cyrilzakka/clinical-trials huggingface dataset:
Risk of Attention Deficit Hyperactivity Disorder (ADHD) in the Children of Adults With ADHD Not Otherwise Specified (NOS)

The researchers plan to explore the validity of the category of ADHD NOS by identifying the risk for ADHD in the children of ADHD NOS adult probands and identifying common correlates of ADHD in these children. The researchers hypothesize that the rate of ADHD will be higher in the children of the ADHD NOS probands than the rate of ADHD previously published for siblings of proband children with ADHD; and ADHD children of ADHD NOS adults will have higher rates of school failure (as measured by their rate of repeated grades, need for tutoring, and placement in special classes) than their non-ADHD siblings.

We plan to explore the validity of the category of ADHD NOS by identifying the risk for ADHD in the children of ADHD NOS adult probands and identifying common correlates of ADHD in these children. We hypothesize the rate of ADHD will be higher in the children of the ADHD NOS probands than the rate of ADHD previously published for siblings of proband children with ADHD; and ADHD children of ADHD NOS adults will have higher rates of school failure (as measured by their rate of repeated grades, need for tutoring, and placement in special classes) than their non-ADHD siblings.

The proposed study includes a one-time fifteen minute survey derived from the ADHD module of the Kiddie Schedule for Affective Disorders - Epidemiological Version (KSADS-E) with the proband of an ADHD NOS study regarding his/her children, in order to assess possible ADHD symptoms of that child. We also ask "school questions" regarding certain aspects of a child's educational experience.

Eligibility Criteria:
Inclusion Criteria:

Must be a biological child of an ADHD NOS proband. The proband must meet the following criterion:

1. Age: above 18 years
2. Sex: male or female
3. Intelligence quotient (IQ) above 80
4. Met criteria for the diagnosis of attention deficit hyperactivity disorder not otherwise specified (ADHD NOS), by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), as manifested in clinical evaluation and confirmed by structured interview. This is operationalized by either:

   * having at least 6 out of 9 current DSM-IV items of either inattention or hyperactivity/impulsivity but \< 5 items from either list in childhood, or
   * having 5 out of 9 current DSM-IV items of either inattention or hyperactivity/impulsivity, but not having the 6 current symptoms in either category. This second category will be included independent of the presence or absence of ADHD symptoms in childhood.
5. Had a Clinical Global Impression: ADHD score of 4 (moderately ill) or higher illness severity at a clinical evaluation.
6. Has at least one biological offspring

Exclusion Criteria:

1. No adequate informant is available to answer the survey questions.
2. Sensorimotor deficits. (These include deficits that would impede the survey process, e.g. profound deafness, blindness, inadequate command of the English language, or profound disorders of language.)
3. Psychosis, autism, schizophrenia.
Neuraxial and Neurolytic Analgesia for Intractable Pain

The purpose of this study is to collect longitudinal data on outcomes of neuraxial or neurolytic procedures in patients with intractable cancer and chronic noncancer pain so that we may contribute to the growing evidence for or against these therapies and to provide data for ongoing quality improvement activities.


Eligibility Criteria:
Inclusion Criteria:

* treated for intractable pain by the UW Interventional Pain Treatment program
* inpatient or outpatient

Exclusion Criteria:

* less than 18 years of age
Combination Chemotherapy +/- Radiation in High Risk Hodgkin's Disease

Patients with 3 or more adverse prognostic factors have a higher relapse rate. Significant anti-tumor activity in Hodgkin's lymphoma has been reported with two new drugs:gemcitabine and vinorelbine. The introduction of these new agents with their different mechanisms of action into the Stanford V regimen may increase effectiveness while maintaining a favorable toxicity profile with respect to fertility and a low risk of secondary leukemia. On this basis, we propose a new regimen, Stanford VI, for patients with bulky and advanced HD with 3 or more risk factors.

Patients will receive chemotherapy weekly for 19 weeks, alone or followed by irradiation as indicated per protocol guidelines.

* Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
* Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
* Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
* Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
* Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
* Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
* Gemcitabine 1250 mg/m2 IV w 13,15,17,19
* Vinorelbine 25 mg/m2 IV w 13,15,17,19
* Prednisone 40 mg/m2 PO qod w 1-10, taper

Eligibility Criteria:
Inclusion Criteria:

* Untreated, locally extensive or advanced stage classical Hodgkin's disease
* 3 or more adverse risk factors
* Age \> 18 years and \< 70 years.
* No prior invasive malignancies for \> 5 years except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
* ECOG performance status 0 to 2
* WBC \> 4000/µL
* Platelets \> 100,000/µL
* Creatinine \< 2.0mg/dL
* Bilirubin \< 5.0mg/dL

Exclusion Criteria:

* HIV-positive
* Pregnant or currently breast feeding women
* Lymphocyte predominant Hodgkin's disease
Vitamin D in Egyptian Children With Atopic Dermatitis

There is an emergent evidence demonstrating the role of Vitamin D deficiency in eczema. Vitamin D supplementation with standard treatment yielded positive clinical outcomes for children and adolescents with mild and moderate AD; however, the potential benefit of vitamin D in severe cases remains unclear


Eligibility Criteria:
Inclusion Criteria:

1.diagnosis of severe AD according to Hanifin and Rajka criteria and the Eczema Area and Severity Index (EASI) score

Exclusion Criteria:

1. serious skin disorder other than AD.
2. taking systemic corticosteroids or anti-inflammatory medications, prior vitamin D supplementation
3. receiving oral or topical antibiotics or topical calcineurin inhibitors for at least one week prior to enrollment
4. known gut absorption problem, presence of active skin infection at baseline any known hepatic and/or renal disease.
Central Hemodynamics

Guidelines recommend measuring end organ damage and in particular arterial stiffness in patients with hypertension. However, until now it was not possible to measure arterial stiffness with the use of simple methods. Recently, novel and innovative devices offering determination of arterial stiffness and central hemodynamics from simple and non-invasive arm cuff measurements have now become available. This study therefore evaluates the value of non-invasively measured arterial stiffness and central hemodynamics for guiding antihypertensive treatment in selected patient populations (i.e. elderly patients, patients with diabetes mellitus, patients with heart failure, and patients with resistant hypertension).


Eligibility Criteria:
Inclusion Criteria:

* Patients \>70 years (elderly cohort)
* Patients with diabetes mellitus (diabetes cohort)
* Patients with heart failure (heart failure cohort)
* Patients with resistant hypertension (resistant hypertension cohort)

Exclusion Criteria:

* Patient refuses study participation
* Severe renal failure
* Reduced life expectancy
Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)

The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)


Eligibility Criteria:
Inclusion Criteria:

* Female between 16 to 26 years old
* Has never had Pap testing or have only had normal Pap test results
* Lifetime history of 0 to 4 sexual partners

Exclusion Criteria:

* History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser
* History of severe allergic reaction that required medical attention
* Are pregnant
* Received a marketed HPV vaccine
* Currently enrolled in a clinical trial
* Currently has (or has a history of) certain medical conditions or is currently taking or has taken certain medications (details will be discussed at time of consent)
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder

The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive dyskinesia in subjects with schizophrenia or schizoaffective disorder.


Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), 333.82 (see Appendix 17.1) for at least 3 months prior to screening.
* Be receiving a stable dose of antipsychotic medication for a minimum of 30 days before study start. Subjects who are not using antipsychotic medication must have stable psychiatric status.
* Have the doses of concurrent medications and the conditions being treated be stable for a minimum of 30 days before study start and be expected to remain stable during the study.
* Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study.
* Female subjects must not be pregnant.
* Be in good general health and expected to complete the clinical study as designed.
* Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive).
* Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
* Have a negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and study start, except for any subject receiving a stable dose of benzodiazepine.
* Have a negative alcohol breath test at screening and study start.

Exclusion Criteria:

* Have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening.
* Have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start(nicotine and caffeine dependence are not exclusionary).
* Have a known history of neuroleptic malignant syndrome.
* Have a significant risk of suicidal or violent behavior.
* Receiving any excluded concomitant medication such as reserpine, metoclopramide, stimulants, or tetrabenazine
* Receiving medication for the treatment of tardive dyskinesia.
* Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a history of positive result.
* Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
* Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
* Have had previous exposure with NBI-98854.
Medication Adherence Improvement Support App For Engagement - Blood Pressure

The purpose of this study is to evaluate the impact of the Medisafe smartphone application on blood pressure control and self-reported medication adherence for patients with uncontrolled blood pressure.

The Medication adherence Improvement Support App For Engagement - Blood Pressure (MEDISAFE-BP) trial is a prospective, intent-to-treat randomized control trial that will evaluate the impact of the Medisafe smartphone application on blood pressure control and self-reported medication adherence for patients with uncontrolled blood pressure.

