bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Narrative Exposure Therapy (NET) in Treating Women After Human Trafficking or Forced Prostitution
Condition: Posttraumatic Stress Disorder; Depression; Dissociation
MeSH terms: Stress Disorders, Post-Traumatic; Dissociative Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to perform an evaluation of a trauma-focused short-term
      intervention (Narrative Exposure Therapy; Schauer, M., Neuner, F. & Elbert, T.) on a variety
      of clinical outcome measures (PTSD, Depression, Somatic Complaints, Dissociation) in women
      after sexual exploitation and women trafficking.
    


Intervention name(s): Narrative Exposure Therapy
Intervention type(s): Behavioral
Intervention description(s): Trauma-Focused short term intervention (8-12 sessions)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Somatic Complaints
Visual Function After Bilateral Implantation of AcrySof® Toric
Condition: Visual Function
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof
      Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.
    


Intervention name(s): AcrySof® Toric IOL; AcrySof Natural
Intervention type(s): Device; Device
Intervention description(s): AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery; AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Visual function;; Refractive cylinder;; AcrySof® Toric;; AcrySof® Natural
Staining and Calculus Formation After 0.12% Chlorhexidine Rinses
Condition: Dental Calculus; Tooth Discoloration
MeSH terms: Tooth Discoloration; Dental Calculus; Calculi
Study type: Interventional
Phase: Phase 2

Summary: 
      The presence of plaque on tooth surfaces as a predictor of chlorhexidine side effects has not
      been evaluated especially because most studies utilized a previous disruption of biofilms in
      all dental surfaces before the beginning of rinsing. The purpose of this study is to compare
      staining and calculus formation after 0.12 percent chlorhexidine between previously
      plaque-free and plaque-covered surfaces by means of an experimental gingivitis model.
    

Detailed description: 
      Test panel

      The test panel will be recruited from the dental students of the Lutheran University of
      Brazil, Canoas, Rio Grande do Sul, Brazil. At recruitment, subjects will be asked about their
      medical and dental history. Written and oral explanations detailing the study purpose and
      design will be given for each subject. Subjects that preliminarily met inclusion/exclusion
      criteria will be selected for a dental screening appointment. If the subject met all the
      inclusion/exclusion criteria, an informed consent was handed out and, upon acceptance, signed
      by the volunteers.

      The following clinical parameters were assessed in the order listed below from all teeth,
      excepting the third higher/lower molar.

      Presence of calculus (C) in all teeth, at 6 sites per tooth (mesio-buccal, mid-buccal,
      disto-buccal, mesio-lingual, mid-lingual and disto-lingual) was scored as a dichotomous
      index: 0 - Absence of calculus; 1 - Presence of calculus.

      Discoloration Index proposed by Lobene 36 and modified by Macpherson et al. 2000. This
      involves visual stain assessment of the buccal/labial and lingual/palatal aspects of the
      index teeth.
    

Intervention name(s): Dental prophylaxis
Intervention type(s): Other
Intervention description(s): Two randomized quadrants will be cleaned with a prophylaxis to disrupt dental biofilm presence.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Chlorhexidine; adverse effects; staining; dental calculus; dental plaque
Optical Coherence Tomography Angiography and Pseudophakic Cystoid Edema
Condition: Pseudophakic Cystoid Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Observational

Summary: 
      This study evaluates the retinal vascular features in macula and papillary regions in
      patients affected by pseudophakic cystoid edema using optical coherence tomography
      angiography
    

Detailed description: 
      Pseudophakic cystoid edema represents one of the most common causes of poor visual outcome
      following cataratta surgery.

      It is still source of debate the pathogenesis of Pseudophakic cystoid edema. Optical
      coherence tomography angiography represents a novel and non-invasive diagnostic technique
      that allows a detailed analysis of retinal vascular features. The study evaluates
      retrospectively the changes in optical coherence tomography angiography parameters at
      baseline and after three monthly after surgery.
    

