bioihbjkbjnl/mcl2 huggingface dataset:
Oral Cannabidiol for Opioid Withdrawal
Condition: Opioid Withdrawal; Opioid Craving; Opioid Use Disorder
MeSH terms: Opioid-Related Disorders; Substance Withdrawal Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This pilot study will examine the safety of the cannabinoid cannabidiol (Epidiolex) in a
      human laboratory model of clinically relevant withdrawal. The study will be a residential
      within-subject comparison; all participants will receive placebo dosing and active
      cannabidiol. Results may be used to support an R01 grant application to more closely examine
      this hypothesis.
    

Detailed description: 
      Based on preclinical research and emerging human research, cannabidiol (CBD; a major
      constituent of the cannabis plant) is a promising pharmacotherapy for the treatment of opioid
      withdrawal. Most recently, CBD decreased cue-induced craving and anxiety (two common
      withdrawal symptoms) among abstinent heroin-dependent individuals relative to placebo. As of
      June 2018, Epidiolex, an oral formulation of plant-derived pure CBD, has been approved by the
      U.S. Food and Drug Administration (FDA) for treating severe forms of epilepsy and can be
      prescribed for other off-label indications. Epidiolex has a low side effect and high safety
      profile. Given the recent FDA approval of Epidiolex, and a growing interest to develop
      existing pharmaceuticals to address issues related to Opioid Use Disorder (OUD) and its
      recovery, the investigators are proposing a pilot study to examine the safety of Epidiolex in
      a human laboratory model of clinically relevant withdrawal. The study will be a residential
      within-subject comparison; methadone-maintained participants will undergo spontaneous
      withdrawal and receive placebo dosing and active cannabidiol. Data collected for this study
      will establish: (1) the safety of administering two dosing regimens of Epidiolex within the
      investigators' withdrawal paradigm and (2) the feasibility of the investigators' withdrawal
      paradigm for demonstrating clinically meaningful increases in withdrawal. Results may be used
      to support an R01 grant application to more closely examine this hypothesis.
    

Intervention name(s): Epidiolex; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Epidiolex 100 mg/mL Oral Solution; Cherry syrup oral solution
Other intervention name(s): Cannabidiol
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Within subject comparison of Epidiolex to placebo. The order of study drug (active Epidiolex or placebo) is randomized across participants. Epidiolex is flavor masked with cherry syrup.
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Omegas 3 and 6 on Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 3

Summary: 
      Context: The treatment of alcoholism is a challenge for psychiatrists and patients. Some
      studies have shown that alcohol alters the environment of the membranes, mainly by modifying
      their permeability through the lipid fraction. These lipids are known as essential fatty
      acids (EFA) because they are obtained only through the diet, as the human body is unable to
      synthesize them. Linolenic acid (LA), or omega 6, and alpha-linolenic acid (ALA), or omega 3,
      are polyunsaturated fatty acids (PUFAs). Finally, ethanol changes the absorption and
      metabolism of PUFAs, and it's supplementation may be helpful for alcohol dependence recovery.

      Objective: to assess the effectiveness of PUFAs supplementation in the treatment of alcohol
      dependent patients.
    


Intervention name(s): Naltrexone; PUFAs; Placebo; Naltrexone + Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A pill of naltrexone chlorhydrate 50mg, associated to yellow liquid paraffin pills simulating borage seed and fish oil.; Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs; associated to a pill with 50mg of talcum powder, identical to the pill of naltrexone.; A pill with 50mg of talcum powder, identical to the pill of naltrexone; associated to PUFAs Placebo pills (yellow liquid paraffin identical to the pills of borage seed and fish oil).; A pill of naltrexone chlorhydrate 50mg, associated to Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs.
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PUFAs; Alcoholism; Treatment; Effectiveness
Reducing Behavioral Risk Factors of NCDs: Protocol for a School-based Health Education Program in Bangladesh
Condition: Non-communicable Disease Risk Factors
MeSH terms: Noncommunicable Diseases
Study type: Interventional

