis, retinal detachment or retinal tear).
Study of ORL-1B in Patients With Biotinidase Deficiency

An Open-label, Single-arm, Phase 2 Study of Biotin in Patients With Biotinidase Deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of biotinidase deficiency.
* Less than 18 years old.

Exclusion Criteria:

* Diagnosis of any other disease that is not a manifestation of biotinidase deficiency.
Alpha Lipoic Acid in Pediatrics on Hemodialysis

The goal of this clinical trial is to test alpha lipoic acid in children undergoing hemodialysis. The main questions it aims to answer are:

* Will the use of alpha lipoic acid lower cardiovascular events in that population?
* Is the incidence of those cardiovascular events linked to the oxidative stress and endothelial dysfunction in that population?
* Will the drug cause side effects?

Participants will:

* take either one dose daily of 600mg tablet Alpha lipoic acid orally or a look-alike tablet containing no drug.
* be monitored for the occurrence of cardiovascular events (stroke, angina, etc.)
* be monitored for the occurrence of side effects
* give blood samples for testing serum levels of E-selectin biomarker and superoxide dismutase enzyme
* undergo clinical examinations (Echocardiogram, Duplex ultrasonography, Intima-Media-Thickness) Researchers will compare between the group taking alpha lipoic acid and the group taking the look-alike tablet.

A Double-Blinded, Paralleled, Randomized, Placebo-Controlled Clinical Trial will be conducted at the Pediatric Nephrology and Dialysis Unit, Children's Hospital, Ain Shams University, Cairo, Egypt to detect the efficacy of alpha lipoic acid in reducing cardiovascular events by reducing oxidative stress-mediated endothelial dysfunction in pediatric population on regular hemodialysis by assessment of:

1. E-selectin as an Endothelial biomarker
2. SOD as an Oxidative stress biomarker
3. Indicators of CVS dysfunction by;

   * Duplex ultrasonography
   * Echocardiogram with stress on Ejection Fraction
   * Intimal medial thickness
4. Occurrence of CVS events

Eligibility Criteria:
Inclusion Criteria:

* Pediatric participants admitted to Pediatric Hemodialysis Unit for regular hemodialysis.
* The ability to swallow capsules will be enrolled in the study.

Exclusion Criteria:

* Participants who suffered from severe congestive heart failure
* Participants suffering from inflammatory diseases or other diseases that may increase oxidative stress.
* Participants taking supplements that decrease oxidative stress or inflammatory markers
* Participants with hypersensitivity to alpha lipoic acid
* Participants who are non-compliant.
Factors Affecting the Prognosis of Early Ovarian Cancer

To elucidate factors affecting survival of early stage ovarian cancer

To analyze factors affecting survival of early ovarian cancer, such as cell type, cell grade, intraoperative rupture, and laparoscopy vs. laparotomy, etc.

Eligibility Criteria:
Inclusion Criteria:

* early stage ovarian cancer

Exclusion Criteria:

* Nil.
LUS and Consequences of High FiO2 in Children

The purpose of this study is

1. to evaluate effect of high FiO2 on the development of intraoperative atelectasis in mechanically ventilated children using LUS.
2. to investigate the correlation between lung consolidation score and patient clinical variables including pulmonary mechanics, Sao2%, ABG, and perioperative respiratory complications.

The WHO and United States centers for disease control and prevention (CDC) recently recommended the administration of 80% inspired oxygen fraction (Fio2) during and immediately after surgery performed with general anesthesia and endotracheal intubation.

The recommendation was based on some data suggesting that intra-operative high Fio2 reduces incidence of surgical site infections.

The dilemma of applying high or low perioperative FiO2 arises in daily practice of pediatric anesthesia because children are at increased risk of developing hypoxemia due to their physiological characteristics including smaller functional residual capacity and increased metabolic requirement compared with adult.

However, considering that atelectasis occurs in most pediatric patients undergoing general anesthesia, it is important to titrate perioperative level of FiO2 to minimize the risk of developing atelectasis and hypoxemia.

The use of FiO2 80% at induction and emergence, whilst limiting FiO2 to 35% during maintenance of anesthesia, may prevent the occurrence of atelectasis and ensure sufficient oxygenation.

Conversely, the use of FiO2 100% at induction and emergence, which is reduced to FiO2 80% during maintenance of anesthesia, may increase the margin of safety to avoid hypoxemia.

In children, the pulmonary consequences of using high FiO2 during general anesthesia have not been fully characterized over the early perioperative period. LUS has shown reliable sensitivity and specificity for diagnosis of anesthesia-induced atelectasis in children \[7\]. It can identify children needing a recruitment maneuver to re expand their lung and help optimize ventilator treatment during anesthesia.

Our hypothesis is that clinical data are necessary to validate the lung sonographic findings of atelectasis and negative consequences of administrating high perioperative oxygen concentration.

Eligibility Criteria:
Inclusion criteria:

* Age of 1-6 years.
* ASA physical status (I-II).
* Endotracheal intubation and mechanical ventilation.
* Elective non-abdominal and non-thoracic surgery
* lasting for more than 2 hours.

