bioihbjkbjnl/mcl2 huggingface dataset:
DEPS-R Turkish Version in Adults With Type 1Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      A growing body of research has revealed the good psychometric properties and three-component
      factor structure of DEPS-R in children and adolescents with type 1 diabetes (T1D) but
      research with adults has limited and has differing results. The Diabetes Eating Problem
      Survey-Revised (DEPS-R) developed by Markowitz et al is a diabetes-specific self-report
      instrument to screen eating disorders for individuals with T1D. DEPS-R is a 16-item
      diabetes-specific self-report questionnaire to test for diabetes-specific eating disorders.
      Answers are scored on a six-point Likert scale, with higher scores indicating more DEB and a
      total score of ≥20 indicating a high risk for eating disorders (range 0-80). The original
      DEPS-R has been shown to have a good internal consistency (Cronbach's alpha=0.86) and
      construct validity in a sample of the pediatric population with T1D. This study aimed to
      evaluate the validity and reliability of the Turkish version of the DEPS-R questionnaire for
      adults with T1D, investigate its psychometric properties and factor structure, and examine
      its relationship with the EDE-Q questionnaire.
    

Detailed description: 
      In this cross-sectional study, participants answered a DEPS-R and EDE-Q questionnaire during
      a regularly scheduled medical visit after obtaining written informed consent. All
      participants had established that patients with T1D were treated with multiple daily insulin
      or insulin pump therapy. Height was measured using a stadiometer to the nearest 0.1 cm in all
      participants. Weight was measured unclothed to the nearest 0.1 kg using a calibrated balance
      scale. Body Mass Index (BMI) was calculated by using the weight (kg)/height (m²) equation.
      Clinical data including HbA1c, T1D onset, birth date, and treatment model etc. was conducted
      as part of a standard clinical assessment. HbA1c was measured with ion-exchange
      high-performance liquid chromatography (Bio-rad Variant ll Turbo, Japan).
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The sample of this study consists of 100 participants with T1D who were being followed at
        the Istanbul University, Istanbul Faculty of Medicine, Endocrine and Diabetes Outpatient
        Clinic.
      
Keywords: type 1 diabetes; DEPS-R; confirmatory factor analysis; diabulimia; distributed eating disorder
A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)
Condition: Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat
      reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is
      superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10%
      with respect to mean relative reduction from baseline in liver fat content (LFC) after 24
      weeks.
    


Intervention name(s): Efinopegdutide 20 mg/mL; Semaglutide 1.34 mg/mL
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg; Subcutaneous injection in a dose-escalation administration of 0.25 mg, 0.5 mg, and 1.0 mg
Other intervention name(s): MK-6024; HM12525A; JNJ-64565111; Ozempic®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Rising Dose Study With Intravenous Infusion and Subcutaneous Injection of BI 1005273 in Healthy Male Volunteers.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety and tolerability of BI 1005273 in healthy male volunteers following
      intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection.
      Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics
      of BI 1005273.
    


Intervention name(s): BI 1005273 s.c.; BI 105273 i.v. Placebo; BI 1005273 s.c. Placebo; BI 1005273 i.v.
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): injection; infusion; injection; infusion
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Effect of Video Information on the Dental Anxiety Levels of the Endodontic Patients
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study compared the effect of the detailed video visual information and basic verbal
      information on patients' anxiety levels (using anxiety scales) before endodontic treatment
      and stress levels (using electrodermal activity method) during endodontic treatment.
    

Detailed description: 
      Patients (n=120) aged between 18-65 with single-rooted teeth with the single canal that
      diagnosed with asymptomatic irreversible pulpitis and/or pre-prosthetic root canal treatment
      were included in this study. Patients were randomly divided into two groups after completing
      anxiety scales and socio-demographic/dental habits form. Before the treatment, visual video
      information was given to the video group patients, while the control group patients were
      routinely informed verbally. The stress levels during the endodontic treatment process were
      recorded by placing a electrodermal activity measurement device on the wrists of the
      patients. Anxiety scales and feedback-satisfaction forms were administered to all patients
      after the treatment process.
    

Intervention name(s): Information Types Before Endodontic Treatment
Intervention type(s): Other
Intervention description(s): The first aim of this study is to compare the effect of detailed video information or basic verbal information on the anxiety levels of patients by using anxiety scales before treatment. The second aim is to evaluate the effect of pretreatment video or verbal information on the stress level occurring in patients during the endodontic treatment steps by using electrodermal activity. The third aim is to investigate the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics which are thought to play a role in anxiety's etiology.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Video information; Electrodermal activity; Endodontic treatment
Biomarkers in the Diagnosis and Assessment of Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional

Summary: 
      The investigators hypothesize that baseline plasma brain natriuretic peptide (BNP) and
      migration inhibitory factor (MIF) levels are surrogate markers of clinical severity of PAH
      and that changes in plasma brain natriuretic peptide (BNP) and MIF levels pre and post
      exercise.
    

Detailed description: 
      As above
    

Intervention name(s): Blood draw
Intervention type(s): Other
Intervention description(s): Venous and Arterial Blood draw samples; 6 Minute Walk test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PAH; Biomarkers; MIF; BNP; 6 Minute Walk (6MW)
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB)
      Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive
      gastroesophageal reflux disease (eGERD).
    

Detailed description: 
      This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects
      who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment
      groups, Rabeprazole Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the
      treatment of mild to moderate erosive Gastroesophageal Reflux Disease (GERD).
    

Intervention name(s): Rabeprazole sodium; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks.; Esomeprazole 40 mg capsule, once daily for 4-8 weeks.
Other intervention name(s): Aciphex
Intervention MeSH terms: Esomeprazole; Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GERD; erosive GERD; erosive esophagitis
Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2
Condition: Intestinal Diseases; Gastrointestinal Hemorrhage
MeSH terms: Intestinal Diseases; Gastrointestinal Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Capsule endoscopy has been shown to be the first-line endoscopic procedure for small bowel
      disease. This study was aimed to compare the performance between the frequency-altering AKE-1
      capsule and the Pillcam SB2 in patients with suspected small bowel disease.
    


Intervention name(s): AKE-1; Pillcam SB2
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Capsule Endoscopy
Brain Imaging of rTMS Treatment for Depression
Condition: Major Depressive Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The overarching goal of this research program is to elucidate causal and directional neural
      network- level abnormalities in depression, and how they are modulated by an
      individually-tailored, circuit-directed intervention. By using concurrent TMS and fMRI, the
      investigators can overcome a major limitation of neuroimaging - the inability to demonstrate
      causality. The investigators' findings will serve as a platform for future studies wherein
      TMS treatment can be directly guided by the investigators' ability to image and causally
      manipulate specific neural networks.

      Aim 1: To examine causal interactions between two major brain networks in depression.

      Aim 2: To examine the impact of antidepressant TMS on causal network abnormalities in
      depression.

      Hypothesis 1: Depressed subjects will show blunted responses, compared to healthy controls,
      in two targeted and interacting networks, using concurrent transcranial magnetic stimulation
      (TMS) and functional magnetic resonance imaging (fMRI).

      Hypothesis 2: Treatment of patients with high-frequency repetitive TMS (rTMS) will result in
      normalization of baseline network-level deficits, and be predicted by degree of baseline
      network abnormalities.
    

Detailed description: 
      This study has a single primary outcome measure and other measures are exploratory. Previous
      versions of this study record incorrectly listed some exploratory outcome measures as
      secondary.
    

Intervention name(s): rTMS Treatment; Sham rTMS Treatment
Intervention type(s): Device; Device
Intervention description(s): MRI-compatible TMS stimulator
Other intervention name(s): Magstim Stimulator; Magventure Stimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center, open label, phase IV study conducted to evaluate the efficacy and
      safety of agalsidase beta (Fabrazyme [recombinant form]) administered by intravenous drip
      infusion in participants with cardiac Fabry disease.

      Participants participated for 4 weeks or less in the baseline period and 156 weeks for the
      treatment period.
    


Intervention name(s): Agalsidase beta
Intervention type(s): Drug
Other intervention name(s): Fabrazyme®
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiac fabry disease
Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - 202
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to test the safety and efficacy of a noninvasive cortical
      electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical
      Electrostimulation" (RINCE) in the treatment of pain associated with fibromyalgia. Patients
      who meet the 2010 American College of Rheumatology criteria for fibromyalgia will receive up
      to 24 RINCE treatments delivered by a medical device called "NeuroPoint". Approximately 45
      fibromyalgia patients will be randomized into one of three study groups. One of these groups
      will receive sham treatment, meaning they will receive no treatment at all. A second group
      will receive active RINCE treatment at a nominal signal amplitude level (treatment mode 1). A
      third group will receive active RINCE treatment at a higher than nominal signal amplitude
      level (treatment mode 2). The study's primary outcome measure will be the difference between
      active and sham treatment groups in the mean change from baseline in patients' 24-hour recall
      average pain scores. The study's hypothesis is that there will be a difference between
      treatment groups in primary outcome measure.
    


Intervention name(s): RINCE
Intervention type(s): Device
Intervention description(s): The NeuroPoint device is used to deliver repeat applications of RINCE therapy
Other intervention name(s): RINCE therapy; RINCE therapy delivered by the NeuroPoint device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: fibromyalgia; pain; stimulation
Study of Enzyme Supplements to Treat Celiac Disease
Condition: Celiac Disease; Dermatitis Herpetiformis
MeSH terms: Celiac Disease; Dermatitis; Dermatitis Herpetiformis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to examine whether a cocktail of two common food-grade enzyme
      supplements leads to decrease of serum activity markers in celiac disease patients
      insufficiently treated by previous gluten exclusion.
    

Detailed description: 
      Celiac disease is genetically determined abnormal immune response to gluten, a component of
      wheat, rye and barley proteins that cause damage to the villous structure in the small bowel.
      The active disease is characterized by the induction of gluten-dependent autoantibodies to
      transglutaminase type-2, which are sensitive and specific non-invasive markers of
      gluten-sensitivity. Gluten-free diet normally leads to clearance of antibodies from serum in
      6-12 months. Persistent seropositivity is a problem in patients who only incompletely exclude
      gluten or frequently transgress the diet. In such cases, damage of the small bowel may
      persist and complications may occur at higher frequency. The central hypothesis to be tested
      is that enzyme treatment designed to degrade a certain amount of gluten before absorption in
      the gastrointestinal tract will lead to a clinically meaningful decrease in auto-antibody
      levels in these patients.
    

Intervention name(s): STAN1; Placebo enzyme; STAN1+gluten
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3-4 capsules/day at meals; 3-4 capsules/day at meals; 3-4 capsules/day at meals plus 500 mg gluten b.i.d
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: celiac disease; transglutaminase antibody
Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Diagnostic validity of [18F]FSPG for assessing disease activity will be assessed in subjects
      with inflammatory bowel disease.
    

Detailed description: 
      [18F]FSPG PET/CT imaging will noninvasively assess system xc- of cancer and inflammation.
      Diagnostic validity of [18F]FSPG for assessing disease activity will be assessed in subjects
      with inflammatory bowel disease.
    

Intervention name(s): [18F]FSPG
Intervention type(s): Drug
Intervention description(s): Patients will receive 200 MBq of [18F]FSPG and undergo PET/CT for assessing disease activity in inflammatory bowel disease
Other intervention name(s): FSPG
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
N-acetyl Cysteine for Ovulation Induction in Clomiphene Citrate Resistant Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Polycystic ovary syndrome is a major endocrinological disorder affecting 5-8% of reproductive
      aged women. Anovulation is a major feature of the syndrome, managed primarily by clomiphene
      citrate. Failure to respond to clomiphene citrate is termed clomiphene resistance and second
      line treatment is either laparoscopic ovarian drilling or gonadotrophin ovulation induction.
      Although laparoscopic drilling is effective in restoring ovulation and achieving pregnancy,
      some women still remain anovulatory and infertile after the procedure. N-acetyl cysteine has
      emerged as a novel therapeutic adjuvant to laparoscopic drilling to improve ovulation and
      pregnancy rate.
    

Detailed description: 
      Resistance to ovulation induction therapy with clomiphene citrate (CC) is a significant
      problem affecting as many as 25% of patients. Laparoscopic ovarian drilling is an accepted
      second line treatment option, achieving ovulation in 75-90% and pregnancy in 50-69% of the CC
      resistant patients.

      Adjuvants to laparoscopic drilling have been explored by researchers some studies have shown
      evidence of improved outcome with the use of N-Acetyl cystiene (NAC), a long used mucolytic
      drug which has been used for various other indications including detoxification and cancer
      chemoprotection. Several studies have addressed the possibility of using NAC as adjuvant
      therapy to Clomiphene citrate for induction of ovulation in resistant patients with some
      showing encouraging results. The use of NAC as adjuvant to laparoscopic ovarian drilling was
      addressed in a single pilot study showing good results with improved ovulation and pregnancy
      rates compared to the non users.
    

Intervention name(s): N-Acetyl cysteine; laparoscopic ovarian drilling
Intervention type(s): Drug; Procedure
Other intervention name(s): Acetyl cysteine; NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: polycystic ovary syndrome; laparoscopic drilling; clomiphene citrate; n acetyl cysteine; insulin resistance
Hygiene Protocol of Complete Dentures
Condition: Denture Hygiene Protocol
Study type: Interventional

Summary: 
      Adequate denture hygiene is important to patient's oral health maintenance in particular
      because of Candida albicans, responsible for the development of denture stomatitis. The aim
      of this study is to conduct a randomized controlled trial seeking for the best hygiene
      protocols to be used in removable denture wearers. The null hypothesis tested is that there
      will be no difference among the denture hygiene protocols tested.
    


Intervention name(s): water; sodium hypochlorite; sodium bicarbonate; chlorhexidine
Intervention type(s): Other; Other; Other; Other
Other intervention name(s): placebo
Intervention MeSH terms: Chlorhexidine; Sodium Hypochlorite; Eusol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy and Safety Study of JNJ-32729463 for Treating Complicated Skin and Skin Structure Infections Compared to Linezolid (Zyvox)
Condition: Complicated Skin and Skin Structure Infections
MeSH terms: Infections; Communicable Diseases; Skin Diseases, Bacterial
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the clinical efficacy, safety, and tolerability of
      a 250 mg BID oral dose of JNJ-32729463 compared with linezolid in subjects with complicated
      skin and skin structure infections (cSSSIs).
    


Intervention name(s): JNJ-32729463; linezolid; JNJ-32729463 placebo; linezolid placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 250 mg tablet twice daily; 600 mg tablet twice daily; 1 placebo tablet twice daily; 1 placebo tablet, twice daily
Other intervention name(s): Zyvox
Intervention MeSH terms: Linezolid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cSSSI; complicated skin and skin structure infections; acute bacterial skin and skin structure infections; abscess; cellulitis; bacterial infections; anti-bacterial agents; anti-infective agents; skin diseases, infectious; skin diseases; wound infection
Seasonal Allergic Rhinitis In Pediatric Subjects
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the investigational drug is effective and safe
      in children with seasonal allergic rhinitis.
    


Intervention name(s): GW685698X
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: pediatric; Seasonal allergic rhinitis