Recruitment will be conducted by Evidation Health, which uses an online strategy to virtually announce, recruit, verify eligibility and enroll participants in clinical studies. Potential study subjects will be evaluated for inclusion and exclusion criteria, will give informed consent, complete the baseline assessment, and then be sent a Bluetooth-enabled home blood pressure cuff to verify that they have uncontrolled blood pressure (systolic blood pressure ≥ 140 mmHg but overall blood pressure ≤ 180/120 mmHg). Patients will be provided with a study overview and blood pressure measurement guide that will outline how to set up the monitor and take an accurate measurement, as well as the standard insert for how to use the home monitor and its associated smartphone application. Blood pressure readings will be electronically transmitted to Evidation Health via an Application Program Interface (API) with the blood pressure monitor manufacturer. Blood pressure will be calculated as the average of two measurements that are taken five minutes apart. Once their blood pressure readings have been confirmed as being elevated, patients will undergo randomization in a 1:1 ratio to intervention or control using simple randomization through a random number generated at the time of study enrollment.

Analyses will be performed by an intent-to-treat basis, where subjects will be analyzed in the groups they are assigned to during randomization. We will use linear regression to assess the impact of Medisafe on the study's two primary outcomes (change in systolic blood pressure and self-reported adherence) between the two study groups, three months after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 - 75 years of age
* Self-reported systolic blood pressure greater than or equal to 140 mmHg
* Self-reported use of 1-3 of the following anti-hypertensive medications (thiazide, CCB, beta-blocker, ACE-I, ARB)
* Systolic blood pressure greater than or equal to140 mmHg (+/- diastolic blood pressure greater than or equal to 90 mmHg), but blood pressure less than or equal to 180/120 mmHg confirmed by home BP-cuff

Exclusion Criteria:

* Current use of a smartphone medication adherence application
* No ownership of a smartphone with iOS or Android operating system
* Currently taking more than 3 anti-hypertensive medications (thiazide, CCB, beta-blocker, ACE-I, ARB) by self report
* Currently undergoing dialysis
* Currently receiving chemotherapy or radiation
* Does not understand English
Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues

This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension

Exclusion Criteria:

* Known contraindication to latanoprost, bimatoprost or travoprost
* Uncontrolled systemic disease
* Active ocular disease other than glaucoma or ocular hypertension
* Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control
Oxytocin Effect on Attention Inhibition

Effects of intranasal oxytocin (24IU) on cognitive control of attention

The cognitive control of attention towards neutral and emotional stimuli represents a key functional domain and disruptions in this domain have been associated with a range of psychiatric disorders. Saccadic eye movement tasks have been used to assess individual differences in the cognitive control of attention and alterations in psychiatric disorders. Recent evidence suggests that the hypothalamic neuropeptide Oxytocin (OXT) may modulate attention allocation and regulation. To this end the present randomized between-subject placebo-controlled experiment examined whether intranasal OXT modulates behavior in an eye-tracking saccade / anti-saccade paradigm in healthy male subjects. The paradigm used non-social (neutral shape) as well as social (happy, sad, angry, fear, and neutral faces) stimuli to explore emotion-specific effects of OXT.

Eligibility Criteria:
Inclusion Criteria:

* Male, healthy participants
* Non smokers

Exclusion Criteria:

* Previous or current medical, psychiatric, neurological disorder
* Regular medication
* Use of any psychoactive substances in the 24 hours before experiment
* Contra-indications for oxytocin
* Contra-indications for eye-tracking data acquisition
Comparison of Polyethylene Glycol With Ascorbic Acid and Oral Sulfate Solution for Bowel Preparation

Colonoscopy is considered by many the preferred mode of screening for colorectal cancer (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate bowel preparation.

For bowel preparation, effective, well-tolerated and safe methods should be applied.

Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel preparation

For direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation

Eligibility Criteria:
Inclusion Criteria:

1. Age, between 20 and 75
2. Patients who were visited the outpatient clinic for National Cancer Cancer or Daehang hospital to undergo colonoscopy

Exclusion Criteria:

* Gastrointestinal obstruction
* Bowel perforation
* Gastric retention
* Ileus
* Toxic colitis or toxic megacolon
* Known allergies to components of the OSS and PEG-Asc
* History of colorectal resection
* History of abdominopelvic surgery within 6 months
* uncontrolled electrolyte imbalance
* hereditary Phenylketonuria
* Severe dehydration status
* seizure
* coma
* Glucose-6-phosphate dehydrogenase deficiency
A Study of HD-tDCS and Cognitive Training to Improve Cognitive Function in MCI

The primary objective of this project is to assess the feasibility of multi-field, extended HD-tDCS (MFE-HD-tDCS) with simultaneous computerized CT as a viable intervention to improve cognitive function in patients with MCI. This double-blinded, randomized pilot clinical trial of repetitive daily HD-tDCS/sham HD-tDCS, administered in combination with CT to subjects with MCI in 3 monthly blocks of 5 daily sessions for a total of 15 sessions will enroll 8 participants.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥50-90 years
2. Right handed
3. Willing and able to undergo all procedures
4. Retains decisional capacity at initial visit
5. Meets criteria for MCI, amnestic type (Petersen, 2004).