Intervention name(s): OCTA and pseudophakin cystoid edema
Intervention type(s): Diagnostic Test
Intervention description(s): Patients underwent OCT angiografia after cataract surgery
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 18 years with diagnosis of pseudophakic cystoid macular
        oedema. The participans did not present other ophthalmological diseases.
A Phase 4 Study to Evaluate Pharmacokinetics and Safety of Darunavir Along With Ritonavir in Healthy Male Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (explores what the body does to
      the drug) and safety of darunavir, and will be administered in combination with Ritonavir in
      healthy adult Japanese male participants.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single oral-dose
      and post-marketing study of darunavir administered in combination with low-dose ritonavir in
      healthy adult Japanese male participants. The total study duration will be approximately of
      14 days per participant. The study consists of 3 parts: Screening (that is, 28 days before
      study commences on Day 1); Treatment (that is, Day 1-5); and Follow-up (that is, up to Day
      13). The participants will be hospitalized for 6 nights and 7 days. All the eligible
      participants will receive Darunavir oral tablet on Day 3 and ritonavir capsule orally twice
      daily from Day 1-5. Participants will keep upright position until 4 hours after study drug
      administration. Both the drugs will be administered within 15 minutes after completion of
      meal. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and
      post-dose of study treatment. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Darunavir; Ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): Darunavir ethanolate will be administered as single oral dosing of two tablets of 300 milligram (mg) on Day 3.; Ritonavir capsule will be administered orally twice daily at a dose of 100 mg for 5 days.
Other intervention name(s): JNS011; Ritonavir will be administered orally twice daily as 100 mg capsule from Day 1-5.
Intervention MeSH terms: Ritonavir; Darunavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Darunavir; JNS011; Ritonavir
A Study of Ziprasidone for the Treatment of Psychosis in Patients Who Had Already Had Benefits From Ziprasidone Treatment in a Previous Study
Condition: Pyschotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and tolerability of ziprasidone in
      patients who successfully completed a study of ziprasidone treatment of psychosis (Protocol
      A1281074).
    


Intervention name(s): Ziprasidone
Intervention type(s): Drug
Intervention description(s): Oral ziprasidone tablets 40 or 80 mg twice daily with meals for 3 months. Doses were flexible based on investigator's discretion.
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
A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the safety and efficacy of Vacyless® and Valtrex® in
      patients with acute herpes zoster.
    

Detailed description: 
      Primary Endpoint:

      - Lesion assessment - Rash severity, in terms of rash counts

      Secondary Endpoints:

        -  Pain assessment

        -  Clinical global impression

        -  Safety information of valacyclovir
    

Intervention name(s): valacyclovir hydrocholoride
Intervention type(s): Drug
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age
Condition: Influenza; Influenza Vaccines
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate
      vaccine GSK1557484A in children 6 months to < 18 years of age.
    


Intervention name(s): Influenza A (H5N1) Virus monovalent vaccine; Saline placebo
Intervention type(s): Biological; Biological
Intervention description(s): All subjects will receive 2 doses administered as an intramuscular (IM) injection.; All subjects will receive 2 doses administered as an intramuscular (IM) injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; H5N1; Pandemic
The Effect of Naproxen on the Pharmacokinetic Profile of LC350189 in Healthy Adults
Condition: Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, fixed-sequence, 3-period, 2-way drug interaction study
      designed to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of
      LC350189 and Naproxen when administered alone and in combination in healthy subjects.
    


Intervention name(s): Xanthine Oxidase Inhibitor; nonsteroidal anti-inflammatory drug
Intervention type(s): Drug; Drug
Intervention description(s): LC350189 200mg qd; Naproxen 500mg BID
Other intervention name(s): LC350189; Naproxen
Intervention MeSH terms: Naproxen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Myofascial Trigger Points in the Upper Limb in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      One source of shoulder pain can be myofascial trigger points (MTrPs). MTrPs are localized,
      hyperirritable points in the skeletal muscles that are associated with palpable nodules in
      muscle fibres. MTrPs can be classified into active and latent. Latent MTrPs demonstrate the
      same clinical characteristics as active MTrPs but they do not provoke spontaneous pain.
      Numerous studies have shown that MTrPs are prevalent in patients with chronic non-traumatic
      neck and shoulder pain.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with a complaint of shoulder pain following a stroke were recruited to be subjects
        in the study following referral to physical therapy to the outpatient department at
        orthopedic rehabilitation facility by a family practice physician.
      
Keywords: Stroke; Pain; Shoulder
Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off Reversal
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Dose, Safety and
      Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of
      Decarboxylase Inhibitor to L-dopa Responsive Parkinson's Disease Patients
    

Detailed description: 
      This is a Phase IIa randomized, double-blind, placebo-controlled, single dose study to
      compare the safety, tolerability and PK/PDyn of intranasal L-dopa following administration of
      INP103 in the presence of L-dopa decarboxylase inhibitor (DCI) during an OFF episode.
    

Intervention name(s): Placebo; L-dopa 35 mg; L-dopa 70mg; L-dopa 140 mg; L-dopa 70mg/carbidopa 7mg
Intervention type(s): Combination Product; Combination Product; Combination Product; Combination Product; Combination Product
Intervention description(s): Delivered via the I231 POD (Precision Olfactory Delivery) device; Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril; Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril; Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril; Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
Intervention MeSH terms: Carbidopa; Levodopa; Dihydroxyphenylalanine
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Thirty-Two (32) to Thirty-Six (36) subjects will be randomized to treatment or placebo. INP103 is a drug-device combination product containing a drug component, L-dopa, and device component, the I231 Precision Olfactory Delivery (POD) device. In Cohorts 1, 2, and 3, L-dopa will be administered intranasally in single doses of one (35 mg), two (70 mg) or four (140 mg) puffs of INP103, 60 minutes after oral benserazide hydrochloride 25 mg.
In Cohort 4 the INP103 formulation will contain L-dopa:carbidopa administered nasally. Dosing will take place once OFF episode is confirmed and will not include predosing with oral benserazide.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinsons; L-dopa; levodopa; ON; OFF; PD; POD device; I231; benserazide; Precision olfactory delivery; MDS-UPDRS; Carbidopa; DCI; Decarboxylase Inhibitor
Probiotic Efficacy in VRE Eradication
Condition: VRE Colonization
Study type: Interventional

Summary: 
      This study will evaluate the efficacy of a probiotic lactobacillus strain in eradicating VRE
      in non-symptomatic carriers after 4 weeks of treatment. It will also evaluate the long-term
      efficacy after 8,16 and 24 weeks.
    

Detailed description: 
      With the increased number of Vancomycin-Resistant Enterococcus faecium (VRE)
      infected/colonized people it is evident that new treatment options are needed to reduce the
      number of VRE cases. One such option could be to use probiotics. We hypothesize that
      treatment with a probiotic lactobacillus strain can reduce the number of VRE carriers
      significantly. The aim is to investigate if this strain can eradicate VRE in non-symptomatic
      VRE-carriers measured as the number of subjects without VRE colonization at week 4.

      This is a multi-center, randomized, double-blind, placebo-controlled parallel-group trial in
      non-symptomatic VRE-carriers.

      The Trial consists of a 4 weeks intervention period followed by a 20-week follow-up period.

      After patients have been confirmed as carriers of VRE, the subjects are randomized to 4
      weeks' treatment with a lactobacillus probiotic strain (60 billion CFU per day) or to
      placebo. Subjects' VRE carrier-state is assessed at weeks 4, 8, 16 and 24, by an in-house PCR
      analysis. Stool samples are collected before intervention (baseline) and at week 4, 8, 16 and
      week 24.
    

Intervention name(s): lactobacillus probiotic strain; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Approved Dietary supplement; placebo comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on
      the number of reflux episodes, in patients who have GERD and still experience symptoms
      despite proton pump inhibitor (PPI) treatment.
    


