bioihbjkbjnl/mcl2 huggingface dataset:
European Deep Brain Stimulation (DBS) Depression Study
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      To evaluate the effects of two different programming settings of deep brain stimulation (DBS)
      in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for TR-MDD,
      single or recurrent episode on mood as measured by the MADRS.
    


Intervention name(s): Deep Brain Stimulation; Deep Brain Stimulation
Intervention type(s): Device; Device
Intervention description(s): Normal DBS Programming; Low Programming
Other intervention name(s): Libra Deep Brain Stimulation System (St. Jude Medical Neuromodulation Division); Libra Deep Brain Stimulation System(St. Jude Medical Neuromodulation Division)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depressive Disorder; Unipolar; Implantable Stimulation Electrodes
AMG 853 Phase 2 Study in Subjects With Inadequately Controlled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to determine if AMG 853 is effective compared with placebo as
      measured by change in Asthma Control Questionnaire (ACQ) composite symptoms scores from
      baseline to week 12.
    


Intervention name(s): AMG 853; AMG 853; AMG 853; AMG 853; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): AMG 853 5 mg (BID); AMG 853 200 mg (QD); AMG 853 25 mg (BID); AMG 853 100 mg (BID); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Psychoeducation Reaches HCV-infected Methadone/Buprenorphine Substituted Patients in Standard Antiviral Treatment
Condition: Intravenous Drug Abuse; Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Substance-Related Disorders; Substance Abuse, Intravenous
Study type: Interventional
Phase: Phase 4

Summary: 
      Study objective: Feasibility and efficacy of a standardised psychosocial intervention
      (psychoeducation) in substituted opioid dependent patients
    

Detailed description: 
      Primary objective:

        -  Retention in antiviral treatment (feasibility)

      Secondary objectives:

        -  Mental Health Mental health is monitored by means of the Symptom Checklist 90-R
           (SCL-90-R). Its sum score, the Global Severity Index (GSI), serves as indicator. Mental
           health will be regarded as stable in case of a change of less than 6 GSI-points,
           otherwise mental health will be regarded as improved (GSI - 6 points) or decreased (GSI
           + 6 points).

        -  Course of Addiction Course of addiction under antiviral treatment will be monitored
           according to retention in substitution treatment, compliance with scheduled visits, and
           co-consumption of illicit drugs (patients record, urinalysis).

        -  Sustained viral response (SVR) SVR as measured by polymerase chain reaction 6 months
           after per protocol antiviral treatment (ITT-analysis).
    

Intervention name(s): Psychoeducation
Intervention type(s): Behavioral
Intervention description(s): Group-therapeutic intervention with 12 sessions plus 5 update sessions with 24-week therapy duration and/or 12 sessions plus 10 update sessions with 48-week therapy duration Module I: Create understanding, resources, problems and solutions Module II: Information on hepatitis C infection Module III: Information on treatment Module IV: Specific information on depression and withdrawal symptoms under interferon The meetings take a minimum of 60 min. time, should be once weekly. The group size should lie between 6 and 12 participants.
The group leaders are trained in performance of the psycho-education.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opiate Dependence; Chronic Hepatitis C
Transvaginal Appendectomy
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility and safety of transvaginal
      appendectomy and determine and compare the postoperative pain and quality of life after
      surgery to standard laparoscopic transabdominal appendectomy.
    


Intervention name(s): transvaginal appendectomy
Intervention type(s): Procedure
Intervention description(s): patient undergoes transvaginal appendectomy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: appendicitis; surgery; laparoscopy; natural orifice transluminal surgery
Zinc Supplementation and Severe and Recurrent Diarrhea
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and
      recurrent diarrhea in 6 to 36 months age children in Bandarabbaas
    

Detailed description: 
      Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and
      recurrent diarrhea in 6 to 36 months age children in Bandarabbaas in 2009
    

Intervention name(s): Zinc Supplement
Intervention type(s): Drug
Intervention description(s): 10mg daily for under 1 years old children and 20mg daily for above 1 years old children
Other intervention name(s): Zinc sulfate; Oral Zinc
Intervention MeSH terms: Zinc; Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Zinc Supplement; Diarrhea; Sever Diarrhea
Bleeding Pattern Study
Condition: Oral Contraceptive
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy
      and safety of this oral contraceptive in two different regimens of intake.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.

      Bayer Schering Pharma AG, Germany is the sponsor of the trial.
    

