cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

The study is designed to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy (in the morning). It incorporates a 6-week acute treatment period and a 2-week discontinuation phase. The assessments in this study include a standard assessment of ADHD symptomatology using a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition™, investigator-administered rating scale.


Eligibility Criteria:
Inclusion Criteria

* Subjects must have ADHD that meets the DSM-IV criteria
* Aged 6 to 16 years.
* Subjects must not have taken any medication used to treat ADHD.
* Laboratory results must show no significant abnormalities
* Baseline ECG results must not show an abnormality
* Subjects must be able to swallow capsules.
* Subjects must be of normal intelligence.

Exclusion Criteria

* Weigh less than 20 kg or more than 60 kg at study entry.
* Subjects who, after an adequate trial with methylphenidate or amphetamine experience some benefit in ADHD signs and symptoms are excluded from participating.
* Have a history of Bipolar I or II disorder, psychosis, or PDD.
* Meet DSM-IV criteria for an anxiety disorder.
* Have a history of any seizure disorder.
* Patients at serious suicidal risk.
* Patients with narrow angle glaucoma
* Subjects who have a history of severe allergies .
* Have a history of alcohol or drug abuse within the past 3 months
* Screen positive for drugs of abuse not prescribed by a physician.
* Have cardiovascular disease and an increased heart rate and blood pressure.
* Have a medical condition that would increase sympathetic nervous system activity markedly or who are taking a medication on a daily basis.
* Have severe gastrointestinal narrowing
* Are during the study time likely to need psychotropic medications.
* Are likely to begin a structured psychotherapy aimed at ADHD symptoms.
* Have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks
* Female subjects who are pregnant or who are breast-feeding.
* Are investigative site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study.
* Are, in the opinion of the investigator, unsuitable in any other way to participate in this study.
* Are employed by Lilly.
Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial

Gastrointestinal bleeding originating from the small bowel is difficult to diagnose and treat because the small bowel is difficult to see and reach. Balloon assisted enteroscopy (BAE) is a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis and treatment of bleeding originating from this part of the intestine. Unfortunately, BAE is unsuccessful in identifying the cause of bleeding in 40-50% of patients. This may be due to limited visualization of the small bowel lining during conventional endoscopy. One way to improve visualization of the small bowel lining is by adding a transparent plastic cap to the end of the endoscope (camera), which allows the endoscope to see around sharp turned and behind folds in the small bowel.

The investigators goal in this randomized controlled study is to see if adding a transparent cap to the end of the endoscope will help to identify and treat small bowel bleeding. The investigators will invite patients referred for BAE to participate in the study; the alternative to participating in the study is having standard BAE (without a cap). If patients choose to participate in the study they will be randomized to BAE with or without a cap on the end of the endoscope. Subjects time commitment will be limited to the consent process and pre-procedure paperwork at time of initial endoscopy and time required to complete telephone questionnaire at 12 months follow up.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years old) patients undergoing BAE for the evaluation of OGIB or iron deficiency anemia.

Exclusion Criteria:

* Unable to provide written informed consent.
* Pregnancy or lactation.
* Suspected bowel obstruction or GI perforation.
* Unable to tolerate sedation or general anesthesia due to medical co-morbidities.
* Uncorrected coagulopathy (platelet count \<50,000, INR\> 2, PTT\> 2x upper limit of normal).
* Patient undergoing retrograde BAE.
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block

The objective of this study is to identify the minimum effective dosage of a commonly used local anaesthetic drug "levobupivacaine" required to produce an effective ultrasound guided (USG) superior trunk block (STB) in at least 90% of patients for shoulder arthroscopic surgeries.

Shoulder arthroscopic surgery is one of the most commonly performed procedures worldwide, and associated with significant postoperative pain. Currently, such surgery is performed either under general anaesthesia or under Interscalene brachial plexus block (ISBPB), which is a regional anaesthesia technique. However, ISBPB is associated with the highest incidence of hemi-diaphragmatic palsy of the operative side. Since majority of the innervation to the shoulder arises from or passes through the superior trunk of the brachial plexus, superior trunk block has been shown to have lesser impact on the phrenic nerve and it has been gaining popularity worldwide. Ultrasound is widely used for brachial plexus block and current evidence indicates that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks (superior, middle, and inferior trunks). However, there are no data describing an optimal volume of local anaesthetic for superior trunk block. The aim of this study is to identify the minimum effective dosage of a commonly used local anaesthetic drug "levobupivacaine" required to produce an effective ultrasound guided (USG) superior trunk block (STB) in at least 90% of patients for shoulder arthroscopic surgeries.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-III scheduled to undergo elective upper shoulder arthroscopic rotator cuff repair procedure

