cyrilzakka/clinical-trials huggingface dataset:
Anger Control Therapy (ACT) With RAGE-Control: An Outpatient Videogame-assisted Therapy for the Treatment of Anger

The purpose of this study is to determine whether adding an interactive biofeedback video game to anger control cognitive behavioral therapy is an effective and feasible treatment.

Current treatments for pathological anger and aggression in youth are lacking in their effectiveness to motivate and engage patients in treatment. As a result, mental health providers encounter challenges due to the limited generalizability of treatment effects to real-world situations outside of the therapist's office. When behavioral treatments fail to show lasting results, children and adolescents are often placed on antipsychotic medication to control their behaviors, which may result in significant toxicity levels and for which there is limited knowledge of the long-term effects on pediatric growth and development. This study tests an interactive biofeedback video game called RAGE-Control (for Regulate and Gain Emotional-Control) as a treatment for youth exhibiting anger and aggression. Treatment with RAGE-Control seeks to motivate children and adolescents to learn and practice coping skills taught in therapy within the environment of a fun and enjoyable video game. The game provides patients a venue to practice self-regulation techniques in response to the increasing stress of the game. Providing patients with the opportunity to refine their self-regulation skills in a fast-paced challenging game is hypothesized to result in greater generalization of therapeutic skills to situations outside of the therapist's office. The goal of the treatment is to decrease patients' feelings of anger, and to increase the patients' levels of control in their emotional and behavioral responses.

Eligibility Criteria:
Inclusion Criteria:

* Ages 10 to17 years old (inclusive).
* STAXI-CA score \>15 on the Trait Anger subscales.

Exclusion Criteria:

* Inability to consent, comprehend, or effectively participate in the study.
* Cognitive impairment, defined as IQ \< 75.
* Change in mood stabilizing and/or anti-psychotic medication dose within 4 weeks of beginning the study or anticipation of medication changes during the study period (10 weeks).
Neurophysiological Attention Test (NAT) for Objective Assessment of Attention Deficit Hyperactivity Disorder (ADHD)

The purpose of this study is develop a new assessment tool for Attention Deficit-Hyperactivity Disorder (ADHD) and to then test its validity (i.e. ability to discriminate between individuals with ADHD and healthy controls).

The purpose of this study is to develop a novel approach and software for analyzing electroencephalography (EEG) data to identify biomarkers of ADHD. Then to test the ability of this assessment tool to differentiate between adults with ADHD and healthy controls by comparing the classification accuracy of the metrics from the new tool to the classification accuracy of existing behavioral tests for ADHD.

Eligibility Criteria:
Inclusion Criteria:

* Specific inclusion criteria for ADHD are:

  1. meet established DSM-5 criteria for ADHD predominately inattentive or combined subtype with clinically significant levels of impairment, diagnosed by structured clinical interview, the Mini International Neuropsychiatric Interview, and corroborating information
  2. Clinical Global Impression-Severity (CGI-S) score ≥ 4 for ADHD
  3. no lifetime history of DSM-5 bipolar disorder, psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse, or substance dependence (except nicotine) as assessed wit the MINI
  4. able in the opinion of the investigator to complete all required study procedures.

Exclusion Criteria:

* Exclusion criteria for both groups are:

  1. History of diagnosis of childhood disorder other than ADHD (e.g. autism, dyslexia)
  2. history of any general medical condition likely to require chronic use of medication with identified CNS effects suspected to alter cognitive performance
  3. history of seizure disorder, brain tumor, other major neurological disorder or head injury resulting in loss of consciousness
  4. serious oxygen deprivation
  5. current psychopathology requiring ongoing treatment with antipsychotic medications, mood stabilizers, benzodiazepines, or anticonvulsants
  6. current untreated psychopathology which is rated to be primary in terms of severity (greater than ADHD severity)
  7. current treatment with guanfacine.
Hormones Inflammation and Thrombosis

The investigators are attempting to determine if the response to aspirin in women is related to the level of estrogen and progesterone that a woman has.

