bioihbjkbjnl/mcl2 huggingface dataset:
Correlation Between Oral Health and Systemic Inflammation (COHESION)
Condition: Inflammation; Periodontal Disease; Gingivitis
MeSH terms: Gingivitis; Periodontal Diseases; Inflammation
Study type: Interventional

Summary: 
      COHESION is a randomized trial targeting reduction of systemic inflammation through an oral
      hygiene regimen incorporating a plaque-disclosing toothpaste and a control toothpaste.
    

Detailed description: 
      The present pilot trial will test the hypothesis that regular brushing with Plaque HD
      (interventional toothpaste) compared to conventional toothpaste (control) for 30 days in
      participants with confirmed mild to severe PD will significantly reduce hsCRP levels, a
      sensitive marker of inflammation and predictor of CVD. By completing the COHESION trial, we
      will collect important and relevant data to support application for investigator-initiated
      research funding from the US National Institutes of Health to directly test whether Plaque HD
      reduces CVD in larger, scaled multi-center randomized trial.

      Participants will be asked to participate in three visits. During Visit One, we will be
      reviewing their medical and dental information as well as performing an oral evaluation to
      determine their level of gingivitis or periodontal disease. If the participant remains
      eligible, their blood will be drawn to determine whether the baseline hsCRP level falls
      within the eligible range (≥0.5 to ≤10.0 mg/L).

      During Visit Two, if the participant remains eligible, they will be randomized and given a
      30-day supply of the interventional or control toothpaste along with a study diary to track
      their progress.

      The participant will receive a follow-up call 15 days after Visit Two to track compliance
      with study activity and monitor for any adverse events.

      30-days later, during Visit Three, the participants will undergo another oral evaluation in
      addition to a second blood draw to measure the hsCRP level after using their assigned
      toothpaste for 30 days.
    

Intervention name(s): Plaque disclosing toothpaste; Non-plaque disclosing toothpaste
Intervention type(s): Other; Other
Intervention description(s): Plaque identifying toothpaste with a FDA-registered seed-extract dye (Annatto (Bixa Orellana)) and FD&C Blue No. 1.; Toothpaste that does not contain the FDA-registered seed-extract dye (Annatto (Bixa Orellana)) and FD&C Blue No. 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to brush twice daily for 30 days with the plaque disclosing agent toothpaste or a reference, non-plaque disclosing toothpaste. Toothpastes are comparable based on equivalent content of the active ingredient: fluoride.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Toothpaste; Inflammation; Periodontal Disease; hsCRP; Oral health; Oral hygiene
Interactive Study to Increase Glaucoma Adherence to Treatment
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      Study participants who receive the I-SIGHT intervention will have higher rates of glaucoma
      treatment compliance (e.g., medication-taking and refill compliance, return for clinical
      follow-up) and more positive eye health outcomes at 12-month follow-up than participants who
      receive the control group intervention.
    

Detailed description: 
      The intervention is telephone-based and individually-tailored to participants' compliance
      knowledge, attitudes, and behaviors; psychosocial predictors of compliance; health literacy;
      race and culture; and prescribed medication regimen. The intervention calls utilize
      interactive voice recognition technology to facilitate interest, participation, and
      interaction with call recipients. We evaluated the intervention in a randomized controlled
      trial with telephone interviews administered to all participants at baseline, 6, 9, and
      12-months
    

Intervention name(s): Telephone and Print based intervention
Intervention type(s): Behavioral
Intervention description(s): Thiss intervention consisted of tailored phone calls and follow-up mailings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Treatment Compliance
The Effect of Assisted Reproductive Technology on Male Sexual Function.
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Observational

Summary: 
      Men participating in assisted reproductive technology treatments will be recruited to a study
      involving filling erectile function questionnaires throughout fertility treatments, pregnancy
      and up to 1 year after birth.
    

Detailed description: 
      Men participating in fertility will be recruited to a study involving filling erectile
      function questionnaires throughout fertility treatments, pregnancy and up to 1 year after
      birth. In addition, participants will be questioned regarding marital life, sexual
      intercourse frequency, medical history and treatments for erectile dysfunction in relevant
      cases. Thes control group will be comprised of male subjects who did not require fertility
      treatments to conceive.
    

Intervention name(s): Questionnaire and personal interviews.
Intervention type(s): Other
Intervention description(s): Questionnaire and personal interviews.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male patients participating in fertility treatments.
Vayarin® Medical Food Study for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults.
    


Intervention name(s): Vayarin®; Placebo
Intervention type(s): Other; Other
Intervention description(s): Medical Food; Cellulose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
Condition: Typhoid Fever
MeSH terms: Typhoid Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the
      Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is
      highly endemic and an efficacious vaccine against this disease is very much needed.
    


Intervention name(s): Vi-CRM197 vaccine; Vi Polysaccharide (PS) vaccine; Pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological; Biological
Other intervention name(s): Typherix; Prevenar 13
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Microboosting of Atazanavir 300 mg With 50 mg Versus 100mg Ritonavir Daily in HIV-infected Patients: a Pharmacokinetic Study
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single group study to determine the pharmacokinetic profile of
      atazanavir 300 mg daily boosted with ritonavir 100mg daily in HIV-infected patients over a
      period of 9 days.

      Ritonavir and atazanavir are protease inhibitors used to treat HIV. However, ritonavir, when
      used at low doses (up to 100mg) does not have HIV activity, but will enhance (boost) the
      blood concentrations of other drugs like atazanavir.

      Recently, a study showed that taking 50mg of ritonavir administered in an oral solution led
      to similar blood concentrations of atazanavir than when given with 100mg of ritonavir.
      Potential benefits associated with a lower dose of ritonavir may include a reduction of side
      effects such as upset stomach and an improvement in cholesterol level. This study will look
      at the amount of atazanavir into your blood when given with ritonavir in a tablet formulation
      at 50mg or 100mg with standard atazanavir dose (300mg).
    


Intervention name(s): atazanavir 300mg boosted with ritonavir 50 mg
Intervention type(s): Drug
Intervention description(s): atazanavir 300 mg with ritonavir 100 mg once a day at 8:00 am for study day 1 and 9.
atazanavir 300 mg with ritonavir 50 mg once a day at 8:00 am for 7 consecutive days (study days 2-8)
Other intervention name(s): Reyataz; ATV; Norvir; RTV
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: PK; pharmacokinetic; HIV-infected; atazanavir; ritonavir
Dexmedetomidine-Ropivacine Versus Sufentanil-Ropivacaine for Epidural Labor Analgesia
Condition: Pregnancy Related
Study type: Interventional
Phase: Phase 4

Summary: 
      Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is
      associated with some adverse events. Dexmedetomidine is a high selective alpha2-adrenoceptor
      agonist. Mounting evidences show that dexmedetomidine-ropivacaine combination can also be
      used effectively for epidural labor analgesia. This pilot trial is designed to compare the
      effect of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine combination
      on neonatal outcomes when used for epidural labor analgesia, and to test the feasibility of a
      future large randomized trial.
    

Detailed description: 
      Sufentanil combined with ropivacaine is commonly used for epidural labor anesthesia. However,
      this combination is associated with some adverse events including increased risk of neonatal
      depression. Dexmedetomidine is a high selective alpha2-adrenoceptor agonist and possesses
      opioid-sparing and analgesic effects when used in combination with local anesthetics.
      Recently published data suggest that dexmedetomidine-ropivacaine combination can effectively
      relieve labor pain.

      We suppose that, when compared with traditional sufentanil-ropivacaine combination, the
      dexmedetomidine-ropivacaine combination used for epidural labor analgesia may reduce
      sufentanil-related adverse neonatal outcomes. The purpose of this pilot trial is to compare
      the effect of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine
      combination used for epidural labor analgesia on neonatal outcomes, and also to test the
      feasibility of a future large randomized trial.
    

Intervention name(s): Dexmedetomidine; Sufentanil
Intervention type(s): Drug; Drug
Intervention description(s): loading dose of 0.45 microgram/ml dexmedetomidine plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml dexmedetomidine plus 0.07% ropivacaine.; loading dose of 0.45 microgram/ml sufentanil plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml sufentanil plus 0.07% ropivacaine.
Other intervention name(s): Dexmedetomidine-ropivacaine combination; Sufentanil-ropivacaine combination
Intervention MeSH terms: Sufentanil; Dexmedetomidine; Dsuvia; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a randomized, double-blind, pilot trial with two parallel-arms
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: epidural labor analgesia; dexmedetomidine; neonatal outcomes
Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional

Summary: 
      The proposed study is a randomized, single blind trial of intermittent versus continuous
      stimulation among essential tremor (ET) patients with a chronic history of continuous
      stimulation.
    

Detailed description: 
      The proposed study is a randomized, single blind trial of intermittent versus continuous
      stimulation among essential tremor (ET) patients with a chronic history of continuous
      stimulation. The trial is 10 weeks in length with clinical evaluations (about 60 minutes)
      performed on weeks 1, 2, 6, and 10, and phone interviews (about 5 minutes) on weeks 3, 4, 5,
      7, 8, and 9. The study includes outcome measures of tremor, stimulation-induced side effects,
      sleep quality, and voltage threshold for optimal tremor control and sustained side-effects.
    

Intervention name(s): Deep Brain Stimulation (Model 7438 Therapy Controller)
Intervention type(s): Device
Intervention description(s): Deep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms
Other intervention name(s): Model 7438 Therapy Controller
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects With Epicutanoeus Allergen Administration
Condition: Allergic Rhinoconjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Seasonal rhinoconjunctivitis or hay fever is a common atopic condition that is frequently
      seen in clinical practice. Grass pollen is the major cause of pollinosis in many parts of the
      world. Immunotherapy is the only treatment that may affect the natural course of allergic
      diseases, and it may also prevent the development of asthma in patients with allergic
      rhinitis. With conventional subcutaneous desensitization the duration of treatment is around
      3-5 years and usually comprises around 30-100 allergen injections. As high allergen doses
      have to be injected, allergic side effects may occur and patients must stay under medical
      supervision for at least 1 hour. Transcutaneous immunization (TCI) is a needle -free
      technique that delivers antigens and adjuvants to potent epicutaneous immune cells. The aim
      of the new epicutaneous route of desensitization is to more specifically target the immune
      system by loading Langerhans cells with the allergen. Lower antigen doses can be applied,
      such that side effects are reduced.
    


Intervention name(s): Patch; Placebo patch
Intervention type(s): Drug; Drug
Intervention description(s): epicutaneous application of allergen patch; epicutanoeus application of a placebo patch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Spinal Anesthesia for Cesarean Delivery is Associated With Decreases in Regional Cerebral Oxygen Saturation as Assessed by Near- Infrared Spectroscopy
Condition: Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery
Study type: Interventional

Summary: 
      The cerebral oxygen saturation is assessed by means of near-infrared spectometry in
      parturients undergoing cesarean delivery under spinal anesthesia. The investigators
      hypothesis was that spinal anesthesia does not influence cerebral oxygen saturation.
    


Intervention name(s): Spinal Anesthesia with cerebral oxygen saturation monitoring
Intervention type(s): Other
Other intervention name(s): INVOS (cerebral oximeter model 5100, Somanetics, Troy, MI, USA)
Intervention MeSH terms: Anesthetics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: cerebral oximetry; cesarean delivery
Pathogenic Mechanisms in C Diff Infection and Colitis
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections; Colitis
Study type: Observational

Summary: 
      The purpose of this study is to learn more about infection by Clostridium difficile (also
      known as C. difficile). C. difficile is a common bacterium (a germ that may cause disease)
      that can live in the human gut. Some people have it without having any symptoms. In other
      people it can cause illness ranging from mild diarrhea to severe colitis (infection of the
      colon).

      C. difficile makes toxins that damage the cells that line the colon. The study doctors want
      to find out how these toxins cause damage to the cells in the colon.
    

Detailed description: 
      The purpose of this study is to examine pathogenic mechanisms of Clostridium difficile
      toxin-mediated intestinal injury and inflammation. Two primary mechanisms will be examined.

        -  To examine the hypothesis is that microRNA expression profiles are dysregulated by
           Clostridium difficile toxin exposure and that dysregulation of miRNA expression plays a
           role in the pathogenesis of C. difficile associated diseases.

        -  To examine the hypothesis is that the TLR9 receptor mediates key inflammatory events in
           response to Clostridium difficile toxin exposure.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be selected from patients undergoing a routine screening colonoscopy at Beth
        Israel Deaconess Medical Center
      
Biospecimen description: 
      Colonic biopsy samples
    
Keywords: Clostridium difficile infection
A Study of EDP-323 in Healthy Subjects
Condition: RSV Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will
      assess the safety, tolerability, and pharmacokinetics of orally administered single and
      multiple doses of EDP-323 in healthy adult subjects.
    


