bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals
Condition: Marijuana Abuse
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      Recent research has identified the following withdrawal symptoms to be associated with
      abruptly stopping marijuana use: anxiety, irritability, bodily aches and pains, and
      difficulty sleeping. These symptoms resemble those of both depression and nicotine
      withdrawal, suggesting that a similar treatment drug may be useful. This study will evaluate
      the effectiveness of two antidepressant drugs, bupropion and nefazodone, in reducing
      withdrawal symptoms in marijuana dependent individuals.
    

Detailed description: 
      There have been few controlled studies that focus on treatments for marijuana dependence. The
      symptoms associated with marijuana withdrawal, including anxiety, irritability, bodily aches
      and pains, and difficulty sleeping, resemble those caused by depression and nicotine
      withdrawal. Therefore, antidepressant or nicotine withdrawal medications may be effective in
      treating marijuana dependence. Nefazodone and bupropion are two medications currently used to
      treat depression. The purpose of this study is to determine the effectiveness of nefazodone
      and bupropion in alleviating marijuana withdrawal symptoms. In addition, this study will
      evaluate whether these medications successfully treat marijuana dependent individuals in
      terms of treatment adherence and drug abstinence.

      Participants in this double-blind trial will be randomly assigned to receive nefazodone,
      bupropion, or placebo. Daily doses of medication will be provided to participants in dated
      pill boxes; pill boxes will then be returned to the study nurse at each study visit.
      Medication will be taken in three daily doses; one of the doses will be a nonmedicated pill.
      Nefazodone will initially be given at a dose of 150 mg per day, which participants will take
      at bedtime. Every 5 days, the daily dose will increase by 150 mg, to a maximal dose of 600 mg
      of nefazodone per day. Bupropion will be given at an initial dose of 150 mg, which
      participants will take in the morning. After 3 days, the daily dose will increase to a total
      dose of 300 mg of bupropion per day.

      Study visits will occur daily, at which time participants will complete drug use and
      withdrawal symptom reports. In addition, participants will partake in weekly therapy visits,
      which will consist of four sessions of motivational enhancement therapy followed by sessions
      of relapse prevention therapy. Bi-weekly psychiatry visits will include evaluations on
      substance use behavior and overall clinical symptoms, and will last 15-30 minutes.
    

Intervention name(s): Nefazodone; Bupropion
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bupropion; Nefazodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: marijuana dependence
Cranberry (Poly)Phenol Consumption on Vascular Function
Condition: Healthy Young
Study type: Interventional

Summary: 
      Epidemiological studies suggest that the consumption of (poly)phenols rich foods such as
      cocoa, tea, fruits and vegetables is associated with lower blood pressure, reduced
      cholesterol and decreased cardiovascular risk. Cranberries are a rich source of
      (poly)phenols, including anthocyanins, proanthocyanidins and phenolic acids. Whether
      cranberries can improve vascular function when given over relevant time periods and in
      relevant populations is not known. Therefore, it is the overall hypothesis of the study
      proposal that chronic consumption of cranberries can improve endothelial function, a
      prognostically validated surrogate of cardiovascular risk. This study also aims to reveal
      which cranberry (poly)phenols have bioactive properties in healthy men. Consequently, plasma
      and urine metabolite peaks will be correlated with vascular outcomes and genome-wide
      expression microarrays will be performed to reveal cell signaling pathways associated with
      cranberry (poly)phenol-mediated cardioprotective events.
    


Intervention name(s): cranberry (poly)phenol containing supplement; Placebo comparator: cranberry (poly)phenol deprived supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Sustained intake of 9 grams of freeze-dried cranberry powder per day (2x 4.5 grams daily over 1 month). The powder is dissolved in water and administered as a drink.; Sustained intake (2x 4.5 grams daily over 1 month) of a control supplement dissolved in water
Intervention MeSH terms: Phenol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: vascular function; endothelial function; polyphenols
A Study to Investigate Biomarkers After Single Doses of Anticoagulants in Healthy Young Male and Healthy Elderly Participants (MK-0000-216 AM1)
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to investigate biomarkers after single oral doses of the anticoagulant agents
      dabigatran etexilate and rivaroxaban in healthy young male subjects and in healthy elderly
      subjects.
    


