cyrilzakka/clinical-trials huggingface dataset:
Examining Genetic Influence on Response to Beta-Blocker Medications in People With Type 2 Diabetes

Beta-blockers are medications used to treat cardiovascular disease (CVD) symptoms, including high blood pressure and chest pain. People with diabetes who receive beta-blockers may experience adverse health effects, but the exact cause of why this happens remains unknown. This study will examine the genetic factors that may influence how atenolol, a beta-blocker medication, affects fat breakdown, blood sugar levels, and heart function in people with type 2 diabetes.

People with diabetes who develop CVD have worse health outcomes than people without diabetes who develop CVD. Beta-blockers are medications used to treat high blood pressure, angina (i.e., chest pain), arrhythmias, and other CVD conditions. While beta-blockers are effective at treating these conditions, they may also have damaging effects on cholesterol or glucose levels, thereby possibly lessening their ability to prevent CVD events in people with diabetes. It is important to identify which patients may not benefit from receiving beta-blocker medications. Genetic factors may influence how people respond to beta-blocker medications. The purpose of this study is to evaluate the influence of genetic variation on beta-blocker-induced changes in insulin sensitivity, fat breakdown, and heart function in people with type 2 diabetes.

This study will enroll people with type 2 diabetes. At a series of up to three baseline study visits, participants will have a blood collection, a glucose tolerance test, an echocardiogram to obtain images of the heart, and biopsies of muscle from the thigh and fat from the stomach. All participants will then receive atenolol once a day for 8 weeks. During Week 1, participants will receive a low dose of atenolol. They will then attend a study visit at the end of Week 1, and study researchers will examine how well participants are tolerating the medication. If the atenolol is well tolerated, the dose will be increased. Study researchers will call participants 1 week after any dosage changes to monitor for side effects. Blood collection will occur again at a study visit at Week 4. At Week 8, participants will then attend up to three study visits for repeat baseline testing. Participants will then be slowly tapered off of atenolol over a 1-week period.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Pre-Diabetes

Exclusion Criteria:

* Insulin therapy
* Treatment with any beta-blocker in the 30 days before study entry
* Asthma
* Chronic obstructive pulmonary disease (COPD)
* Greater than first degree heart block
* Heart rate less than 60 bpm
* Systolic blood pressure less than 90 mm Hg
* Raynaud's phenomenon
* Known history of angina, heart attack, heart failure, coronary revascularization, or automatic implantable cardioverter defibrillators
* Pregnant
* Creatinine clearance less than 35 ml/min
* Hematologic dysfunction (white blood cell \[WBC\] count less than 3000 or hematocrit less than 28%)
* Allergy to amide anesthetics
Attentional Bias Retraining in Veterans

The study has two goals. First to develop a computer-based intervention meant to alter cognitive biases that contribute to ongoing PTSD symptoms. Second, we sought to pilot test the intervention in a small sample of veterans for feasibility and acceptability.

Aim 1: Develop Attentional Bias Retraining protocol (Phase 1)

* 1.1 Computerized assessment \& retraining programs
* 1.2 Procedures and measures

Aim 2: Implement in pilot sample (Phase 2)

* 2.1: Assess feasibility and tolerability
* 2.2: Collect pilot data to plan future studies
* 2.3: Efficacy estimates based on changes in response time to dot probe task

Eligibility Criteria:
Inclusion Criteria:

* Participated in ground combat operations in Vietnam
* Scored 40 - 80 on PTSD Checklist - Military version
* Availability and willingness to attend 2x weekly computer sessions for 6 weeks

Exclusion Criteria:

* Active substance dependence
* Significant cognitive impairment
* Current and active suicidal or homicidal ideation
Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder

The purpose of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran ER relative to placebo in adolescent outpatients (12-17 years) with Major Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics (PK) data to guide dose selection for future pediatric studies of levomilnacipran.

