bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Escalating Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ND-L02-s0201 Injection in Normal Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety, tolerability, and pharmacokinetics of ND-L02-s0201 in
      normal, healthy, subjects
    


Intervention name(s): ND-L02-s0201 Injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single IV infusion.; Single IV infusion.
Other intervention name(s): BMS-986263
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Study of the Absorption, Metabolism, and Excretion of [14C]-Ecopipam in Healthy Male Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, single-center (United Kingdom), open-label, nonrandomized, single-dose study in
      healthy adult male subjects to assess the absorption, metabolism, and excretion of
      [14C]-Ecopipam in Healthy Male Subjects.
    

Detailed description: 
      This study will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male
      subjects. Potential subjects will be screened to assess their eligibility to enter the study
      within 29 days prior to dose administration. Subjects will be admitted into the clinical
      research unit (CRU) on Day -1 and be confined to the CRU until at least Day 8 (Discharge). On
      Day 1, subjects will receive a single oral dose of 200 mg ecopipam HCl containing
      approximately 88.5 µCi of [14C]-ecopipam HCl. Subjects will be discharged when the following
      discharge criteria are met:

        -  plasma radioactivity levels below the limit of quantitation for 2 consecutive
           collections;

        -  ≥ 90% mass balance recovery; and

        -  ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in
           2 consecutive 24-hour periods in which collections occur. If discharge criteria are not
           met on Day 8, subjects will remain in the CRU and additional 24-hour collections (blood,
           urine, and feces) for total radioactivity will continue until these criteria are met, up
           to a maximum of Day 15.
    

Intervention name(s): [14C]-Ecopipam
Intervention type(s): Drug
Intervention description(s): [14C]-Ecopipam
Intervention MeSH terms: Ecopipam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Single Intraarticular Injection of Platelet-Rich Plasma on Pain and Physical Function in Patients With Ankle OA
Condition: Ankle Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Platelet-rich plasma (PRP) has been reported to be an effective treatment for knee
      osteoarthritis (OA). The application in ankle OA has rarely been investigated. The aim was to
      evaluate the efficacy and safety of a single intraarticular injection of PRP for the
      treatment of patients with ankle OA.
    

Detailed description: 
      Methods: In a prospective study, patients with symptomatic ankle OA for at least 6 months
      were recruited. Patients received a single injection of 3-ml of PRP into symptomatic ankles.
      The primary outcome was the change from baseline in the visual analog scale (VAS) pain score
      (0-10cm) at 6 months. Secondary outcomes included the Ankle Osteoarthritis Scale (AOS) score,
      American Orthopedic Foot and Ankle Society (AOFAS) ankle/hindfoot score, single leg stance
      test (SLS), use of rescue analgesics and patient satisfaction. Adverse events were recorded
      during the study.

      Patients were followed at 1, 3 and 6 months postinjection .
    

Intervention name(s): PRP
Intervention type(s): Other
Intervention description(s): , For PRP preparation, specialized platelet concentrate separator containing acid citrate dextrose as anticoagulant and a specific separator gel that harvest PR, preventing contamination of red blood cells and leukocytes were used.
Intervention model: Single Group Assignment
Intervention model description: patients with symptomatic ankle OA for at least 6 months were recruited. Patients received a single injection of 3-ml of PRP into symptomatic ankles.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ankle joint; Osteoarthritis; Platelet rich plasma
A Peer-based Mobile-health Intervention to Increase Access & Adherence to Hepatitis C Treatment & HIV Viral Suppression
Condition: Hepatitis C; HIV; Risk Reduction Behavior
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional

Summary: 
      The purpose of this study is to test an intervention designed to train persons who inject
      drugs (PWID) and are infected with hepatitis C (HCV) and HIV in communication skills to 1)
      promote new HCV treatment and care 2) risk reduction and 3) recruit their social network
      members for HIV and HCV testing and linkage to care.
    

Detailed description: 
      The investigators propose recruiting 300 HIV/HCV co-infected PWID (i.e. Index participants).
      Half will be randomly assigned to the experimental condition and half to the equal attention
      comparison. The experimental intervention will include 8 group sessions that focus on
      communication to social network members, medical adherence and risk reduction skills, 2 dyad
      sessions with network members, monthly booster sessions for 6 months, and mHealth cuing of
      behavior for 6 months. These Index participants will be followed for 24 months (3, 6, 12, 18,
      & 24 month assessments). Participants who test positive for HCV will be linked to the Johns
      Hopkins Viral Hepatitis clinic to assess liver function and HCV chronicity and if applicable
      offered HCV treatment. Additionally, 450 network members will be recruited and will be tested
      for HIV and HCV and followed longitudinally to examine the social diffusion and social
      network factors associated with adherence among the Index participants.
    