Exclusion criteria:

* ASA classification more than II
* Thoracic or abdominal surgery.
* pre-existing lung disease.
* Pre-operative chest infection or abdominal chest US finding. Any thoracic deformity Patients with cardiac, liver or kidney disease.
An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents

The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.


Eligibility Criteria:
INCLUSION CRITERIA

* Current primary diagnosis of bipolar I disorder, mania or mixed type
* Outpatient between 10 and 17 years of age
* Young Mania Rating Scale score greater than or equal to 20 during screening/washout and at Day 1

EXCLUSION CRITERIA

* Axis I other than Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder; or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
* Current manic episode is drug-induced or secondary to a medical disorder (e.g., anti-depressants, hyperthyroidism)
* Expected to require hospitalization for the current manic episode
* Participation in psychotherapy that was started within the past 3 months, or if any significant changes are anticipated
* Has taken atomoxetine or has taken allowed stimulant medication that has not been stable for at least 3 months prior to Day 1, or a dosage adjustment is expected during the study, or that may worsen mood symptoms
* Unable to swallow tablets
* Has received depot psychoactive medication within one inter-injection interval of Day 1
* Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine, barbiturates, benzodiazepines or amphetamines
* History of alcohol or substance dependence within past 3 mos. or substance abuse within past month
* History of failed treatment on adequate Depakote (DR or ER) for a manic episode within past 12 months
* Has taken Depakote (DR or ER) regularly for the current manic episode
* Has serious violent, homicidal, or suicidal ideation
A Retrospective Observational Study to Assess the Impact of Co-morbidities on Treatment Response in Inflammatory Bowel Disease

The purpose of this study was to evaluate the impact of the co-morbidities profile on treatment response to biological therapy in inflammatory bowel disease (IBD) participants.

This was a retrospective, non-interventional, observational study that included participants diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) who started treatment with biologics between June 2011 and June 2013. The study looked at the impact of the co-morbidities on the treatment response in IBD participants.

The study enrolled 310 patients included both UC and CD patients.

This multicenter trial was conducted in Spain. Investigator collected retrospective data in a single visit from participants who started biologic treatment between June 2011 and June 2013. Time since participants started biological treatment until study visit or until lack of treatment response or until treatment change constituted the reference period for the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants (aged ≥18).
* Were diagnosed with UC or CD according to the "World Gastroenterology Organization Practice Guidelines for the Diagnosis and Management of inflammatory bowel disease (IBD) in 2010".
* Who were naive to biologics that started treatment with biologics between June 2011 and June 2013.
* Participants in whom biological treatment was prescribed according to clinical practice.
* Who gave written informed consent.

Exclusion Criteria:

* Were participating in a clinical trial during the study reference period.
* Participant that, according to investigator's criteria was not capable to understand and fill in the study questionnaires or to give written informed consent.
Pharmacokinetics of Propofol in Morbidly Obese Patients

The objectives of this study are

* To determine PK of propofol in bariatric patients
* To identify the physiological variables that induce propofol PK changes in bariatric patients, when compared to a normal-weight population.
* To define context-sensitive half-time profiles for propofol in bariatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients admitted to the Aker University Hospital, scheduled for general or bariatric surgery,
* Both genders. Female subjects of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative pregnancy test (urine beta-HCG).
* Aged 18 - 60 years, both inclusive
* Body mass index (BMI) ≥ 20 kg/m2
* Written informed consent

Exclusion Criteria:

* Patients that are considered not to tolerate a standard dose of propofol administered as a bolus.
* Known hypersensitivity to propofol or its ingredients (soy, lecithin, glycerol, oil acid)
* Known hypersensitivity to any of the anesthetic agents to be used
* Pregnant women
* Lactating women
Efficacy of a New Thickened Extensively Hydrolyzed Formula

Cow Milk Allergy (CMA) occurs in 2 to 5 % of all infants. Reflux, regurgitation and vomiting are well recognised symptoms of CMA. The recommended treatment of CMA is an extensive hydrolysate. The North American Society of Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN) \& the European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) reflux guidelines have no strict recommendations for the treatment of distressed infants with reflux, suspected of CMA. One of the preferred proposed options is to thicken an extensive hydrolysate .

This study aims at evaluating the additional value of a thickened extensive hydrolysate in children suspected of CMA and presenting with frequent regurgitation.


Eligibility Criteria:
Inclusion Criteria:

* term born infants
* Having a Vandenplas' score of regurgitation of at least 2
* With suspected diagnosis of CMA because of clinical history/symptoms (based on a Cow's Milk Protein hypersensitivity (CMPH) score of 10 or more) and/or positive Immunoglobulin E (IgE) testing, radioallergosorbent test (RAST) or skin prick test

Exclusion Criteria:

* Exclusively breast fed infants
* Fed with an extensively hydrolysed formula or amino acid formula
Colorectal Cancer Screening Intervention Study

Colorectal cancer (CRC) is one of the leading causes of cancer mortality in the United States, and African Americans (AfAms) still fare worse in CRC incidence and mortality compared to European Americans (EuAms). We propose to examine whether combining both fear-reduction and racially-targeted norm-based messages will increase at-home stool-based CRC screening receptivity and uptake for all African American regardless of level of racial identity. Given low return rates of at-home screening kits, we will also explore whether making an explicit commitment to return screening kits is associated with increased kit returns.

