bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of a 24 Hour Phone Line on the Rate of Suicide Attempts in Borderline Patients
Condition: Borderline Personality Disorder
MeSH terms: Suicide; Personality Disorders; Borderline Personality Disorder; Suicide, Attempted
Study type: Interventional

Summary: 
      This randomized multicentric clinical trial assesses the effectiveness of 24 hour phone line
      on the rate of suicide attempts and self-injurious behaviors in borderline patients.
    

Detailed description: 
      Borderline personality disorder is very frequent among psychiatric populations, and chronic
      suicidality is a major problem in clinical practice with borderline patients. In a lot of
      countries, suicide prevention centers are available, but most of these centers are not
      supervised by professionals of mental health, and none is specifically oriented to the
      borderline population.

      The main goal of this study is to assess the effectiveness of a 24 hour crisis phone line on
      the rate of suicide attempts in a clinical population of borderline patients (the
      effectiveness of this phone line access on the rate of self-injurious behaviours will also be
      studied).

      In this multicentric controlled trial, 600 borderline patients (men or women, in or
      out-patients, between 18 and 40 years-old) are randomized in two arms :

        -  one with treatment as usual

        -  one with treatment as usual, PLUS one year of access to a 24 hour crisis phone line
           (with a team of psychiatrists specialized in borderline personality disorder).

      All patients are assessed with standardized instruments (interviewers are blind to the
      patient's status), at entry (T1) and one year later (T2).
    

Intervention name(s): 24 hour phone line; treatment as usual
Intervention type(s): Other; Other
Intervention description(s): 24 hour phone line is available as soon as the patient himself feels necessary. This phone line is supported by professionals of mental health, all specialised in borderline personality disorder; Treatment as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: borderline personality disorder; suicide; suicidality; suicide attempt; suicidal behavior; self-injurious behavior; self-harm behavior; suicide prevention center; telephone intervention
Effects of Motor Imagery and Action Observation Training on Pain Perception in Patients With Chronic Neck Pain
Condition: Pain, Chronic
MeSH terms: Neck Pain; Chronic Pain
Study type: Interventional

Summary: 
      This study evaluates the influence of motor imagery or action observation training on pain
      perception in patients with chronic neck pain. Perception of pain will be measured by the
      pain pressure threshold.

      A group of patients will receive an action observation training of neck movements, another
      will receive a protocol of motor imagery of the same movements and the last group will be a
      placebo group, through the viewing of a documentary video.
    

Detailed description: 
      Motor imagery is defined as a dynamic mental process of an action, without its real motor
      execution. Action observation training consists of watching an action performed by someone
      else. Both motor imagery and action observation have been shown to produce a
      neurophysiological activation of the brain areas related to the planning and execution of
      voluntary movement in a manner that resembles how the action is performed in reality.

      Both motor imagery and action observation are interventions that can generate adaptive
      neuroplastic changes on a cortical level, leading to a decrease in chronic pain. These
      rehabilitation techniques are used in pain treatment and impaired movement injuries that
      could be due to a nervous system alteration.

      The effectiveness of motor imagery is controversial; several studies have presented
      unfavorable outcomes from this technique. Some variables, such as the duration of the
      sessions, the time employed the type of motor task or the number of sessions can influence
      the outcomes of these studies. Thus, it is necessary to clarify the controversial aspects of
      motor imagery, which lead us to perform this study.
    

Intervention name(s): Action Observation; Motor imagery; Placebo Action observation
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Action Observation training; Motor imagery protocol; Placebo Action Observation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Motor Imagery; Action observation; Pain perception
Efficacy and Safety of DLBS2411 in Healthy Volunteers
Condition: Gastric pH Regulation in Healthy Volunteers
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a 3-arm, double-blind, randomized, controlled, parallel and dose ranging clinical
      study for 3 days of therapy to investigate the effect of DLBS2411 in gastric pH regulation as
      well as its safety in healthy volunteers.

      DLBS2411 has similar mechanism of action with proton-pump inhibitors (PPIs). However, it is
      hypothetically more potential than PPIs in suppressing gastric acid as our previous
      preclinical studies with DLBS2411 have proven its effects not only on the activity of H+/K+
      ATPase, the enzyme that regulates proton pump in stomach, but also on its gene expression. It
      is hypothesized that DLBS2411 may benefit on gastric pH regulation in healthy volunteers.
    

Detailed description: 
      There will be 3 groups of treatment; each group will consist of 18 subjects with the
      treatment regimens :

        -  Treatment I : 1 caplet of DLBS2411 250 mg and 1 placebo caplet of DLBS2411, once daily

        -  Treatment II : 2 caplets of DLBS2411 250 mg, once daily

        -  Treatment III : 2 placebo caplets of DLBS2411, once daily

      Clinical examination to evaluate the investigational drug's efficacy will be performed by a
      24-hour-gastric pH monitoring after the first dose of study drug administration. Besides, the
      pH of the gastric fluid will also be measured at the end of study (Day 3 of treatment).
      Safety examination will be performed at baseline and at end of study. The occurrence of
      adverse event will be observed during the study.

      All subjects will be under direct supervision of a medical doctor during the study period.
    

Intervention name(s): DLBS2411; DLBS2411; Placebo DLBS2411
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 caplet of DLBS2411 @250 mg and 1 placebo caplet, once daily; 2 caplets of DLBS2411 @250 mg, once daily; 2 placebo caplets of DLBS2411, once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Proton pump inhibitor (PPI); DLBS2411; gastric pH
Advanced HIV Prevention (PrEP Chicago)
Condition: HIV
Study type: Interventional

Summary: 
      This study will evaluate the feasibility of a network intervention to train individuals to
      disseminate PrEP information and motivate initial PrEP interest and knowledge of PrEP in
      their social networks.
    

Detailed description: 
      The specific aims of this study are:

        1. To recruit 450 participants in Chicago, Illinois, and to train them as peer change
           agents (randomized to cross-over groups) to disseminate PrEP information and motivate
           PrEP interest and knowledge of PrEP in their local networks.

        2. To evaluate feasibility of the program over 2 years of participant follow-up through: 1)
           peer change agent exit survey; 2) peer change agent booster sessions; 3) peer change
           agent communication with University of Chicago PrEP program social media; 4) referrals
           into the project and; 5) calls into the PrEP warmline.
    

Intervention name(s): PrEP Intervention Group; Control Group
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pre-exposure prophylaxis (PrEP); diffusion of innovation; men who have sex with men; LGBT; African American; Black; HIV; network analysis; network intervention
Preemptive Analgesia Using Intravenous Paracetamol
Condition: Adverse Anesthesia Outcome
Study type: Interventional

Summary: 
      Dental treatment for children should be done in a calm atmosphere and without pain. Oral
      Propacetamol has been shown to be effective in a variety of postsurgical pain models.

      There are no studies on paracetamol preemptive analgesia effect on the pediatric population
      in the dental setting which compare analgesic effect when administered before Vs after the
      dental treatment.

      The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the
      prevention of postoperative pain in children undergoing dental treatment.
    

Detailed description: 
      Dental treatment for children should be done in a calm atmosphere and without pain in purpose
      to achieve a positive feelings and response towards dental treatment.Postoperative pain is
      the main issue which may cause a negative attitude of the child to dental treatment in future
      appointment. One of the affective options to deal with this pain is to give analgesic drug
      before the initiative of treatment which should continue its effect during and may also after
      treatment which is known as "preemptive analgesia. Oral Propacetamol has been shown to be
      effective in a variety of postsurgical pain models. In double blind clinical trials single or
      multiple dose of intravenous paracetamol, generally provided significantly better analgesic
      effect than placebo treatment in adults' patients who had undergone dental, orthopedic or
      gynecological surgery. There is considerable evidence that the analgesic effect of
      paracetamol is central and is due to activation of descending serotonergic pathways, but its
      primary site of action may still be inhibition of prostaglandin synthesis by its selective
      inhibition of Cox-2 isoenzyme.

      At the best of the investigators knowledge, there are no studies on paracetamol preemptive
      analgesia effect on the pediatric population in the dental setting which compare analgesic
      effect when administered before Vs after the dental treatment.

      The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the
      prevention or modification of postoperative pain in children undergoing dental treatment.

      The primary outcome of this study is to investigate the post dental treatment analgesic
      effect of intravenous paracetamol in children when administered before compared to after
      dental treatment.
    

Intervention name(s): Paracetamol; Paracetamol; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Paracetamol; Paracetamol; Placebo
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Postoperative pain; Dental treatment; Paracetamol
Brain Nicotine Receptor Density & Response to Nicotine Patch
Condition: Cigarette Smoking
Study type: Observational

Summary: 
      Even though the health risks and societal costs of cigarette smoking are well-known, roughly
      19.8% of American adults continue to smoke. While most smokers endorse a desire to quit, very
      few (< 5%) will actually quit in a given year without treatment, and only about 20-25%
      achieve abstinence after 6 months or more of effective treatment. Therefore, there continues
      to be a vital need to improve outcomes for cigarette smokers seeking treatment. Current
      first-line medications for Tobacco Dependence include nicotine replacement therapies (such as
      the patch, gum, lozenge, nasal spray, and inhaler), varenicline HCl (Chantix), and bupropion
      HCl (Zyban), with the current standard of care in most treatment settings being to choose
      specific medications based primarily on availability, ease of use, and patient preference.
      The goal of the proposed research is to improve the delivery of smoking cessation treatment
      by determining if pre-treatment nicotine receptor density in cigarette smokers is associated
      with smoking cessation outcome with the standard nicotine patch taper. The study's main
      hypothesis is that cigarette smokers with less pre-treatment upregulation of nicotine
      receptors will have a greater likelihood of quitting smoking from a standard course of
      nicotine patch treatment than smokers with more up-regulation of these receptors. Positron
      emission tomography (PET) will be used to test this hypothesis.
    


Intervention name(s): Transdermal Nicotine Patch; Transdermal Placebo Patch
Intervention type(s): Drug; Drug
Intervention description(s): 1 patch per day; dosages of 21 mg/day for 4 weeks, 14 mg/day for 2 weeks, and 7 mg/day for 2 weeks; 8 weeks total; 1 patch per day; 8 weeks total
Intervention MeSH terms: Nicotine
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Tobacco dependent cigarette smokers will be recruited through newspaper and internet
        advertisements from populations living in the counties surrounding the West Los Angeles
        Veterans Affairs Medical Center.
Assessment of the Efficacy of an Experimental Occlusion Technology Dentifrice in Dentinal Hypersensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of an experimental dentifrice containing stannous
      fluoride, an established dentine tubule occlusion technology, at reducing dentine
      hypersensitivity (DH) compared to a negative control dentifrice. The test and control
      dentifrices will be administered for a total of 8 weeks, with assessments (via evaporative
      air and tactile stimuli) at baseline, and after 4 and 8 weeks twice-daily use.
    

Detailed description: 
      This single centre, randomized, controlled, examiner-blind, 2 treatment arm, parallel group
      design study, stratified by maximum baseline Schiff sensitivity score (of the two selected
      teeth), with a treatment period of 8 weeks will investigate the clinical effectiveness of an
      experimental stannous fluoride dentifrice in the reduction of DH. DH will be assessed at
      Baseline, and after 4 and 8 weeks treatment to monitor clinical efficacy and safety.
    

Intervention name(s): Stannous fluoride (SnF2); Sodium monofluorophosphate (SMFP)
Intervention type(s): Other; Other
Intervention description(s): Dentifrice containing 0.454% weight by weight (w/w) SnF2 and 0.072% w/w NaF; Dentifrice containing 1400 ppm fluoride as SMFP
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      This open-label extension trial will assess the long-term use of Lacosamide monotherapy and
      safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset
      seizures who were previously enrolled in the conversion to monotherapy trial (SP902).
    


Intervention name(s): Lacosamide
Intervention type(s): Drug
Intervention description(s): 50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years
Other intervention name(s): Vimpat
Intervention MeSH terms: Lacosamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Partial-onset Seizures; Lacosamide; Monotherapy; Vimpat
Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis
Condition: Liver Cancer; Bile Duct Cancer; Pancreatic Cancer
MeSH terms: Bile Duct Neoplasms; Cholangiocarcinoma; Constriction, Pathologic
Study type: Interventional

Summary: 
      Only a small proportion of patients with biliary obstruction caused by hepatopancreatobiliary
      malignancies are suitable for surgical resection. Therefore, most patients with malignant
      biliary obstruction will need palliation of their obstructive jaundice to relieve the
      symptoms and prevent life threatening complications such as biliary sepsis. The endoscopic or
      percutaneous/transhepatic routes, such as endoscopic retrograde cholangiopancreatography
      (ERCP) and percutaneous transhepatic cholangiography (PTC), and stents are accepted
      approaches for the relief of jaundice in malignant biliary obstruction. Improvement in the
      bilirubin level is also essential before palliative chemotherapy is considered in these
      patients. However, tumor ingrowth still remains a major cause of obstruction. In this trial,
      the investigators will use HabibTM EndoHPB (EMcision Ltd., UK) catheter which was used for
      the endobiliary radiofrequency ablation (RFA) treatment as a form of neoadjuvant therapy in
      hepatopancreatobiliary adenocarcinoma.
    

Detailed description: 
      The HabibTM EndoHPB (EMcision Ltd., UK) catheter which was used for the endobiliary
      radiofrequency ablation (RFA) treatment is an endoscopic bipolar catheter designed to ablate
      tissue in malignant tumors within luminal structures. HabibTM EndoHPB has Food and Drug
      Administration (FDA) and European Conformity approval for such indications. It has also
      approved by Ministry of Health and Welfare in 2016. In this study, the investigators will
      perform intra-luminal RFA for 20 inoperable patients with malignant biliary stenosis. HabibTM
      EndoHPB will be deployed via an endoscopic retrograde cholangiopancreatography (ERCP) route.
      By using radiofrequency energy to heat the tissue in the duct prior to insertion of the
      stent, the surrounding tissue becomes coagulated and this may delay tumor growth and the time
      before the stent lumen becomes occluded. If stent occlusion occurs in a participant during
      the follow up period, the participant will be reassessed and investigations will be used to
      determine cause of stent occlusion and whether it is appropriate to repeat RFA treatment. The
      aim will be to detect an improvement in survival and safety in the treated patients compared
      to patient receiving palliative treatment recorded in literatures.
    

Intervention name(s): 'Intra-luminal radiofrequency ablation (Habib EndoHPB)
Intervention type(s): Device
Intervention description(s): endobiliary radiofrequency ablation device
Intervention MeSH terms: Phenobarbital
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: radiofrequency ablation; malignant biliary stenosis
Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral
      tablets, patients experience withdrawal and cravings when the variable BPN levels in the
      blood are low. Probuphine (buprenorphine implant) is an implant placed just beneath the skin
      that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study
      will test the safety and efficacy of Probuphine in the treatment of patient with opioid
      dependence. Patients who have completed 24 weeks of treatment in the Randomized,
      Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients with Opioid
      Dependence, will be re-treated with Probuphine over an additional 24 weeks.
    


Intervention name(s): Probuphine (buprenorphine implant)
Intervention type(s): Drug
Intervention description(s): Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug. (4 implants, 6-month duration).
Intervention MeSH terms: Buprenorphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opioid dependence; opioid addiction; buprenorphine; methadone; heroin; implant; opioid withdrawal; opioid pain medication; suboxone
Initial Local Anesthetic Dose With Continuous Interscalene Analgesia
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Objective: To determine a minimally effective initial local anesthetic bolus required to
      provide satisfactory analgesia using continuous brachial plexus infusion following
      arthroscopic shoulder surgery using a double-blind, randomized, study comparing 3 initial
      doses.
    

Detailed description: 
      Aims:

        1. To compare pain ratings and supplemental analgesic requirements at discharge from PACU,
           24 hours, and 48 hours and 12 weeks following 5, 10, and 20 ml boluses.

        2. To compare adverse events including clinical dysphonia, Horner's syndrome, dyspnea,
           unexpected hospitalization, evidence of local anesthetic toxicity, and hand weakness at
           discharge from PACU following 5, 10, and 20 ml boluses.

        3. To compare impairment in diaphragmatic excursion at discharge from PACU following 5, 10,
           and 20 ml boluses.

        4. To compare patients' satisfaction with analgesia at 24 and 48 hours following 5, 10, and
           20 ml boluses.

        5. To compare patient rating of functional outcome at baseline and at 12 weeks following 5,
           10, and 20 ml boluses.

        6. To compare the rate of general anesthesia required following 5, 10, and 20 ml boluses.
    

Intervention name(s): Ropivacaine; Ropivacaine; Ropivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Initial Bolus 5 ml Ropivacaine via interscalene injection; Initial Bolus 10 ml Ropivacaine via interscalene injection; Initial Bolus 20 ml Ropivacaine via interscalene injection
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peripheral Nerve Infusion,; continuous brachial plexus block,; post-operative pain; diaphragmatic paresis