cyrilzakka/clinical-trials huggingface dataset:
Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation

The purpose of this study is to investigate whether Risperidone is effective in children and adolescents with severe mood dysregulation.

Severe Mood Dysregulation(SMD) is a new construct in children and adolescents characterized by persistent and non episodic irritability, hyperarousal and emotional reactivity.

This is an open label trial using Risperidone in children and adolescents( 7-17 years old) diagnosed with SMD.

We hypothesized that Risperidone would improve externalizing symptoms as well as depressive and/or maniac symptomatology. We also consider the effect of the pharmacological intervention in the co-morbid disorders especially ADHD.

Eligibility Criteria:
Inclusion Criteria:

* Diagnose of Severe Mood Dysregulation
* 7-17 years
* IQ \> 70

Exclusion Criteria:

* Bipolar disorder
* IQ\<70
* Psychosis
Manual Therapy Techniques on Cervical Spine and Psychological Interaction

Manual therapy (MT) techniques applied over cervical region have over both local (neck) and distant regions (elbow) in both asymptomatic and symptomatic populations. Neurophysiological mechanisms are hypothesized to explain the underlying effects, with effects originating from peripheral mechanisms, spinal cord and supraspinal mechanisms.

There is also an increasing interest in the study of the role of psychological variables in the treatment success in neck pain. Psychological variables, like anxiety catastrophizing or kinesiophobia are related to poor prognosis in the development of pain outcomes and disability in neck pain, being the Fear-Avoidance Model of pain one of the most tested models in this field.


Eligibility Criteria:
Inclusion Criteria:

* Neck pain

Exclusion Criteria:

* myelopathy
* fracture
* infection
* dystonia
* tumor
* inflammatory disease
* fibromyalgia
* or osteoporosis
Pilot Study of 18F-FMISO PET/CT and MRI Imaging to Explore Tissue Hypoxia and Arteriovenous Shunting in Subjects With Recurrent Glioblastoma Before and After Bevacizumab Treatment

Subjects with recurrent glioblastoma who are candidates for bevacizumab treatment according to standard of care will be eligible for this study. Positron emission tomography (PET/CT) imaging will use the investigational radiotracer \[18F\]FMISO to image the brain and evaluate for hypoxia pre and post therapy.. Subjects will also undergo up to three Brain MRIs.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be ≥ 18 years of age
* Biopsy proven glioblastoma
* Must meet one of the following criteria:
* Recent surgery (within 2 months) showing recurrent glioblastoma with measurable (20 mm in 2 dimensions) residual tumor.

Radiologic evidence of recurrent tumor based on conventional and advanced MRI findings.

* Recommended for clinically indicated bevacizumab therapy
* Life expectancy of greater than 3 months in the opinion of an investigator or treating physician.
* Karnofsky performance status ≥ 60
* Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

* Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
* Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
* Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
* Less than 3 months from finishing the most recent radiation or immunotherapy.
* Contraindications to MRI or use of gadolinium contrast
* Only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must understand and be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Pregnant women, children, fetuses, neonates, or prisoners are not included in this research study.
Exercise Interventions, Running Biomechanics and Injury in Novice Runners

The purpose of this study is to understand the effects of muscle strengthening and balance exercise interventions on muscle strength, running mechanics and postural control in novice recreational runners. Participants will be assessed before and after they engage in an 8-week exercise intervention program.


Eligibility Criteria:
Inclusion Criteria:

* Novice recreational runners
* Less than one year of running experience
* Run at least twice a week for a total weekly distance between 5 and 15 km as your main form of physical activity
* 18-50 years of age

Exclusion Criteria:

* Neurological abnormalities or lower extremity injury or pain within three months of enrollment.
* No extensive history with balance training or isolated ankle strengthening within the last year.
Perfusion and Diffusion Magnetic Resonance Imaging, and Phosphorylation of Circulation Endothelial Cells to Determine Anti-anogenic Effect of Chemotherapeutic Regimens in Colorectal Liver Metastasis Patients

The purpose of our study is to establish the accuracy of the perfusion MRI parameters and the availability of the VEGFR2 signaling assay using phosphospecific flow cytometry in predicting the response of liver metastasis from colorectal cancer to treatment with antiangiogenic agent.