Summary: 
      This is a before-after designed intervention study conducted in two randomly selected
      secondary schools- one was selected randomly as intervention school and the another as
      control school. A baseline survey was conducted among the students of both schools by a
      pre-tested questionnaire to attain their current status of knowledge, attitude and practices
      related to NCDs. Afterward, students were enrolled in the intervention group who met the
      eligibility criteria from the intervention school. The intervention was given through a
      health promotion session to a group of students, not more than 25 at a time, by trained
      facilitators. A post-intervention end line survey was conducted among all the participants
      from both schools using the same questionnaire three months after the baseline survey. An
      intervention has been developed based on some principals of two psychosocial theory-
      Motivational Interview and Social Cognitive Theory. Emphasis was given on motivating the
      adolescents towards a healthy lifestyle, supporting self-efficacy to be changed, guiding
      self-regulatory ways along with facilitating desired changing process by empowering them with
      choices about the preventive measures of NCDs. This intervention is expected to increase
      awareness by equipping the adolescents with specific knowledge and skills and thus,
      facilitate an eventual change in their practiced risk behaviors.
    


Intervention name(s): Health education; Carrier Guidance
Intervention type(s): Behavioral; Other
Intervention description(s): In this health education intervention, emphasis is given on evoking adolescents' internal desire to change, supporting self-efficacy to be changed, guiding self-regulatory ways along with facilitating desired changing process by empowering them with choices and skills.; Carrier opportunities and counselling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: NCDs; Risk behaviors; Adolescents; Health education intervention
A Study of Danavorexton (TAK-925) in Adults With Obstructive Sleep Apnea
Condition: Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The main aim of the study is to check the side effects from overnight treatment with
      danavorexton and assess the tolerability of varying doses of danavorexton administered
      intravenously.

      Before starting treatment with danavorexton, participants will keep a sleep diary and use an
      under-mattress sensor for at least 7 nights to check regular sleep habits.

      There will be 3 Treatment Period up to 14 days apart. In each Treatment Period, participants
      will receive an intravenous (through the vein) infusion of either danavorexton or a placebo
      starting in the evening and continuing over a 10-hour period. A placebo looks exactly like
      danavorexton but does not have any medicine in it.

      Participants will take part in a follow-up phone appointment about a week after the last
      Treatment Period.
    

Detailed description: 
      The drug being tested in this study is called danavorexton. The study will look at the
      safety, tolerability, pharmacokinetic (PK), and pharmacodynamics (PD) effects of
      danavorexton.

      The study will enroll approximately 18 participants (to acquire data in 'n' greater than or
      equal to [>=] 12). Each participant will receive one of the following treatments in each
      Treatment Period: Danavorexton low dose (LD), danavorexton high dose (HD), or placebo. All
      participants will receive all 3 treatments. A washout period of a minimum of 2 days up to 14
      days will be maintained between the end of infusion to the start time of next infusion. The
      order in which each participant receives the 3 treatments will be randomly assigned.
      Treatment order will remain undisclosed to the participants and study doctor during the study
      (unless there is an urgent medical need).

      This single-center trial will be conducted in Australia. The overall time to participate in
      this study is up to 69 days. Participants will be followed remotely until 5 to 9 days after
      the last dose of study drug in the Treatment Period 3.
    

Intervention name(s): Danavorexton; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Danavorexton intravenous infusion.; Placebo intravenous infusion.
Other intervention name(s): TAK-925
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Drug Therapy
ANCHORS Study: UH2 Project
Condition: HIV-1-infection
Study type: Interventional

Summary: 
      According to the National HIV/AIDS Strategy, men who have sex with men (MSM), young adults,
      Black and Latino men and people in the Southern U.S. are at highest HIV risk and should be
      targeted with cost-effective, scalable interventions. The study team propose a synergistic
      mobile intervention to reduce alcohol and HIV risk in young adult MSM that combines 3
      efficacious approaches.
    

Detailed description: 
      New prevention efforts must address alcohol and HIV and be directed to the highest-risk
      groups. While interventions have targeted MSM, few have targeted young MSM specifically.
      Young people and MSM bring particular challenges. Thus, it is important that prevention be
      targeted to them and developed with their input. To that end, the goal of this project is to
      lay the groundwork for a synergistic, mobile intervention to reduce alcohol use and risky sex
      and prevent HIV among young adult MSM. This research study is made up of three related
      sub-projects: 1) a web-based survey; 2) a series of focus groups and 3) a small, preliminary
      acceptability and usability to study to test the mobile intervention. The proposed
      intervention to be tested on a preliminary basis in this study combines brief motivational
      intervention with daily interactive voice response (IVR) monitoring including personalized
      feedback. Ultimately, this combined intervention will also include pre-exposure prophylaxis
      (PrEP), however there will be no medication in this particular study. Each of these
      components has efficacy in enhancing treatment adherence, reducing alcohol and/or HIV risk
      but requires other interventions to maximize its potential benefit. Combining them will
      capitalize on the strength of each, leading to a higher impact alcohol and HIV preventive
      intervention.
    

Intervention name(s): Survey; Focus Group; Usability study
Intervention type(s): Other; Other; Other
Intervention description(s): Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated; After informed consent, participants will complete the web-based intervention component in development. Afterward, participants will be engaged by an experienced facilitator in a discussion of aspects of the intervention they liked and disliked and suggestions they have for enhancing its cultural appropriateness to young MSM.; After informed consent, participants will utilize the mobile intervention in development for 30 days to establish usability, acceptability and correct any functionality issues.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: MSM, young adult
Episodic Future Thinking and Compassion
Condition: Compliant Behavior; Self-Control; Impulsive Behavior
MeSH terms: Impulsive Behavior
Study type: Interventional

Summary: 
      During the COVID-19 (Coronavirus Disease 2019) pandemic, public health departments have
      issued guidelines to limit viral transmission. In this environment, people will feel urges to
      engage in activities that violate these guidelines, but research on guideline adherence has
      been reliant on surveys asking people to self-report their typical behaviour, which may fail
      to capture these urges as they unfold. Guideline adherence could be improved through
      behaviour change interventions, but considering the wide range of behaviours that COVID-19
      guidelines prescribe, there are few methods that allow observing changes of aggregate
      guideline adherence in the 'wild'. In order to administer interventions and to obtain
      contemporaneous data on a wide range of behaviours, the researchers use ecological momentary
      assessment. In this preregistered parallel randomised trial, 95 participants aged 18-65 from
      the United Kingdom were assigned to three conditions using blinded block randomisation, and
      engage in episodic future thinking (n = 33), compassion exercises (n = 31), or a sham
      procedure (n = 31) and report regularly on the intensity of their occurrent urges (min. 1,
      max. 10) and their ability to control them. The researchers investigate whether state
      impulsivity and vaccine attitudes predict guideline adherence, while assessing through which
      mechanism these predictors affect behaviour.
    


Intervention name(s): Episodic Future Thinking; Compassion Training; Sham
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants are invited to imagine themselves in a positive situation after COVID-19 public health restrictions and guidelines are lifted. They are then reminded that their actions are able to change how soon this future can be achieved.; Participants are invited to imagine themselves in someone else's situation, who is in a bad situation due to COVID-19 (e.g., ER nurse, family of someone in ICU). They are then reminded that their decisions have an impact on the occurrence of these situations.; Participants are invited to reflect on some COVID-19 related news, and reminded that their actions have bearing on the COVID-19 situation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Episodic future thinking; Compassion; Impulsivity; Self-control; Pandemic; Public Health
Research Study in Patients With Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to evaluate an intravenous (by injection) investigational
      medication to treat severe ulcerative colitis refractory to steroid therapy. The research is
      being conducted at up to 8 clinical research sites in the US and is open to both men and
      women ages 18 to 70 years old. Participants in the study will have a number of visits to a
      research site. All study-related care and medication is provided to qualified participants at
      no cost: this includes all visits, examinations and laboratory work.
    

Detailed description: 
      A Phase I, dose-escalation, pilot study designed to obtain safety and tolerability data on
      visilizumab administered to patients with severe ulcerative colitis that has failed to
      respond to steroid therapy. Patients who are currently receiving IV corticosteroids, but
      whose disease has not responded after at least 5 days of this therapy, will be eligible for
      the study.
    

Intervention name(s): Visilizumab
Intervention type(s): Drug
Intervention MeSH terms: Visilizumab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colitis; Gastrointestinal Disease; Digestive System Disease; Intestinal Disease; Colonic Disease
Health Effects of CLA Versus Industrial Trans Fatty Acids
Condition: Healthy
Study type: Interventional

Summary: 
      The knowledge of the health effects of CLA on the human body is limited. However, CLA
      supplements are sold over the counter in several countries and various techniques are used to
      increase the content of CLA in food.

      The CLARINeT study will be performed to investigate the effect of CLA on blood lipoproteins,
      inflammatory markers, blood pressure and insulin status in human volunteers relative to
      industrial trans fatty acids and to oleic acid.
    

Detailed description: 
      It will be a double-blind randomized multiple cross-over trial with 3 treatments:

        -  CLA;

        -  Industrial trans fatty acids (as a positive control);

        -  Oleic acid (Cis 18:1, the monounsaturated fatty acid in unhydrogenated vegetable oils)
           as a reference fat.

      Each volunteer receives each diet for three weeks, in random order, for a total of 9 weeks.
      Three weeks is sufficient to reach new stable lipoprotein levels.
    

Intervention name(s): Consumption of CLA enriched food
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: CLA; Industrial trans fatty acids; Oleic acid; Controlled dietary trial
Tension-free Vaginal Tape (TVT) Versus Bulking Agent for the Treatment of Post Vulvectomy Urinary Incontinence
Condition: Urinary Incontinence, Stress
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 3

Summary: 
      The surgical treatment of vulvar cancer is characterized by a radical approach as standard,
      often associated to an important rate of functional complications. This surgery often
      includes the partial excision of urethra, resulting in a reduction of urethral closure
      pressure. The radiotherapy-induced fibrosis in addiction leads to a reduction of urethral
      mobility. As consequence women treated for vulvar cancer may develop urinary incontinence.
      The incidence of this complication has been differently reported, but seems to reach the
      100%. Poor data are available regarding the treatment of post vulvectomy urinary incontinence
      and no clear indication may be given at regards.

      Based on these considerations the aim of this trial will be to compare tension free vaginal
      tape and bulking agent injection in women with urinary stress incontinence developed after
      radical surgery for vulvar cancer.
    

Detailed description: 
      Women with urinary stress incontinence developed after radical vulvectomy will be enrolled
      and randomized in two groups (arm 1 and arm 2). Patients of group 1 will be treated with the
      tension free vaginal tape, whereas in patients of arm 2 will be used the bulking agent
      injection.

      All eligible patients will undergo baseline assessment consisting of anthropometric,
      clinical, and urodynamic evaluations. During the study, the surgical outcomes, the clinical
      subjective and objective efficacy data, and the adverse experiences will be evaluated in each
      patient.

      Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less
      will be considered significant.
    

Intervention name(s): Tension free vaginal tape; Bulking agent injection
Intervention type(s): Procedure; Procedure
Intervention description(s): Small incision sites in the vagina and suprapubically. Bilateral retropubic insertion of the sling by means of needles; Three Periurethral injections of Bulkamid ® (Ethicon,Somerville, NJ, USA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bulking agent; emivulvectomy; radical vulvectomy; TVT; urinary incontinence; vulvar cancer
A Study to Compare the Pharmacokinetics of BR4002 and BR4002-1 in Healthy Volunteers
Condition: Dementia Alzheimers
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is designed as a randomized, open-label, single-dose, 6x3 crossover study.
    

Detailed description: 
      A total of 18 subjects will be randomized into 6 sequence groups. The investigational
      products will be administered according to the treatment groups (R, T1, and T2) assigned to
      each sequence group in Period 1, Period 2, and Period 3. In between each period, there will
      be a washout period (28 days) long enough for the administered IP to be metabolized and
      eliminated.
    

Intervention name(s): BR4002; BR4002-1
Intervention type(s): Drug; Drug
Intervention description(s): Administration to the T1 group: 5 mg of BR4002 (patch) will be attached using an applicator for 24 hours
Administration to the T2 group: 5 mg of BR4002 (patch) will be attached without using an applicator for 24 hours; Administration to the R group: 5 mg of BR4002-1 (oral formulation) will be administered with 150 mL of water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment