cyrilzakka/clinical-trials huggingface dataset:
Intrinsic Optical Imaging Study to Map Neocortical Seizure in Human Epilepsy Patients

The purpose of this study is to develop a technique for the intraoperative identification of human functional and epileptiform cortex using intrinsic signal imaging. The investigators propose that the ability to optically monitor neuronal activity in a large area of cortex in "real-time" will be a more sensitive and time-saving method than the electrical methods currently available. The applications of this technique will not only theoretically increase the safety and efficacy of many of neurosurgical procedures, but will be useful as an investigational tool to study human cortical physiology.

Epilepsy is a disease affecting 1-2% of the population. Currently, the only known cure for epilepsy is surgery, which is much more effective at eliminating seizures arising from the medial temporal lobe compared with the neocortex. The problem with neocortical epilepsy is that the population of neurons underlying each epileptiform discharge varies over time. In addition, the spatial relationship between interictal events and the ictal onset zones, which are critical in defining the region of epileptogenesis, is not well understood and essential to the surgical treatment of epilepsy. Electrophysiological recording methods, although currently the "gold standard" in mapping epilepsy, are inadequate to address these questions based on restrictions due to volume conduction or sampling limitations. Optical recording techniques can overcome many of these limitations by sampling large areas of cortex simultaneously to provide information about blood flow, metabolism and extracellular fluid shifts that are intimately related to excitatory and inhibitory neuronal activity. In fact, optical recordings may actually be more sensitive to certain aspects of epileptic activity than electrophysiologic recordings. The goal will be to translate these findings into the operating room and map human neocortical epilepsy with the same optical techniques. Outcome following surgical resections to treat neocortical epilepsy will be correlated with the optical maps to determine the utility of intrinsic signal imaging in guiding brain surgery. These experiments will set the groundwork for implementing optical recordings in general clinical practice as a novel technique for mapping and predicting human seizures.

Eligibility Criteria:
Inclusion Criteria:

* Medically intractable epilepsy
* Subjects undergoing neurosurgical operations requiring cortical mapping

Exclusion Criteria:

* Subjects NOT undergoing neurosurgical operations requiring cortical mapping.
Study of the Effectiveness and Safety of Darunavir/Cobicistat (DRV/c) Containing Regimens in Routine Clinical Practice

This is a retrospective observational study of patients who have taken a regimen containing DRV / c at least 24 weeks prior to study initiation

The study will include 750 patients and will record data at 24 weeks. The study will also record data at 48 weeks for those patients whom these data are available

Eligibility Criteria:
Inclusion Criteria:

* Patients with HIV infection
* Inform consent document.
* To have initiated therapy containing DRV / c and have a follow-up of at least 24 Weeks.

Exclusion Criteria:

* Not having evaluable clinical data of the patient
* Patients not routinely followed in the center
* Patient less than 18 years of age.
Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema

The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC) 1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.

Approximately 60 subjects will be enrolled to ensure 52 subjects complete the study (39 subjects: active treatment and 13 subjects: positive control).

Adults and children (ages 12 and over) will receive either a marketed or not yet marketed investigational product for the treatment of eczema. Subjects will be asked to stop use of prescription and all eczema treatments 2 days before the start of the study and during the study. Subjects will apply study product as indicated for 7 days to affected areas.

Subjects will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the eczema and symptoms. Skin moisture levels will also be tested.

Eligibility Criteria:
Inclusion Criteria:

1. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates)
2. Male or female of any race or ethnicity, ages 12 and older
3. Diagnosed as having eczema
4. Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study

Exclusion Criteria:

1. Known sensitivity to any investigational product ingredient
2. Females who are pregnant , breastfeeding , or planning on becoming pregnant during the study
3. Individuals with a history of skin cancer
4. Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema
5. Participation in any clinical study within 30 days of Visit 1
6. Active infection of any type at the start of the study
7. Diagnosed as having severe eczema
8. Has a compromised immune system
9. Individuals with any planned surgeries and/or invasive medical procedures during the course of the study
10. Requires greater than 2.0mg/day inhaled or intranasal corticosteroids
Passive Calf Stretching Therapy in Peripheral Artery Disease

The goal of this clinical trial is to assess the effects of passive calf muscle stretching in patients diagnosed with peripheral artery disease (PAD). The main question it aims to answer are:

1. To determine if daily calf muscle stretching at home improves calf muscle and vascular health.
2. To determine if daily calf muscle stretching at home improves walking performance.

Participants will use inflatable ankle splints for 30 minutes a day, 5 days a week for 4-weeks on both days and 4-weeks of no stretching.