Exclusion Criteria:

1. Left handed patients
2. Significant kidney injury requiring hemodialysis
3. Automatic Internal Cardiac Defibrillator (AICD) or Pacemaker
4. Significant congestive heart failure
5. History of clinically significant ischemic or hemorrhagic stroke, or lacune or infarct considered by radiologist likely to cause or contribute significantly to cognitive symptoms
6. History of thalamic lacunar stroke
7. Modified Hachinski Ischemia Score \>4 points
8. History of seizure disorder requiring medication
9. History of brain surgery (for seizure disorder, aneurysms, or benign/malignant tumor)
10. History of HIV/AIDS
11. Severe untreated obstructive sleep apnea
12. Greater than three servings alcohol daily or illicit drug use
13. Major neurologic disorders other than dementia (e.g., MS, ALS)
14. Schizophrenia, bipolar disorder, other serious mental illnesses
15. Other significant medical conditions at investigators' discretion
16. Pregnancy
N-acetyl Cysteine Effect on Liver Function After Mitral Valve Replacement

This study aimed at the impact of the N-acetyl cysteine on the improvement of liver function subsequently on-pum mitral valve replacement. Following a clinical trial design, 34 candidates of on-pump MVR, aged 30 to 70 years, with normal liver and renal function were selected. The candidates were randomly divided into intervention: IV150 mg/ kg N-acetyl cysteine over 15 min, and control groups (normal saline as placebo) (n = 17 in each group).

In a randomized controlled prospective study in a teaching hospital after approval of the ethical committee and informed consent 34 candidates of on-pump MVR, aged 30 to 70 years, with normal liver and renal function were selected. The candidates were randomly divided into intervention: IV150 mg/ kg N-acetyl cysteine over 15 min then 50 mg/kg over 4 hrs, and control groups (normal saline as placebo) (n = 17 in each group).and we will assess the effect of NAC on intra-operative hemodynamics and post-operative its protective rule against oxidative stress and liver dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Age from30 to 65 years
* Both sexes
* Patients undergoing on-pump elective MVR with cold cardioplegia.

Exclusion Criteria:

* • Patient refusal.

  * Allergy to any of the study medications.
  * Emergency procedures.
  * systolic dysfunction left ventricular ejection fraction \<40%.
  * Pre-existing hepatic dysfunction, as evident by elevated liver enzymes and bilirubin which is defined as an increase in liver enzymes AST and ALT \>10 times of baseline.
  * Patients on chronic use of drugs that might affect liver functions, e.g. NSAID, steroids, and anticonvulsants.
Comparative Study of a Smartphone-Linked Self-Monitoring System Versus a Traditional One for Improving Metabolic Control and Compliance to Self-Monitoring of Blood Glucose

The purpose of this study is to demonstrate the superiority of iBGstar as a component of the diabetes treatment vs. traditional blood glucose self-monitoring system for improving glycemic control after 6 months in young patients with type 1 diabetes. The study is intended also to demonstrate the superiority of iBGStar as a component of the diabetes treatment vs. usual blood glucose self-monitoring system for improving the compliance to self monitoring of blood glucose after 6 months.

The planned study duration will be 20 months (5 quarters) with screening/enrollment of 7 months, followed by 2-3 weeks of a qualification phase, a 6 month experimental phase, plus a 6 month follow-up in the post-trial observational phase.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Males and females
* Age between 14-24 years
* Any diabetes duration
* Cared for by the diabetes center for at least 1 year
* HbA1c ≥ 8%
* Basal bolus treatment (any insulin)
* Poor compliance with Self-Monitoring of Blood Glucose (less than 30% of the recommended Blood Glucose measurements recorded in the glucose meter in the two previous weeks, i.e. \<16 Blood Glucose measurements in the last two weeks)
* Written informed consent obtained from patient or legal representative (for minor)

Exclusion Criteria:

* Treatment with other insulin regimen or Continuous Subcutaneous Insulin Infusion
* Refusal or inability to give informed consent to participate in the study
* Patients with short life expectancy
* Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint according to physician's judgment
* Requirement for concomitant treatment that could bias primary evaluation
* Patients with high likelihood of being unavailable for 6 and/or 12 months visits
* Subject is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, other study site staff or relative of study site staff thus considered directly involved in the conduct of the study
* Current addition/abuse of alcohol or drugs
* Severe visual or dexterity impairment
* Patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study
* Pregnant or breast-feeding women
* Subjects unlikely or unable to comply with the Protocol requirements