cyrilzakka/clinical-trials huggingface dataset:
Peer to Peer (P2P): Mental Health Interventions with Persons with Substance Use Disorders

This study provides substance use and mental health peer support services to address behavioral health disparities in rural areas. Specifically, the project aims to address persistent mental health symptoms, such as anxiety and depression, that become barriers to care for patients working towards long-term recovery from co-occurring mental health and substance use disorders. Participants will be assessed and evaluated for opioid use disorder (OUD), social determinants of health (SDoH), and infectious diseases by a nurse practitioner and a social worker. A certified peer support specialist (CPSS) will provide additional support, connecting patients to sustainable mental health resources and implementing a modified version of the Friendship Bench intervention, which involves six weekly 45-minute problem-solving therapy sessions with the option to participate in six or more peer support sessions. The CPSS will follow the patient for up to 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of OUD via Diagnostic Statistical Manual (DSM)-V Text Revision (TR)
* Receiving MOUD through the Mobile Recovery Program for at least 3 months
* Age 18 or older
* Moderate to Severe Depression with or without co-occurring anxiety as determined by PHQ-9 conducted during the most recent MRP clinical visit

Exclusion Criteria:

* Severe cognitive, medical, or psychiatric disability that could impair ability to perform study-related activities as determined by the MRP clinician or principal investigator.
* Unable to read/speak English
* Unable to read and comprehend the consent materials and other study materials
* Current suicidal ideation based on the Patient Health Questionnaire-9
Effect of Diabetes Control on Outcome in Hospitalized Patients: A National Israeli Study

To test whether tight glucose control is associated with better clinical outcome compared to less-tight control, among diabetic patients hospitalized in internal medicine wards.

Patient characteristics:

Patients admitted to internal medicine departments in public hospitals of Israel who have pre-admission diagnosis of diabetes, or have a random plasma glucose \>200 mg/dl on admission

Eligibility criteria

1. Age: \>18 years
2. Fasting plasma glucose \> 140 mg/dl or non-fasting plasma glucose \>200 mg/dl in two separate blood tests if non-diabetic, or in a single blood test if have pre-diagnosed diabetes
3. Able to understand the study objective and methods and willing to provide a written informed consent
4. No significant liver disease
5. Serum creatinine \<2.0 mg/dl

Exclusion criteria

1. Significant cognitive impairment
2. History of hypoglycemia unawareness or clinical autonomic diabetic neuropathy
3. Known allergy to insulin analogues
4. Diabetic ketoacidosis or non-ketotic hyperosmolar coma on admission

Process of patient recruitment and randomization:

1. Enrolment of eligible patients signing the informed consent.
2. Assignment of patients to different treatment arms according to randomization scheme provided by the central organizing committee.
3. The ratio of patients' assignment to the active or to the control study arm will be 1:1 for each participating ward.

Protocol:

Basal bolus insulin treatment will be applied to achieve tight glucose target (mean fasting blood glucose\<130 mg/dl and not above 180 mg/dl during the day) compared to patients treated to achieve less tight glucose targets (mean fasting blood glucose\<200 mg/dl and not above 220 mg/dl during the day)will influence cardiovascular and general clinical outcome.

Primary outcome: All-cause mortality (including in-hospital and up to 12 months post discharge) or re-admission to hospital

Secondary outcomes:

Total number of in-hospital days during one year follow-up (including the index hospital admission)

The rate of any major clinical events (all-cause mortality, hospital acquired infection, organ failure, need of ventilation support, need of vasoactive amine administration, need of central line insertion, hospital admission for stroke, acute coronary event, severe bacterial or fungal infection) during one year follow-up

Hypoglycemic events during index hospital stay.