Thrombosis plays a significant role in both acute coronary syndromes (ACS) and early saphenous vein graft (SVG) failure. Women with coronary heart disease have higher levels of the inflammatory mediator thromboxane, which is produced by platelets, monocytes, macrophages and the endothelium. Data show that higher levels of urinary thromboxane (UTXB2) are associated with SVG failure 6 months after Coronary Artery Bypass Graft (CABG). Women in the study cohort had higher levels of UTXB2 and higher odds of graft failure when compared to men. The elevated urinary thromboxane seen in the women in our study cohort may represent a marker and/or an etiology of thrombosis.

Are the levels of UTXB2 higher in women due to hormonal differences? In a prior pilot study we investigated whether hormonal levels are associated with changes in urinary thromboxane. We looked at hormonal and urinary thromboxane levels in 48 postmenopausal and 52 premenopausal women. We found that postmenopausal women had higher levels of UTXB2 than did premenopausal women (2495 vs. 2299, p=.02) and that in premenopausal women a higher estrogen/progesterone ratio was associated with the highest levels of urinary thromboxane.

The goal of the current study is to measure the response to seven days of aspirin administration as it relates to urinary thromboxane levels in pre and post-menopausal women. With this study we will be able to examine the change in UTXB2 comparing the premenopausal to post menopausal women. We will also be able to see if the change in UTXB2 in response to aspirin is affected by hormone levels in the premenopausal women. Lastly this study will provide reference data for more far-reaching studies exploring how global changes in hormonal balance (as seen in pregnancy or menopause) or in the level of inflammation (as seen in aging or with Coronary Artery Disease (CAD) risk factors), affect UTXB2 and platelet hyperreactivity.

Eligibility Criteria:
Inclusion Criteria:

1. Women age 18-80
2. Signed informed consent.

Exclusion Criteria:

1. History of CAD, Cerebrovascular Accident (CVA) or Peripheral Artery Disease (PAD),
2. On chronic aspirin therapy,
3. On chronic NSAID therapy.
4. Chronic anticoagulation with coumadin,
5. Known thrombocytopenia (Platelet count \< 100,000),
6. Pregnancy (self-report),
7. Currently on any type of contraceptive or hormone replacement therapy,
8. Hysterectomy and/or oophorectomy.
9. Recent GI bleeding
10. Bleeding diathesis
11. Chronic Systemic Infection
A Comparison of the Effect of Carvedilol and Metoprolol on Airways Tone in Patients With Heart Failure

This study looks at the effect of two drugs (carvedilol and metoprolol) which are used for patients with CHF (chronic heart failure).

These agents are beta-blockers and, although effective in heart failure, may cause increases in airways tone and thus limit air getting into the lower parts of the lungs. Carvedilol is more active at blocking the receptor that opens up the airways and therefore theoretically may be more likely to reduce airways tone than metoprolol, although this has never been studied in patients with heart failure, and that is the purpose of the present study.

We are looking to enrol 45 patients with heart failure and mild obstruction to the flow of air in their lungs. Patients will be randomised to either carvedilol or metoprolol (standard doses). Following a minimum of 2 weeks of therapy of study medication the patient will undergo a study day involving an assessment of their lung function, an assessment of their heart failure, a "living with heart failure" questionnaire, blood tests and blood pressure and heart rate readings.

Patients will then be crossed over to the alternate medication. Following 2 weeks on the target dose the patient will undergo their second study day which will be the same as the first.

The results obtained from each study day will be compared.


Eligibility Criteria:
Inclusion Criteria:

* males and females over 18 years of age
* Documented CHF (NYHA class II-IV symptoms)
* Airflow obstruction defined as patients with symptomatic obstructive respiratory disease as manifest by any of the following Symptoms of wheeze, primarily attributed to airflow obstruction Requirement for intermittent or regular bronchodilator therapy FEV1 less than 70% predicted pre-salbutamol
* Confirmed written informed consent.
* Clinically indicated to receive β-blockade.
* No evidence of heart block on ECG.
* Patients will be in one of the following categories:

Currently on carvedilol Currently on Toprol-XL or Metoprolol tartrate Currently on bisoprolol Clinically indicated to receive β adrenoceptor blockade but not currently prescribed a β-blocker.