Intervention name(s): AZD3355; AZD3355; AZD3355; AZD3355; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 30 mg orally in the morning and 30 mg in the evening for 1 day; 90 mg orally in the morning and 90 mg in the evening for 1 day; 120 mg orally in the morning and 120 mg in the evening for 1 day; 240 mg orally in the morning and 240 mg in the evening for 1 day; Placebo capsules orally in the morning and placebo capsules in the evening for 1 day
Intervention MeSH terms: Lesogaberan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GERD; lesogaberan; impedance; pH; pharmacokinetics; safety; tolerability
Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this research is to identify the functional neural mechanisms (as assessed
      using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained
      individuals with cocaine dependence.
    

Detailed description: 
      The objective of this research is to identify the functional neural mechanisms (as assessed
      using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained
      individuals with cocaine dependence. Specifically, this application proposes to conduct a
      randomized, double-blind, placebo-controlled, cross-over pilot study to examine the effects
      of 7-day NAC administration (2400mg/day) on the neural networks engaged during response
      inhibition (Go/No-Go task) and affective (emotion-regulation task) processes among
      cocaine-dependent, methadone-maintained individuals (n=40; 20 per treatment-order condition).
    

Intervention name(s): N-acetylcysteine; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications.; Sugar pill
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Focal Accumulation of Iron in Cerebral Regions in Early ALS (Amyotrophic Lateral Sclerosis) Patients
Condition: ALS (Amyotrophic Lateral Sclerosis); Iron Overload
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Iron Overload; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The FAIR-ALS study is to investigate the safety and efficacy of a scavenger treatment of iron
      deferiprone, which would reduce the brain iron to limit the development of amyotrophic
      lateral sclerosis.

      It has been shown an excess of iron in the central nervous system carrying a sporadic ALS
      patients. Iron overload associated with a loss of motor neurons may explain the signs of the
      disease (atrophy).

      The investigators discuss the hypothesis that reducing excess iron, the investigators can
      reduce the loss of neurons and thus the progression of signs of the disease.
    

Detailed description: 
      At the end of the study, it will propose to continue the usual quarterly patient follow up,
      as recommended by the French ALS centers.

      Deferiprone can be administered as part of a compassionate use, for patients who want it and
      who do not have hypoxemia.

      We therefore plan a treatment period compassionate relatively short and less than 3 years.
    

Intervention name(s): Deferiprone
Intervention type(s): Drug
Intervention description(s): 30 mg/kg per day, oral use
Other intervention name(s): Ferriprox
Intervention MeSH terms: Deferiprone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Respiratory Biofeedback Device and Reduction of Dental Anxiety Associated With Local Anesthesia in Children
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of the study was to investigate the effect of a respiratory biofeedback device
      (RESPeRATE TM) in reduction of preoperative anxiety in children undergoing dental procedures
      under local anesthesia.
    

Detailed description: 
      The study was a randomized controlled clinical trial. A total of 110 anxious pediatric dental
      patients, of age range 7-12 years, were selected from the Pediatric Dentistry and Dental
      Public Health Department, Faculty of Dentistry, Alexandria University, Egypt, after securing
      parental informed consents. Children were chosen according to the Faces version of Modified
      Child Dental Anxiety Scale scoring 26 or more.

      The participants will be randomly allocated into 2 groups: Group I: Study group and Group II:
      Control group. The patients of group I (Study group) will undergo a session of biofeedback
      regulation by using "RESPeRATETM" as an anxiety reducing method. Group II patients will be
      managed by a routine behavioral management technique "Tell,show,do". Local anesthesia
      injection will be administered to the child, after which heart rate measurement and salivary
      sample for salivary amylase analysis will be repeated.
    

Intervention name(s): RESPeRATE™; Tell, Show and Do technique
Intervention type(s): Device; Behavioral
Intervention description(s): Fifty-five anxious pediatric dental patients received a breathing session of 10 minutes, using the RESPeRATE™ device.; Fifty-five anxious pediatric dental patients received a traditional behavior management technique (Tell-Show-Do).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will be a randomized controlled clinical trial, with 1:1 allocation ratio.
Masking: None (Open Label)
Primary purpose: Treatment