Eligibility Criteria:
Inclusion Criteria:

1. Age: \>18 years
2. Fasting plasma glucose \> 140 mg/dl or non-fasting plasma glucose \>200 mg/dl in two separate blood tests if non-diabetic, or in a single blood test if have pre-diagnosed diabetes
3. Able to understand the study objective and methods and willing to provide a written informed consent
4. No significant liver disease
5. Serum creatinine \<2.0 mg/dl

   -

Exclusion Criteria:

1. Significant cognitive impairment
2. History of hypoglycemia unawareness or clinical autonomic diabetic neuropathy
3. Known allergy to insulin analogues
4. Diabetic ketoacidosis or non-ketotic hyperosmolar coma on admission

   -
Internet-based CBT for Insomnia in Chronic Pain

The main goal is to study the effect of therapist-guided internet-delivered cognitive behavioural therapy for insomni comorbid with chronic pain in a clinical sample.

Both chronic pain and sleep disorders are prevalent and potentially very debilitating problem. The prevalence of insomnia in people with chronic pain seems to be about 50%, but figures up to 88% have been reported. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to be an effective treatment for both primary insomnia and co-morbid insomnia. CBT-I is a psychotherapeutic multicomponent treatment that seeks to influence the behaviors and cognitions which perpetuates the problem. Usually, the treatment is 6-8 weeks long with one session a week, individually or in a small group setting.

Internet Mediated CBT-I has been shown to be an effective alternative to more traditional CBT. How well internet mediated CBT-I work for individuals with insomnia and co-morbid chronic pain has however not previously been investigated. The aim of the project is to study the effects of internet mediated cognitive behavioral therapy for individuals with insomnia and co chronic benign pain. The aim is to compare the effect of Internet-mediated cognitive behavioral therapy with a group that offered internet-based relaxation training. CBT-I comprises eight modules with evidence-based treatment components for insomnia (e.g. sleep restriction, stimulus control and cognitive techniques). The relaxation training comprises eight modules of applied muscular relaxation.

Hypothesis: Patients suffering from both insomnia and chronic benign pain gets significantly better treatment outcome with respect to insomnia symptoms if they receive internet-based cognitive behavioral therapy compared to those receiving internet mediated relaxation training.

Primary outcome measure: the Insomnia Severity Index (ISI), a well-used, valid and reliable self-report scale, which has been shown possible to administer via internet.

Eligibility Criteria:
Inclusion Criteria:

* Chronic insomnia Chronic benign pain No or stable pharmacological treatment for insomnia and or pain

Exclusion Criteria:

* Participation in pain management programme Pregnancy Shift work Untreated medical or psychiatric disease or disorder that could be negatively affected by insomnia treatment
Correlation of Motor Metrics and Neurological Data

This is a pilot study to collect data with the Ceraxis product and standard movement disorders tests in order to prove and codify potential correlations.


Eligibility Criteria:
Inclusion Criteria:

* Adult with a diagnosis of idiopathic Parkinson's disease or essential tremor by a movement disorders neurologist
* Age greater than or equal to 21 years
* Hoehn and Yahr stage I-III
* Ability to ambulate 200+ meters independently
* Ability to follow 2-step commands
* Clinically responsive to medication or Deep Brain Stimulation (DBS)
* Clinically optimized medication or DBS for at least six months
* Able to tolerate withdrawal of medication and/or DBS

Exclusion Criteria:

* Any comorbidity which would exclude them from being able to use the Ceraxis product
* Inability to learn how to use the system
* Diagnosis of dementia or impairment that compromises the ability to provide informed consent
* Neurological disease other than Parkinson's disease or essential tremor (i.e. multiple sclerosis, stroke with residual motor deficits)
* Musculoskeletal injury that significantly alters gait
Alefacept in Subjects With Chronic Plaque Psoriasis Who Failed to Respond to Anti-TNF Therapy

Study Status:

Duke University Health System Institutional Review Board has received notification of study termination; final IRB closure date is 12/12/2008. Study enrollment is now closed.

Enrollment Update:

Only one subject was entered into this study out of an expected enrollment of 15 patients in this single site clinical trial. With no recruitment interest, the financial sponsor and Sponsor-PI chose to close the clinical trial.

This is an open-label study using alefacept in the treatment of patients with chronic plaque psoriasis who have not responded to treatment with an anti-TNF agent. Patients not responding to Enbrel® 50 mg weekly with a 75% reduction of Psoriasis Area and Severity Index (PASI) Score or a Physician Global Assessment (PGA) score of 'almost clear' or 'clear', will be treated with 15 mg alefacept intramuscularly (IM) once weekly for up to 20 weeks. Patients who have 'cleared' or 'almost cleared' at the end of 12 weeks of treatment with alefacept will have completed the 'standard treatment' phase of the study. Study subjects who have not responded to treatment during the initial 12 weeks will continue with alefacept therapy for an additional 8 weekly doses or until the subject has reached a PGA of 'almost clear' or 'clear'. Alefacept is FDA approved for this indication for 12 weeks of treatment and this clinical trial is extending the treatment window for up to 8 additional weeks. Because of this increased exposure to alefacept, all subjects will be carefully monitored while on treatment and followed post-treatment at 3, 4, 6, 9 and 12 months after the last dose of alefacept is given.

Purpose:

This open-label study will determine the safety and efficacy of Amevive® 15 mg IM weekly in subjects with chronic plaque psoriasis who have not sufficiently responded to etanercept, an anti-TNF agent. The plan also is to determine the length of response time to point of relapse and to determine the length of time before retreatment with alefacept is necessary.

Patient Population:

This study is for adult men and women, ages 18 to 80, with chronic plaque psoriasis. At the time of enrollment, the subject must have received 50 mg per week of Enbrel without achieving a response of 'almost clear' or 'clear' according to PGA or has not responded with a 75% reduction of PASI Score.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between ages of 18 and 80 years
* Subjects diagnosed with chronic plaque psoriasis who require systemic therapy.
* Must be receiving anti-TNF treatment without achieving response of 'almost clear' or 'clear' according to PGA or has not responded with 75% reduction PASI score.
* Must be willing to receive up to 20 weeks of IM injections weekly
* CD4 counts must be above 250 cells/mm3 at screening

Exclusion Criteria:

* Diagnosis of unstable erythroderma or pustular psoriasis or guttate psoriasis
* Serious local infection or systemic infection 3 months prior to receiving study drug.
* Subjects with CD4 lymphocyte count less than 250 cells/mm3 at study entry
Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer

The most common long-term problems after rectal surgery are bowel problems. These problems can include needing to pass bowel movements a lot, loose or mushy stools, inability to fully clear your bowels, and/or poor control of gas and stool. The investigators believe that a major cause of these problems is too much bacteria in the bowel and treatment with antibiotic tablets will hopefully help improve these bowel problems. In order to test this idea, the Colorectal Surgery Service of Memorial Sloan Kettering Cancer Center is sponsoring a clinical trial. This trial will compare the antibiotic rifaximin and a placebo (a harmless tablet that has no effect) in the treatment of these bowel problems. Following this we will attempt to see if another antibiotic metronidazole also helps to treat these bowel problems. Both Metronidazole and rifaximin are well established drugs that have minimal side effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of rectal cancer treated with an anterior resection preformed at MSKCC (tumor at or below 12cm from anal verge) with restoration of bowel continuity ≥1 and ≤ 5 years. (Patients may also have had procedures to construct neo-rectums including j-pouch, coloplasty, and end to side anastomosis).
* Patients ≥ 21 years of age.
* Presence of anterior resection symptoms by patients own assessment. These symptoms may include any of the following: incomplete evacuation, clustering of bowel motions, frequency of bowel motions, unformed stool, excessive flatus, or incontinence of flatus and/or feces.

Exclusion Criteria:

* Local recurrence of rectal cancer.
* Antibiotic treatment within the last 4 weeks for any condition.
* Pregnancy or breast feeding.
The Effect of Experiential Classroom on Establishing Healthy Behaviors During Pregnancy

A multi-center, prospective, randomized controlled clinical trial was conducted to explore the effect of experiential classroom on establishing healthy behaviors during pregnancy.

Adverse pregnancy outcomes, including maternal complications (eg, gestational hypertension, preeclampsia (PE), gestational diabetes mellitus (GDM), placental abruption) and fetal complications (eg, preterm birth, intrauterine growth restriction, large for gestational age (LGA), small for gestational age (SGA), macrosomia) , pose a significant public healthy problem which needs to be addressed. Several studies found that the health status and behaviors of mothers during pregnancy, including dietary patterns, physical activity and emotional well-being, not only affect pregnancy outcomes such as GDM and PE, but also have the long-term implications for the health of the offspring. Therefore, through effective preconception education, helping pregnant women establish healthy behaviors during pregnancy is of great significance in reducing the incidence of adverse pregnancy outcomes. However, traditional educational methods, mostly in the form of face-to-face lectures, have proven to be ineffective. On the other hand, experiential classroom emphasizes putting pregnant women at the center, based on their subjective willingness and previous knowledge and experience, creating an environment for free discussion, exchange, and reflection, and utilizing peer education to fully mobilize the subjective initiative of pregnant women. This approach allows them to explore, discuss, reflect, and learn autonomously, aiming to truly absorb, master, and apply theoretical knowledge. Therefore, to explore the impact of experiential classroom on the establishment of healthy behaviors during pregnancy, we conducted a multicenter, prospective, randomized controlled clinical trial. The study included pregnant women aged 20 and above, married, with singleton pregnancies in early pregnancy, who were randomly assigned to either the experiential classroom group or the routine prenatal care group. Both groups received routine prenatal care. The pregnant women in the personalized exercise guidance group learned about perinatal health knowledge under the guidance of multidisciplinary teachers and were supervised and managed through WeChat groups. The primary outcome measure was the total weight gain during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Older than 20.
* Singleton pregnancy.
* The first trimester.
* Be able to undergo regular prenatal follow-ups and delivery in PUMCH.
* Be able to participate in each experiential classroom on time.
* Capable of independently completing questionnaire surveys.

Exclusion Criteria:

* With severe mental illness.
* Severe impairment of liver and kidney function.
* With malignant tumors.
* With contraindications to exercise during pregnancy.
Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects

Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X. Bleeding events related to rivaroxaban are the consequence of physiopathologic, pharmacokinetic issues or poisoning. Few results are available on the use of activated charcoal in rivaroxaban poisoning. Moreover, a recent study, in healthy subjects, shows that activated charcoal can reduce significantly exposition to apixaban (a direct oral anticoagulant of the same class). The objective of this study is to evaluate the effect of activated charcoal on rivaroxaban pharmacokinetics. It corresponds to a randomised open trial with an incomplete cross over design (3 occasions). It will enrol 12 healthy subjects. Four treatments modalities will be studied: rivaroxaban alone and rivaroxaban with activated charcoal administrated 2, 4 or 8 hours after rivaroxaban administration.


Eligibility Criteria:
Inclusion Criteria:

* affiliated or beneficiary of a social security category
* having signed the inform consent form
* having signed the genetic consent form
* BMI between 18.5 and 25
* normal clinical exam
* normal biological exam

Exclusion Criteria:

* contra-indication to rivaroxaban
* contra-indication to activated charcoal
* previous history of psychiatric disease, or antidepressant treatment, or convulsion, or hemorrhagic disease smoker
* Organic lesion likely to bleed
* severe liver disease
* severe kidney failure
* previous surgery within one month
Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.

The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction. The main question this study aims to answer is:

1. To compare the rates of procedure related adverse events (AE's) between patients undergoing Endoscopy Ultrasound-guided gastro-jejunostomy (EUS-GJ) and Surgical gastro-jejunostomy (S-GJ).

Study participants will be randomized into one of the two standard procedures and followed for up to 12 months post procedure for collection of outcomes related data

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age.
2. Radiographic OR Endoscopic evidence of an obstructing neoplasm in the distal stomach or duodenum.
3. GOOSS of 0 or 1
4. BOTH surgical and endoscopic GJ are technically and clinically feasible
5. Can understand and is willing to sign informed consent form prior to the initiation of any study procedures (or when applicable the subject's LAR).

