bioihbjkbjnl/mcl2 huggingface dataset:
Implantology and Sjögren's Syndrome
Condition: Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional

Summary: 
      Until now it has not been investigated whether placement of implants in SS patients is less
      successful than compared to non-SS patients. The risk factors and the efficacy of dental
      implants in dry mouth patients are not known because of the lack of scientific evidence. The
      aim of this study is to investigate changes in marginal peri-implant bone loss and the
      clinical performance of dental implants in SS patients compared to implants in healthy
      patients.
    

Detailed description: 
      Rationale: Until now it has not been investigated whether placement of implants in SS
      patients is less successful than compared to non-SS patients. The risk factors and the
      efficacy of dental implants in dry mouth patients are not known because of the lack of
      scientific evidence.

      Objective: to investigate changes in marginal peri-implant bone loss and the clinical
      performance of dental implants in SS patients compared to implants in healthy patients.

      Study design: A prospective multicenter clinical trial.

      Study population: N = 120

      Intervention: All patients receive Biohorizons Laser-lok bonelevel implants to replace the
      missing (pre)molars or to support a full denture in the upper and lower jaw .

      This study is comprised of four study groups:

        -  30 human adults affected by SS with the need of replacement of missing premolars or
           molars in the upper or lower jaw.

        -  30 healthy human adults with the need of replacement of missing premolars or molars in
           the upper or lower jaw.

        -  30 human edentulous adults affected by SS with the need of stabilization of the
           dentures.

        -  30 healthy human edentulous adults with the need of stabilization of the dentures.

      Main study parameters/endpoints: changes in marginal peri-implant bone loss of dental
      implants between the healthy and SS groups and differences in clinical performance 1.5 years
      after finalization.
    

Intervention name(s): Biohorizons Laser-lok bonelevel dental implants
Intervention type(s): Device
Intervention description(s): Insertion of Biohorizons Laser-lok bonelevel dental implants to replace missing (pre)molars or to stabilize a denture
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sjogren's Syndrome; Dental Implants
Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage of Labor After Second-trimester Abortion
Condition: Abortion, Induced; Labor Stage, Third/Drug Effects; Pregnancy Trimester, Second; Oxytocin/Administration & Dosage
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compares oxytocin infusion to spontaneous follow-up for third-stage of labor at
      induced mid-trimester abortions. Patients will be randomized to oxytocin infusion or
      observation with no pharmacologic intervention. Primary outcome of the study is complete
      abortion rate within two hours of fetal delivery.
    


Intervention name(s): Oxytocin
Intervention type(s): Drug
Intervention description(s): 20 IU oxytocin in 500 ml normal saline will be infused 100 ml/h i.v. after fetus is delivered
Other intervention name(s): Synpitan; Pitocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Effects of Silk and Polyester Suture on Postoperative Complications
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted; Postoperative Complications
Study type: Interventional

Summary: 
      Some undesirable complications such as pain, swelling, trismus, paresthesia, hematoma,
      infection and, albeit rare, fractures may occur after lower impacted wisdom tooth surgery.
      More effective wound closure methods with fewer complications have positive effects on
      postoperative recovery. Suturing is the most commonly used wound closure technique after
      lower impacted wisdom tooth surgery. Suturing, which is the last step of the operation,
      contributes to wound healing in order to reposition and stabilize the tissue components and
      to control bleeding. In our study, it was aimed to evaluate the efficacy of silk and
      polyester sutures used in wound closure techniques, which are frequently used in lower
      impacted wisdom teeth surgery.
    

Detailed description: 
      This randomized, single-blind, split-mouth study was carried out on 30 patients who applied
      to Van Yuzuncu Yıl University, Faculty of Dentistry, Department of Oral, Dental and
      Maxillofacial Surgery. Silk suture was used on one side of the patients and polyester suture
      was used on the other side. When the patients first applied to the clinic, their anamnesis
      was taken and panoramic images were taken after clinical evaluations were made.

      Evaluations were made with preoperative face measurements (for evaluation of swelling),
      maximum mouth opening (for evaluation of trismus) and periodontal measurements for all
      patients. The mentioned measurements and evaluations were repeated on the 2nd and 7th
      postoperative days. In addition, postoperative pain was evaluated with the VAS scale.

