bioihbjkbjnl/mcl2 huggingface dataset:
Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis
Condition: Diskectomy; Intervertebral Disk Displacement
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional

Summary: 
      The purpose of this study is to find out if use of a cervical disc prosthesis in the
      treatment of a cervical disc herniation preserves or restores normal mobility and movement in
      the cervical spine.
    

Detailed description: 
      Intractable nerve pain to the arm caused by a cervical disc herniation is typically treated
      by removal of the protruding disc through an operation. Fusion of the discs follows in about
      70% of cases.

      Adjacent disc disease (ADD), symptomatic degenerative changes in the levels adjacent to the
      operated level is regarded as a late complication. Fusion at the operated level is thought to
      contribute to this process due to compensative increased mobility and stress on the adjacent
      segments.

      Keeping the operated segment mobile through the use of a cervical disc prosthesis possibly
      prevents ADD.

      We hypothesize that use of a cervical disc prosthesis preserves or restores normal mobility
      to the cervical spine. To test this hypothesis subjects are randomised in a group receiving a
      standard anterior cervical discectomy, and a group receiving a standard discectomy with
      placement of a cervical disc prosthesis. Digital X-ray cinematographic videos are made of a
      flexion/extension movement. The videos will be analyzed manually and through a newly designed
      automated program, to check for mobility and order of movement.
    

Intervention name(s): Activ C disc prosthesis; Anterior cervical discectomy
Intervention type(s): Device; Procedure
Intervention description(s): cervical disc prosthesis; Removal of protruding cervical disc through an anterior approach
Other intervention name(s): Activ C cervical disc prosthesis, B.Braun/Aesculap Spine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical degenerative disc disease; Anterior cervical discectomy; Cervical disc prosthesis; Activ-C; Mobility; Movement
Muscle Perfusion and Protein Metabolism in Elderly
Condition: Aging
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to examine the role skeletal muscle perfusion plays in
      mediating muscle protein synthesis in healthy older and younger individuals. The
      investigators hypothesized that normalization of muscle perfusion in older men and women via
      exercise or infusion of a vasodilator would enhance nutritive flow and skeletal muscle
      protein synthesis in the elderly similar to that of their younger counterparts.
    

Detailed description: 
      The purpose of this study was to examine muscle protein metabolism in healthy young and
      elderly subjects during pharmacologic vasodilation of the lower limb vasculature in
      combination with increased amino acids delivery. We obtained femoral arteriovenous blood
      samples and v. lateralis muscle biopsies during a primed continuous infusion of L-[ring-13C6]
      Phenylalanine. Muscle protein kinetics were measured in the basal state and during a 180 min
      infusion of sodium nitroprusside (SNP) and amino acids (Premsol 10%) (SNP+AA). Skeletal
      muscle microvascular recruitment and flow were measured during the basal state and SNP+AA
      using contrast-enhanced ultrasound (CEU).
    

Intervention name(s): Aerobic Exercise; Sodium Nitroprusside; Amino Acid Drink
Intervention type(s): Other; Drug; Dietary Supplement
Intervention description(s): 45 minuties of treadmill walking was completed at 40% VO2 peak; Sodium Nitroprusside was given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min; 7.5 gram Amino Acid drink
Other intervention name(s): Nitropress
Intervention MeSH terms: Nitroprusside
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: metabolism; exercise; sodium nitroprusside
Validation of the Effect of Propofol and Opiates Closed-loop Administration Device During Anesthesia and Sedation
Condition: Surgery With General Anesthesia
Study type: Observational

Summary: 
      Sleeping medication and analgesia are standard administered during anesthesia. Sleeping
      medication, Propofol (Diprivan, AstraZeneca), and analgesia, Remifentanil (GlaxoSmithKline),
      are most frequently used In the University Hospital Ghent.

      The clinical effect of administration of pharmaca can be measured in the changes of
      heartbeat, blood pressure, respiration and the changes of brain activity by registering EEG.
      These measurements are performed standard, to secure the safety of the patient.

      The heartbeat and the EEG will be measured by non invasive adhesive electrodes on the skin of
      the patient.

      The blood pressure will be measured by non invasive blood pressure cuff around the arm and
      the respiration parameters will be measured by non invasive spirometry, which are all
      standard available on a anesthesia device.

      Most of the pharmaca are administered by a fixed dosage schedule based on the patient's
      weight.

      A more individualized administration of this pharmaca could lead to a better anesthesia
      quality.

      Since considerable time, we know that a computer-controlled administration of these products
      by automatic coupling between the measured effects and the "spuit"pump to administer the
      product, could lead to a better administration, optimalisation of the administered dose,
      because the patients individual effect of the administration can be taken in consideration.
      This device is called the "closed-loop system". The department of Anesthesia has already
      proofed the utility of the device for automatic administration of Propofol and opiates in
      small specific patient groups.
    


Intervention name(s): Automatic administration of propofol and opiates during routine clinical practice
Intervention type(s): Procedure
Intervention description(s): The clinical effect of administration of pharmaca can be measured in the changes of heartbeat, blood pressure, respiration and the changes of brain activity by registering EEG. These measurements are performed standard, to secure the safety of the patient.
The heartbeat and the EEG will be measured by non invasive adhesive electrodes on the skin of the patient.
The blood pressure will be measured by non invasive blood pressure cuff around the arm and the respiration parameters will be measured by non invasive spirometry, which are all standard available on a anesthesia device.
Intervention MeSH terms: Propofol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing a surgery with general anesthesia
A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy
Condition: Sedation
Study type: Interventional
Phase: Phase 3

Summary: 
      A multicenter, randomized, single-blind, active controlled, parallel group study comparing
      remimazolam tosilate to propofol in patients undergoing bronchoscopy.
    


Intervention name(s): Remimazolam Tosilate; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous injection at a dose of 0.3mg/kg for sedation induction and continuous intravenous infusion at an initiative dose of 1 mg/kg/h for sedation maintenance.; Intravenous injection at a dose of 1.5~2.5mg/kg for sedation induction and continuous intravenous infusion at the dose of 0~12 mg/kg/h for sedation maintenance
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study of LY3471851 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to explore the safety and tolerability of LY3471851 in
      healthy Japanese and Caucasian participants. The study will also estimate how much LY3471851
      gets into the blood stream and how long it takes the body to remove it. The study is expected
      to last about 7 weeks for each participant.
    


Intervention name(s): LY3471851; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): NKTR-358
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study Assessing The Efficacy And Safety Of Avodart (Dutasteride) At Improving Urinary Symptoms In Men With Prostate Cancer Who Are Undergoing Seed Implantation
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Avodart (dutasteride) reduces the male hormone (DHT) that leads to prostate growth and
      stimulates cancerous growth. Avodart is currently approved by the FDA to treat men with
      symptoms of an enlarged prostate. Avodart works by reducing DHT and prostate size; therefore,
      the drug may be useful in improving lower urinary tract symptoms (LUTS) such as frequency,
      urgency, weak stream, and urination difficulty (dysuria), among others, in men with prostate
      cancer. Avodart may be effective in men with prostate cancer who are being treated with
      hormonal therapy with one injection of Zolodex (goserelin) followed one month later with a
      trans-urethral incision of the prostate (TUIP), and three months after that, seed
      implantation (SI) of the prostate.

      The purpose of this study is to test whether Avodart (dutasteride) is effective on LUTS and
      dysuria in men with localized prostate cancer being treated with single-dose goserelin, TUIP,
      and interval SI.
    

Detailed description: 
      Dutasteride is an inhibitor of the 5 alpha reductase type I and type II enzymes that convert
      testosterone to DHT, the male hormone that leads to benign prostate growth and drives
      malignant growth. Dutasteride has been shown to significantly decrease intraprostatic DHT in
      men with localized prostate cancer, and additionally cause apoptosis and regression of some
      prostate cancers [Andriole, 2004a; Andriole, 2004b]. Furthermore, reduction in tumor volume
      has also been demonstrated in human prostate tissue [Iczkowski, 2004]. Dutasteride is
      currently indicated to treat symptomatic BPH in men with enlarged prostates, but is also
      being studied to reduce the risk of prostate cancer in men at risk (elevated PSA and previous
      negative biopsy). Dutasteride is clinically useful at improving lower urinary tract symptoms
      (LUTS) in men with clinically-localized prostate cancer and voiding difficulty being treated
      with single-dose goserelin, TUIP, and interval SI. [Mitcheson, personal observation].
    

Intervention name(s): avodart; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 avodart once daily for 13 weeks; placebo
Other intervention name(s): dutasteride
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: prostate; cancer; avodart; dutasteride; mitcheson
Study of the Safety of Intravenous Artesunate
Condition: Malaria; Malaria, Cerebral
MeSH terms: Malaria; Malaria, Cerebral
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish the safety, tolerability and pharmacokinetics of a
      single dose of the antimalarial drug artesunate.
    


Intervention name(s): Intravenous artesunate
Intervention type(s): Drug
Intervention MeSH terms: Artesunate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: artesunate; artemisinin; falciparum
Building Resilience and Attachment in Vulnerable Adolescents
Condition: Suicidal Ideation
MeSH terms: Suicidal Ideation
Study type: Interventional

Summary: 
      Suicide is the second leading cause of mortality for Canadian adolescents. Mental health
      complaints are one of the leading reasons for an emergency department visit at the Children's
      Hospital of Eastern Ontario and 60% of adolescents report suicidal ideation. The goal of the
      present investigation is to test the efficacy of a brief group intervention for adolescents
      with passive suicidal ideation and their caregivers that will focus on coping, familial
      support, and emotional regulation. The investigators hypothesize that a brief group
      intervention, delivered in the weeks following presentation for crisis services, will reduce
      suicidal ideation and improve coping and familial support.
    


Intervention name(s): Group Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention will consist of 6 psycho-educational group sessions for caregivers and 6 psycho-educational group sessions for adolescents. Adolescent and caregiver sessions will be held separately and will focus on different issues. For adolescents, the group sessions will focus on coping strategies and emotional regulation. For caregivers, the group sessions will be focused on attachment, family environment, and validation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent; Suicidal Ideation; Emergency Department; Crisis; Attachment; Coping
Intraoperative Placement of Cesium-131 Permanent Interstitial Brachytherapy in Head and Neck Cancer
Condition: Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma
MeSH terms: Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to explore the use of a treatment called interstitial
      brachytherapy for patients who have a high risk resectable (able to be treated with surgery)
      recurrent head and neck cancer.

      Brachytherapy is a form of radiation therapy that uses radioactive seeds and implants them
      into a specific place on your body. This study is using Cesium-131 permanent interstitial
      brachytherapy.

      Cesium-131 is FDA approve for brachytherapy use, however, there are currently no research
      studies to show how effective it is for head and neck cancer. The goal of this study is
      determine the effect that the placement of Cesium-131 brachytherapy seeds has on overall
      survival as well as to assess possible side effects.
    

Detailed description: 
      Primary Objective:

      To assess the effect of Cesium 131 brachytherapy in subjects with resectable recurrent cancer
      of the head and neck by evaluating disease free survival (DFS) and comparing to a previous
      cohort. Potential effects on locoregional control rate and overall survival will be explored.

      Secondary Objective:

      To assess toxicity associated with cesium 131 brachytherapy treatment.

      Study Design Patients with a head and neck recurrent cancer who are planned to undergo
      definitive tumor resection surgery that meet our inclusion and exclusion criteria will be
      offered participation in this clinical trial.

      Participant's Follow-up. The participant's medical records will be reviewed every 3 months
      for 24 months to assess: loco-regional control, distant metastasis free survival, disease
      free survival, and overall survival. This will allow us to assess the potential treatment
      effect of cesium 131.
    

Intervention name(s): Cesium 131
Intervention type(s): Drug
Intervention description(s): The number sources and activity will be based on the target volume to deliver total radiation dose, this will vary per patient.
Other intervention name(s): Cs-131; Cesium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: resectable; Cesium 131; brachytherapy
A Study of Modified Stem Cells in Traumatic Brain Injury (TBI)
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of the clinical study is to evaluate the clinical efficacy of
      intracranial administration of SB623 cells on patients with chronic motor deficit from
      Traumatic Brain Injury. A secondary purpose of the study is 1) to evaluate the effect of
      intracranial administration of SB623 cells on disability parameters and 2) to evaluate the
      safety and tolerability of intracranial administration of SB623 cells. Patients with stable,
      chronic motor deficits secondary to focal traumatic brain injury must be 12 months post TBI.
    