Exclusion Criteria:

* Patient refusal
* pregnancy
* skin infection at the site of block placement
* history of allergy to local anaesthetic drugs
* bleeding tendency or with evidence of coagulopathy
* pre-existing neurological deficit or neuromuscular disease.
Promotion of Breastfeeding Intervention Trial

The overall goal of the PROBIT study is to investigate the influence of a randomized breastfeeding promotion intervention designed to increase the duration and exclusivity of breastfeeding ("the breastfeeding promotion intervention") on the development of maternal and child health outcomes. The hypothesis is that randomization to the intervention will be associated with lower child adiposity, lower risk of asthma and atopy, improved lung function, and improved cognitive outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Birth at one of 34 Maternity Hospitals in Republic of Belarus
* Breastfeeding initiated at birth, with no contraindications to breastfeeding
* Apgar score \>=5 at 5 minutes
* Full term gestation
* Birth weight \> 2500g
Effectiveness of BP Remote Monitoring With Virtual Physician Management in Hypertensive Patients.

To assess the feasibility and adoptability of DailyDoctor's remote monitoring clinical decision support software tool in helping physicians virtually manage systolic blood pressures among patients with history of stroke or TIA to a target systolic blood pressure (\<140 mmHg or a lower target range specified by referring physicians) using remote monitoring and independent clinical judgement.

To assess the feasibility and adoptability of DailyDoctor's remote monitoring clinical decision support software tool in helping physicians virtually manage systolic blood pressures among patients with history of stroke or TIA to a target systolic blood pressure (\<140 mmHg or a lower target range specified by referring physicians) using remote monitoring and independent clinical judgement.

To assess the feasibility and adoptability of DailyDoctor's digital platform in helping Stanford Stroke Center lower and maintain systolic blood pressures among patients with history of stroke or TIA to a target systolic blood pressure (\<140 mmHg or a lower target range specified by referring physicians) using remote monitoring and a virtual medical team focused on BP management.

Eligibility Criteria:
Inclusion Criteria:

Age 18 years or older. A history of ischemic or hemorrhagic stroke, or transient ischemic attack. The ability to report blood pressure values by phone (either a patient or designated caregiver may call to report values).

At least 2 BP measurements that are ≥140 mmHg systolic or ≥90 mmHg diastolic obtained on different days in the last 6 months in any setting (including at home, in clinic, or in the hospital setting).

The referring physician feels the patient would benefit from BP optimization. Consent to receive care from telehealth physicians available through the DailyDoctor monitoring platform.

English or Spanish speaking.

Exclusion Criteria:

Currently enrolled in another interventional research study Inability to comply with study protocol Have a planned surgical procedure during the study period Upper arm circumference \> 20 inches Has diagnosis of end-stage renal disease (GFR \< 15 mL/min), Serum creatinine \> 2.0 mg/dL (176.8 μmol/L), or currently undergoing dialysis treatment (10) Women who are pregnant or who are planning to become pregnant during the study period.

Blood pressure reduction is not indicated (e.g. patients who have a high blood pressure target to augment cerebral perfusion).

Any other reason that, in the opinion of the investigator, makes the person a poor candidate for participation in this study
Using Telephone Technology to Prevent Relapse After Alcoholism Treatment

The purpose of this study is to determine whether a telephone based self-help program will prevent relapse among individuals undergoing standard substance abuse treatment.

Relapse rates in the first few months following substance abuse treatment are as high as 50%, in spite of the immediate effectiveness of treatments such as Cognitive Behavioral Therapy (CBT). Continuing use of therapy skills following treatment is associated with maintenance of treatment gains. We have programmed a telephone to deliver pre-recorded summaries and rehearsal sessions of skills learned in therapy. The system also includes monthly feedback messages from therapists. We expect that this ad-lib access to therapy skills would allow patients to generalize skills to their personal post-treatment lives. It would also allow individuals in remote or rural areas to obtain access to assistance without travel barriers.

Comparison(s): patients completing group CBT for substance abuse will be randomly assigned to two conditions. In one condition, patients will have unlimited access to the therapeutic telephone system for 4 months. The other condition is standard care (i.e., no formal relapse prevention).