Study LVM-MD-11 is a randomized, double-blind, placebo- and active-controlled, parallel group, fixed-dose study in adolescent patients, ages 12-17 years. The study will be approximately 10 weeks in duration:

* 1-week screening/washout period
* 8-week double-blind treatment period
* 1-week double-blind down-taper period

Participants who meet the eligibility criteria at Visit 2 (Baseline) will be randomized to 1 of 4 treatment groups: placebo, levomilnacipran 40 mg/day, levomilnacipran 80 mg/day, or fluoxetine 20 mg/day.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female outpatients;12-17 years of age
* Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL)
* Score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
* Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
* Reliable caregiver
* Physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG) normal or not clinically significant

Key Psychiatric Exclusion Criteria:

* DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment
* Mental retardation or amnestic or other cognitive disorders
* Significant suicide risk:
* Suicide attempt within the past year OR
* Investigator judgment (based on psychiatric interview and Columbia-Suicide Severity Rating Scale (C-SSRS))

Key Treatment-Related Exclusion Criteria:

* Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)
* Use of prohibited concomitant medication that cannot be discontinued

Other Key Medical Exclusion Criteria:

* Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect participants safety
* Liver enzyme tests aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2X the upper limit of normal (ULN)
* Clinically significant cardiovascular disorders
* Seizure disorder or risk of seizure
* Drug or alcohol abuse or dependence (within the past year)
* Positive urine drug screen or blood alcohol
Cancer in Infants: South Egypt Cancer Institute Experience

The aim of this study is to investigate the spectrum of various types of malignant neoplasms of infancy, according to the experience of South Egypt Cancer Institute, which represents the largest referral site in Upper Egypt.

Background:

Cancer in the first year of life is relatively rare ; however, the age of peak cancer incidence among children occurs during the first year of life, representing 10% of all cancer that was diagnosed among children younger than 15 years of age. Female and male infants have essentially the same overall cancer incidence rates.

Cancer occurring in infants often has a clinical and biological behavior that is different from cancers occurring in older children. The histologic distribution of cancers in infants and that in older children are also different.

Patients \& Methods:

From January 2001 to December 2015, retrieval \& analysis of the medical records of infant patients, diagnosed with any of malignant tumors, at the pediatric oncology department at South Egypt Cancer Institute will be done. Pathologic diagnoses \& age of the patients will be verified for the enrollment in the study. The collected data will be analyzed to delineate the spectrum of these disease entities, their clinico-pathologic features, associated patients' demographics and characteristics, treatment modalities received, and outcomes of these treatments.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose age less than or equal to 1 year.
* Patients diagnosed with any of malignant neoplasms.

Exclusion Criteria:

• Patients whose age more than 1 year.
Progressive Strength Training in Spinal Muscular Atrophy

The proposed feasibility study is necessary to test if children and young adults will participate in and adhere to a 12-week, home-based, supervised progressive strength training exercise program and to obtain preliminary data that will subsequently allow us to determine the safety and impact of strength training in spinal muscular atrophy. Our pilot study will address 3 aims: (1) Ascertain the feasibility of, and potential barriers to, participation in and adherence to a 12-week home-based, supervised, progressive strength training exercise program in children and young adults aged 5-21 years with SMA types II and III; (2) Determine the safety and tolerability of progressive strength training in a pilot study sample of children and young adults with SMA types II and III; and (3) Determine candidate outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* age 5-21 years
* diagnosis of SMA type II or III
* at least antigravity strength in elbow flexors
* ability to follow commands and stay on task
* place of residence within a 60-minute or 60-mile drive of the University of Utah

Exclusion Criteria:

* planned surgery or out-of-town trips during the proposed intervention period
* inability to travel to study center for testing
* neurological diagnosis other than SMA
Cognitive Remediation Therapy and Schizophrenia

Objectives:

The purpose of this study is to determine the impact of a new Cognitive Remediation Therapy (CRT) on cognition, social autonomy, symptoms and brain functioning in patients with schizophrenia.

Methods:

In a 2 arms blind study versus sham,80 patients with schizophrenia were enrolled in a program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software. Measures of cognitive functioning using the Cogtest® battery as well as social autonomy (Social Autonomy Scale, EAS) and schizophrenia symptoms (Positive And Negative Syndrome Scale, PANSS) were undertaken at the beginning and the end of the meetings of remediation.

Among those 80 participants, 30 patients to (15 active / 15 sham) were randomized to participate in an fMRI study in order to investigate the impact of such CRT program on brain functioning (n-back task before CRT and 3 months later).

Eligibility Criteria:
Inclusion Criteria:

* schizophrenia (DSM IV criteria)
* remitted symptoms
* french language
* informed consent

Exclusion Criteria:

* addiction, neurological disease
* only for second randomized patient participating in MRI study (n=30) : MRI counterindications
Vitamin D Intervention in Infants - Pilot

The aims of the present study are to evaluate the concentrations of vitamin D in the plasma and of calcium in the plasma and in the urine as well as to evaluate bone mineral density using peripheral quantitative computed tomography (pQCT), after supplementation of vitamin D with 30µg (1200 IU) and 40µg (1600 IU), in comparison with currently recommended supplementation of vitamin D with 10µg (400 IU). In this pilot study supplementation is given to infants from 2 weeks of age to 3 months of age.

Vitamin D deficiency is common around the world. In Finland vitamin D levels are low in all age groups. Especially infants are predisposed to vitamin D deficiency. Partly this is due to low exposure to sunlight but mainly it is due to low dietary intake of vitamin D. Vitamin D prophylaxis was introduced in Finland in the 1950´s to overcome rickets. However, the recommended dose has decreased from 50µg (2000 IU) in the 1960´s to 10µg (400 IU) from beginning of the 1990´s. The serum concentration of 25-hydroxyvitamin D (S-25OHD) is used as a marker of vitamin D status in the body. Although there is no consensus of optimal concentration of S-25OHD, it has been proposed that concentrations lower than 50 nmol/l indicate deficiency. According to recent findings on 25-OHD concentrations in Finnish children, currently recommended intake of vitamin D is inadequate.

Eligibility Criteria:
Inclusion Criteria:

* healthy Caucasian women with an uneventful pregnancy
* healthy infants born at term and appropriate for gestational age
A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* CKD (stage V) on outpatient hemodialysis therapy for \>= 3 months;
* CKD-related anemia treated with epoetin alfa iv 3x/week for \>= 3 months;
* average hemoglobin (Hb) 10-12 g/dL over last 3 months.

Exclusion Criteria:

* failed renal transplant within 12 months prior to screening;
* poorly controlled hypertension;
* previous treatment with Mircera.
Registry Study - Whipple at the Splenic Artery

The purpose of this study is to determine how effective Whipple at the Splenic Artery (WATSA).

Primary

The primary objective of this registry study is to collect clinical data from patients who undergo the WATSA procedure. Specific hypotheses to be tested are

* To determine how effective Whipple at the Splenic Artery (WATSA) is at resecting tumors with negative microscopic margins (R0) at the resection line on the pancreas and at the tangential posterior, uncinate, and venous margins.
* To determine if WATSA can be performed within the usual range of morbidity and mortality (30 day postoperative mortality) for a standard a Whipple procedure.

Secondary

The secondary objectives of this registry study are to

* To determine the survival/recurrence rates at 2 years.
* To determine the effect of occlusion of the splenic vein at the confluence.

Eligibility Criteria:
Eligibility Criteria - Prospective Portion:

* Patient must have diagnosis of ductal adenocarcinoma of head and/or neck of pancreas, ampullary adenocarcinoma, or pancreatic neuroendocrine tumor confirmed by tissue diagnosis.
* Patient must be between 18 to 85 years of age.
* Patient must be a candidate for the WATSA procedure or have had the WATSA surgery performed within 1 year.
* Patient must be able to understand and willing to sign a written informed consent document.

Eligibility Criteria - Retrospective Portion:

Patient underwent WATSA procedure at our institution between 01/01/2009 and 12/31/2011.
A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis

The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed with bacterial conjunctivitis

Exclusion Criteria:

* Signs and/or symptoms of conjunctivitis for more than 96 hours
* Signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis
* Clinical diagnosis of chlamydia in either eye
Can a Novel Manual Therapy Technique Help Relieve Stress? Assessing Effects of Primal Reflex Release on the Body's Stress Response

Stress, when left unmanaged, can have detrimental effects on both physical and mental health, contributing to conditions such as high blood pressure, anxiety, and even cardiovascular disease. Effective stress management therapies may help maintain overall well-being and reduce the risk of long-term health complications. The Primal Reflex Release Technique (PRRT) is a novel manual therapy that may reduce markers related to stress such as heart rate variability (HRV) and patient-reported outcomes (PROs). Therefore, the purpose of this study is to elucidate the potential for PRRT to improve HRV and PROs.

This randomized, controlled experimental intervention study evaluates acute impacts of a reflex-targeted manual therapy called Primal Reflex Release Technique (PRRT) on cardiovascular indices of stress and sympathetic tone. After consenting and baseline characteristics, subjects are allocated to receive either the PRRT or the control condition.

Continuous electrocardiography (ECG) and impedance cardiography (ICG) monitoring will be used to track heart rate variability (HRV) changes across three phases:

1. Pre-intervention during a 5-minute video of aquatic nature scenes to establish resting baseline
2. 5 minutes of a practitioner administering targeted spinal manipulation PRRT protocol in the treatment group to stimulate innate protective reflexes OR continued relaxation video viewing for control group
3. Post-intervention repeat of the standardized video to assess changes after PRRT session without ongoing manipulation

The PRRT targets precise anatomical locations and neural pathways including stimulating facial muscles, upper spinal reflexes and traction of the suboccipital muscles. Brief, reversible sensations will occur without expected harm or lasting effects.

Psychological state assessed via paper mood scales pre/post tracks subjective stress correlates. Analysis using linear mixed effects models contrast whether indices of cardiovascular reactivity and psychological responses shift acutely with PRRT versus control video. Findings could provide physiological validation for integration as stress-alleviating treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subject can refrain from caffeinated beverages in the 6 hours prior to data collection
* Subject is not currently taking any beta blockers
* Subject is comfortable with a manual therapy technique where the clinician touches your face and head

Exclusion Criteria:

* Subject has had caffeine within 6 hours
* Subject is currently taking any beta blockers
Global Anticoagulant Registry in the FIELD- Venous Thromboembolic Events

The protocol is a large registry to describe acute, sub-acute and extended duration of anticoagulation management, clinical and economic duration of anticoagulation management, clinical and economic outcomes in patients with treated acute VTE (DVT and PE) in the real-world setting.

Main objectives are to clarify the:

* treatment related details for acute VTE (either conventional anticoagulation therapy, treatment with a direct oral anti-coagulant or other modalities of treatment)
* Rate of early and late symptomatic VTE recurrence
* Rate and nature of complications of VTE including post thrombotic syndrome and chronic thromboembolic pulmonary hypertension
* Rate of bleeding complications
* Rate of all-cause mortality at six months

Other objectives are to clarify the additional outcomes of:

* Stroke (Measured by number of incidences)
* Transient Ischemic Attack (TIA) (Measured by number on incidences)
* ST Elevated Myocardial Infarction (STEMI) (Measured by number of incidences)
* Non-ST Elevated Myocardial Infraction (NSTEMI) (Measured by number of incidences)
* Unstable Angina (Measured by number of incidences)
* Quality of life and patient reported outcomes and costs associated with the management of VTE.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18 years and over
* Treated first time or recurrent DVT (lower or upper extremity), PE alone or overlapping DVT and PE confirmed by appropriate diagnostic methods (patients must be assessed for eligibility within 30 days of diagnosis)
* Patients included with recurrent VTE must have completed treatment for the previous VTE episode

Exclusion Criteria:

* Patients for whom long-term follow-up is not envisaged within the enrolling hospital or the associated primary care physician
* Patients participating in an interventional study that dictates treatments, visit frequency, or diagnostic procedures
* Patients with only superficial vein thrombosis (SVT)
Impact on the Time to Diagnosis of Serious Postoperative Complications by a Controlled Connected Medical Device

Post-operative mortality in case of scheduled surgery is 3% in France (Lancet 2013) mainly due to cardiovascular or respiratory complications, by decompensation of pre-existing pathologies.

Complications due to the medical practice are the third cause of morbidity (BMJ, 2016). More than half are preventable and are mainly observed in surgical patients. In conventional hospitalization, excluding intensive care, monitoring is done discontinuously for most of the patients, which does not allow early diagnosis of a vital cardiovascular or respiratory failure.

Diagnosis and late treatment do not allow good recovery. The early identification of a vital failure by the continuous monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) would allow faster management by the hospital staff and a reduction in immediate and possibly delayed postoperative mortality.

The challenge of this research is to transpose in an ordinary hospitalization unit the continuous monitoring of vital functions carried out in intensive care by the continuous measurement of simple parameters using the "SMART ANGEL Intra-hospital" System's (connected medical devices and alerts).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients receiving a scheduled non-ambulatory surgical or interventional procedure
* Affiliation to a social security scheme, beneficiary or entitled person (excluding AME)
* Patient's written consent or of the trusted person in case of physical incapacity

Exclusion Criteria:

* Inclusion in emergency situations
* ASA1 patient (without associated pathology)
* Patient with a multi-drug resistant germ in isolation
* Known linguistic inability of the patient to understand the study
* Known pregnancy or breastfeeding woman
* Patients with implantable pacemakers, implantable defibrillators or neurostimulators.
* Person under legal protection or unable to give consent
* Person deprived of liberty by judicial or administrative decision