Intervention name(s): EDP-323; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Placebo to match EDP-323, oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: First-in-Human; Single Ascending Dose; Multiple Ascending Dose; Healthy Volunteer
A Dose Response Study of UT-15C SR in Patients With Exercise-Induced Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, randomized, parallel group study to assess the hemodynamic effect of
      three different dose regimens of a sustained release (SR) tablet of UT-15C in patients with
      exercise-induced pulmonary hypertension (PH), as measured by the change in peak total
      pulmonary resistance index (TPRI) during exercise from Baseline to Week 12.
    

Detailed description: 
      Prospective, randomized, parallel group study with two periods: a 10 week, dose titration
      period, followed by a 2 week, dose maintenance period in patients with exercise-induced PH.

      The study population will be randomized into Dose Group 1, Dose Group 2, or an Individual
      Maximum Tolerated Dose (iMTD) of UT-15C SR by Week 10 and maintained through Week 12.
      Patients may be either currently receiving an approved oral background therapy for their PH
      (phosphodiesterase-5 [PDE-5] inhibitor, OR endothelin receptor antagonist [ERA]) (no dual
      background therapy), or not currently receiving therapy for PH.
    

Intervention name(s): UT-15C
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): treprostinil diethanolamine, sustained release
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Dermacyd Infantile (Lactic Acid) - Photo Evaluation.
Condition: Hygiene
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To demonstrate the absence of photo irritation and photosensitization potential of the
      product Dermacyd Infantile (Lactic Acid).
    


Intervention name(s): LACTIC ACID(ND)
Intervention type(s): Drug
Intervention description(s): Dermacyd infantile (Lactic Acid)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Computer Aided Evaluation of Orbital Volume
Condition: Orbital Fractures
MeSH terms: Orbital Fractures
Study type: Observational

Summary: 
      A retrospective review to assess the performance and clinical predictive value of a novel
      software program (Maxillo) designed to perform complex volumetric analysis with application
      in the field of orbital trauma.
    

Detailed description: 
      The concept of open reduction and internal fixation of large and complex traumatic orbital
      deformities is well established. It is known that successful orbital reconstruction hinges
      upon restoration of native orbital volume in order to establish pre-morbid function and avoid
      long-term complications. To date, a facile, reliable, and reproducible method to measure
      orbital volume has not been rendered, despite numerous approaches. The objective of this
      study is to assess the performance and clinical predictive value of a novel software program
      designed to perform complex volumetric analysis with application in the field of orbital
      trauma.
    

Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with complex maxillofacial and orbital trauma that underwent operative repair of
        orbital fractures. Computer tomography scans from a cohort of patients with normal CT data
        sets will also be collected to assess "normative" orbital volumes.
      
Keywords: orbital fractures
Safety Study of Surgical Technique to Treat Acute Dorsal Trans-Scaphoid Perilunate Dislocations
Condition: Operative Time; Grip Strength; Pain; Functional Status
MeSH terms: Joint Dislocations
Study type: Interventional

Summary: 
      The purpose of this study is to determine a surgical technique is effective in the treatment
      of acute dorsal trans-scaphoid perilunate dislocations.
    

Detailed description: 
      Open reduction and internal fixation is an effective method of treating acute trans-scaphoid
      perilunate dislocations. We study a new surgical technique that allows for early wrist
      excises postoperatively. We compare this technique to Inoue et al. 's techniques affect the
      objective and subjective outcomes. We also compared the long-term outcomes of these two
      procedures performed in similar patient groups.Although both groups had satisfactory results
      with regard to their pain relief, sufficient grip strength and union of scaphoid fracture,
      the technique using in group I was more easily and quickly to perform. It allows early
      postoperative excises and results better functional wrist range of motion.
    

Intervention name(s): Open reduction and internal fixation
Intervention type(s): Procedure
Intervention description(s): Inoue et al.'s technique is most commonly used which required placing three K-wires to immobilize both midcarpal joint and radiocarpal joint. This technique is effective, however, it has some problems. In the study, we improve the surgical technique.
Other intervention name(s): Techniques for Perilunate Dislocations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Acute trans-scaphoid perilunate dislocations; Open reduction and internal fixation; Kirschner-wire; Range of motion