Colorectal cancer (CRC) is one of the leading causes of cancer mortality in the United States, and African Americans (AfAms) still fare worse in CRC incidence and mortality compared to European Americans (EuAms).Interventions to increase CRC screening rates among AfAms are instrumental to address the disparities in CRC incidence and mortality. Despite literature indicating that AfAms' fears (e.g., of colonoscopy procedures or cancer diagnosis) serve as barriers to CRC screening, no interventions have used theory-guided methods to directly target fear-based beliefs. Additionally, no research has examined the extent to which racial identity moderates the effects of racially targeted messaging, despite the ubiquity of using targeted health messaging entreaties among minority groups. This is particularly relevant given our work showing that racially-targeted screening entreaties increased CRC screening intentions among AfAms who identified less strongly, but depressed those intentions among AfAms who identified more strongly with their racial group. Lack of focus on other salient CRC screening barriers may have been off-putting to highly identified African Americans. We propose to examine whether combining both fear-reduction and racially-targeted norm-based messages will increase at-home stool-based CRC screening receptivity and uptake for all African American regardless of level of racial identity. Given low return rates of at-home screening kits, we will also explore whether making an explicit commitment to return screening kits is associated with increased kit returns.

Aim 1: To develop and refine a fear-reduction intervention guided by the theory of planned behavior and by published literature, in conjunction with AfAm community experts.

Aim 2: To examine whether the fear-reduction entreaty increases receptivity to, and uptake of at-home CRC screening when coupled with racially-targeted norm-based messages.

Aim 3: To examine the moderating roles of racial identity and perceived CRC risk on the effects of fear-reduction and racially-targeted norm-based messaging entreaties.

Aim 4: We will explore whether participants who make explicit commitments to return FIT Kits return them at a higher rate compared to those who do not make such commitments.

Eligibility Criteria:
Inclusion Criteria:

African American Overdue to colorectal cancer screening Has primary care physician Not at high risk for colorectal cancer

Exclusion Criteria:

Not meeting inclusion criteria
A Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus

This study is a randomized controlled trial to study the effect of the use of a risk stratification screening tool for high- and low-risk gestational diabetes mellitus (GDM), and the implementation of a new low-impact care pathway for women with low-risk GDM. The study will measure how well the screening tool and new care pathway are used, and the effect of the new low-impact care pathway on glycemic control, perinatal outcomes (large for gestational age, rate of labor induction, mode of delivery, obstetric anal sphincter injury, neonatal hypoglycemia, neonatal anthropometry) and health resource utilization in women with GDM that are at low-risk of dietary therapy failure.


Eligibility Criteria:
Inclusion Criteria:

* Women able to understand and sign the study consent form
* singleton pregnancy
* planning to give birth to at St. Michael's Hospital
* diagnosed with GDM between 24-32 weeks' gestation based on a positive GCT or GTT result as defined by the Canadian Diabetes Association Clinical Practice Guidelines

Exclusion Criteria:

* Women with preexisting diabetes (Type 1 or 2 diabetes)
* multiple gestation, or a diagnosis of GDM before 24 weeks' or after 32 weeks' gestation
* not continuing care at St. Michael's Hospital after the DIP clinic visit
Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress

The objective of the STRESS trial is to investigate in a mode of action setting the effect of Zeller Entspannung film coated tablets on saliva cortisol response versus Placebo after acute stress in healthy male volunteers. In addition, data on safety and tolerability of Zeller Entspannung will be obtained.

A third arm including no treatment is tested as well. Approximately 72 healthy volunteers will be included into this randomized, double blind study. Study duration will be 7 days, study medication intake will be over 4 days: participants will take the medication one tablet three times a day (morning, midday, evening) the first 3 days, whereas on day 4 only two tablets will be taken (morning and midday).


Eligibility Criteria:
Inclusion Criteria:

* Age:18 - 45 years
* Written informed consent
* Male gender

Exclusion Criteria:

* Any acute or chronic somatic or psychiatric disorder
* Smoking
* Any clinically relevant hepatic disorder
* Any clinically relevant renal disorder
* Any clinically relevant cardiac disorder
* Any clinically relevant respiratory disease (e.g. Asthma)
* Diabetes mellitus
* Any abnormal lab values suggesting diseases from exclusion criteria
* Known allergies to trial medication and excipients
* Alcohol or other drug abuse (e.g. cannabis)
* Concomitant participation in another clinical trial or \<4 weeks ago
* Participation in any psychotherapy
* Already participated in a TSST