      The same surgical procedure was performed by the same surgeon for all patients. After local
      anesthesia (2ml of 80 mg Articaine hydrochloride + 0.02mg Epinephrine bitartrate) a 3-corner
      flap containing the vertical incision passing through the mesial of the number 7 was lifted,
      the bone removed under saline cooling and the teeth were separated when needed. Afterwards,
      the extraction sockets will be irrigated with saline to control bleeding, and the area is
      closed primarily with silk or polyester suture material.
    

Intervention name(s): Silk suture; Polyester suture
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients with bilateral impacted lower third molars will have operations for both sides. On one side for primarily closure after operation silk suture will be used.; Patients with bilateral impacted lower third molars will have operations for both side. On one side for primarily closure after operation polyester suture will be used.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Cardioprotective and Metabolic Effects of Metformin in Patients With Heart Failure and Diabetes
Condition: Insulin Resistance; Chronic Heart Failure
MeSH terms: Heart Failure; Insulin Resistance
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the study is to evaluate the effect of metformin on myocardial function, insulin
      resistance and selected metabolic markers in patients with type 2 diabetes and heart failure
      (HF+DM+) in a cross-over, randomized, placebo controlled trial.

      Hypothesis:

      Metformin treatment in HF+DM+ group will lead to better myocardial function and load
      tolerance in comparison to placebo. The degree of improvement will be linked to selected
      metabolic parameters.
    

Detailed description: 
      40 patients with HF and DM without previous diabetes treatment will be randomized into 2
      groups (A succession: MET-placebo, B succession: placebo-MET) - stratified randomization with
      following parameters weighted: HF etiology (ischemic /non-ischemic), diabetes duration,
      gender, BMI, age, NYHA, smoker/non-smoker). After 3 months the treatment will be switched.
      All participants will undergo standardized selection of metabolic and cardiovascular tests
      (hyperinsulinemic euglycemic clamp with indirect calorimetry, measurement of endothelial
      function, echocardiography, spiroergometry, proton/phosphor MR spectroscopy, adipose tissue
      biopsy, selected cytokines in plasma and adipose tissue at the beginning and the end of each
      intervention period (3 times in total).
    

Intervention name(s): Metformini hydrochloridum (Siofor 1000 tbl, Berlin); placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be randomized into 2 groups (A succession: MET-placebo, B succession: placebo-MET. After 3 months the treatment will be switched.
Titration:
500 mg per day(1/2 tbl 1000 mg once a day - in the morning) after a week increase the dose to 1 tbl á 1000 mg after two weeks increase the dose to 2 x tbl 1000 mg (in the morning and in the evening); Patients will be randomized into 2 groups (A succession: MET-placebo, B succession: placebo-MET. After 3 months the treatment will be switched.
Other intervention name(s): A10BA02 Metformin
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: chronic heart failure; type 2 diabetes; metformin; insulin resistance
Clinical Evaluation of Healthy Subjects Receiving Intradermal Saline Using the Microneedle Adapter (Model UAR-2S)
Condition: Intradermal Injection
Study type: Interventional

Summary: 
      Microdermics Inc. is a British Columbia-based Canadian incorporation primarily focusing on
      microneedle-based painless and effective drug delivery systems.The Microneedle Adapter (model
      UAR-2S) is a single-use disposable medical device intended to provide a mechanism for
      intradermal bolus fluid delivery when used with a standard syringe with a Luer-lock tip
      connection. The Microneedle Adapter consists of a single-use gold-coated metallic microneedle
      integrated within the microneedle adapter with fluidic connections to a standard Luer syringe
      mount. The primary function of the Microneedle Adapter is to guide the microneedle into the
      skin in a controlled manner for successful insertion passing the stratum corneum layer. The
      fluid loaded onto the syringe can then be injected precisely intradermally into the skin.The
      primary objective of this study is to evaluate the performance of the Microneedle Adapter in
      healthy subjects in 3 different injection sites. Pain perception of the Microneedle Adapter
      will be a key secondary outcome, compared with the control device.
    


