bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Posttraumatic Stress Disorder (PTSD) in Adult Survivors of Early Chronic Interpersonal Trauma
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Eye movement desensitization and reprocessing (EMDR) and trauma-focused cognitive-behavioural
      therapy (TF-CBT) have both been found to be effective in treating post-traumatic stress
      disorder (PTSD) following single-event traumas and to be more effective than pure anxiety
      management or stabilization treatments. However, much less is known about the efficacy of the
      different treatment approaches in survivors of repeated or chronic interpersonal trauma.
      Recent evidence suggests that a combination of stabilization treatment + TF-CBT is
      efficacious in this population. Although EMDR is also often used in survivors of chronic
      interpersonal trauma, evidence on its efficacy are still poor. The aim of the current study
      is to compare the efficacy of (1) stabilization + TF-CBT and (2) stabilization + EMDR using a
      randomized controlled trial in a routine clinical setting.
    


Intervention name(s): STAIR; MPE; EMDR
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Skills Training in Affective and Interpersonal Regulation; Modified prolonged exposure (MPE); Eye movement desensitization and reprocessing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of Bedaquiline (TMC207) in Participants With Multibacillary Leprosy
Condition: Leprosy, Multibacillary
MeSH terms: Leprosy; Leprosy, Multibacillary
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy of an 8-week bedaquiline monotherapy
      regimen in participants with treatment-naive, multibacillary (MB) leprosy.
    


Intervention name(s): Bedaquiline 200 mg
Intervention type(s): Drug
Intervention description(s): Participants will receive bedaquiline 200 mg (2*100 mg tablets) once daily for 2 weeks followed by 100 mg tablet tiw for 6 weeks with at least 48 hours between doses.
Other intervention name(s): TMC207
Intervention MeSH terms: Bedaquiline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multicenter Study: Dexmedetomidine Combined With Sufentanil for Patient Controlled Intravenous Analgesia After Caesarean Section
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this multicenter study is to evaluate the effectiveness and safety of
      dexmedetomidine combined with sufentanil for patient-controlled analgesia after caesarean
      section
    


Intervention name(s): Normal saline; Dexmedetomidine; Sufentanil; Sufentanil and dexmedetomidine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Control Group receives normal saline bolus after delivery; Dex Group receives dexmedetomidine bolus 0.5mcg/kg after delivery; sufentanil PCA after surgery; sufentanil combined with dexmedetomidine PCA after surgery
Intervention MeSH terms: Sufentanil; Dexmedetomidine; Dsuvia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
To Evaluate the Influence of the A118G Polymorphism in the mu Opioid Receptor Gene (OPRM1) on Effects of GSK1521498 and Naltrexone on Physiological and Behavioural Markers of Brain Function in Healthy Social Drinkers
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      A total of at least 48 healthy subjects with a history of social drinking will be recruited
      into this single-centre, randomized, double-blind, cross-over study. Subjects will be
      genetically stratified to result in equal numbers of A118G 'AA' homozygotes (n=24) and A118G
      'G' carriers (n=24).

      Subjects will participate in all three treatment periods and will be randomized to receive
      each of the following for 5 days: Treatment A: Placebo, Treatment B: Naltrexone (NTX) 50 mg
      once daily (25 mg once daily for the first two days) and Treatment C: GSK1521498 10 mg once
      daily. A washout period will be of at least 14 days between treatments. Subjects will return
      for a follow-up visit 7-10 days after the final treatment session washout period has been
      completed.

      Subjects will attend the clinical research unit on days 1, 2, 3, 4 and 5 to monitor safety
      and tolerability for both drugs. Subjects will attend the clinical unit on days 4 and 5 for a
      two day assessment, using a series of pharmacodynamic measurements known to be sensitive to
      the effects of GSK1521498 and/or NTX: Functional brain response to alcohol and food cues;
      plasma cortisol; hedonic and consummatory eating behaviors; subjective response to an ethanol
      challenge; experimental pain threshold; and cognitive tests of attention bias towards alcohol
      and food cues.
    


Intervention name(s): GSK1521498; Naltrexone (NTX); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): White HPMC capsule containing 10 mg of GSK1521498; Swedish orange gelatin capsule containing 25mg of NTX or 50mg of NTX; Matching placebo capsules to GSK1521498 or NTX
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacogenetics; OPRM1; Pharmacodynamics; Addiction; mu opioid receptors
Shared Decision Making in Parents of Children With Acute Otitis Media
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional

Summary: 
      This study will evaluate the efficacy of shared decision making in treatment of Acute Otitis
      Media in the Emergency Department setting.
    

