bioihbjkbjnl/mcl2 huggingface dataset:
Correlation Between Plasma- and Endothelial DPP-4 Activity
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators want to estimate both the endothelial and the plasma activity of dipeptidyl
      peptidase 4 during different doses of sitagliptin in healthy subjects and patients with type
      2 diabetes. Furthermore, the investigators want to investigate whether the current clinical
      dose of 100 mg of sitagliptin is sufficient to inhibit both the plasma and the endothelial
      activity of the enzyme dipeptidyl peptidase 4.
    

Detailed description: 
      The two incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent
      insulinotropic polypeptide (GIP) are secreted from the intestinal L- and K- cells,
      respectively in response to ingestion of nutrients. The two hormones are able to lower blood
      glucose levels during high glucose levels - by the so called incretin effect. GIP and GLP-1
      are both rapidly inactivated by the enzyme dipeptidyl peptidase 4 (DPP-4). The remaining
      metabolites are without insulinotropic effects. The effect of DPP-4 inhibitors used in
      treatment of type 2 diabetes relies on their impact on DPP-4 activity.

      DPP-4 exists in a soluble form in plasma ad as a membrane-bound form in blood vessels and
      other tissues. The impact of DPP-4 inhibitors on DPP-4 activity has only been evaluated in
      plasma. We aim to investigate plasma and endothelial DPP-4 activity (i.e. whole-body DPP-4
      activity) in patients with type 2 diabetes during different doses of the DPP-4 inhibitor
      sitagliptin.

      Both healthy control subjects and patients with type 2 diabetes are subjected to 4
      experimental days (in a randomized order) with continuous infusion of GLP-1 and pre-treatment
      with 25 mg sitagliptin, 100 mg sitagliptin, 200 mg sitagliptin and placebo, respectively.
      Afterwards, we are going to measure the whole-body DPP-4 activity by comparing plasma levels
      of active (intact) GLP-1 and total GLP-1, and relate to plasma DPP-4 activity.
    

Intervention name(s): sitagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In randomized order:
Day 1: tablet of 25 mg of sitagliptin + i.v. GLP-1 infusion Day 2: tablet of 100 mg of sitagliptin + i.v. GLP-1 infusion Day 3: tablet of 200 mg of sitagliptin + i.v. GLP-1 infusion; Day 4: placebo tablet
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Glucagon-like peptide 1; Dipeptidyl peptidase 4; Dipeptidyl peptidase 4 inhibitor; sitagliptin; Enzyme activity
Cell Therapy by Autologous BMC for Large Bone Defect Repair
Condition: Humerus Fracture Displaced Proximal
MeSH terms: Humeral Fractures
Study type: Interventional
Phase: Phase 2

Summary: 
      In the present phase-II clinical trial the researchers investigate efficacy and proof of
      concept of the augmentation with preoperatively isolated autologous BMC cells seeded onto
      ß-TCP in combination with an angle stable fixation (Philos plate®) for the therapy of
      proximal humeral fractures.
    


Intervention name(s): BMC2012; beta-TCP Chronos® Synthes
Intervention type(s): Biological; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: large bone defect; bone marrow-derived mononuclear cells
Comparison of Direct and Video Laryngoscope During Endotracheal Intubation in Sellick and Trendelenburg Position
Condition: Intubation;Difficult
Study type: Interventional

Summary: 
      Pulmonary aspiration during tracheal intubation for anesthesia can cause fatal respiratory
      complications. Takenaka's study of mannequins reported that the risk of airway contamination
      by reflux gastric contents could be minimized by applying a 15-degree Trendelenburg position
      and a Sellick position with neck extention. However, the clinical performance of tracheal
      intubation in this position has not been studied. Also, the difference between the effects of
      direct laryngoscope and video laryngoscope on tracheal intubation is not known yet.

      Therefore, this study aims to compare the intubation time among intubation through direct
      laryngoscope and video laryngoscope in the Sellick and Trendelenburg position, and intubation
      in the conventional sniffing position.
    


Intervention name(s): Macintosh in sniffing position; Macintosh in Trendelenburg position and Sellick position; AceScope in Trendelenburg position and Sellick position
Intervention type(s): Other; Other; Other
Intervention description(s): Macintosh direct intubation in sniffing position; Macintosh direct laryngoscopic intubation in Trendelenburg position and Sellick position; AceScope videolaryngoscopic intubation in Trendelenburg position and Sellick position
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Trendelenburg position; Sellick position; pulmonary aspiration; video laryngoscope
Intralymphatic Immunotherapy in Increasing Doses, Substudy
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy
      in increasing doses. Patients with allergy to grass or birch will be treated with three
      intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or
      placebo.

      ***IMPORTANT INFORMATION!*** The up-dosing protocol is changed due to adverse events at 5000
      SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One
      patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic
      injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New
      regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.
    

Detailed description: 
      40 patients with seasonal allergic rhinitis will be recruited. Study subjects are randomized
      to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch. Injections are
      given with 4-5 (-7) weeks interval.
    

Intervention name(s): ALK Diluent; ALK Alutard SQ 5-grasses or ALK Alutard Birch
Intervention type(s): Drug; Drug
Intervention description(s): Depot formulation of relevant allergen adsorbed to aluminium hydroxide in a suspension.
Other intervention name(s): 0,3% human albumin. ATC-code V07AB; Allergen, grass pollen. ATC-code V01AA02 or V01AA05
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hay fever; Pollen allergy; Allergic rhinitis
Comparison of Ocular Findings in Patients Between Surgical and Natural Menopause
Condition: Menopause Surgical; Macula Edema; Visual Acuity Reduced Transiently
Study type: Observational

Summary: 
      It is aimed to compare the ocular findings in patients with natural and surgical menopause.
    

Detailed description: 
      To compare the parameters such as fundus examination, macular thickness, visual acuity and
      lens opacities among female patients diagnosed with menopause between the ages of 40-65.The
      criteria for exclusion from the study are the presence of a history of illness, drug use,
      smoking and alcohol use.Inclusion criteria were female patients who were in menopause and who
      did not use any medications. For surgical menopause, the uterus and ovaries were surgically
      removed at least 3 months ago.
    

Intervention name(s): measurement of macular thickness, corneal thickness and lens opacities
Intervention type(s): Diagnostic Test
Intervention description(s): The incidence of macular thickness, Corneal thickness, intraocular pressure and lens opacities will be investigated by an ophthalmologist.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Will be studied in a patient population with low sociocultural level.
      
Keywords: menopause; Eye disease; Macular changes
OIT and Xolair® (Omalizumab) in Cow's Milk Allergy
Condition: Milk Allergy
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Food allergy affects up to 4% of the U.S. population and is most common in young children.
      Milk allergy is the most common cause of food allergy in infants and young children, and
      usually develops in the first year of life. There is no treatment for food allergy and the
      current standard of care for milk-allergic individuals is the avoidance of milk-containing
      products. Research is underway to identify potential therapeutic strategies to reduce or
      eliminate the adverse effects experienced by milk-allergic individuals when they consume
      milk-containing products.

      Several studies have suggested that milk-allergic children who receive milk protein oral
      immunotherapy (OIT) may become desensitized to milk, resulting in short term protection
      against accidental ingestion of milk products. However, these children did not develop
      "tolerance," which is long term protection even after milk immunotherapy is stopped. A
      potential strategy to induce tolerance to milk uses milk in combination with Xolair®
      (omalizumab). Xolair consists of anti-IgE molecules that attach to IgE, the major antibody
      involved in allergic reactions. The goal of this clinical trial is to see whether Xolair® in
      combination with milk protein OIT is safer and more effective than OIT alone in inducing
      tolerance to milk and milk products. Participants will be administered a double blind,
      placebo controlled milk challenge at various time points in the study. If desensitization is
      achieved participants will be tested for tolerance at a certain time point after stopping
      treatment.
    


Intervention name(s): Placebo for omalizumab; Omalizumab; Milk powder
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Placebo for omalizumab is injected subcutaneously every 2-4 weeks for 16 months at a volume designed to match that of the verum treatment group (determined by the participant's IgE level and weight).; Omalizumab is injected subcutaneously every 2-4 weeks for 28 months at a dose determined by the participants IgE level and weight.; Milk powder is ingested orally at a dosage of up to 3.84 grams of of milk protein daily from Month 4 through Month 28 if the Month 28 10 g milk OFC is failed, and through Month 30 if the Month 28 10 g milk OFC is passed.
Other intervention name(s): Placebo for Xolair; Xolair
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: food allergy
Investigating the Effects of Different Soft Tissue Mobilizations on Delayed Onset Muscle Soreness
Condition: Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      Delayed onset muscle soreness (DOMS) is associated with the initiation of a new physical
      activity or a sudden increase in exercise volume and intensity. DOMS also occurs following
      eccentric exercises such as ballistic stretching, downhill running, weight training and
      plyometrics. DOMS might prevent performing sports and decreases the performance of
      professional or recreational athletes. Recently, different soft tissue mobilization
      applications (massage, foam roller) have been preferred by many athletes to prevent DOMS.
      However, there is no study comparing the effects of these techniques on DOMS. Therefore, the
      aim of the present study is to investigate the effects of different soft tissue mobilization
      practices on DOMS and sportive performance in recreational athletes. In order to achieve this
      goal, a total of 36 recreational athletes will be included and will be allocated to three
      groups as foam roller group (n=12), massage group (n=12) and control group (n=12).
      Demographic data, thermal camera measurements, fatigue level assessments, and performance
      measurements will be performed. All measurements will be carried out four times as before the
      application, immediately after the application, after 24 hours and after 48 hours.
    

Detailed description: 
      After being invited to the study, the demographic data of all participants who agreed to
      participate in the study will be recorded on a structured form. Participants will be randomly
      divided into three groups: Massage application group, Foam Roller application group and
      Control group. Afterwards, thermal imaging, perceived fatigue and pain level, blood lactate
      level measurements, and vertical jump assessments will be done for the quadriceps femoris
      muscle. Then, the fatigue protocol will be applied for the quadriceps femoris muscle and
      five-minute applications will be made according to the groups in which they are randomly
      separated. Evaluations made in the first applications will be made immediately after the
      applications, 24 hours and 48 hours later, as the 2nd, 3rd and 4th measurements. The assessor
      will not know which group the participants are from.
    

Intervention name(s): Foam roller application; Massage application
Intervention type(s): Other; Other
Intervention description(s): Following the fatigue protocol, foam roller application will be applied to the quadriceps femoris muscle for five minutes in the prone position.; Following the fatigue protocol, sports massage will be applied to the quadriceps femoris muscle for five minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Recreational athlete; Soft Tissue Mobilization; Delayed Onset Muscle Soreness
The Effect of Mandala Activity on Life Satisfaction
Condition: ART; Life Satisfaction; Gynecologic Cancer
Study type: Interventional

Summary: 
      This study aimed to determine the effect of mandala activity on life satisfaction of women
      receiving chemotherapy for gynecological cancer.
    

Detailed description: 
      Data will be collected using the descriptive information form and the Life Satisfaction
      Scale.
    

Intervention name(s): mandala
Intervention type(s): Behavioral
Intervention description(s): The Life Satisfaction Scale was administered to patients in the control group at the first encounter (pre-test) and three weeks after the first encounter (post-test). Although the pre- and post-test treatment protocols were the same for both intervention and control groups, the only difference between their treament was the mandala activity, which was not applied to those in the control group. Patients in the control group continued their routine lives at home for three weeks. After the application, the mandala activity was applied to all patients who wanted it.
Other intervention name(s): control group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was designed as a randomized controlled prospective double-blind clinical trial.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Gynecologic Cancer; Life satisfaction; Mandala
The Distribution of Gingival Display and Possible Related Factors Resulting in Gummy Smile
Condition: Gummy Smile
Study type: Observational

Summary: 
      This study primarily aimed to evaluate smile line distribution and prevalence of gummy smile
      in patients. The secondary purpose was to examine parameters that might be risk factors for
      gummy smile.
    

Detailed description: 
      this study primarily aimed to evaluate smile line distribution and prevalence of gummy smile
      in patients. The secondary purpose was to examine parameters that might be risk factors for
      gummy smile.Age, gender, marital status, medical history, and medication status of the
      patients were recorded. All individuals were instructed to sit on a dental chair and the
      measurments were made by using a millimetric ruler.Next, the patients were grouped according
      to Liebart's classification by gingival display at maximum smile as follows: Class
      1.Excessive gingival display (Gummy smile): ≥ 3mm gingival display Class 2.High smile line:
      0-2 mm of gingival display Class 3. Average smile line: Dental papilla is visible. Class 4.
      Low smile line: Gingival margin, dental papilla is not visible at all. Presence of altered
      passive eruption, short lip and hypermobile upper lip were also evaluated.
    

Intervention name(s): Measurement of gingival display
Intervention type(s): Other
Intervention description(s): All individuals were instructed to sit on a dental chair and the measurements were made by using a millimetric ruler. Next, the patients were grouped according to Liebart's classification by gingival display at maximum smile as follows:
Class 1.Excessive gingival display (Gummy smile): ≥ 3mm gingival display Class 2.High smile line: 0-2 mm of gingival display Class 3. Average smile line: Dental papilla is visible. Class 4. Low smile line: Gingival margin, dental papilla is not visible at all.
Sampling method: Non-Probability Sample
Study population: 
        Patients who applied to Baskent University Faculty of Dentistry for seeking dental
        treatment
An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAject™ and Regular Human Insulin in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate equivalent blood glucose control in patients with
      type 2 diabetes mellitus with insulin VIAject™ and regular human insulin as prandial insulin
      and to demonstrate an equivalent safety profile for VIAject™ in comparison to regular human
      insulin.
    


Intervention name(s): VIAject™; Regular Human Insulin
Intervention type(s): Drug; Drug
Intervention description(s): Dosage as individually required; Dosage as individually required
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus type 2; Diabetes; Insulin; NIDDM; Rapid acting
A Study of the Relationship of Psychosocial Function With Mood Symptoms in Offspring of Parents With Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      The primary purpose of this study is to compare, over 24 months, the time spent with
      clinically significant mood symptoms (ie, mania, depression), as measured by the Longitudinal
      Interval Follow-Up Evaluation (LIFE) and the Psychiatric Status Rating Scale (PSR), in
      offspring of bipolar parents with and without at least mild impairment in psychosocial
      functioning.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Offspring of parents with Bipolar Disprder (BD) will be recruited primarily at selected
        sites which are already conducting research in prodromal BD and have the necessary setup
        and resources already in place to conduct such a study.
      
Biospecimen description: 
      Blood and Saliva
    
Keywords: Bipolar; High-Risk Off-Spring; Psychosocial Functioning
Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute STEMI
Condition: Left Ventricular Thrombus; ST Segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; Thrombosis; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the safety and efficacy of rivaroxaban-based versus
      warfarin-based antithrombotic regimens on outcomes of patients with left ventricle thrombosis
      following acute ST elevation myocardial infarction at 3 months from enrollment in an
      open-label parallel groups pilot randomized clinical trial
    

Detailed description: 
      Direct oral anticoagulants (DOACs), are currently recognized as the first-line treatment of
      AF and VTE in most clinical scenarios, distinguished by their short half-life, fast onset of
      action, fewer medication interactions, rare food interactions, and the lack of a need for
      frequent laboratory monitoring, compared with vitamin K antagonists. Although the use of
      DOACs has earned a class III recommendation for patients with mechanical prosthetic valves,
      moderate-to-severe mitral stenosis, and antiphospholipid syndrome, their application in some
      situations, such as acute limb ischemia and LVT, remains uncertain. Until now, no completed
      randomized clinical trial has compared the efficacy and safety of left ventricle thrombosis
      in patients with acute STEMI and the existing evidence is limited to observational studies.
    

Intervention name(s): Rivaroxaban 15 MG; Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): Rivaroxaban 15 MG once daily orally + Dual anti-platelet therapy (clopidogrel (75 mg daily, orally)+aspirin (80 mg once daily, orally)); Warfarin (to reach an INR goal of 2-2.5)+ Dual anti-platelet therapy (clopidogrel (75 mg daily, orally)+aspirin (80 mg once daily, orally))
Other intervention name(s): XARELTO
Intervention MeSH terms: Warfarin; Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 open-label parallel group randomized controlled trial with concealed allocation sequence and blinded outcome adjudication
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Left Ventricle; Ventricle, Left; Thrombosis; Thromboses; Blood Clot; ST Segment Elevation Myocardial Infarction; ST Elevated Myocardial Infarction; STEMI