Intervention name(s): Peer Mentor
Intervention type(s): Behavioral
Intervention description(s): comparison of communication training to equal attention control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Testing; Access
Honest Open Proud for Adolescents With Mental Illness
Condition: Secrecy Versus Disclosure Among Adolescents With Mental Illness
MeSH terms: Mental Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy of the group-based intervention 'Honest
      Open Proud' among adolescents with mental illness.
    

Detailed description: 
      Both due to fear of public stigma and due to self-stigma or shame, people with mental illness
      may decide to keep their condition a secret or even to withdraw from other people altogether
      in order to minimise the risk of being labelled. Secrecy can help on the short term to
      protect individuals from public stigma, but often it has negative long-term consequences such
      as social isolation, distress and unemployment. Disclosure, on the other hand, carries the
      risk to be discriminated by others, but can reduce the burden of secrecy, lead to support by
      others and reduce public stigma. In this study investigators aim to evaluate whether a group
      program run both by people with mental illness (peers) and professionals helps to reduce
      self-stigma and makes it easier for adolescents to handle the necessary choices related to
      secrecy versus disclosure.
    

Intervention name(s): Honest Open Proud (HOP)
Intervention type(s): Behavioral
Intervention description(s): five lessons in three modules, two for each two-hour session
Considering pros and cons of disclosing:
hurtful and helpful attitudes about mental illness
identify beliefs participants hold about themselves
explore five-step process to challenge their personally hurtful beliefs
weigh pros and cons of coming out in order to facilitate a decision on whether to disclose
Different ways to disclose:
different levels of (non-) disclosure and how to weigh the cons and pros
disclosure via social media versus disclosing face to face
how to find people that are better to disclose to than others and how to 'test them out'
participants will discuss how others might respond to their disclosure and how that will affect them
Telling your story:
how to tell one's story in a personally meaningful way, how to identify peers who might help with the coming out process, to review how telling one's story felt
Other intervention name(s): Coming Out Proud (COP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mental illness; adolescents; intervention; stigma; disclosure; secrecy
Joint Status in Subjects With Severe Hemophilia A in Relation to Different Treatment Regimens
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 4

Summary: 
      The joint status (knees, ankles) of patients suffering from severe Hemophilia A (too little
      blood clotting factor VIII in blood) is evaluated in a single magnetic resonance imaging
      session. No study medication is given.
    


Intervention name(s): No Drug; No Drug; No Drug; No Drug; No Drug
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Patients have received primary FVIII prophylaxis (started < 2 years of age); Patients have received secondary FVIII prophylaxis (started 2 - < 6 years of age); Patients have received secondary FVIII prophylaxis (started 6 - < 12 years of age); Patients have received secondary VIII prophylaxis(started 12 - 18 years of age); Patients have received on-demand therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Hemophilia A; Joint Status; Bleeds; Magnetic Resonce Imaging
Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 mg for Post Lobectomy Analgesia
Condition: Solitary Mass; Lung Diseases
MeSH terms: Lung Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the amount of total pethidine requirement during the
      48 hour postoperative period after receiving spinal morphine 0.2 and 0.3 mg.
    

Detailed description: 
      Thoracotomy causes severe pain to the patients. Continuous thoracic epidural is a gold
      standard for postoperative pain. However, it needs skill. There are many alternatives such as
      spinal morphine, intercostal nerve block, cryoalangesia or interpleural block.
    

Intervention name(s): spinal morphine 0.3 mg; spinal morphine 0.2 mg
Intervention type(s): Drug; Drug
Intervention description(s): spinal morphine 0.3 mg; spinal morphine 0.2 mg
Other intervention name(s): morphine; morphine
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: thoracotomy; postoperative pain; spinal morphine
Dermacyd Delicata Breeze - Photo Evaluation
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to prove the absence of photo irritation and photo sensitivity
      potential of the product Dermacyd Breeze.
    


Intervention name(s): Lactic acid (Dermacid)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hygiene
Development and Validation of the Food Acceptability Questionnaire
Condition: Healthy
Study type: Observational

Summary: 
      The Food Acceptability Questionnaire (FAQ) is a self-report measure of palatability, ease of
      preparation, satisfaction, and perceived benefits and adverse effects related to a prescribed
      or self-selected diet. This study intends to develop a reliable and valid food acceptability
      questionnaire for use in clinical studies in which dietary interventions are administered.
    

Detailed description: 
      Two hundred adult participants who follow a therapeutic diet will be recruited from the
      Washington DC area. Participants will be asked to rate their impression on the foods that
      they were eating in the past two weeks. Fifty participants will be chosen at random and asked
      to complete the questionnaire a second time, three weeks later, to assess reliability.
      Ratings will be used to assess the validity and reliability of the Food Acceptability
      Questionnaire (FAQ).
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Men and women following a theraputic diet for at least 1 month
      
Keywords: diet; acceptability; palatability; food; questionnaire; Food habits
Electroencephalography Predictors of Repetitive Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder
Condition: Obsessive Compulsive Disorder (OCD)
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      This study used electroencephalogram (EEG) to predict the efficacy of repetitive transcranial
      magnetic stimulation (rTMS) in patients with obsessive-compulsive disorder.
    

Detailed description: 
      Repetitive Transcranial Magnetic Stimulation (rTMS), as a relatively mature non-invasive
      neuromodulation technology, has been recommended for the treatment of patients with
      refractory OCD in multinational guidelines. However, due to the treatment setting and the
      patient's feature, nearly half of the patients have no significant changes after rTMS
      treatment.

      In order to better predict the outcome of rTMS and improve the treatment efficiency, this
      project intends to look for markers that have a predictive effect at baseline or early
      treatment. Electroencephalogram (EEG) is a cheap and fast method that usually occurs before
      the symptoms change, thus it is possible to determine whether the patient has responded to
      the intervention.

      In this project, the supplementary motor area (SMA) is selected as the stimulation target.
      The individual head magnetic resonance image positioning and navigation and rTMS compatible
      real-time EEG acquisition technology are used to monitor the resting state of EEG and rTMS
      single pulse stimulation and changes in neural networks before and after treatment. This is a
      preliminary exploration looking for effective predictive indicators of efficacy in EEG and
      the relationship between EEG and symptoms changes. In order to lay the foundation for further
      research and guide clinical treatment.
    

Intervention name(s): Continuous theta burst stimulation (cTBS)
Intervention type(s): Device
Intervention description(s): 50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Augmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat PTSD
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a small, open-label treatment study that tests the potential safety and treatment
      effectiveness of a stellate ganglion block combined with Massed Prolonged Exposure (PE). Each
      of the 12 participants will receive ten 90-minute sessions of Massed Prolonged Exposure and
      an injection of a stellate ganglion block between the first and second PE sessions.
    

Detailed description: 
      Massed PE will be conducted by doctoral-level therapists. Participants will meet with their
      providers for individual, 90-minute sessions. They will then be asked to complete
      out-of-session treatment assignments throughout the rest of the day. Between the individual
      therapy session and out-of-session treatment assignments, participants will engage in
      approximately four to six hours of treatment per day, Monday through Friday, for two weeks.
      The stellate ganglion block injection will be administered between the first and second
      massed PE session by qualified medical personnel as per standard operating procedure for the
      placement of a stellate ganglion block. A research nurse will be in attendance during the
      procedure and for an hour recovery period following the block administration.

      During PE treatment, participants will complete interim assessments of their PTSD symptoms,
      mood symptoms, trauma-related cognitions, and suicidal ideation proceeding sessions 6 and 10.
    

Intervention name(s): Ropivacaine injection
Intervention type(s): Drug
Intervention description(s): 6.5cc of Ropivacaine HCl 0.5%, one time into the stellate ganglion
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Intervention model: Single Group Assignment
Intervention model description: A small open-label treatment study
Masking: None (Open Label)
Primary purpose: Treatment
Preload, Weight Management, Risk of Cardiovascular Disease
Condition: Body Weight
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 3

Summary: 
      Investigators presumed that preload consumers will have more weight reduction and lower risk
      of cardiovascular disease
    

Detailed description: 
      To our knowledge, all previous studies evaluated the energy intake in a dietary meal after
      consuming a low-energy-dense preload while none assessed the sustainability of lower amount
      of energy intake and body weight changes in a long-term. On the other hand, the
      sustainability of lower energy intake in a long term might be affected by higher dietary
      diversity score due to considering preload in diets. Notably, increased diet variety is
      associated with higher overall dietary energy intake and weight gain.
    