Detailed description: 
      The Investigators long-term goal is to promote evidence-based, patient-centered evaluation in
      the acute care setting to more closely tailor antibiotic use to disease risk for Acute Otitis
      Media (AOM) in children.

      The Investigator will conduct a single-center cluster randomized control trial comparing the
      efficacy, safety and patient-centered outcomes of the shared decision-making decision aid
      'Acute Otitis Media Choice' to usual care among children diagnosed with acute otitis media in
      the ED for whom antibiotics are being considered to engage parents in shared decision-making.
    

Intervention name(s): Acute Otitis Media Choice Decision Aid; Usual Care
Intervention type(s): Other; Other
Intervention description(s): Decision Aid; Usual Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)
Condition: Parkinson's Disease Dementia
MeSH terms: Parkinson Disease; Dementia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to provide long-term safety data for rivastigmine capsule and
      transdermal patch treatments, in particular the effect of rivastigmine on worsening of the
      underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately
      severe dementia associated with PD.
    


Intervention name(s): Rivastigmine capsule; Rivastigmine transdermal patch
Intervention type(s): Drug; Drug
Intervention description(s): Rivastigmine capsules orally twice a day. Target dose 12 mg/day.; Rivastigmine patch once a day in the morning, worn for 24 hours. Target dose 10 cm^2/day delivering 9.5 mg over a 24 hour period.
Other intervention name(s): Exelon®; Exelon®
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease dementia; cholinesterase inhibitor; rivastigmine
A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis
Condition: Schizophrenia; Mania; Delusional Disorder; Acute Exacerbation of Psychosis
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia, Paranoid
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the efficacy, safety, and tolerability of intramuscular ziprasidone in the
      treatment of the acute exacerbation of non-organic psychosis of any etiology, including
      schizophrenia, acute mania, delusional disorder and others.
    


Intervention name(s): Ziprasidone
Intervention type(s): Drug
Intervention description(s): Intramuscular ziprasidone 10 or 20 mg at the investigator's discretion for 1 to 3 days followed by oral ziprasidone capsules 40 to 80 mg twice daily at the investigator's discretion to complete 7 days of treatment
Other intervention name(s): Geodon, Zeldox
Intervention MeSH terms: Ziprasidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Purified Vero Rabies Vaccine Serum Free Compared With Reference Purified Vero Rabies Vaccine in Healthy Adults
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to generate data in human on immunogenicity and safety of
      Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration.

      Primary Objective:

        -  To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab,
           in terms of seroconversion rate at Day 42 of the primary vaccination series.

      Secondary Objectives:

        -  To assess the clinical safety of VRVg after each vaccination when administered in a
           pre-exposure vaccination schedule with a booster at 12 months after the first
           vaccination in all subjects.

        -  To describe the immune response induced by VRVg 21 days after two vaccinations in a
           subset of randomized subjects and 14 days after the last vaccination of the primary
           vaccination series.
    

Detailed description: 
      All subjects will receive three vaccinations for primary series and a booster vaccination at
      12 months after the first vaccination.
    

Intervention name(s): Purified Vero Rabies Vaccine - Serum Free; Purified inactivated rabies vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): VRVg; Verorab
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rabies; Rabies virus; Purified Vero Rabies Vaccine; Serum Free
Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate safety and 2-year local control rate for extensive
      clinical target volumes in postoperative radiotherapy concurrent with chemotherapy for
      esophageal squamous cell carcinoma.
    


Intervention name(s): Paclitaxel; Carboplatin; Radiotherapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw*5; carboplatin AUC=2, ivgtt, d1, qw*5; 1.8Gy/d, d1-5/week, 25Fx
Intervention MeSH terms: Paclitaxel; Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess Safety, Tolerability, Pharmacokinetic & Pharmacodynamic Effect of UCB5857 in Healthy & Psoriatic Subject
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of UCB5857. Part 1 of the study explores single doses
      of the drug. Part 2 of the study explores giving the drug every day for 14 days. The study
      uses healthy and psoriasis subjects.
    

Detailed description: 
      This is a first-in-human (FIH), Phase 1, randomized, double-blind, placebo controlled, single
      center study designed to evaluate the safety/ tolerability, pharmacokinetics (PK), and
      pharmacodynamics (PD) of UCB5857 following oral administration of single ascending doses
      (SAD) in healthy subjects (Part 1) and multiple ascending doses (MAD) in healthy and
      mild-to-moderate psoriatic subjects (Part 2).

      The primary objective of this study is to investigate the safety and tolerability of UCB5857
      when given as single oral doses in healthy subjects and as ascending multiple oral doses in
      healthy subjects and mild-to-moderate psoriatic subjects.
    

Intervention name(s): UCB5857 Part 1; UCB5857 Part 2; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Active substance: UCB5857
Pharmaceutical form: Capsule
Concentration: 1 mg, 5 mg, 10 mg or 15 mg
Route of administration: Oral; Active substance: UCB5857
Pharmaceutical form: Capsule
Concentration: 5 mg, 8 mg, 15 mg
Route of administration: Oral; Active substance: Placebo
Pharmaceutical form: Capsule
Concentration: Avicel PH 102, 50 mg
Route of administration: Oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy Subjects; Mild to moderate Psoriasis; Subjects
Roasted Pulse Snacks, Post-prandial Food Intake, Appetite, and Glycemia
Condition: Normal Weight; Overweight; Normoglycemic
MeSH terms: Overweight
Study type: Interventional

Summary: 
      An investigation on the effects of roasted pulse snacks on post-prandial glycemic and satiety
      response in healthy young adults.
    

Detailed description: 
      An acute, randomized, controlled cross-over trial examining the post-prandial glycemic and
      satiety response to six snacks will be conducted. The study treatments are: 1) roasted corn
      nuts, 2) roasted chickpeas, 3) roasted yellow peas, 4) roasted pinto beans 5) roasted
      soybeans, and 6) roasted almonds. They will be matched for calorie content and provided in
      200 kcal servings.
    

Intervention name(s): Corn nuts; Chickpeas; Yellow peas; Pinto beans; Soybeans; Almonds
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Roasted corn nut snack; Roasted chickpea snack; Roasted yellow pea snack; Roasted pinto bean snack; Roasted soybean snack; Roasted almond snack
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, controlled cross-over acute trial
Masking: None (Open Label)
Primary purpose: Other
Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy
Condition: Borderline Lepromatous Leprosy; Lepromatous Leprosy
MeSH terms: Leprosy; Leprosy, Lepromatous; Leprosy, Multibacillary
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a double-blind, randomized controlled trial examining the effect on ENL
      reactions of giving an additional year of clofazimine after completion of MDT in leprosy.
    

Detailed description: 
      Clofazimine is an anti-bacterial agent used to treat leprosy; it is a normal component of
      WHO-recommended multi-drug therapy (MDT). It is also known to have a beneficial effect in one
      of the common immunological reactions that occur in leprosy, known as erythema nodosum
      leprosum, or ENL. When MDT was reduced in length from 24 to 12 months, evidence suggests that
      ENL became worse. This study is a double-blind, randomized controlled trial examining the
      effect of giving an additional year of clofazimine after completion of MDT. The endpoints are
      the incidence and severity of ENL over a period of 3 years in the 2 groups.
    

Intervention name(s): Clofazimine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Clofazimine 100mg daily for 12 months after completion of MDT.; Daily for 12 months
Other intervention name(s): Lamprene; Vitamin capsule
Intervention MeSH terms: Clofazimine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: leprosy; ENL; clofazimine
Effectiveness of Midwife Phone Support With the to Reduce the Early Abandonment of Breastfeeding
Condition: Breastfeeding
Study type: Interventional

Summary: 
      Objective: To evaluate the effectiveness of telephone support of the reference midwife, in
      relation to the abandonment of breastfeeding of primiparous mothers and to identify, both the
      risk factors and the protective factors for the early abandonment of breastfeeding.

      Material and Method Randomized parallel controlled clinical trial.
    

Detailed description: 
      Sample: 220 primiparous mothers with access, during the 8 weeks postpartum, to a mobile phone
      to contact the midwife randomization of 110 mothers to the experimental group and 110 to the
      control group. The mothers of the experimental group will be offered the mobile phone number
      to contact their midwife after delivery. The mothers of the control group will receive the
      usual attention of the portfolio of services that includes the spontaneous visit in the
      center, the telephone call in the center, the home visit and the health education groups.
    

Intervention name(s): Phone care support by midwife
Intervention type(s): Other
Intervention description(s): Mothers can call the midwife's telephone every working day from 8 a.m. to 8 p.m.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: phone support; midwife; early abandonment of breastfeeding
The Effect of Scapular Proprioceptive Neuromuscular Facilitation Techniques on Pain and Functionality in Subacromial Impingement Syndrome
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effects of scapular proprioceptive neuromuscular
      facilitation (PNF) techniques applied in addition to exercise therapy in patients with
      Subacromial impingement syndrome (SIS) on pain, pressure pain threshold (PPT), range of
      motion (ROM), functionality, scapular dyskinesis, active trigger points and emotional state.
    

Detailed description: 
      32 patients between the ages of 20-60 diagnosed with SIS were included in the study.

      The patients were randomly divided into two groups. The exercise group received an exercise
      program of 12 sessions. Scapular PNF techniques were applied to the PNF group with the same
      exercise program. Patients were evaluated twice; one before and one after 6 weeks of
      treatment; using Visual Analogue Scale (VAS) for pain, algometer for PPT, digital goniometer
      for range of motion (ROM), The Disabilities of Arm, Shoulder and Hand (DASH) for functional
      status, lateral scapular slide test (LSST) for scapular dyskinesis, Travell and Simons
      criteria for trigger point and Hospital Anxiety and Depression Scale (HADS) for emotional
      state. At the end of treatment patient satisfaction was evaluated with Global Change Scale.
    

Intervention name(s): Scapular PNF; Exercise program
Intervention type(s): Other; Other
Intervention description(s): Rhythmic initiation and repetitive stretching techniques in scapula anterior elevation-posterior depression and anterior depression-posterior elevation patterns were applied twice a week for 6 weeks.; An exercise program consisting of exercises used in the conservative treatment of shoulder impingement syndrome for both groups was applied twice a week for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Proprioceptive Neuromuscular Facilitation; Shoulder pain
Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects
Condition: Alzheimer's Disease; Healthy Non-elderly and Elderly Adults
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 1/2a, multi-center, placebo-controlled, double-blinded, randomized, multiple
      ascending dose (MAD) clinical trial to determine the safety and maximum tolerated dose of
      AL001. Up to 72 participants will be randomly assigned to receive study drug (active AL001)
      or placebo. The study consists of a 4-week screening period, a 14-day treatment period, and a
      42-day follow-up period.
    

Detailed description: 
      This is a Phase 1/2a, multi-center, placebo-controlled, double-blind, randomized, multiple
      ascending dose (MAD) clinical trial to determine the safety and maximum tolerated dose (MTD)
      of AL001, a crystal engineered lithium-salicylate-proline lithium delivery product that in
      nonclinical studies was shown to enhance and prolong the pharmacokinetic (PK) profile of
      lithium in the brain with enhanced efficacy potential in Alzheimer's models compared to
      lithium carbonate.

      A maximum of approximately 72 participants will be enrolled. Participants will be randomly
      assigned to receive study drug (active AL001) or placebo in a ratio of 6:2, respectively,
      with 8 patients in each dosing cohort. Cohorts 2a, 3a, 4a and 5a will involve 1:1 healthy
      non-elderly and elderly subjects; cohorts 1, 2b, 3b, 4b and 5b will involve Alzheimer's
      subjects. The study will consist of a screening period (Days -28 to -2), a 14-day treatment
      period, and a 42-day follow-up period.
    

Intervention name(s): AL 001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): a crystal engineered lithium-salicylate-proline lithium delivery product; matching placebo formulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-center, placebo-controlled, double-blind, randomized, multiple ascending dose clinical trial to determine the safety and maximum tolerated dose of AL001.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Fixation of Comminuted Distal Radius Fracture
Condition: Distal Radius Fracture
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      comparison between different methods in fixation of comminuted distal radius fractures
    

Detailed description: 
      This clinical study aims at comparison of treatment outcomes of Spanning plate versus
      spanning External fixator in fixation of comminuted distal radius fracture.

      The primary outcomes that we like to measure are pain, healing. Stiffness and range of motion
      .
    

Intervention name(s): dorsal plating
Intervention type(s): Procedure
Intervention description(s): Spanning Plate inserted dorsally below tendons Spanning External Fixator by rods inserted in distal radius and metacarpals
Other intervention name(s): External fixator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: distal radius fracture