Intervention name(s): dabigatran etexilate; rivaroxaban
Intervention type(s): Drug; Drug
Intervention description(s): dabigatran etexilate, orally, as 2 x 75-mg capsules (150 mg), single administration; rivaroxaban, orally, as 2 x 10-mg tablets (20 mg), single administration
Intervention MeSH terms: Rivaroxaban; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemophilia B
SpineJack® Versus Conservative Treatment Study (SPICO Study)
Condition: Spinal Fractures; Vertebral Compression Fractures; Back Injuries; Trauma
MeSH terms: Fractures, Bone; Fractures, Compression; Spinal Fractures; Back Injuries
Study type: Interventional

Summary: 
      This study will compare two standard treatments in acute stable traumatic vertebral fractures
      (types A1 and A3.1 by Magerl Classification). The two treatments are as follows:

        1. SpineJack® system

        2. Conservative Orthopedic Management consisting of brace and pain medication.
    

Detailed description: 
      100 subjects (18 to 60 years old) will be enrolled (1:1) with one to two painful traumatic
      fractures, non-pathological (types A1 and A3.1 by Magerl Classification).

      Subjects will be followed at admission, procedure, discharge, 1 month, 3 months, 12 months
      and 24 months post Vertebral Compression Fracture (VCF) reduction procedure or the set-up of
      the brace.

      The estimated enrollment period is 12 months and each patient should perform a 24 months
      follow-up period. Therefore, the total study duration is estimated to be 36 months for the
      complete study.
    

Intervention name(s): SpineJack system; Conservative management
Intervention type(s): Device; Device
Intervention description(s): Spine fracture management for traumatic vertebral compression fracture; Surgical corset according to measurement's impression, rigid corset with sternal support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intervention on Development and Growth at Children in Poverty
Condition: Child Malnutrition
MeSH terms: Malnutrition; Child Nutrition Disorders
Study type: Interventional

Summary: 
      Children in extreme poverty lack adequate care and face increased health risks. The earlier
      poverty strikes in the developmental process, the more deleterious and long-lasting its
      effects. There is, however, growing evidence that early interventions can prevent the
      negative consequences. Such interventions are effective, particularly when they are of high
      quality, organized at home and parents are involved. Recently, baseline assessment of
      developmental and nutritional status of SOS children and children in extreme poverty in Jimma
      region of South-West Ethiopia revealed that these children have developmental problems in
      language, motor, social-emotional skills and nutritional status. The impact of play-oriented
      stimulation activities integrated into the existing SOS basic program, on developmental
      outcomes, has never been investigated in this context. The main objective of the study is,
      therefore, to evaluate the impact of play-oriented stimulation integrated into the basic SOS
      program on the developmental outcomes of children living with foster families. This was done
      by comparing the intervention children with their age-matched children (control), not
      receiving the stimulation package. It was hypothesized that this package would significantly
      improve the developmental skills of these children.
    


Intervention name(s): basic services; the play-based developmental stimulation
Intervention type(s): Other; Other
Intervention description(s): The age-matched control children received the basic services such as family-home, food, clothing, health care, protection and education. However, they were not provided with the play-based developmental stimulation.; Children in the intervention group received basic services such as family-home, food, clothing, health care, protection and education for older children. In addition, there received play-based developmental stimulation integrated into the services.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
A Study of Laquinimod Eye-drops in Healthy Participants
Condition: Eye Diseases
MeSH terms: Eye Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 randomized, double-masked, placebo-controlled study performed with healthy
      participants to assess the safety and tolerability of laquinimod eye-drops.
    

Detailed description: 
      Laquinimod administered as an oral capsule formulation has previously been studied in
      neurodegenerative and autoimmune diseases. The clinical side effect profile of orally
      administered laquinimod is well-characterized based on this previous experience.

      This trial will establish a safe and tolerated dose of laquinimod when administered as an
      eye-drop formulation following single ascending dose (SAD) and multiple ascending dose (MAD)
      administrations. There are four planned groups in the SAD-part of the study which will enroll
      28 participants, if all dose levels are explored. The subsequent MAD-part of the study will
      enroll another 28 participants.
    

Intervention name(s): Laquinimod; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eye-drops; Eye-drops
Other intervention name(s): TV-5600; ABR-215062
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
tRNS in Anterior Cingulate Cortex Reduces Craving Over Dual Pathology Patients
Condition: Substance Use Disorder; Attention Deficit Disorder With Hyperactivity; Bipolar Disorder; Schizophrenia; Personality Disorder
MeSH terms: Hyperkinesis; Substance-Related Disorders; Schizophrenia; Bipolar Disorder; Attention Deficit Disorder with Hyperactivity; Personality Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to study the efficacy and security of noninvasive brain
      stimulation as a new approach for patients with Substance Use Disorders (SUDs) plus other
      psychiatric conditions like ADHD, Schizophrenia, Bipolar disorder, etc.
    

Detailed description: 
      Background: There is an intimate relationship between addictive behaviors and other mental
      disorders, proven by clinical practice and many epidemiological studies, genetic and
      neuroscience. This gives risk to the diagnosis of Dual Pathology: an addiction and another
      mental disorder.

      Functional neuroimaging studies have shown that anterior cingulate cortex is associated with
      substance´s dependence and craving. Transcranial random noise stimulation (tRNS) stimulates
      parts of the brain and can change it´s activity.

      Researchers are interested in reduce cravings for substance dependence on patients with Dual
      Pathology using tRNS in anterior cingulate cortex.

      Aims: To determine whether tRNS in anterior cingulate cortex can reduce craving over Dual
      Pathology patients.
    

Intervention name(s): Transcranial Random Noise Stimulation
Intervention type(s): Device
Intervention description(s): Random Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas
Other intervention name(s): tRNS, tES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Substance Use Disorder; Attention Deficit Disorder With Hyperactivity; Schizophrenia; Bipolar disorder; Personality disorder
Osteosarcoma Maintenance Therapy With OST31-164
Condition: Bone Cancer
MeSH terms: Osteosarcoma; Bone Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Up to 45 Patients aged 12 to 39 with osteosarcoma (bone cancer) that had recurred in the
      lungs and has recently been surgically removed will be enrolled. Patients will receive
      OST31-164 infusions every 3 weeks over 48 weeks and be followed after that for 3 years.
    

Detailed description: 
      This is a Phase 2, open-label, multicenter, single-arm study in patients (12-39 years) with a
      recent history of pulmonary recurrent osteosarcoma that has been completely resected. Planned
      enrollment is a maximum of 45 patients who will receive OST31-164 as a single agent every 3
      weeks for 48 weeks with 4 doses constituting 1 treatment cycle (12 weeks per cycle). Each
      patient will receive treatment at a dose of 1x109 CFU until week 48 or until disease
      progression, unacceptable toxicity, or the patient meets any other treatment discontinuation
      criteria. Following treatment discontinuation, all patients will enter a 3-year survival
      follow-up period. Exploratory evaluation of immune response will be conducted. If available,
      tissue from the recent resection will be sent to the COG Biobank for future genomic and
      pathologic analysis by the COG.
    

Intervention name(s): OST31-164
Intervention type(s): Drug
Intervention description(s): Patients who will receive OST31-164 as a single agent every 3 weeks for 48 weeks with 4 doses constituting 1 treatment cycle (12 weeks per cycle). Each patient will receive treatment at a dose of 1x109 CFU until week 48 or until disease progression, unacceptable toxicity, or the patient meets any other treatment discontinuation criteria.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteosarcoma; Bone Cancer
Impact of Swallowing Impairment on Individuals With Parkinson Disease
Condition: Parkinson Disease; Dysphagia
MeSH terms: Deglutition Disorders; Parkinson Disease
Study type: Observational

Summary: 
      In this online study, investigators will explore the psychosocial burdens of swallowing
      difficulties in people with Parkinson's Disease. This study is completely virtual, so you can
      participate from wherever you live in the United States. Participation requires you to
      complete a one-hour Zoom interview and a brief questionnaire. You will be compensated with a
      $25 Walmart gift card. To learn more, please use the "send email" feature. Thank you!
    

Detailed description: 
      This is a mixed methods study. The investigators will collect qualitative data from
      participants by conducting 1-2 hour semi-structured interviews on Zoom. The interview
      questions are designed to systemically inquire about patient experiences, affective
      reactions, coping strategies, social support, self-identity issues, and treatment
      experiences. The investigators will collect quantitative data by asking participants to
      complete The Brief Illness Perception Questionnaire. The data will be analyzed using a
      comprehensive stress and coping model, which has not been done previously in the field. The
      investigators hope to discover themes about psychosocial burdens and related coping
      mechanisms.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited from 1) local Parkinson Disease support groups, 2) through
        referrals from local speech-language pathologists, and 3) through the Fox Trial Finder on
        the Michael J. Fox Foundation website.
Preventative Delirium Protocol in Elderly Patients
Condition: Delirium
MeSH terms: Delirium
Study type: Interventional

Summary: 
      The current study aims to elucidate the effectiveness of a preventative delirium protocol in
      patients older than 65 years of age undergoing elective surgery.
    

Detailed description: 
      A comprehensive analysis of patient specific risk factors and predisposing perioperative risk
      factors will be completed. The objective is to see if delirium incidences are significantly
      lower in the group that receives a preventative delirium protocol compared to a control
      group, while not increasing other adverse undesirable side effects. We hypothesize that a
      preventative delirium protocol will reduce the incidence of delirium compared to the control
      group (primary outcome), but this protocol may lead to increased side effects such as PONV,
      poor pain control, and increased awareness (secondary outcomes).
    

Intervention name(s): Control; Preventative Delirium Protocol
Intervention type(s): Other; Other
Intervention description(s): Standard Of Care without Preventative Delirium Protocol; Preventative Delirium Protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Efficacy of Optison Echo Contrast to Detect Thrombus in Left Atrial Appendage
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Thrombosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators intend to determine if using Optison echocardiography contrast increases
      sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal
      echocardiography studies as opposed to standard 2D and 3D TEE imaging without the use of echo
      contrast.
    

Detailed description: 
      Accurate determination of the presence or absence of left atrial appendage (LAA) thrombus has
      a large impact on the clinical course of patients with atrial fibrillation or ischemic stroke
      and has large financial implications as well. Misdiagnosing the presence of LAA thrombus can
      lead to unnecessarily cancelled procedures (cardioversion and atrial fibrillation ablation)
      and potentially hazardous, unnecessary changes in clinical care (such as prolonged Coumadin
      anticoagulation). Missing LAA thrombus can result in continuation of cardioversion or atrial
      fibrillation ablation procedures at a time when there is higher risk of subsequent embolic
      stroke.

      Several of the patients with atrial fibrillation require transesophageal echocardiography
      (TEE) performed prior to cardioversion or atrial fibrillation ablation procedures. There is
      opportunity to enroll most of these patients in our proposed study. There has been
      essentially no work published about the use of echo contrast materials in TEE (other than
      agitated saline), particularly the use of Optison. Thus, the investigators will be exploring
      a new field in echocardiography and echo contrast.
    

Intervention name(s): Optison echocardiography contrast agent
Intervention type(s): Drug
Intervention description(s): Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.
Other intervention name(s): Perflutren Protein-Type A microspheres
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Atrial fibrillation; stroke; TEE; Left atrial thrombus
High-fat Meal Challenge in Pediatrics
Condition: Pediatric Obesity; Insulin Resistance
MeSH terms: Insulin Resistance; Pediatric Obesity
Study type: Interventional

Summary: 
      The objective is to determine if how physical fitness, measured using a treadmill maximal
      oxidative capacity test, is associated with the capacity to metabolize a high-fat meal in
      pediatrics (ages 8-17 years). Ability to metabolize the meal will be assessed by profiling
      mitochondrial and extra-mitochondrial fatty acid metabolites. The investigators will test if
      fatty acid oxidation mediates the relationship between fitness and markers of metabolic
      health, such as insulin resistance.
    


Intervention name(s): High-fat Challenge
Intervention type(s): Dietary Supplement
Intervention description(s): The shake will be composed of a mixture of BOOST Glucose Control(R) (Nestlé Products) supplemented with palm oil. Each participant will consume a volume of liquid equivalent to 25% of their estimated daily caloric needs, calculated by the USDA Dietary Reference Intakes using a moderate activity factor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science