Detailed description: 
      This study was a multicenter, randomized (3:1) double-blind, active and sham-surgery
      controlled study to evaluate the safety, tolerability, and efficacy of stereotactic
      intracranial injection of SB623 cells in patients with fixed motor deficits from TBI. The
      study was conducted at approximately 22 sites across the United States, Ukraine, and Japan.

      Two groups, Group 1 and Group 2, received investigational product SB623 and sham surgery,
      respectively, in a 3:1 randomization scheme. Group 1 was further randomized in a 1:1:1 ratio
      to receive either 2.5 million, 5 million, or 10 million SB623 cells. Randomization was
      performed via an interactive web response system (IWRS).
    

Intervention name(s): SB623 cells; Sham Control
Intervention type(s): Biological; Procedure
Intervention description(s): SB623 cells will be implanted in the peri-infarct area using stereotactic surgery.; Sham Surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Coronary Flow Reserve in Patients With Bio-active Stent or Everolimus-eluting Stent Implanted in Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Observational

Summary: 
      The aim of the trial is to assess coronary artery reactivity using adenosine-induced coronary
      flow reserve (CFR) by transthoracic echocardiography in patients with Bio-active stent (BAS)
      and Everolimus-eluting stent (EES) distal to the original culprit lesion at 6-8 months.
    

Detailed description: 
      Objective: The aim of the trial is to assess coronary artery reactivity using
      adenosine-induced coronary flow reserve (CFR) by transthoracic echocardiography in patients
      with Bio-active stent (BAS) and Everolimus-eluting stent (EES) distal to the original culprit
      lesion at 6-8 months.

      Design: BASE-CFR is a substudy of the larger randomized multicenter BASE-ACS trial comparing
      bio-active Titan stent to everolimus-eluting stent in patients with acute coronary syndrome.
      CFR assessment will be performed at 6-8 months after stent implantation at the same time with
      OCT assessment. In-stent restenosis will be ruled out using OCT.

      Primary endpoint: CFR at 6-8 months after stent implantation.

      Secondary endpoint: Coronary flow velocity at baseline and during adenosine-induced hyperemia
      6-8 months after stent implantation..

      Association of CFR to unendotheliazed stent struts and stent malapposition.

      Enrollment: 40 patients (20 receiving BAS and 20 receiving EES).

      Clinical site: Satakunta Central Hospital, Finland Turku University Hospital, Finland
    

Intervention name(s): CFR
Intervention type(s): Device
Intervention description(s): CFR will be assessed using transthoracic echocardiography with adenosine infusion.
Other intervention name(s): Xience-V stent, Abbott vascular, USA
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with acute coronary syndrome who were treated with BAS or EES during index PCI.
      
Keywords: acute coronary syndrome; coronary flow reserve; OCT; healing; drug eluting stent
Evaluate Therapeutic Equivalence and Safety of Two Clindamycin Phosphate and Benzoyl Peroxide Gels in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% gel marketed by Valeant
      Pharmaceuticals, North America, is a safe and effective topical therapy used for the
      treatment of acne vulgaris.
    

Detailed description: 
      Watson Laboratories, Inc. has developed a generic formulation of Clindamycin Phosphate and
      Benzoyl Peroxide Gel, 1.2%/2.5%,and the current study is designed to evaluate the safety and
      efficacy of this formulation to determine if it is bioequivalent to Acanya.
    

Intervention name(s): Clindamycin Phosphate / Benzoyl Peroxide Gel; Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%; Placebo (Vehicle Gel)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes.; Dosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes.; Dosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes.
Other intervention name(s): Generic; Acanya; Vehicle Gel
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acne; Clindamycin Phosphate/Benzoyl Peroxide; Acanya; Mild to severe acne vulgaris