The purpose of our study is to establish the accuracy of the perfusion MRI parameters and the availability of the VEGFR2 signaling assay using phosphospecific flow cytometry in predicting the response of liver metastasis from colorectal cancer to treatment with antiangiogenic agent.

IRB approval will be obtained to enroll 60 naïve patients (30 patients who will get antiangiogenic agent (Avastin) combined chemotherapy and 30 patients who will get chemotherapy without antiangiogenic agent) with liver metastasis from colorectal cancer. MRI and blood test (VEGFR2 signaling assay) will be undergoing at three time points in the patients with Avastin chemotherapy; at baseline (pretreatment), 3 days after Avastin alone treatment, 3 days after Avastin combined chemotherapy (about 10 days after initial Avastin alone treatment). MRI and blood test (VEGFR2 signaling assay) will be undergoing at two time points in the patients who will get chemotherapy without antiangiogenic agent; at baseline (pretreatment), 3 days after chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have single or multiple liver metastasis from colorectal cancer
* Patients willing to undergo the study procedure
* Patients who are fully informed about the study and have signed the informed consent form
* 60 patients (30 patients who will get antiangiogenic agent(Avastin) combined chemotherapy and 30 patients who will get chemotherapy without antiangiogenic agent)

Exclusion Criteria:

* Patients (men or women) under 20 years of age
* Patients who have previously entered this study
* Patients who have received or will receive any investigational drug 48 hours before injection of the study drug or during study participation
* Women who are pregnant, lactating or who are of childbearing potential and have not had a negative pregnancy test at baseline visit
* Patients not eligible to contrast media injection according to product labeling
* Patients with a contraindication for MRI or CT
* Patients with impaired renal function (e.g. acute renal failure) or patients on dialysis
PrEP Affect Regulation Treatment Innovation

This multi-site randomized controlled trial enrolling sexual minority men who use stimulants and are currently taking pre-exposure prophylaxis (PrEP). This randomized controlled trial will test the efficacy of a PrEP Affect Regulation Treatment Innovation (PARTI) condition comprised of a 5-session positive affect intervention delivered during smartphone-based Contingency Management (CM) for directly observed PrEP doses (PARTI+CM) compared to an attention-control condition delivered during CM. The primary outcome is HIV acquisition risk measured using a combination of tenofovir-diphosphate levels in dried blood spots that are indicative of sub-optimal adherence to PrEP and recent condomless anal sex.


Eligibility Criteria:
Inclusion Criteria:

* Assigned male at birth
* Identifies as male
* Age 18 or older
* Reads and speaks English
* Reports condomless anal sex (CAS) with men in the past 6 months
* self-reported HIV negative
* Active prescription for daily oral PrEP for at least 2 months and reports any non-adherence in the past month OR initiated daily oral PrEP in the past 2 months, regardless of self-reported adherence
* Has an iPhone or Android smartphone
* Screens positive for a moderate or severe stimulant use disorder with an abbreviated version of the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST; total score of 4 or more) OR reports using stimulants at least weekly in the past 3 months.
* Lives in California or Florida with no plans to move out of state in the next 6 months

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Unwilling to upload upload 3 video recordings of directly observed PrEP doses using a smartphone application
* Identifies as transfeminine (e.g., transgender woman)
* Unable or Unwilling to provide dried blood spot (DBS) specimen at baseline
* Switched from daily oral PrEP with disoproxil fumarate (TDF) to daily oral PrEP with tenofovir alafenamide (TAF) in the past 5 months
Feasibility of a Brief Trauma-informed Yoga Intervention for Anxiety During the Coronavirus Disease (COVID-19) Pandemic

This study will help the investigators understand whether it is feasible and acceptable for people to practice trauma-informed yoga using a pre-recorded video. This study will also explore the immediate effects of trauma-informed yoga on anxiety, mindfulness, and body awareness. The results of this study will inform future research on remote delivery of trauma-informed yoga for supporting psychological wellbeing.

Emerging data shows a high prevalence of anxiety during the first several months of the COVID-19 pandemic in the United States. Accordingly, there have been calls for supportive interventions for psychological health during the pandemic. Due to physical distancing requirements, supportive interventions for psychological health will be most accessible if they can be administered remotely. Trauma-informed yoga may support psychological health during the COVID-19 pandemic, but research on remote delivery of trauma-informed yoga is needed. The present study will evaluate the feasibility and acceptability of trauma-informed yoga delivered remotely. In this study, the investigators will create an online delivery platform within REDCap, a secure web application for research, that 1) hosts a 45-minute video of a trauma-informed yoga practice, and 2) collects data on participants' present moment experience of anxiety, mindfulness, and body awareness immediately before and after the yoga practice. Feasibility and acceptability data will allow the investigators to evaluate recruitment methods and refine the delivery method of trauma-informed yoga in a way that aligns with participant preferences. The investigators will also evaluate the short-term effects of trauma-informed yoga on state anxiety, state mindfulness, and body awareness. This study will allow the investigators to pilot the remote delivery of trauma-informed yoga during the ongoing, highly stressful COVID-19 pandemic and further develop trauma-informed yoga as a supportive intervention for psychological health.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Has an internet connection
* Willing to try a gentle yoga practice

Exclusion Criteria:

* Cannot read or understand English
A Pilot Study of Nutritional Status in Patients With Huntington's Disease

It is known that weight loss is a poor prognostic marker in HD, but it is not known which dietary interventions are optimal at different stages of the disease. Current guidelines for HD treatment are informed only by studies in people with other causes of weight loss. Our long term goal is to create the evidence base for improved nutritional management in HD. This study will pilot the tools to inform the development of clinical trials protocols. We want to know which measures can be used by patients manifesting obvious clinical features of HD, and which are most helpful in detecting clinically meaningful changes in nutrition status.

Huntington's disease (HD) is a complex autosomal dominant disorder of (generally) adult onset. The clinical features of HD are cognitive decline, psychiatric disturbance, personality change and movement disorder. Although by EU definition a rare disease, better management and establishment of clinics for care of HD around the world have led to recognition of that the condition is much more common than previously considered.

Grampian has one of the longest established clinics for managing HD worldwide, and we now care for more than 150 people at different stages in HD, making us one of the largest five specialist clinics in the UK. Members of our team have led the production of European guidelines for HD management, and within this project, we have highlighted the importance of nutrition in HD. Weight loss is well documented as a clinical feature of all stages of Huntington's disease (HD). However, its metabolic basis is poorly understood and appetite has not been formally studied in patients with the condition. Furthermore, the composition of weight loss - muscle or fat has been little studied and modern nutrition assessment tools have not been applied in this cohort. It is known that weight loss is a poor prognostic marker in HD, but it is not known which dietary interventions are optimal at different stages of the disease. Current guidelines for HD treatment are informed only by studies in people with other causes of weight loss. The long term goal of this study is to create the evidence base for improved nutritional management in HD. This study will pilot the tools to inform the development of clinical trials protocols. The aim is to identify which measures can be used by patients manifesting obvious clinical features of HD, and which are most helpful in detecting clinically meaningful changes in nutrition status.

Eligibility Criteria:
Inclusion Criteria:

* stage 2 or 3 Huntington disease

Exclusion Criteria:

* unable to give consent
A Safety and Feasibility Study of Enteral LVT vs. Standard of Care for Seizure Control in Pediatric CM

Pediatric cerebral malaria (CM) affects more than 3 million children each year killing \~20% and leaving one third of survivors with long term neurologic and psychiatric sequelae. Seizures occur commonly with CM and are associated with an increased risk of death and neuropsychiatric disabilities. In this Malawi-based, safety and feasibility study of enteral levetiracetam in pediatric CM, the investigators will lay the groundwork for future efficacy studies aimed at improving seizure control and ultimately decreasing the neurologic morbidity of pediatric CM.

Cerebral malaria (CM) affects \~3 million children each year, primarily in sub-Saharan Africa. Antimalarial medications can rapidly clear P. falciparum parasites, but mortality rates remain high (12-25%). Survivors do not escape unscathed--\~30% experience neurologic sequelae including epilepsy, behavioral disorders and gross neurologic deficits. Acute seizures occur commonly in CM and are associated with higher neurologic morbidity and mortality. Seizure management in malaria endemic regions is challenging because the available antiepileptic drugs (AED) induce respiratory suppression and assisted ventilation is unavailable. More optimal seizure control may improve neurologic outcomes in pediatric CM survivors, especially if the medication used is affordable and can be delivered safely and easily in resource limited settings. The investigators conducted a dose- escalation study detailed elsewhere (NCT01660672) to determine the optimal dose for use in this safety and feasibility study of enteral levetiracetam (LVT) for seizure control in children with CM and seizures admitted to Queen Elizabeth Central Hospital in Blantyre, Malawi. Enteral LVT given via nasogastric tube (NGT) rather than an intravenous (IV) formulation will be used since LVT has excellent enteral bioavailability and IV formations are not affordable in most malaria-endemic regions. LVT 40mg/kg followed by 30mg per kg Q12 hourly. Children admitted with cerebral malaria and seizures will be randomized to LVT vs. standard of care with phenobarbital as needed comparing seizure control, safety, and neurological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Comatose with Blantyre Comas Score ≤ 2
* P. falciparum parasitemia via thick blood film or rapid diagnostic test
* Active seizure in past 24 hours

Exclusion Criteria:

* Serum creatinine \> 2mg/dL
* Pre-admission/concomitant treatment with antiretroviral medications for HIV (ARVs), antituberculous treatments(ATTs), or chronic use of any other enzyme-inducing medications
Study Assessing the Efficacy and Safety of Octreotide Acetate in Patients With Acromegaly, With Micro or Macroadenomas

The purpose of this study is to evaluate the efficacy of octreotide acetate to decrease GH and IGF-I levels in acromegalic patients, with microadenomas (≤ 10 mm) or macroadenomas (\> 10 mm).


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 - 80 years.
* Newly diagnosed or previously treated acromegalic patients.
* Lack of suppression of GH nadir to \<1.0 microg/L, after oral administration of 75 g of glucose (OGTT).
* IGF-I levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender).

Exclusion Criteria:

* Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass.
* No evidence of pituitary adenoma on Magnetic Resonance Imaging (MRI).
* Symptomatic cholelithiasis.
* Unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or a history of acute myocardial infarction within the three months preceding study entry.
* Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or persistent ALT, AST, alkaline phosphatase 2 x \> upper limit of normal, or total bilirubin 1.5 x \> upper limit of normal.
* Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control. Medically acceptable methods include oral birth control pills, intrauterine devices, or mechanical methods (e.g. vaginal diaphragm, vaginal sponge or condom with spermicidal jelly). If oral contraception is used, the patient must have been practicing this method for at least two months prior to the screening visit and must agree to continue the oral contraceptive throughout the course of the study, and for one month after the study has ended.
* History of immunocompromise, including a positive HIV test result (ELISA and Western blot).

Other protocol-defined inclusion/exclusion criteria may apply
A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] Palbociclib (PD-0332991) In Healthy Male Volunteers

This will be an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of PD-0332991 in approximately 6 healthy male subjects receiving a single oral 125 mg dose of PD-0332991 containing approximately 100 microcuries of \[14C\]-PD-0332991. Subjects will be checked in to the research unit from approximately 12 hours prior to dosing and remain in house until greater than 90% of the administered radioactivity is collected from bodily excreta or until less than 1% of the administered radioactivity is recovered from excreta on consecutive days. This study will investigate the extent of involvement of the renal and hepatic systems in the elimination of PD-0332991 and will seek to identify the compound's major metabolites.


Eligibility Criteria:
Inclusion Criteria:

* A Healthy Male Volunteer between 18 and 55 years of age inclusive
* A Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight \>50kg
* A signed informed consent document

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular,hepatic,psychiatric, neurologic, or allergic disease.
* A positive urine drug or urine cotinine screen.
* Concurrent use of herbal or prescription medications or treatment with an investigational drug within 30 days or 5 half-lives preceding first dose of study medication.
* Subjects whose occupation requires exposure to radiation or monitoring of radiation exposure.
* Subjects with a history of irregular bowel movements (eg, regular episodes of diarrhea or constipation, irritable bowel syndrome (IBS) or lactose intolerance).