Intervention name(s): Valette (Dienogest/EE30, BAY86-5038); Valette (Dienogest/EE30, BAY86-5038)
Intervention type(s): Drug; Drug
Intervention description(s): Oral contraceptive extended cycles; Oral contraceptive conventional cycles
Intervention MeSH terms: Dienogest; Nandrolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception, Bleeding pattern
Phase 2B/3 Double-blinded Placebo-controlled
Condition: Chlamydia Trachomatis Infection
MeSH terms: Infections; Chlamydia Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Phase 2B double-blind placebo-controlled efficacy trial of EVO100 (previously known as
      Amphora ® Gel) for the prevention of acquisition of urogenital Chlamydia trachomatis
      infection
    

Detailed description: 
      Primary: To determine if intravaginal EVO100 reduces the risk of urogenital Chlamydia
      trachomatis (CT) infection.

      Secondary: To determine if intravaginal EVO100 reduces the risk of urogenital Neisseria
      gonorrhoeae (GC) infection.

      Exploratory:To determine if EVO100 use rate (subject adherence to instructed use) has an
      effect on proportion of subjects who experience CT or GC infection during the study
      intervention period.

      Primary Outcome Measures: Proportion of subjects who experience urogenital CT infection
      during the study intervention period (incident infection of CT).

      Secondary Outcome Measures: Proportion of subjects who experience urogenital GC infection
      during the study intervention period (incident infection of GC).

      Exploratory Outcome Measures:

        -  Compliance with EVO100 usage during study (rate of product use adherence).

        -  Sensitivity analyses of the primary parameter (proportion of subjects who experience at
           least one CT or GC infection during the study intervention period) will be performed for
           the following:

        -  Subjects with ≥20%, ≥40%, ≥60% and ≥80% product use adherence

        -  Subject Satisfaction

        -  Sexual satisfaction
    

Intervention name(s): EVO100; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5 g dose applied up to 1 hour prior to coitus; 5 g dose applied up to 1 hour prior to coitus
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 2B double-blind placebo-controlled efficacy trial of EVO100 for the prevention of acquisition of urogenital Chlamydia trachomatis infection
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficiency of Patellar Taping in Treatment of Patellofemoral Pain Syndrome
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Observational

Summary: 
      Patellar subluxation is a common disorder that may cause patellofemoral pain syndrome. The
      efficiency of patellar taping in the treatment of patellofemoral pain syndrome has been
      reported good outcomes in most patients. However, some studies reported less effective in
      patients with higher body mass index, larger lateral patellofemoral angle, and smaller Q
      angle. The investigators hypothesized that femoral internal rotation is a negative factor to
      the patellar taping. The investigators enroll consecutive 100 patients with anterior knee
      pain and radiographic evidence of patellar subluxation. The investigators determine femoral
      rotation via physical examination. The visual analogue scale was evaluate to compare the
      result between the those with and without femoral internal rotation.
    

Detailed description: 
      Consecutive 100 patients with anterior knee pain and compatible with inclusion criteria.
      Before treatment, an independent physiotherapist evaluates whether femoral internal rotation
      or not via physical therapy, and another studying nurse records the visual analog scale and
      measures Q angle. After evaluation, McConnell taping is applied to these patients. Two weeks
      later, outcomes are recorded including visual analog scale, satisfactory, and complication.
      The outcomes are compared between those with and without femoral internal rotation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        100 patients
Evaluating the Fluid Balance of Mechanically Ventilated Patients by Ultrasonography
Condition: Fluid Overload; Fluid Loss
Study type: Observational

Summary: 
      ratio of the diameter of inferior vena cava to the diameter of the thoracic aorta (IVC / Ao)
      depends on the daily balance of fluids.
    

Detailed description: 
      During the routine abdominal ultrasound, the basilar and abdominal aorta were measured using
      a Sparq Philips ultrasonograph with a convex probe set in abdominal mode. All measurements
      were performed in one patient by the same operator who were experienced and performed the
      appropriate course of ultrasonography. The IVC and abdominal aorta were visualized using a
      paramedian long-axis view via a subcostal approach according to the methodology described by
      the American Society of Echocardiography. Inferior vena cava width was assessed at an
      interval of approximately 1 cm distal from connection of the hepatic vein to the inferior
      vena cava. No significant changes were observed in the width of the inferior vena cava during
      various respiratory phases, because of the positive pressure ventilation. The widest value
      was always chosen for the data. The assessment of the width of the abdominal aorta was
      performed above arise of the celiac trunk, at the height of the vein of the lower vena cava.
      The width of the inferior vena cava and the abdominal aorta was assessed using transthoracic
      ultrasound for the following five days. Daily differences in the amount of fluid intake and
      lost was recorded. CVP measurement was performed.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        There were 57 mechanically ventilated patients examined. 8 patients were excluded from the
        study because of spontaneous ventilation within 5 days of data collection. Two patients
        died during the study. Five patients failed to obtain satisfactory results of imaging of
        vascular structures during subsequent examination. Data from 42 patients were analyzed.
      