Intervention name(s): Microneedle Adapter (Model UAR-2S); Hypodermic needle + syringe
Intervention type(s): Device; Device
Intervention description(s): Investigational device; Control device
Intervention model: Single Group Assignment
Intervention model description: Subjects will be first randomized to receive each of the injection (A, B, C, and D) in each of the 3 visits of the study, according to the block randomization scheme produced by inVentiv. The following sequences will be used: 1st (upper right location), 2nd (lower right location), 3rd (upper left location) and 4th lower left location) where:
A. Investigational device with 50 μL saline B. Control device with 50 μL saline C. Investigational device with 100 μL saline D. Control device with 100 μL saline
Masking: None (Open Label)
Primary purpose: Other
Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA)
Condition: Inflammation; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe. The aim of this trial is to evaluate the clinical efficacy
      of a single dose of NNC0142-0002 administered to subjects with active rheumatoid arthritis
      (RA).
    


Intervention name(s): NNC0142-0002; placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin).; A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Staccato Loxapine in Migraine (Out Patient)
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe
      migraine headache with or without aura in an outpatient setting.
    

Detailed description: 
      This study was designed to compare the safety and pharmacodynamic profiles of concomitant
      administration of single doses of ADASUVE and intramuscular (IM) lorazepam compared to that
      of each agent administered alone. Respiratory pharmacodynamics were monitored through
      recordings of respirations/minute and pulse oximetry. Other pharmacodynamic safety measures
      included effects on blood pressure, heart rate, sedation, and psychomotor measures of
      attention, information processing speed, reaction time, and coordination.
    

Intervention name(s): Inhaled Placebo; Inhaled Loxapine 1.25 mg; Inhaled Loxapine 2.5 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inhaled Staccato placebo (0 mg); Inhaled Staccato Loxapine 1.25 mg, single dose; Inhaled Staccato Loxapine 1.25 mg, single dose
Intervention MeSH terms: Loxapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Migraine headache; Loxapine; Staccato
Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18
Condition: Infections, Papillomavirus
MeSH terms: Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and
      genitals in men and women. Several types of HPV infection are transmitted by sexual activity
      and, in women, can infect the cervix (part of the uterus or womb). This infection often goes
      away by itself, but if it does not go away (this is called persistent infection), it can lead
      in women over a long period of time to cancer of the cervix. If a woman is not infected by
      HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the
      efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated
      cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in
      young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study
      subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine)
      administered intramuscularly according to a 0-1-6 month schedule.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      NOTE: Some 178 centers participate in this study. Given that the recruitment is completed,
      the researchers have listed one center per country in this website. If required, further
      details of centers available on request.
    

Intervention name(s): Cervarix™; Havrix™-based investigational formulation
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Other intervention name(s): GSK Biologicals HPV 16/18 VLP/AS04 vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Safety Study For Prevenar 13 Among Chinese Children
Condition: Seizures; Urticaria and Angioedema; Apnea; Fever
MeSH terms: Seizures; Angioedema; Urticaria
Study type: Observational

Summary: 
      This is an observational study based on a population-based EHR database.
    

Detailed description: 
      This observational study based on a population-based EHR database in Yinzhou district of
      Ningbo city in China is to estimate incidence rates of seizures (including febrile seizures),
      urticaria and angioedema, apnea, and fever among Chinese children after receiving Prevenar
      13. In addition, a validation study including validation of International classification of
      diseases, tenth revision (ICD-10) codes or ICD-10 code based algorithm for identifying all
      safety outcomes of interest and a prospective cohort study in a sub-population of the main
      study will be conducted in order to offset the potential biased results from the main study
      because of potential misclassification of the safety outcomes of interest due to miscoding
      and/or undercoding of ICD-10 codes used to identify these safety outcomes in the EHR
      database.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        The main study population consists of eligible children aged 1-24 months receiving at least
        one dose of 13vPnC recorded in Yinzhou EHR database between May 1st, 2017 and July 24th,
        2020 (ie, one week prior to the end of the study).

        For the prospective cohort in a sub-population of the main study, eligible children for the
        main study must receive the first dose of 13vPnC between August 1st, 2018 and July 24th,
        2020. It should be noted that the actual start date for the prospective cohort study is
        pending on the approval of Human Genetic Resources Administration of China (HGRAC)
        application.
Breath and Blood Ammonia Response to an Oral Protein Challenge
Condition: Cirrhosis
MeSH terms: Fibrosis
Study type: Interventional

Summary: 
      The investigators specific aim is to evaluate the changes in breath ammonia in comparison to
      blood ammonia and other physiologic markers after a moderate oral protein challenge in
      healthy subjects and subjects with liver cirrhosis.
    

Detailed description: 
      Ammonia is an important molecule relevant to numerous diseases, especially to the millions of
      patients with cirrhosis worldwide. Venous blood ammonia via limb phlebotomy, can at best
      roughly estimate whole body ammonia, but says little or nothing about intestinal production,
      and cannot "source" ammonia to any particular organ or body compartment. Unfortunately, there
      are no presently available better tests. Therefore, despite these acknowledged limitations,
      venous ammonia the "bronze standard" benchmark by which new metrics are assessed.

      The present protocol attempts to address both concerns and build upon the investigators prior
      high protein experience. By using a standard moderate protein challenge, the investigators
      can evaluate the breath ammonia responsiveness in healthy subjects and those with cirrhosis.
      This protocol leverages the power of breath research to evaluate responses to oral
      challenges. This remains a key asset of breath research.

      Since the protocol proposes a moderate protein challenge, the investigators can evaluate
      disease states with minimal or no risk. As with past high protein studies, lactulose (10gm)
      will still be added to provoke a hydrogen response.
    

Intervention name(s): EAS Myoplex Protein Drink + 10gm lactulose
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Lactulose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: breath; gastroenterology; ammonia; blood; protein; cirrhosis; encephalopathy
Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma
Condition: Malaria, Falciparum; Hookworm Infections; Schistosoma Haematobium
MeSH terms: Infections; Malaria; Hookworm Infections; Malaria, Falciparum; Ancylostomiasis
Study type: Interventional

Summary: 
      The aim of this study is to investigate the change in iron metabolism in relation to malaria
      and helminth infections using a stable isotope technique.
    

Detailed description: 
      The aim of the study is to determine how iron metabolism in subjects with infectious diseases
      (malaria, hookworm or S. haematobium) differs while infected and after treatment, i.e. the
      same individuals will be restudied while free of infection.
    

Intervention name(s): Fe-57 orally, Fe-58 intravenously
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will receive a test drink containing 3 mg Fe-57 in the form of labelled FeSO4 followed by 1 ml of an aqueous solution containing 50 μg Fe-58 as iron citrate.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: iron absorption; iron utilization; malaria; helminth; Ivory Coast; Acute symptomatic uncomplicated falciparum malaria; Asymptomatic falciparum malaria; Moderate to heavy hookworm infection; Heavy Schistosoma haematobium infection
Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial
Condition: Low Back Pain; PTSD
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Aim The aim is to test whether a short psychotherapeutic intervention targeting Post
      Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the
      outcomes of the Standard Multidisciplinary Program (SMP) against chronic back pain
      development.
    

Detailed description: 
      Focus Patients with back pain often demonstrate symptoms of PTSD measured via the Harvard
      Trauma Questionnaire Scale (HTQ). It has been found that PTSD and pain may maintain each
      other.

      Methods Thousand consecutive patients with Low Back Pain (LBP) referred to the Spine Center
      are screened for PTSD. It is expected that 100 patients will meet the inclusion criteria and
      be randomized to SMP or to SMP plus 10 psychotherapeutic sessions, that will include the
      shock-trauma method 'Somatic Experiencing'.

      Conclusion The project started in 2013, so there have not yet been any results. Currently
      total reached 65 back pain patients; 34 patients in the SMP + sessions intervention arm.

      Effect parameters are: Pain, daily function, EuroQOL and (HTQ), anxiety and depression, fear
      avoidance (Tampa Scale for Kinesiophobia) on entry, and at 6/12 months.

      This "Nested Randomized Trial in a Cohort Design" is one of the very first studies targeting
      both PTSD and chronic pain-related symptomatology.
    

Intervention name(s): Standard back pain treatment; Standard back pain treatment + 10 psychotherapeutic sessions
Intervention type(s): Other; Other
Intervention description(s): Standard back pain treatment; Standard back pain treatment plus 10 psychotherapeutic session, that will include the shock-trauma method "somatic experiencing".
Intervention MeSH terms: Psychotropic Drugs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment