bioihbjkbjnl/mcl2 huggingface dataset:
Beta-Tricalcium Phosphate and Concentrated Growth Factors in Treatment of Intra-bony Defect Randomized Clinical Trial
Condition: Chronic Periodontitis; Intrabony Periodontal Defect; Concentrated Growth Factors
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical study aimed to evaluate the efficacy of biodegradable gelatin sponge loaded
      with Beta-tricalcium phosphate socked in concentrated growth factors in the treatment of
      periodontal intra-bony defects, as compared with biodegradable gelatin/beta-tricalcium
      phosphate sponges alone.
    

Detailed description: 
      40 intra-bony defects in 40 patients will be selected from outpatient clinic of Oral
      Periodontology Clinic Faculty of Dentistry, Tanta University to participate in this study.
      Each defect had intra-bony depth > or = 4 mm and probing pocket depth (PPD) > or = 6 mm.
      Patients will be randomly assigned to either test or control group. 20 patients will be
      treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone.

      (control group), the other 20 patients will be treated with the same surgical technique plus
      biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated
      growth factors (test group).

      Gingival index (GI), bleeding on probing, Probing pocket depth and clinical attachment level
      (CAL) will assessed at baseline, 3, and 6 months at the site to be treated. Cone beam
      radiographs evaluation will be taken at baseline, and 6 months after surgery.
    

Intervention name(s): open flap debridement; use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors; use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone
Intervention type(s): Procedure; Other; Other
Intervention description(s): Open flap for removal of diseased periodontal tissues and necrotic cementum; use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate incorporating Concentrated Growth Factors in Periodontal Defect; use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone in the Intrabony Periodontal Defect
Other intervention name(s): periodontal surgery; regenerative surgery; Regenerative surgery
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 40 Patients will be randomly assigned to either test or control group. 20 patients will be treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone.
(control group), the other 20 patients will be treated with the same surgical technique plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Beta-Tricalcium Phosphate; regeneration; concentrated growth factors
Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers
Condition: Adult Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08
      after single i.v. infusion to the adult healthy volunteers. Additionally were assessed
      infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single i.v.
      infusion and to explore TAB mechanism-of-action biomarkers.
    


Intervention name(s): TAB08
Intervention type(s): Biological
Intervention description(s): monoclonal antibody
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: TAB08; healthy volunteers
CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery
Condition: Prescription Opiate/Medication Dependence
MeSH terms: Recurrence; Behavior, Addictive
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed project will use fMRI and specific probes of reward and inhibition as biomarkers
      predicting drug use during and after treatment in 72 subjects addicted to prescription
      opioids/medications. Subjects will be scanned before, during, and after 12 weeks of active
      medication. The brain fMRI measures will be correlated with the primary clinical outcome of
      drug use (by urine drug screen) during the treatment and follow-up phase.
    


Intervention name(s): Vivitrol
Intervention type(s): Drug
Intervention description(s): There are monthly injections of depot naltrexone for 3 months.
Other intervention name(s): depot naltrexone (380 mg)
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prescription opiates/medications; vivitrol; brain imaging
A Study of the Relative Bioavailability of Single Dose RO4917838 and the Effect of Food in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single center, randomized, single dose, open-label, four period cross-over study will
      evaluate the relative bioavailability of RO4917838 and the effect of food following oral
      administration in healthy volunteers. Subjects will receive in randomized order single oral
      doses of RO4917838 film coated tablets, either in the fasted or fed condition, or RO4917838
      hard gelatin capsules or RO4917838 oral suspension, with a washout period of at least 21 days
      between treatments. Anticipated time on study will be up to 23 weeks.
    


Intervention name(s): RO4917838; RO4917838; RO4927838
Intervention type(s): Drug; Drug; Drug
Intervention description(s): film coated tablet, single dose; oral suspension, single dose; hard gelatin capsule, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Study on the Use of Low Dose Ketamine After Gastric Bypass and Gastrectomy
Condition: Pain; Postoperative Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled, two-arm parallel, single-center
      study. One hundred subjects (50 in each arm) will be enrolled. Subjects, between the ages 18
      and 65, undergoing laparoscopic gastric bypass or sleeve gastrectomy will be recruited and
      consented during the preadmission visit prior to surgery.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, two-arm parallel, single-center
      study. One hundred subjects (50 in each arm) will be enrolled. Subjects, between the ages 18
      and 65, undergoing laparoscopic gastric bypass or sleeve gastrectomy will be recruited and
      consented during the preadmission visit prior to surgery. Eligible subjects will be
      randomized to one of the two treatment group in a 1:1 ratio to receive either IV ketamine
      (0.4mg/kg) or matching placebo. Both men and women will be recruited, and there is no
      limitation as to racial and ethnic origin. In the PACU, patients will receive either 0.4mg/kg
      IV ketamine or placebo. All patients will also receive standard post-anesthetic monitoring
      and care, as well as routine care after transfer out of the PACU. Patients are followed until
      the date of discharge, and endpoints (see below) are collected from patient reports as well
      as from medical charts. During their hospital stay (and once after their discharge from the
      hospital), patients will fill out five questionnaires which provide estimates of their
      postoperative pain control, mood and function, and quality of postsurgical recovery. An
      additional component of the study, which is entirely optional, is to obtain patient serum
      samples (about two teaspoons) in the operating room and 15 minutes and 4 hours after ketamine
      infusion. The investigators will use these samples to assess levels of IL-1, IL-6, TNF-α, and
      BDNF, which are markers for pain. In addition, with patient consent, the investigators will
      also store serum samples for future research use to measure other cytokines and neurotrophic
      factors and molecular markers associated with pain and depression.
    

Intervention name(s): Ketamine; Placebo Comparator
Intervention type(s): Drug; Other
Intervention description(s): 0.4mg/kg infusion; 0.4mg/kg infusion
Other intervention name(s): ketalar; Saline Infusion
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: perioperative period; pain; gastric bypass
The Influence of Glutamate on Memory in Humans
Condition: Healthy Individuals
Study type: Interventional

Summary: 
      The hippocampus is particularly laden with n-methyl-d-aspartate (NMDA) receptors, and is at
      the same time one of the most important sites in declarative memory. The rationale of this
      study is that the NMDA partial agonist D-Cycloserine will promote learning compared to a
      placebo. On the other hand, the NMDA receptor antagonist Memantine might lead to reduced
      memory. We believe that the influence of NMDA receptors on memory can be determined via acute
      co-activation of the NMDA receptors with Cycloserine® (King Pharmaceuticals Ltd, active
      ingredient: DCycloserin, dose: 250 mg) and Memantine (Axura®, Merz, active ingredient:
      Memantine, dose: 20 mg)on both a behavioral and functional (fMRI) level.
    


Intervention name(s): Sugar pill; Sugar pill; Sugar pill; Sugar pill; Glutamic Acid; Glutamic Acid; Memantine; Memantine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 250 mg, one dose, 60 min prior; 250 mg, one dose, 60 min prior; 20 mg, one dose, 8 hours prior; 20 mg, one dose, 8 hours prior; 250 mg, one dose, 60 minutes prior; 250 mg, one dose, 60 minutes prior; 20 mg, one dose, 8 hours prior; 20 mg, one dose, 8 hours prior
Other intervention name(s): Placebo condition for D-Cycloserine, behavioral study; Placebo condition for D-Cycloserine, fMRI; Placebo condition Memantine, behavioral; Placebo condition Memantine, fMRI; D-Cycloserine, King Pharmaceuticals; D-Cycloserine, King Pharmaceuticals; Axura, Merz; Axura, Merz
Intervention MeSH terms: Cycloserine; Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Assessment of Sleep and Sleep Disruptors in Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes; Insufficient Sleep
MeSH terms: Sleep Deprivation; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The goal of this study is to identify causes of insufficient sleep and sleep disruptors in
      adolescents with type 1 diabetes. For this study, adolescents will wear an actigraphy watch
      and complete sleep diaries for seven days. On completion of the seven days, they will
      complete several questionnaires regarding sleep, fear of hypoglycemia, and anxiety and
      depression. A subset of participants will additionally complete a qualitative interview
      session to obtain a deeper understanding of sleep disruptors and barriers and facilitators to
      improving sleep health.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents with type 1 diabetes
Study to Evaluate the Safety of Griffithsin in a Carrageenan Gel in Healthy Women
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part study. The first part is a single-dose open label design. The second part
      employs a multiple dose, randomized, placebo controlled study design. Studies have
      demonstrated that GRFT is highly potent for HIV prevention and is effective at very low
      concentrations. One 4 mL dose of PC-6500, designed to provide an adequate vaginal
      concentration of GRFT for the prevention of HIV, based on preclinical data, will be
      evaluated. Rising dose tolerance is not the goal of this study because GRFT is likely to be
      minimally absorbed systemically, if at all.
    