Exclusion Criteria:

1. \< 18 years of age
2. ECOG \>2
3. Expected survival (determined by the treating oncologist) is less than 2 months.
4. Candidates for potential resection of the cancer and obstructed anatomical area (this includes patients with borderline resectable pancreatic cancer)
5. Peritoneal carcinomatosis with associated bowel obstruction on imaging or during laparoscopy
6. Large volume ascites (patients with moderate volume ascites may undergo IR guided drainage prior to randomization)
7. Anatomical factors that technically hinder EUS-GJ OR Surgical-GJ (diffuse tumor involvement in path of LAMS or surgery, surgically altered anatomy that interferes with the ability to perform an anastomosis etc)
8. Pregnancy
Non Invasive Vestibular Stimulation in Modulation of Vestibular and Balance Function

Background: Patients with bilateral vestibular hypofunction (BVH) frequently presented with dysequilibrium, dizziness and oscillopsia, leading to increased risk for fall. The mainstream for treatment of vestibular hypofunction remains to be vestibular rehabilitation, yet the effects can be limited in certain cases. Through the application of minimal amount of electrical stimulation, galvanic stimulation can induce polarization in the vestibular nerve, stimulating the saccule, utricle and semicircular canals within the vestibular apparatus. Galvanic stimulation has also been proven to activate cerebral cortex regions such as parieto-insular vestibular cortex (PIVC) and temporal-parietal junction area. It has been documented that vestibular stimulation with stochastic resonance could improve quiet stance stability in patients with vestibular hypofunction. The 3 dimensional effects of dynamic walking as well as the change of vestibular ocular reflex during stochastic resonance vestibular stimulation have never been discussed. Purposes: This 3-year project aims to investigate the effects of vestibular stimulation in VOR, static and dynamic stability, activation/connectivity of cerebral cortex and mechanisms of neuronal changes. Methods: First year the motion analysis and ICS head impulse video goggles were used to observe walking stability and eye movements in 30 healthy and 30 patients with BVH. In the second year, stochastic resonance vestibular stimulation will be applied to 30 healthy and 30 BVH individuals respectively. Using functional MRI, the changes of activated/deactivated areas in the cerebral cortex during stochastic resonance vestibular stimulation will be observed in both groups. In the third year, 60 BVH patients will be randomized into either sham or real vestibular stimulation group. Both groups will receive 3 times per week for 4 weeks of vestibular rehabilitation with exactly the same exercise protocols. SIRT1 related anti-aging genes will be analyzed through blood samples. Expected achievements: Combining safe stochastic resonance vestibular stimulation and exercises in this 3-year project, the neuroprotective mechanisms of vestibular exercises will be elucidated. The optimal strategy for vestibular rehabilitation can thus be established.


Eligibility Criteria:
Inclusion Criteria:

* vestibular insufficiency

Exclusion Criteria:

* 1. chronic diseases that may compromise vestibular function(eg. benign paroxysmal positional vertigo, post-traumatic vertigo, degenerative neural diseases, Whiplash injury), and patients with intracranial metal inplants or history of seizure
* 2. Patients with difficulty ambulation
* 3. Patients with cognitive function
Extra Time on Brazilian College Level Exam for Students With and Without ADHD

Standardized tests such as the Scholastic Aptitude Test (SAT) and the brazilian National High School Exam (ENEM) give more time for students with Attention Deficit and Hyperactivity Disorders (ADHD) to complete the exam. The goal of this study is to find out if giving students with ADHD more time on tests actually helps them. Additionally, the research aims to find out if more time helps students without ADHD too or not, or even if it only helps students with certain traits.

Initially, the participants of this study will fill out forms and questionnaires online. Then, they will go through a psychiatric evaluation, where they will talk to a psychiatrist, and neuropsychological testing, where they will do some mental activities. Later on, they will do a mock test of the ENEM, with and without extra time.

Eligibility Criteria:
Inclusion Criteria:

* Brazilian citizen;
* Planing to participate in college-entry standardized tests (ENEM, Vestibulares);

Exclusion Criteria:

* Medical condition and/or disability that may hinder the neuropsychological testing;
* Intelligence Quotient (IQ) lower than 80;
* Psychotic disorders, bipolar disorders, current moderate or severe depressive episode, suicide risk, autism spectrum disorders, learning disabilities.