Exclusion Criteria:

* Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method.
* Patients who had received an investigational new drug within the last 4 weeks.
* Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
* Laboratory parameters:

Creatinine \>0.30 mmol/l Liver function tests 3x ULN

* Recent (\<12 months) myocarditis
Sulphonylurea Receptor Mutation and Responsiveness to Gliclazide - a Pilot Proof of Concept, Randomised Cross-over Study

Gliclazide has greater glucose lowering efficacy than glibenclamide among type 2 diabetes mellitus patients with minor haplotype (K23/A1369) at the KCNJ11/ABCC gene locations.

Sulphonylurea (SU) is a glucose-lowering agent used widely to treat type 2 diabetes mellitus (T2DM). SU promotes insulin secretion from the pancreatic islet beta cell via binding and inhibition of the ATP-sensitive potassium (KATP) channel. The KATP channel is made up of two subcomponents, an inner Kir6.2 K+ channel (coded by the KCNJ11 gene) and an outer SU receptor 1 (SUR1) (coded by the ABCC8 gene). Although all SUs are mechanistically similar in terms of increasing insulin secretion, they bind to distinct regions of Kir 6.2 and SUR1 to exert their function. Different types of SU (e.g. tolbutamide, glibenclamide, glipizide, glimepiride and gliclazide) can therefore be grouped by their binding sites (A/B/A+B site) on the KATP channel \[3\]. Interestingly, the KCNJ11 E23K (rs5219) variant was shown to confer susceptibility to T2DM and the ABCC8 S1369A (rs757110) variant was found to be in complete linkage disequilibrium with it i.e. inherited together as a genetic block (haplotype). A recent in vitro molecular study suggested that the minor haplotype (K23/A1369) of KATP channel is sensitive to inhibition by gliclazide (binds to A-site) but not glibenclamide (binds to A+B site), and that the increased responsiveness to gliclazide was largely due to the A1369 allele. Understanding how the response to these two SUs may vary with the presence of the minor haplotype (K23/A1369) would therefore be beneficial for customization of patient treatment to achieve better clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Age 21-65
* HbA1c \>8.0% on two consecutive visits

Exclusion Criteria:

* Currently taking insulin at a regime more complex than basal insulin
* Not willing to perform self-blood glucose monitoring (SBGM)
* Renal impairment i.e. eGFR\<50mls/min
* Pregnancy or unwilling to practice adequate contraception
* Taking other medications that may affect blood glucose e.g. systemic glucocorticoids.
Modified Suanzaoren Decoction Versus Eszopiclone for the Treatment of Chronic Insomnia Disorder

The purpose of this study is to observe the cognitive function and clinical efficacy of modified Suanzaoren decoction and eszopiclone in the treatment of chronic insomnia disorder patients, and to investigate the possible neural mechanisms using MRI techniques.

The subjects were enrolled and divided into two treatment groups using the randomized numeric table method. Each group received either modified Suanzaoren decoction or eszopiclone treatment for a period of 4 weeks. General demographic data were collected, and changes in sleep, mood, cognitive function, and rs-fMRI before and after treatment were observed. Assessment tools included the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Hamilton Anxiety Scale (HAMA), and Hamilton Depression Scale (HAMD) for subjective measures, as well as the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and polysomnography (PSG) for objective evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Have adequate comprehension ability, with at least 9 years of education.
* Western medical diagnosis criteria (meeting the diagnostic criteria for chronic insomnia disorder in ICSD-3).
* Patient's subjective dissatisfaction with either the total duration or quality of sleep: difficulty falling asleep, difficulty maintaining sleep, or early awakening.
* Frequency of sleep problems: occurring at least 3 nights per week, and persisting for at least 3 months.

Exclusion Criteria:

* Individuals who have used sedatives or hypnotics, or psychiatric medications in the week prior to enrollment.
* Individuals who regularly consume strong tea, have a high smoking volume, or are dependent on coffee.
* Women who are pregnant or breastfeeding.
* Patients with severe primary diseases such as severe cardiovascular and cerebrovascular diseases, other mental disorders, or severe obstructive sleep apnea syndrome.
* Individuals with allergies or multiple drug allergies.
Comparison Between Unihemispheric and Bihemispheric TCDS in Subacute Ischemic Stroke Patients

This is a randomized clinical trial to study the effect of tDCS in participants with subacute ischemic stroke, the study participants will be randomly assigned into three groups; bihemispheric, unihemispheric and sham group.

Despite the central origin of stroke affecting the primary motor cortex M1, majority of the rehabilitative techniques of physical therapy and occupational therapy practice depending peripheral methods for gaining motor functions. There is a great need to develop methods in order to improve the outcome of physical or medical rehabilitation and enhance long-term functional outcome. Many researches' work over the past several years have inspected the use of transcranial direct current stimulation (tDCS) to promote the advantageous effect of neurological rehabilitation.

The aim of This study Is to compare between the effect of unihemispheric and bihemispheric tDCS on the motor outcome, and spasticity in sub-acute ischemic stroke patients.

Thirty sub-acute ischemic stroke patients participated in the study, randomly assigned to one of three groups-tDCS bihemispheric or unihemispheric or sham group. Those patients had stroke in the last 3 months at maximum with NIH stroke score less than 25. ActivaDose tDCS (USA), the only FDA cleared device available for tDCS used in the clinical study to deliver noninvasive brain stimulation, consisted of 20 minutes of 2 mA in each session for twelve sessions three sessions per week. All participants received physiotherapy and rehabilitation therapy was tailored to meet all patients' deficits, and lasted a total of 45 minutes per day, 3 days per week for four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Those patients had stroke in the last 3-6 months.
* Subcortical stroke of middle cerebral artery (MCA), caused unilateral hemiplegia.
* National institute of health stroke scale (NIHSS) motor deficits section with score 2 to 15.

Exclusion Criteria:

* Patient with second onset of stroke or history of Transient ischemic attack (TIA)
* Metallic Implant or heart pacemakers.
* Primary cerebral or subarachnoid hemorrhagic stroke.
* Seizure or epilepsy or history of epilepsy at the family.
* Intracranial abscess or brain tumor.
* Cardiovascular disease myocardial infarction, heart failure (unstable cardiac status).
* Atrial Fibrillation or paroxysmal AF in the last 30 days.
* Congenital heart diseases.
* Presence of any other neurological or psychiatric disorder.
* Cognitive/consciousness disorders.
* Oher conditions should be excluded (e.g. tumor, cancer, rheumatologic, Lung disease related to infection, renal/ hepatic diseases, deep venous thrombosis and autoimmune diseases).
* Speech disorders (Dysarthria \& Aphasia).
* NIH Stroke score above 25, will be excluded.
* Patients who underwent thrombolytic therapy or any vascular interventions.
Sirolimus & Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor HCT

GVHD prophylaxis of sirolimus and mycophenolate mofetil for patients undergoing matched related allogeneic transplant for acute and chronic leukemia, MDS, high risk NHL and HL

To explore the novel combination of sirolimus and mycophenolate mofetil (MMF) as graft versus host disease (GVHD) prevention in HLA matched related donor blood or marrow transplantation (BMT). This study will report the toxicities associated with this drug combination and also explore possible correlations between specific blood cell types and antibody production during this therapy.

Eligibility Criteria:
Inclusion Criteria:

* Disease Categories: (one of the following)

  * AML, age 2 - 60 years beyond 2nd remission or relapsed/refractory disease
  * AML, age 51-60 years of age, in first or subsequent remission or relapsed/refractory disease
  * AML with multilineage dysplasia
  * ALL, age 2 - 60 years beyond 2nd remission or relapsed/refractory disease
  * ALL, age 51 - 60 years in first or subsequent remission or relapsed/refractory disease
  * CML Beyond 2nd chronic phase or in blast crisis
  * MDS; Includes World Health Organization classifications of refractory anemia with excess blasts-1 (RAEB-1), RAEB-2 and therapy-related MDS
  * Myeloproliferative disorders; MDS with poor long-term survival including myeloid metaplasia and myelofibrosis
  * High risk NHL in first remission
  * Relapsed or refractory NHL
  * HL beyond first remission
* Males and females of any ethnic background 2 - 60 years of age
* Karnofsky Performance Status ≥ 70% or Lansky performance status \> 70% for patients \< 16 years of age.
* Matched related donor identified: 6/6 HLA-A, B and DRB1
* Willingness to take oral medications during the transplantation period
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Prior myeloablative allogeneic or autologous HCT
* HIV infection
* Pregnant
* Lactating females
* Evidence of uncontrolled active infection
* Organ Dysfunction:
* Serum creatinine \> 1.5 mg/dL or 24 hour creatinine clearance \< 50 ml/min
* Direct bilirubin, ALT or AST \> 2 x ULN
* In adults DLCO \< 60% predicted and in children room air oxygen saturation \< 92%
* In adults, left ventricular ejection fraction \< 45% and in children, shortening fraction \< 26%
* Fasting Cholesterol \> 300 mg/dL or Triglycerides \> 300 mg/dL while on lipid-lowering agents.
* Patients receiving investigational drugs unless cleared by the PI.
* Patients with prior malignancies except basal cell carcinoma or treated carcinoma in-situ.
* Cancer treated with curative intent \> 5 years will be allowed.
* Cancer treated with curative intent ≤ 5 years will not be allowed with PI approval.
Difluoromethylornithine (DFMO) Chemoprevention of Skin Cancer in Organ Transplant Recipients

This is a double blind, placebo controlled study of 52 patients who are at least one-year post-solid organ transplant. Subjects will receive either 12 months of DFMO or a placebo. The specific aims are to determine if DFMO at 500 mg daily will be well tolerated for 12 months and not affect organ transplant viability; will inhibit 12-O-tetradecanoylphorbol-13-acetate (TPA)-induced ornithine decarboxylase (ODC) in skin biopsies by approximately 50% for the 12 months of therapy; and will be able to decrease polyamine levels in skin biopsies for the 12 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* \>1 year post-solid organ transplant of kidney, liver, pancreas, pancreas/kidney
* Adequate organ function
* Hearing age/gender appropriate
* At high risk for developing skin cancer
* Immunosuppressant levels and doses show stable graft function

Exclusion Criteria:

* Use of concomitant Retin-A, Efudex, Accutane or psoralen and ultraviolet light A (PUVA)
* Systemic therapy for cancer treatment or prophylaxis
* Use of concomitant azathioprine, antiseizure medications, non-steroidal anti-inflammatory drugs \[NSAIDs\] (other than cardioprotective doses of aspirin)
Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Ocular hypertension or primary open-angle glaucoma
* Females of non-childbearing potential
* Subject requires IOP-lowering therapy in both eyes
* IOP ≥ 22 mm Hg and ≤ 34 mm Hg
* Has a visual acuity score of 20/100 or better in each eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Active ocular disease
* Alteration of existing chronic systemic medications
* Known allergy or sensitivity to the study medications
* Ophthalmic corticosteroids
* Visual field loss which in the opinion of the investigator is functionally significant
* History of ocular laser, intraocular surgery, or refractive surgery
An N-of-1 Study of Homeopathic Treatment of Fatigue in Patients Receiving Chemotherapy

Fatigue is frequently identified as one of the most troublesome symptoms in cancer patients and there are very few conventional therapies which can address the symptom of fatigue in patients who are undergoing cancer treatment.

This study will be testing whether the administration of a complementary therapy (individualized homeopathy) to a patient undergoing chemotherapy treatment is feasible and whether this treatment can lessen the fatigue symptoms of adults. The study will also test whether the n-of-1 study design is feasible in this population.

This is an n-of-1 pilot trial of individualized homeopathic treatment of fatigue in a single adult who is undergoing any type of chemotherapy administered intermittently (i.e. not continuously). The participant will have a homeopathic consultation within 3 days of a round of chemotherapy ("treatment period") and will be administered either verum or placebo according to a binary randomization allocation sequence unknown to both the clinician and participant. During the subsequent treatment period the participant will be given the other allocation (verum or placebo). The following pairs of allocations will also be randomized with treatment continuing for as long as the participant is undergoing chemotherapy treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with any type of cancer. Patient may have newly diagnosed, relapsed or a second malignant disease.
* Receiving any type of cytotoxic chemotherapy with 6 or more cycles post study enrollment administered intermittently every two or three weeks with no planned radiation treatment.
* Is experiencing fatigue due to the chemotherapy treatments. (or has a score of 2 or higher on the fatigue item of the Symptom Distress Scale)
* Above 18 years of age.
* Able to ingest medications in lactose/sucrose globule or liquid form.

Exclusion Criteria:

* Previous history of allergy to the homeopathic products.
* Pregnant or lactating