Intervention name(s): Griffithsin Gel; Placebo Gel
Intervention type(s): Drug; Drug
Intervention description(s): Griffithsin Gel is a large biologic molecule that is intended for vaginal rather than systemic administration. In addition, Griffithsin Gel is being developed for the prevention of HIV infection and not as a therapeutic agent. The concentration of Griffithsin Gel associated with prevention of HIV in vitro and in vivo has been established in non-clinical studies (see Section 5). Studies have demonstrated that Griffithsin Gel is highly potent for HIV prevention and is effective at very low concentrations.
One 4 mL dose of PC-6500, designed to provide an adequate vaginal concentration of GRFT for the prevention of HIV, based on preclinical data, will be evaluated. Rising dose tolerance is not the goal of this study because GRFT is likely to be minimally absorbed systemically, if at all.; Placebo Gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      A single centre, placebo controlled, blinded (participant, investigator, outcome assessor)
      trial to evaluate the effects of COX-2 inhibition with celecoxib on endothelial function in
      healthy male volunteers.
    

Detailed description: 
      Primary Objective: To perform a systemic analysis of how COX-2 inhibition by celecoxib
      affects vascular function and 'omic biomarkers including those associated with the
      COX-2/prostacyclin/ADMA axis in healthy male volunteers

      Secondary Objective: To investigate how this is altered by L-arginine supplementation

      Methods: A single centre, double blind, placebo controlled trial will be carried out in
      healthy male volunteers between 18 and 40 years of age. In phase 1, participants will be
      blinded and randomised to receive either Celecoxib 200mgBD for 7 days or placebo. The primary
      endpoint is endothelial function measured by EndoPAT. In Phase 2, the same participants will
      receive either Celecoxib 200mgBD for 7 days + 10g L-arginine supplementation or placebo + 10g
      L-arginine supplementation to see if L-arginine can reverse any endothelial dysfunction
      caused by Celecoxib. Secondary outcomes will include measurement of 'omic biomarkers.
    

Intervention name(s): Celecoxib; Placebo; L-arginine + placebo; L-arginine + celecoxib
Intervention type(s): Drug; Other; Other; Other
Intervention description(s): Two 200 mg capsules per day (400 mg/day) for 7 days; 2 capsules/day for 7 days; L-arginine = Five capsules of 2 mg per day (10 mg/day) for 7 days Placebo = 2 capsules/day for 7 days; L-arginine = Five capsules of 2 mg per day (10 mg/day) Celecoxib = Two 200 mg capsules per day (400 mg/day) for 7 days
Other intervention name(s): Celebrex
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy male volunteers will be blinded and randomized to 7 days' treatment with celecoxib (200mg bd) or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: NSAID; Endothelial function; COX-2; Celecoxib; biomarker
The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy in Severe Trauma Patients
Condition: Trauma
MeSH terms: Wounds and Injuries
Study type: Observational [Patient Registry]

Summary: 
      Prospective randomized clinical trial Compare the goal-directed fluid therapy using
      esophageal Doppler and classic fluid therapy
    

Detailed description: 
      Goal directed fluid therapy becomes issue for enhanced recovery after surgery. In goal
      directed therapy, dynamic parameters, like stroke volume and cardiac output, is important.
      Esophageal Doppler is one of device which provides dymanic parameters.

      In severe trauma cases, the effect of goal directed therapy is not known yet. So the aim of
      this study is comparing the results of goal directed therapy using esophageal Doppler and
      conventional fluid therapy.
    

Intervention name(s): esophageal Doppler
Intervention type(s): Device
Intervention description(s): Goal directed fluid therapy using dynamic parameters from esophageal Doppler
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Severe trauma patients

        : Injury severity score > 15
Efficacy and Safety of Spa Treatment in Chronic Shoulder Pain Due to Rotator Cuff Tendinopathy
Condition: Self Efficacy
MeSH terms: Shoulder Pain; Tendinopathy
Study type: Interventional

Summary: 
      To determine whether spa therapy has a beneficial effect on pain and disability in the
      management of shoulder pain due to chronic rotator cuff lesions, this multicentre randomized
      prospective clinical trial includes patients with shoulder pain due to chronic degenerative
      rotator cuff tendinopathy who attend French spa resorts as outpatients. Subjects are
      randomized into two groups: immediate spa therapy (18 days of standardized treatment) and
      control (spa therapy delayed for 6 months). All patients continue usual treatments during the
      6-month follow-up period. The main endpoint is the mean change in the DASH score at 6 months.
      Secondary endpoints are the mean change in SF-36 components, treatments used, and tolerance.
      The effect size of spa therapy is calculated and the proportion of patients reaching minimal
      clinically important improvement (MCII) is compared between groups.
    


Intervention name(s): immediate spa therapy
Intervention type(s): Other
Intervention description(s): , with 18 days of therapy over 3 weeks; The standardized shoulder therapy program was designed by experienced spa therapy physicians. Spa mineral water and treatments are approved and controlled by the French authorities. Spa treatment included: bubble buses at 36°C for 15 minutes, applications of mineral matured mud at 45°C to the shoulder for 20 minutes, mineral hydrojet sessions at 39°C for 7 minutes and general mobilization in a collective mineral water pool at 35°C for 20 minutes supervised by a registered physiotherapist.
Other intervention name(s): spa treatment; balneotherapy; physical treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: chronic shoulder pain; rotator cuff tendinopathy; sap therapy; balneotherapy
Protective Effect of Tranexamic Acid on Shedding of the Endothelial Glycocalyx in Patients Undergoing Spinal Fusion Surgery
Condition: Posterior Lumbar Spinal Fusion Surgery
Study type: Interventional

Summary: 
      The aim of this study was to determine whether the administration of tranexamic acid in
      patients undergoing lumbar spinal fusion surgery can inhibit damage in endothelial glycocalyx
      layer. As a prospective double blinded randomized placebo-controlled trial, the investigators
      detect and compare the changes in concentrations of serum syndecan-1 and heparan sulfate
      before and after surgery.
    


Intervention name(s): Tranexamic acid; 0.9% NaCl (normal saline)
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion of Tranexamic acid(mixed with normal saline) at the dose of 10mg/kg(body weight) for 20 min after induction of anesthesia and then administration another 1mg/kg/hr(body weight) of Tranexamic acid(mixed with normal saline) until the end of the operation.; The same amount of normal saline solution without the addition of tranexamic acid is administered in the same manner as the experimental group(Tranexamic acid intervention group).
Other intervention name(s): glutamine
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized, Double-Blinded, Placebo-Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Interventional

Summary: 
      This study will compare the use of the Chemo MouthpieceTM device along with best supportive
      oral care to best supportive oral care alone to rate the effectiveness of Chemo MouthpieceTM
      in lessening symptoms associated with chemotherapy regimen known to place patients at risk
      for symptomatic mucositis and, of those, chemotherapy regimens for which ice-based
      cryotherapy has been demonstrated to have a favorable impact on oral mucositis symptom
      management. Subjects who are receiving standard chemotherapy regimens will be randomly
      assigned to receive either study device and oral care ingredients or oral care ingredients
      only. All subjects will complete daily diaries for the first 14 days of chemotherapy Cycles 1
      and 2. Subjects who are assigned to the study device arm will use the device during their
      chemotherapy infusion in clinic and will continue to use the device at home ,at least twice
      daily, for the first six (6) days of chemotherapy Cycles 1 and 2. Prior to the first
      chemotherapy infusion in Cycle 3, all subjects in the study regardless of treatment
      assignment will have the option of using the Chemo MouthpieceTM for subsequent cycles.
    


Intervention name(s): Chemo Mouthpiece; Best Supportive Care only
Intervention type(s): Device; Other
Intervention description(s): Frozen tube that fills the oral cavity used during and after chemotherapy to ease and prevent symptoms of oral mucositis; Standard Oral care for Chemotherapy
Other intervention name(s): Oral cryotherapy delivery device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Prospective Studies, Stomatitis, Cryotherapy, Patient Reported Outcome Measures