Eligibility Criteria:
Inclusion Criteria:

* Meets current DSM-IV criteria for alcohol dependence
* Active drinking during the three months prior to entry into treatment
* Minimum age of 19
* Minimum sixth grade reading level.

Exclusion Criteria:

* Meets criteria for a current psychotic illness
* Imminent plans to move or be incarcerated
* Presence of such severe hearing, visual, or cognitive deficit(s) that participation in CBT or use of an Interactive Voice Response (IVR) system are not possible
* Inability to identify at least one "locator" person to assist in tracking for follow-up assessments
* Does not have telephone service within the home
* Incarceration while in active protocol in the study
* Attendance of less than 8 of 12 CBT sessions
Predictive Role of sTREM in Endovascular Thrombectomy Outcomes

Soluble triggering receptor expressed on myeloid cells (sTREM), which reflects microglia activation, has been reported closely associated with neuronal injury and neuroinflammation. This study is to investigatethe prognostic roles of sTREM (sTREM1 and sTREM2) in patients with ischemic stroke who underwent endovascular thrombectomy (EVT).

For acute ischemic stroke, the current treatment strategy involves timely recanalization by intravenous thrombolysis and endovascular thrombectomy (EVT). Patients receiving EVT are more likely to achieve successful revascularization and long--term functional independence compared with those receiving standard medical treatment.1 In patients receiving EVT, significant predictors of a favorable functional outcome include minor initial stroke severity, successful recanalization, and shorter onset--to--treatment time. However, unfavorable outcomes can occur even after early successful recanalization in some cases.Triggering receptors expressed on myeloid cells (TREM-1 and TREM-2) are a familyof receptors involved in the immune system expressed on a variety of innate cells of the myeloid lineage, including microglia. sTREM, which reflects microglia activation, has been reported closely associated with neuronal injury and neuroinflammation. We enrolled adult patients with stroke who received EVT, with blood sampling immediately before (T1) and after EVT (T2), and at 24 hours after EVT (T3). Non--stroke controls and patients with non--EVT stroke were also enrolled. The plasma concentration of sTREM1 and sTREM2 were analyzed by ELISA. The medical information, image findings and levels of plasma sTREM1 and sTREM2 were analyzed to clarify the association with poor functional outcome (modified Rankin Scale 4-6) at 3 months after stroke.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old.
* Patients with acute large vessel occlusion within 24 hours of onset who will receive endovascular treatment.

Exclusion Criteria:

* Impossibility of getting a blood sample.
* Impossibility of performing the test (Invalid results).
* Refusal to provide the informed consent by the patient/relative.
Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine

The purpose of this observational study, which will be initiated as soon as the licensed H1N1 Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the incidence of any medically-attended adverse events in all vaccinated subjects.


Eligibility Criteria:
Inclusion Criteria:

Male and female subjects, per indication on license or per official vaccine recommendations, will be eligible for participation in this study if:

* They will be administered CELVAPAN (= Baxter´s H1N1 pandemic influenza vaccine)
* They are 2 months of age or older at the time of first vaccine administration
* Their medical history is available
* The investigator believes they will comply with the foreseen vaccination schedule and will reliably observe signs or symptoms of adverse events during the observational period
* They and/or their parent(s)/legal guardian(s) provide written informed consent, and assent where appropriate, prior to study entry according to national law

Exclusion Criteria:

Male and female subjects will be excluded from participation in this study if:

* They have already been administered another H1N1 pandemic vaccine
* They have any contraindication to vaccination (as per the Summary of Product Characteristics and/or relevant national immunization guidelines)
Factors That Effect the Gait Speed in Diabetic Individuals Without Neuropathy

This study planned to investigate the role of potential explanatory factors effecting the speed of gait such as muscle mass, aerobic capacity, physical activity status, cognitive function, blood pressure, and metabolic measures considering age, sex, and education years in diabetic individuals without neuropathy.

Type 2 diabetic people will be screened by clinical symptoms of neuropathy and DN4 questionnaire. Among those who did not have neuropathic symptoms or who have DN4 score below 4 will be considered for the study.Then aerobic capacity will be measured by a cycle ergometer and VO2max will be obtained. Weight, body mass index and muscle mass will be measured by bioimpedance analysis. Physical activity status will be determined by International Physical Activity Score (IPAQ). Cognitive function will be evaluated by Mini Mental test. HbA1c and fasting blood glucose will be measured in venous blood after overnight fasting. Blood pressure will be measured in the sitting position after resting from the left arm. Speed of gait will be measured by an accelerometer.Then, the effect of above mentioned factors on speed of gait will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with Diabetes Mellitus less than 10 years but longer than 1 year
* Absence of neuropathic symptoms
* DN4 questionnaire sore less than 4

Exclusion Criteria:

Individuals who had

* insulin therapy,
* poor glycemic control,
* manifesting cardiovascular disease,
* retinopathy or other visual problems,
* diabetic neuropathy,
* nephropathy,
* cerebrovascular disease,
* cognitive impairment,
* heart failure,
* alcohol or cigarette dependence,
* cancer,
* chemo/radiotherapy,
* foot ulcer,
* orthopedical or surgical problems
* wheel-chair or any assistive devices for ambulation
* prominent knee or hip arthritis, prosthesis
Decreasing Emergence Delirium With Personalized Music

This is a prospective randomized controlled trial in children 3-9 years of age undergoing myringotomies at Washington University in St. Louis to assess the impact of perioperative personalized music on the incidence of emergence agitation.

Aim 1: Determine the efficacy of personalized music in decreasing the incidence of emergence agitation in pediatric patients undergoing myringotomies. Patients undergoing myringotomy procedures will be randomized to receive either standard care or personalized music during the perioperative period. The incidence of emergence agitation will be determined using the Pediatric Anesthesia Emergence Delirium scale.

Aim 2: Determine the efficacy of personalized music in reducing preoperative anxiety, postoperative pain, and maladaptive behavioral changes in pediatric patients following myringotomy procedures. Anxiety will be assessed in the preoperative holding area using the modified Yale Preoperative Anxiety Scale and the Induction Compliance Checklist (mask acceptance). Postoperative pain will be assessed in the post-anesthesia care unit using the Face, Legs, Activity, Cry, Consolability and Wong-Baker FACES scales. Behavioral changes will be measured using the Post Hospitalization Behavior Questionnaire via telephone calls on postoperative days 1 and 14 after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Child aged 3-9 years
* Presenting for unilateral or bilateral myringotomy under GA

Exclusion Criteria:

* Combined procedures
* Lack of interest in music (e.g., child who does not have musical preferences)
* Inability to hear music (patients with mild-moderate hearing loss who can perceive music will be included)
* Parent/guardian or patient refusal
A Trial Of CVX-060, An Anti-Angiogenic COVX-Body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma

The safety and tolerability of CVX-060 have been established in the first-in-human clinical trial, CVX-060-101. Thus, this phase Ib/II trial is to assess the safety and pharmacokinetics (PK) profiles of combining CVX-060 with sunitinib in patients with advanced solid tumors, and to subsequently assess the treatment efficacy of the combination treatment, as well as that of sunitinib alone in patients with advanced renal cell carcinoma (mRCC).

On 23-Nov-2010, B1131001 (CVX-060-102) was closed to enrollment due to emerging clinical data which led to a re-assessment of the strategic goals of the PF-04856884 program. The study enrolled the Phase 1b portion only. Subsequently, on 25-Oct-2012, due to data safety signals in a separate clinical trial with PF-04856884 (CVX-060), all PF-04856884 studies were discontinued and ongoing patients on B1131001 were permitted to remain on study at a reduced PF-04856884 dose if determined to have been deriving clinical benefit.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced/metastatic solid tumor
* Having received at least 1 prior systemic therapy for the treatment of advanced/metastatic solid tumors
* Histologically or cytologically confirmed renal cell carcinoma with clear cell histology and evidence of metastasis (No previous systemic therapy for the treatment of metastatic renal cell carcinoma)
* Adequate laboratory tests
* Eastern Cooperative Oncology Group (ECOG) 0-1, Life expectancy \> or = 12 weeks and age \> or = 18 years

Exclusion Criteria:

* Patients intolerant of prior anti-angiogenic agents
* Recent history of bleeding or bleeding disorders
* History of tumors in the brain
* History of heart problems
* History of severe allergic reaction to antibody therapy
The Study of Ropivacaine Median Effective Concentration in Ultrasound-guided Supraclavicular Brachial Plexus Block

To determine the median effective concentration of ropivacaine hydrochloride for ultrasound-guided supraclavicular brachial plexus block. The result can provide reference for choosing appropriate drug concentration in clinical anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA I or II

Exclusion Criteria:

* upper limb paresthesia
* allergic to local anesthetics
* surgery history of clavicle
* BMI\>30kg/m\^2