bioihbjkbjnl/mcl2 huggingface dataset:
Psychometric Measurements of Three Nociception Assessments Methods in Intubated Brain Injured Critical Care Patients
Condition: Intubated Brain Injured
Study type: Observational

Summary: 
      Nociception in intensive care unit is frequently evaluated with some tools such as BPS
      (Behavioral Pain scale) and NCS (Nociception coma scale). These scales were not validated in
      intubated and brain injured ICU patients. The investigators propose to validate the NCS
      adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and the
      Pupillary response (videopupillometry) to noxious stimulation (common procedure of care).
    

Detailed description: 
      Nociception in intensive care unit is frequently evaluated with some tools such as BPS
      (Behavioral Pain scale) and NCS (Nociception coma scale). These scales were not validated in
      intubated and brain injured ICU patients. The investigators propose to validate the NCS
      adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and the
      Pupillary response (videopupillometry) to noxious stimulation (common procedure of care).
    

Intervention name(s): NCS-I (Nociception Coma Scale adapted intubated patients)
Intervention type(s): Other
Intervention description(s): Every included patient will be assessed by the 3 methods 3 times (before, during, after the procedure fo care) in 3 conditions. There will be 2 painful conditions usually performed in ICU (Nursing and bronchoaspiration) and a painless condition (RASS assessment).
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Admission to intensive care unit
      
Keywords: Intensive care unit; Neuro-ICU; Pain; Intubation; critical care; patients
A Study of the Effect of Carbamazepine on the Pharmacokinetics of Paliperidone Extended Release (ER) in Patients With Schizophrenia or Bipolar I Disorder
Condition: Schizophrenia; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to evaluate the effects of a potent metabolic enzyme inducer,
      carbamazepine, on the steady-state pharmacokinetics of orally administered paliperidone ER
      and to evaluate the safety and tolerability of the treatments in clinically stable patients
      with a diagnosis of schizophrenia or bipolar I disorder.
    

Detailed description: 
      The current study is designed as an open-label, multiple-center, multiple-dose, 2 treatment,
      2 period sequential drug interaction study. It consists of 3 phases: a screening phase
      beginning within 21 days before the first study drug administration; an open label treatment
      phase consisting of 2 treatment periods (Period 1 and Period 2), during which patients will
      receive multiple oral doses of 6-mg paliperidone ER alone or in combination with multiple
      oral doses of carbamazepine, and end of study evaluations upon completion of all the study
      procedures in Period 2 or at early withdrawal. There is no washout period between treatment
      periods. Given the potential concomitant use of carbamazepine with antipsychotics, such as
      paliperidone ER, in the treatment of schizophrenia or bipolar I disorder, this study is
      designed to investigate the effect of carbamazepine on the steady-state pharmacokinetics of
      paliperidone ER. Safety and tolerability will be monitored throughout the study.. Period 1: 6
      mg paliperidone ER once daily from Day 1 through Day 7, route oral; Period 2: 6 mg
      paliperidone ER once daily and carbamazepine 200 mg twice daily from Day 8 through Day 28,
      route oral.
    

Intervention name(s): paliperidone ER; Carbamazepine
Intervention type(s): Drug
Intervention MeSH terms: Carbamazepine; Paliperidone Palmitate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Bipolar I disorder; mood disorders; antipsychotic drugs; enzyme inducer; Paliperidone ER
Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects
Condition: Renal Insufficiency; Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Study of the way the body takes up, distributes, and gets rid of ACT-541468 in subjects with
      abnormal kidney function compared to healthy subjects
    


Intervention name(s): ACT-541468
Intervention type(s): Drug
Intervention description(s): ACT-541468 25 mg; administered orally
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center, open-label, single-dose study
Masking: None (Open Label)
Primary purpose: Other
Neurodynamic Intervention for Lumbar Radiculopathy
Condition: Lumbar Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      Low back pain (LBP) is a common condition and has a significant impact on the individual in
      terms of pain and disability. Lumbar radiculopathy occurs often with LBP and may be the
      result of a lumbar herniated disc which will irritate a lumbar nerve trunk resulting in
      intraneural inflammation. There is evidence supporting the use of manual therapies of lumbar
      radiculopathy. One potential manual therapy is neurodynamic mobilization technique. No
      scientific evidence, based on a RCT, exists that this particular approach is beneficial for
      individuals with LBP and lumbar radiculopathy
    


Intervention name(s): Motor Control Exercises; Motor Control Exercise Plus Neurodynamic Intervention
Intervention type(s): Other; Other
Intervention description(s): Patients will receive 8 sessions of motor control exercise program of 30 min duration for 4 weeks, twice per week. Exercises will be demonstrated to the participants by an experienced physical therapist. On each session, the therapist will correct each subject personally. Participants will be asked for practicing the exercises at home once daily for 20 minutes over the 8-week intervention period. The motor control exercise program will consist of a progression from isolated contraction of the transversus abdominis and/or isolated contraction of the multifidi to combined contraction of both transversus abdominis in different positions from supine or prone to bridging or four-point kneeling.; Patients will receive 8 sessions of motor control exercise program of 30 min duration for 4 weeks, twice per week. Exercises will be demonstrated to the participants by an experienced physical therapist. On each session, the therapist will correct each subject personally. Participants will be asked for practicing the exercises at home once daily for 20 minutes over the 8-week intervention period. The motor control exercise program will consist of a progression from isolated contraction of the transversus abdominis and/or isolated contraction of the multifidi to combined contraction of both transversus abdominis in different positions from supine or prone to bridging or four-point kneeling. In addition, participants allocated to the neurodynamic group will also receive a nerve neurodynamic slider intervention targeting the main trunk of the sciatic nerve of the affected side during al treatment sessions (n=8).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Random Clinical Trial (RCT) of the Impact of Electrocoagulation on Ovarian Reserve
Condition: Ovarian Cyst
MeSH terms: Ovarian Cysts
Study type: Interventional
Phase: Phase 4

Summary: 
      Laparoscopic ovarian cystectomy is widely used for the removal of benign ovarian cysts but
      damage to ovarian reserve caused by electrocoagulation has recently been questioned.

      The purpose of this study is to investigate the impact of bipolar and ultrasonic scalpel
      electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.
    

Detailed description: 
      Laparoscopic ovarian cystectomy is currently considered the treatment of choice in women with
      benign ovarian cyst and has gained increasing acceptance among gynecological surgeons(1).
      However, the safety of this technique in terms of ovarian damage to the operated gonad caused
      by electrocoagulation has recently been questioned. Many evidences support that the removal
      of ovarian cysts is associated with an injury to ovarian reserve. On the contrary, some
      retrospective studies did not show adverse outcomes compared with the control group (tubal
      infertility) . There is a lack of good clinical and scientific evidence such as randomized
      controlled study to report definitively the impact of electrocoagulation on ovarian reserve
      after laparoscopic excision of ovarian cyst.
    

Intervention name(s): Laparoscopic ovarian cystectomy using bipolar; Laparoscopic ovarian cystectomy using ultrasonic scalpel; Laparoscopic ovarian cystectomy using suture
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Laparoscopic ovarian cystectomy using bipolar; Laparoscopic ovarian cystectomy using ultrasonic scalpel; Laparoscopic ovarian cystectomy using suture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian Cysts; Electrocoagulation; Ovarian Function Tests; Laparoscopy
Closed Loop Insulin Therapy in Type 1 Diabetics Based on Blood Microdialysis, Online Sensors and an eMPC Algorithm
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The EU funded project CLINICIP (Closed Loop Insulin Infusion for Critically Ill Patients)
      aims to develop a low-risk monitoring and control device which allows maintaining metabolic
      control in intensive care units. A system will be developed comprising three subsystems: a
      body interface for the delivery of biofluids, biosensors for the determination of glucose
      concentration in these biofluids and an adaptive control algorithm that generates advice and
      thus represents a decision support system with respect to insulin infusion rate to establish
      glycaemic control in critically ill patients. Within a closed loop system, intensified
      insulin treatment will make use of the calculations leading to external regulation of
      glucose.

      It is the aim of this study to evaluate the feasibility to establish glycaemic control in
      type 1 diabetic subjects over a period of 30 hours by manually combining these three -
      previously tested - subsystems (ABS System, extracorporeal online glucose sensor and a
      laptop-based computer algorithm).
    