Intervention name(s): preload diet; control diet
Intervention type(s): Other; Other
Intervention description(s): All participants were prescribed a calorie-restricted diet (-200 to -500 kcal/d). Calorie requirements of each subject were estimated based on resting energy expenditure (REE) by using Harris- Benedict equation and also considering the physical activity levels. The diets were constructed to provide similar proportions of carbohydrates (55% energy), protein (15% energy) and total fat (30% energy).; All participants were prescribed a calorie-restricted diet (-200 to -500 kcal/d). Calorie requirements of each subject were estimated based on resting energy expenditure (REE) by using Harris- Benedict equation and also considering the physical activity levels. The diets were constructed to provide similar proportions of carbohydrates (55% energy), protein (15% energy) and total fat (30% energy).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: preload; anthropometric measures; cardiovascular risk factors
Decremental Exercise: a New Training Approach?
Condition: Exercise Performance of Fit Athletes
Study type: Interventional

Summary: 
      Different types of high-intensity interval training (HIIT) sessions are used by athletes in
      order to improve their physical performance, but innovative approaches to training are
      lacking. Therefore, in Part A of this study the physiological response to a standard HIIT and
      a new decremental exercise training (DECT) will be compared in runners and cyclists. Next, in
      Part B the training effects of a 4-week block of the HIIT and DECT will be compared.
    


Intervention name(s): DECT; HIIT
Intervention type(s): Other; Other
Intervention description(s): The DECT program consists of a 4-week training intervention with three weekly sessions of high-intensity interval training, in which during each exercise bout the workload is imposed in a decremental fashion.; The HIIT program consists of a 4-week training intervention with three weekly sessions of high-intensity interval training, in which during each exercise bout the workload is kept constant.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of Baricitinib and Probenecid in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to assess how the body handles baricitinib when it is given
      with another drug called probenecid. The study doctor will measure the amount of baricitinib
      that is absorbed into the blood stream and the time that it takes to remove baricitinib from
      the body. The safety and tolerability of these drugs will be studied. The study will last
      about 18 days from the first dose to the end of the study (not including screening).
    


Intervention name(s): Baricitinib; Probenecid
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Intervention MeSH terms: Probenecid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Single-dose, Dose-escalation Study of a Long-acting MOD-5014 in Healthy Adult Male
Condition: Hemophilia A or B With Inhibitors
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, randomized, single-blind, placebo-controlled, single dose, dose-escalation study
      to assess the safety, pharmacokinetic and pharmacodynamic profile of subcutaneous
      administration of a long-acting recombinant factor VIIa (MOD-5014) in healthy adult males.
    

Detailed description: 
      This will be a single-dose, randomized, single-blind, placebo-controlled, dose-escalating
      study.

      The study will include four escalating dose groups, with eight subjects in each dose group.
      Subjects will be randomized in 3:1 ratio to receive a single SC injection of MOD-5014 (n=6)
      or a placebo (n=2), and will be followed up for 30 days. The initial MOD-5014 dose group will
      receive 100 µg/kg followed by single doses of 200, 400 and 600 µg/kg administered to
      subsequent subject cohorts.

      The decision to proceed to the higher dose level will be made by a Data Safety Monitoring
      Board (DSMB) after review of relevant safety data (including adverse events, clinical
      laboratory and vital signs), collected up to and including 7 days after the last subject of
      the previous dose group has been dosed.

      Common Terminology Criteria for Adverse Events (CTCAE) guidelines will be used to determine
      maximum tolerated dose (MTD) and dose limiting toxicity (DLT). Dose escalation will be
      permitted if the prior dose is well tolerated, and there are no safety or tolerability
      concerns raised by the investigator, sponsor, medical monitor or DSMB over 7 days
      post-dosing.
    

Intervention name(s): MOD-5014; MOD-5014 Placebo
Intervention type(s): Biological; Other
Intervention description(s): MOD-5014, a long-acting modified recombinant Factor VIIa; Placebo solution for SC injection containing the same inactive ingredients used in the active drug product at matching volumes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other