Keywords: Inferior vena cava; Fluid responsiveness; Central venous pressure
Effect of Attentional Touch in Stabilometric Assessments
Condition: Postural Balance
Study type: Interventional

Summary: 
      Postural balance has been studied in the literature and ideal body mass distribution has been
      shown to provide stability to the body in an upright position. The use of stabilometry to
      assess posture is a standard in clinical practice and medical research. In the literature we
      find osteopathic treatment evaluated with stabilometry in specific pathological conditions.
      We will experiment on asymptomatic volunteers how attentive touch is effective compared to
      non-attentive touch and compared to an untreated group by measuring specific parameters that
      indicate postural balance.
    

Detailed description: 
      Stabilometry measurements will be taken on asymptomatic volunteers before and after several
      specific treatments, in particular to measure whether the variance in sway speed is reduced
      after the treatments. The effect of attentional versus non-attentional touch will be compared
      in the other two groups, in addition to a control group that receives no treatment.
    

Intervention name(s): TOUCH ATTENTIVE TREATMENT; AUDITORY ATTENTIVE TREATMENT
Intervention type(s): Other; Other
Intervention description(s): 15-minute treatment using constant touch (0.20 N, approx. 20 grams) developed after training with visual feedback.
5 minutes bilateral touch on external malleolus
5 minutes longitudinal occipital front grip for reciprocal tension membrane movement and Sutherland's fulcrum
5 minutes bilateral touch on acromion, for midline, centring diaphragms
Throughout the treatment, the practitioner maintained a focused attention on touch by voluntarily and constantly directing attention to the sensation/perception of the hands, perceiving texture, density, temperature, reactivity and motility of the tissue.; 15-minute treatment using constant touch (0.20 N, approx. 20 grams) developed after training with visual feedback.
5 minutes bilateral touch on external malleolus
5 minutes longitudinal occipital front grip for reciprocal tension membrane movement and Sutherland's fulcrum
5 minutes bilateral touch on acromion, for midline, centring diaphragms
During the treatment, the operator's attention was focused on acoustic signals delivered through earphones. The beeps were delivered at random intervals between 0.5 and 2.0 seconds. The operator had to count the number of acoustic signals produced during the treatment period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Toric Contact Lens Digital Performance and Comfort Study
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      This study seeks to quantify digital visual performance and subjective visual acceptance of
      toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.
    

Detailed description: 
      This study seeks to quantify the near visual performance and subjective visual acceptance of
      toric contact lenses as compared to spherical lenses in an astigmatic cohort of patients.
      Primary Hypotheses: Subjects will have better near visual acuity and near visual performance
      with toric, as opposed to spherical, contact lens correction. As such, the following
      hypotheses will be tested: H01: There is no statistically significant difference in near
      visual acuity or near vision performance between contact lenses corrections Ha1: There is a
      statistically significant difference in visual acuity or vision performance between contact
      lenses corrections
    

Intervention name(s): Precision1 for Astigmatism; Precision1 Sphere
Intervention type(s): Device; Device
Intervention description(s): Daily disposable soft toric contact lens; Daily disposable soft spherical contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Repeat-Dose Pharmacokinetics Study of NRL-1 in Epilepsy Subjects
Condition: Acute Repetitive Seizures
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the pharmacokinetic and safety of NRL-1 in epilepsy subjects. Subjects
      will receive a single intranasal dose of NRL-1 of either 5 mg, 10 mg, 15 mg or 20 mg and will
      be based on the subject's body weight.
    

Detailed description: 
      Diazepam rectal gel (Diastat) is the only formulation of diazepam indicated for the
      management of selected, refractory patients with epilepsy on stable regimens of antiepileptic
      drugs (AEDs) who require intermittent use of diazepam to control bouts of increased seizure
      activity, i.e., Acute Repetitive Seizures (ARS).

      A diazepam nasal spray is being developed for patients who experience ARS to provide an
      alternative more convenient and acceptable route of diazepam administration.
    

Intervention name(s): NRL-1
Intervention type(s): Drug
Other intervention name(s): Intranasal diazepam
Intervention MeSH terms: Diazepam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: epilepsy; seizure
Does Optical Coherence Tomography Optimise Results of Stenting
Condition: Acute Coronary Syndromes
MeSH terms: Acute Coronary Syndrome
Study type: Interventional

Summary: 
      Optical Coherence Tomography (OCT) is a recent imaging modality that yields cross-sectional
      images with a resolution 10 times greater than that of intravascular ultrasound (IVUS). OCT
      uses a near-infra-red light source to obtain images of the interior walls of the coronary
      arteries and is increasingly used to evaluate vulnerable atherosclerotic plaques and assess
      placement and response to stenting. - To date, no study has evaluated whether optical
      coherence tomography (OCT) contributes to optimizing percutaneous coronary intervention (PCI)
      and stenting.

      The DOCTORS study is a randomized, open label study to evaluate whether OCT-guided
      angioplasty would provide useful clinical information beyond that obtained by angiography,
      and whether this information would subsequently modify physician behavior and treatment
      choices. In particular, we will evaluate the impact of changes in procedural strategy
      resulting from the use of OCT on the value of fractional flow reserve (FFR) obtained after
      angioplasty and stent implantation of a lesion responsible for non-ST segment elevation acute
      coronary syndromes.
    


Intervention name(s): OCT
Intervention type(s): Procedure
Intervention description(s): Optical Coherence Tomography (OCT) is a recent imaging modality that yields cross-sectional images with a resolution 10 times greater than that of intravascular ultrasound (IVUS). OCT uses a near-infra-red light source to obtain images of the interior walls of the coronary arteries and is increasingly used to evaluate vulnerable atherosclerotic plaques and assess placement and response to stenting.
OCT images are acquired by automated pullback over 2 to 3 seconds of the light source that yields a helicoidal image of a longitudinal segment of 50 mm. Intravascular imaging is obtained by injecting contrast medium or saline solution.
Other intervention name(s): Optical coherence tomography
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute coronary syndromes; non-ST elevation myocardial infarction; angioplasty; fractional flow reserve; optical coherence tomography
Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
Condition: Adenocarcinoma of the Prostate
MeSH terms: Adenocarcinoma
Study type: Interventional

Summary: 
      This pilot study aims to investigate the diagnostic utility of 18F-DCFPyL, a novel
      low-molecular weight PSMA PET/CT imaging agent, in men with an elevated PSA following radical
      prostatectomy.
    

Detailed description: 
      18F-DCFPyL is a novel low-molecular weight PSMA imaging agent. A recent study of patients
      with metastatic prostate cancer found that PSMA PET/CT identified more sites of disease than
      conventional imaging with CT, MRI and bone scan. In this study we aim to investigate
      18F-DCFPyL PET/CT in patients with an elevated PSA following radical prostatectomy. During
      the course of this study, patients will undergo two 18F-DCPyL PET/CT scans. The first scan
      will take place within 45 days of staging imaging and the second will take place following
      six months of standard of care therapy.
    

Intervention name(s): 18F-DCFPyL
Intervention type(s): Drug
Intervention description(s): 18F-DCFPyL PET/CT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Safety and Efficacy of Risperidone as Adjunctive Therapy to Mood Stabilizers in the Long-term Treatment of Bipolar Mania
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate effect of risperidone as a long-term combination
      therapy to mood stabilizers in the treatment of bipolar mania
    

Detailed description: 
      The use of mood stabilizers such as lithium and carbamazepine is known to be effective for
      preventing and treating bipolar disorder. But the use of antipsychotic drugs is more
      effective in patients suffering severe episodes of mania as it elicits behavioral changes and
      spurs the effects of mood stabilizers. Antipsychotic drugs are used for patients who failed
      to respond to mood stabilizers or for the acute management of manic episodes associated with
      bipolar disorders.

      This study aims to evaluate the safety and efficacy of risperidone as an adjunctive therapy
      to mood stabilizers in the long-term treatment (6months) of bipolar disorder using various
      assessment instruments, including the Young Mania Rating Scale. The Simpson-Angus Rating
      Scale will be also employed to assess the presence of extrapyramidal side effects and other
      adverse events. The patients will receive orally 0.5, 1, 2 mg risperidone tablet once daily
      for 6 months
    

Intervention name(s): risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar; risperidone; Adjunctive therapy