Patients with peripheral artery disease will passively stretch their calf muscles using a stretch device on both feet for 30 minutes a day for 4 weeks. Blood vessel health and size, length and function of the calf muscles and tendons and walking performance will be measured. Joint and foot movements as well as calf muscle oxygen levels will be measured during walking performance tests.

Eligibility Criteria:
Inclusion Criteria:

* Presence of PAD
* Stable condition (PAD symptoms) for at least 3 months
* Age 40-85
* Men and women who are not pregnant or nursing

Exclusion Criteria:

* Ischemic leg pain at rest; critical limb ischemia (ulceration or gangrene)
* Any condition other than PAD that limits the ability to walk
* Major surgery or lower extremity revascularization surgery in the past 6 months
* Myocardial infarction within past 6 months or unstable angina
* Severe lung disease (on supplemental oxygen or frequently use rescue inhalers)
* Participants with non-compressible vessels (ABI \> 1.40)
* Habitual exercise (30 minutes of continuous activity on 3 or more days per week)
* Current tobacco smoker or use of nicotine-containing products
* Pregnant or nursing women
* History or ankle reconstruction or surgery Recent history (\<1 year) of injuries to the ankle, Achilles tendon, or feet
* History of rheumatoid arthritis or other degenerative joint disease
* Major medical illness treatment during the prior 12 months
* Uncontrolled hypertension
* Uncontrolled diabetes
* Inability to walk on a treadmill at a slow pace (1.0 mile/hour)
Competitive Revision for CLARO: Collaboration Leading to Addiction Treatment and Recovery From Other Stresses

The purpose of this study is to develop and then test an enhanced version of the parent study's collaborative care intervention for co-occurring disorders (CC-COD) to reduce the risk of suicide and overdose among individuals with opioid use disorder (OUD) in combination with PTSD/depression. The parent study is CLARO, Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (NCT04559893).

People with OUD co-occurring with depression or PTSD (COD) may not seek out treatment for their substance use or mental health issues, but they do visit their primary care provider. However, because providers generally lack specialized training in substance use and mental illness and are focused on the immediate reason for the visit, patients' substance use and mental disorders often go unrecognized and untreated. This missed opportunity can have lethal consequences. Individuals with COD are at higher risk of dying from suicide or overdose than individuals with mental illness or OUD alone. The parent study (NCT04559893) will provide a definitive answer as to whether collaborative care (CC) improves access, quality, and outcomes of care for individuals with COD. While a primary goal is to improve access to and retention in medication treatment for OUD (MOUD) (which is linked to decreased mortality and overdose risk), the interventions CC-COD supports do not proactively address suicide or overdose risk, an important limitation. In addition, CC-COD does not include families in the patient's care. The investigators address these limitations and tackle the public health crisis of increasing deaths from suicide and overdose with this study. Because family members can play an important role in a patient's decision to engage with treatment and in overdose and suicide prevention, the study team investigates family members' views and use this information to strengthen CC-COD. This revision will develop and then test the incremental effectiveness of three additional CC-COD components. Care coordinators will (1) educate family members about MOUD with the goal of increasing patient retention in treatment; (2) train family members and the patient to administer naloxone and on how to reduce overdose risk behaviors; and (3) implement Caring Contacts, a suicide prevention intervention that sends compassionate mailed or text messages to individuals to decrease social isolation and reduce suicide risk.

Eligibility Criteria:
Inclusion Criteria:

* 18 and older
* Receiving primary care at one of the participating clinical sites
* Has OUD and one or more specific co-occurring behavioral health disorders (depression and PTSD)

Exclusion Criteria:

* Under 18
* Does not speak English or Spanish
* Unable to consent
* Receiving both MOUD and psychotropic medication from a provider outside of the primary care health system at which the patient is enrolled.
* Not receiving primary care at one of the participating clinical sites
Immunological Repertoire in Patients With Lymphoma and Chronic Lymphocytic Leukemia

RIPAL is a prospective cohort study, which main goal is to define T and B immune repertoire diversity and magnitude in patients with non-Hodgkin lymphoma of high and low grade and chronic lymphocytic leukemia before and after treatment, and to evaluate the association of these parameters with clinical patient data and outcomes.

Constitution of a prospective cohort of 128 patients with 8 different groups of patients. This protocol is designed to evaluate a new tool for detecting the diversity of the repertoire T and B in patients with hematological disease. This in vitro diagnostic device is consisting of molecular biology kits Human ImmunTraCkeR® and Human Immun'IgH® and the analysis tool NDL®

Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older
* Subjects with a diagnosis of large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, MALT, marginal zone, Waldenstrom's disease, chronic lymphocytic leukemia, T-cell lymphoma, anaplastic, cytotoxic or peripheral unspecified angioimmunoblastic.
* Have signed an informed consent for participation in the study and preservation of blood samples for biomedical research.
* Accept to appear in consultation biological samples at the sampling points corresponding to its group.
* The benefits of social security.

Exclusion Criteria:

* Subjects with a diagnosis of Hodgkin disease
* Subjects with a diagnosis of T-prolymphocytic leukemia
* Subjects with a diagnosis of Burkitt's lymphoma
* Subjects with a diagnosis of lymphoblastic lymphoma
* Subjects who had prior-treatment for hematological disease
* Patients under judicial safeguards
Robot-assisted Training in Children With CP

Cerebral palsy (CP) is the most common physical disability in early childhood causing serious motor and sensory impairments. Effective interventions for the recovery of motor functions are of profound significance to children with CP, their families, caregivers, and health professionals. Robot-assisted rehabilitation represents a frontier with potential to improve motor functions and induce brain reorganization in children with CP.

This study is designed to test whether robot-assisted hand training with Amadeo improves manual functions and induces cerebral neural plasticity in children with CP. To evaluate the efficacy of the robot-assisted hand training, investigators will measure manual motor and sensory functions with behavioral tasks and assess neural activities in the sensorimotor cortical network with high-density electroencephalography (HD-EEG) and transcranial magnetic stimulation (TMS) one day before, one day after, and two months after the robot-assisted training. The study will provide direct evidence on the effectiveness of the robot-assisted training in recovering of manual functions in children with CP. It will provide detailed insights on potential experience-dependent neuraplastic changes in the brain of children with CP. It has the potential to insight the development of more effective rehabilitation for children with CP and also children with other neurological disorders, like pediatric stroke. It may uncover factors that will be predictive of functional improvements in individual CP patient.

Eligibility Criteria:
Inclusion Criteria:

* An evaluation by a pediatric neurologist, Physical Medicine and Rehabilitation (PMNR) physicians (physiatrists), neonatal developmental specialist, or neonatologist with a diagnosis of CP.
* Classified as high-functioning (I or II) at the Gross Motor Function Classification System (GMFCS)
* Participants in the control group should have no history of neurological disorder or brain injury

Exclusion Criteria:

* Psychoactive or myorelaxant medication during study procedures
* Genetic syndrome diagnosis
* History of trauma or brain operation
* Inability to sit still
* Metal implants
* Baclofen pump
* Inability or unwillingness of patient or parent/legally authorized representative to give written informed consent
Efficacy and Safety of THR-4109 in Obese Subjects

The purpose of this study is to evaluate the safety and effect of THR-4109 on weight loss in obese subjects over a 24-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* 30 to 60 years of age
* Body mass index between 30 and 40 kg/m2
* Women of child bearing potential with a negative pregnancy test prior to entry and who agree to use an acceptable method of contraception throughout the study
* Able and willing to give written informed consent

Exclusion Criteria:

* Weight loss of more than 3 kg in the previous 3 months
* Current or previous use (within 3 months) of medications that influence weight
* Known endocrine origin for obesity, such as hypothyroidism and Cushing's syndrome
* Current or history of eating disorder such as bulimia, anorexia nervosa, binge eating or laxative abuse
* Current serious/unstable medical condition
* Current pharmacologically treated diabetes or fasting plasma glucose ≥ 126 mg/dL
Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies

The study is a prospective, multi-center, open label, randomized; two-arms cross over study.

This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.

Fifty five(55) type 1 IDDM subjects in three centers who use the MiniMed paradigm insulin pump, meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will be enrolled in the study.

The study will be done with subjects randomized into one of two procedure sequences. Each subject will undergo 3 procedures (two clamps with the InsuPatch and one clamp without the InsuPatch) and will thus serve as his/her own control. The same 55 subjects will be randomized into one sequence or the other. The order of the procedures will be selected randomly and will be performed both within one month.

There will be six Device visits starting with a screening and randomization visit, 3 clamps and a completion visit.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18- 65 years old (including = 18 years and =65 years)
2. Gender: men and women
3. BMI: 18-35 kg/m2
4. Type 1 Insulin dependent diabetes using the MiniMed paradigm insulin pumps for at least six months and using insulin Lispro or Insulin Aspart.
5. Diabetic subjects with HbA1c values below 9.5% (including 9.5%).
6. Subject understands the study requirements and the treatment procedures and has signed an Informed Consent before any study-specific tests or procedures are performed
7. Subject is willing to comply with all specified follow-up evaluations -

Exclusion Criteria:

1. Pregnancy
2. Breast feeding women.
3. Alcohol addiction
4. Had CABG (Coronary Artery Bypass Graft), are Post MI (Myocardial Infarction) or had active Ischemic heart disease prior to the study date
5. Had CVA (cardiovascular accident) or TIA (transient ischemic accident) prior to the study
6. Suffer from uncontrolled Hypertension (blood pressure in mm HG \>160 systolic or \> 95 diastolic)
7. Low blood hemoglobin concentration \<9 g/dL for female and \<11g/dL for male.
8. Abnormal kidney and/ or liver function tests. (If any of the liver or kidney function test parameters are greater than 3 fold normal values.
9. Subjects with Hyperthyroidism or Hypothyroidism with TSH level outside the normal range, TSH\>5.5 mIU/L or TSH\<0.4 mIU/L
10. Psychological incompetence
11. Any other clinical condition or history, that seems to be relevant to the principle investigator to disqualify the participant.
12. Subjects with diminished skin integrity
13. Subjects with heat sensitivity
14. Subjects involved in or planed to participate in other studies
15. Subjects using other drugs therapies to control blood glucose level other than insulin.
Evaluation of Radiology Resident Anxiety When Beginning Emergency Room (ER) Call

The purpose of this study is to quantify levels of resident anxiety under the current system (take call alone) and compare results to a modified system.

The study purpose is to quantify resident perceptions and feelings under the current 1700 call system (take call alone) and compare those with resident perceptions and feelings under a modified system where two partial shifts are taken with an experienced resident ("buddy call") prior to taking call alone.

Eligibility Criteria:
Inclusion Criteria:

* first year radiology residents
Tanezumab and Nerve Function In Arthritis Patients

Tanezumab reduces pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves.

This study was terminated on 16 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Eligibility Criteria:
Inclusion Criteria:

* BMI less or equal to 39 kg/m2
* Osteoarthritis (arthritis) of the knee or hip with pain score that qualifies
* Willing to comply with study visit schedule and study requirements, including, for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control, one of which is a barrier method.
* Patients must consent in writing to participate in the study.

Exclusion Criteria:

* Untreated, uncontrolled diseases,
* Unwilling or unable to discontinue the use of prohibited medications, including other pain medications, during the screening period and during the study,
* Significant cardiac disease within the past 6 months
* Significant neurological disease (e.g. peripheral neuropathy, multiple sclerosis, stroke) or signs of neuropathy at screening
* Known bleeding disorder or anticoagulation therapy
* Planned surgery during the study period
* History of alcoholism or drug abuse in the past 2 years
* Unable to use acetaminophen
* Use of a biologic (including live vaccines, with the exception of Flumist) within the past 3 months
* Allergic reaction to a biologic or an antibody in the past
* Disqualifying laboratory values, including Hepatitis B or C, HIV or drug test
* Cancer in the past 5 years. Basal cell or squamous cell carcinoma are okay.
* Medical condition that may interfere with study endpoints or safety of the subject as determined by the investigator.
Maintenance Interpersonal Psychotherapy for Sustaining Remission of Depression

This study will evaluate the effectiveness of maintenance interpersonal psychotherapy (IPT) in preventing relapse of depression in women who have required combined psychotherapy and pharmacotherapy treatment to obtain a remission of depression symptoms.

Depression is a serious medical illness that can recur more than once in a person's lifetime. Effective treatment methods are needed to maintain a state of remission in people who have had prior episodes of depression. IPT is a brief and highly structured type of psychotherapy that addresses interpersonal issues associated with depression. Previous studies have shown that it is an effective method for treating depression. This study will evaluate the effectiveness of maintenance ITP in preventing relapse of depression in women who have required combined psychotherapy and pharmacotherapy treatment to obtain remission of depressive symptoms.

Participants in this open label study will be recruited from a previous study, "Maintenance Psychotherapy in Recurrent Depression: Study I." In this study participants will initially receive weekly sessions of IPT as well as medication treatment with fluoxetine. Any participants who do not reach remission of depressive symptoms after 6 weeks will be given other standard treatments for depression. Once remission of depressive symptoms is reached, participants will continue receiving weekly IPT and fluoxetine treatment for 20 weeks. After 20 weeks, fluoxetine treatment will be discontinued, and all participants will receive IPT alone for 6 weeks before entering the maintenance phase of the study. Upon entrance into this phase, participants will be randomly assigned to receive IPT weekly, biweekly, or monthly for 18 months. Functioning and depressive symptoms will be assessed at Month 24.

Eligibility Criteria:
Inclusion Criteria:

* Met all entry criteria for the parent study, "Maintenance Psychotherapy in Recurrent Depression, Study I"
* Began IPT as outlined in the parent study
* Demostrated compliance with IPT sessions during the parent study
* Exhibits less than a 50% reduction in score on the Hamilton Rating Scale for Depression after 12 weeks of psychotherapy or fails to meet stabilization criteria after 24 weeks of psychotherapy during the parent study

Exclusion Criteria:

* Any unstable medical illness