Time perspective: Prospective
Keywords: blood microdialysis; glucose monitoring; glucose control; automated blood sampling; online-sensor; algorithm; type 1 diabetes
Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI
Condition: Acute Upper Respiratory Track Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if treatment with Mucinex D lowers the use of
      antibiotics in the treatment of upper respiratory infection when compared to placebo
    


Intervention name(s): Guaifenesin; Placebo
Intervention type(s): Drug; Device
Intervention description(s): 1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days; Placebo bid for 7 days
Other intervention name(s): Mucinex D; Mucinex; Pseudoephedrine
Intervention MeSH terms: Phenylpropanolamine; Pseudoephedrine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Acute Upper Respiratory Track Infection Who Seek Treatment
Total Knee Replacement With Tourniquet or Aquamantys
Condition: Knee Replacement
Study type: Interventional

Summary: 
      The purpose of this study is to compare quadriceps muscle strength, pain, opioid consumption
      and patient function during the first three months after short-stay total knee replacement
      between patients treated with short-duration tourniquet knee replacement with the Aquamantys®
      bipolar sealer versus those treated with the standard of care (tourniquet used throughout the
      case and no Aquamantys®).

      By doing this study, investigators hope to learn if short duration tourniquet knee
      replacement with the Aquamantys® bipolar sealer is more effective than standard of care
      (tourniquet used throughout the case and no Aquamantys®). The purpose of this study is to
      compare quadriceps muscle strength, pain, opioid consumption and patient function during the
      first three months after short-stay total knee replacement between patients treated with
      short-duration tourniquet knee replacement with the Aquamantys® bipolar sealer versus those
      treated with the standard of care (tourniquet used throughout the case and no Aquamantys®).
    


Intervention name(s): Aquamantys; Tourniquet
Intervention type(s): Device; Device
Intervention description(s): The Aquamantys bipolar sealer is a device used during surgery to help reduce bleeding in the joint. The system uses radiofrequency energy and sterile saline (salt water) to close small blood vessels in the knee to help reduce bleeding.; Standard of care for reducing bleeding during the total knee arthroplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tourniquet; Aquamantys; Arthroplasty; Total Knee; Standard of Care Tourniquet
Study to Evaluate the Safety, PK, PD and Efficacy of AMG 827 in Adults With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This Phase 1b/2a study will evaluate safety, tolerability pharmacokinetics (PK) and
      pharmacodynamics (PD) of brodalumab when administered in multiple subcutaneous (SC) and
      intravenous (IV) doses in patients with active rheumatoid arthritis (RA) in combination with
      a stable dose of disease modulating anti-rheumatic drugs (DMARDs). Part A is dose escalation
      (to assess safety & tolerability), and Part B is dose expansion (to assess clinical efficacy)
      at the highest tolerated dose level of brodalumab from Part A.
    

Detailed description: 
      The dose-escalation phase consisted of 5 sequentially enrolled dose cohorts. Within each
      cohort participants were randomly assigned in a 3:1 ratio to receive brodalumab or placebo
      subcutaneously (cohorts 1 to 3) or intravenously (cohorts 5 and 6).

      Dose escalations required acceptable safety data based on blinded review following completion
      of the day 15/week 3 visit by the final participant in each cohort and when six or more
      participants in a cohort had been administered at least three doses of brodalumab (cohorts 1,
      2, 3 and 5). In cohort 6, dose escalation followed completion of the day 15/week 3 visit by
      the final patient in cohort 5 and six or more participants in cohort 5 had been administered
      two or more IV infusions of brodalumab.

      Cohort 4 was designed to be used in the dose expansion phase to provide evidence of
      biological impact in 70 patients with RA receiving brodalumab at the dose determined during
      the dose escalation phase of the study. This cohort was not enrolled because a decision was
      made not to conduct Part B of the study; instead a separate phase 2 multiple-dose study was
      conducted to evaluate efficacy of brodalumab in patients with RA (Study 20090061;
      NCT00950989).
    

Intervention name(s): Brodalumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Solution for subcutaneous or intravenous administration; Solution for subcutaneous or intravenous administration
Other intervention name(s): AMG 827
Intervention MeSH terms: Brodalumab
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage
Condition: Skin Aging
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite
      in facial photodamage in a randomized double blind trial.
    

Detailed description: 
      It has been demonstrated that photodamage leads to wrinkles, mottled pigmentation,
      lentigines, telangiectasias, and textural changes, but more importantly, it can also lead to
      pre-cancerous conditions with the development of actinic keratosis (AK). The majority of
      photorejuvenation or photodamaged published studies have used 5-Amino-Levulinic acid (5-ALA)
      as a photosensitizer, and either a blue light or an Intense Pulsed Light source with a
      70%-95% global facial skin improvement. The molecular mechanism of such improvement is
      unknown, but activation of a non-specific immune response in addition to increased fibrosis
      and new collagen formation, have both been suggested.

      Methyl Aminolevulinate ( MAL) is another marketed photosensitizer mainly utilized in Europe.
      Lipophilicity, higher penetration depth and tumor selectivity has been advocated for MAL
      compared to 5-ALA. However, its effect in photodamaged skin has not been well documented.

      The aim of the study is to determine the efficacy of MAL + Aktilite (PDT) in facial
      photodamage.

      Study Type: Interventional

      Study Design: Randomized, double-Blind, placebo-controlled trial. Official Title: A
      randomized, double-Blind, placebo-controlled trial of Methyl Aminolevulinate + Aktilite in
      patients with facial photodamage.
    

Intervention name(s): Moisturizer; Methyl Aminolevulinate
Intervention type(s): Other; Drug
Intervention description(s): Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes); Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite)
Other intervention name(s): Cetaphil; Metvix
Intervention MeSH terms: Aminolevulinic Acid; Methyl 5-aminolevulinate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Skin Aging; Rejuvenation; Photodynamic Therapy; Methyl Aminolevulinate
Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of
      the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease
      and compare it to its activity in healthy subjects.
    

Detailed description: 
      For each at risk subject enrolled, an age-matched healthy subject will be enrolled. Age
      matching will be performed according to the following age strata: 1-5 years, 6-10 years,
      11-17 years.
    

Intervention name(s): Meningococcal vaccine GSK134612
Intervention type(s): Biological
Intervention description(s): 2 doses of the vaccine administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal vaccines; Vaccines, conjugate; Neisseria meningitidis; Immunocompromised patient
Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Aromatase inhibitor therapy is used in treating postmenopausal women who have
      hormone-dependent breast cancer. It is not yet known what effect aromatase inhibitor therapy
      has on blood vessel function.

      PURPOSE: This clinical trial is studying the effect of aromatase inhibitor therapy on blood
      vessel function in postmenopausal women with breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the effect of adjuvant aromatase inhibitor therapy on endothelial function in
           postmenopausal women with breast cancer.

      OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups
      according to breast cancer hormone-receptor status (positive vs negative).

        -  Group 1 (hormone receptor-positive): Patients receive aromatase inhibition therapy for
           up to 6 months in the absence of unacceptable toxicity.

        -  Group 2 (hormone receptor-negative): Patients do not receive adjuvant treatment.

      Endothelial function is measured in both groups at baseline and at follow up by the room
      temperature peripheral arterial tonometry (RT-PAT) index using the EndoPAT method.
    

Intervention name(s): anastrozole; exemestane; letrozole; assessment of therapy complications
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention description(s): Patients receive aromatase inhibition therapy.; Patients receive aromatase inhibition therapy.; Patients receive aromatase inhibition therapy.; Endothelial function is measured
Intervention MeSH terms: Letrozole; Anastrozole; Exemestane
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with recently diagnosed breast cancer
      
Keywords: stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; ductal breast carcinoma in situ
Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo
Condition: Insomnia
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigation of Psychomotor and Cognitive Residual Effects of Single Oral Doses of Zolpidem
      Tartrate Extended Release 12.5 mg and Eszopiclone 3 mg Compared to Placebo in Healthy Young
      Volunteers, Using Flurazepam 30 mg as an External Comparator
    

Detailed description: 
      This is a crossover study, with 4 different treatments (Ambien, Lunesta, placebo, and
      flurazepam). The flurazepam arm always comes last due to the long washout period associated
      with it. The other 3 arms are randomized.
    

Intervention name(s): zolpidem tartrate
Intervention type(s): Drug
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment