bioihbjkbjnl/mcl2 huggingface dataset:
Incomplete Total Body Protein Recovery in Adolescent Patients With Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      The study aimed to assess protein accretion during weight gain in adolescent patients with
      Anorexia nervosa
    

Detailed description: 
      Background: Bone health and growth during adolescence require adequate Total Body Protein
      (TBPr). Re-nutrition for patients with anorexia nervosa (AN) should aim to normalize body
      composition, i.e. recovery of fat mass and TBPr.

      Objective: The study intended to analyze predictors of protein status, including exercise
      status, in adolescents with AN, and to investigate whether weight gain would replete body
      protein deficits.

      Methods: The investigators assessed TBPr in a longitudinal, observational study as
      height-adjusted nitrogen index (NI) using in-vivo neutron activation analysis in adolescents
      with AN at the commencement of refeeding (T0), as well as seven months thereafter (T1), and
      in age-matched normal weight controls. Lean tissue and fat mass were assessed with
      Dual-Energy X-Ray Absorptiometry (DXA). BMI, BMI-SDS and lean tissue mass were tested as
      predictors of protein status using Receiver Operating Characteristic (ROC) analysis.
    

Intervention name(s): Inpatient treatment for Anorexia nervosa
Intervention type(s): Other
Intervention description(s): Nutritional rehabilitation in a clinic with specialized eating disorder service
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        At baseline assessment, ten patients had primary amenorrhea and 87 girls secondary
        amenorrhea. Six girls were not amenorrhoeic but were taking oral contraceptives or had lost
        more than 20% of their weight and fulfilled the remaining diagnostic criteria for AN. The
        mean duration of the eating disorder at the time of testing was 15 ± 12 months, ranging
        from 3 to 60 months and estimated premorbid BMI of the AN patients was 20.4 ± 2.9 (13.5 -
        28.7 kg/m2; data available for 98 patients). Before admission, the patients (n = 97) had
        lost 15 ± 7 (2 - 36) kg. The mean weight on hospital admission (data available for 88
        patients; 10 patients were outpatients; missing data, n = 5) was 41.1 ± 6.1 kg.
      
Keywords: Body composition; Total body protein; nutritional recovery; Exercise status; In-vivo neutron activation analysis; Protein depletion
Navigated Total Knee Arthroplasty, the Correlation to CT Scans and Clinical Results
Condition: Osteoarthrosis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      Total knee replacement is one of the most commonly performed orthopedic procedures. As of
      2010, about 600,000 total knee replacements were being performed annually in the United
      States and these numbers are rising. The normal knee joint functions as a complex hinge
      allowing primarily ﬂexion and extension, rotation and gliding. The knee joint is made up of
      three compartments, the lateral, medial and anterior (patellofemoral). Damage to the
      cartilage of one or more compartments may be the result of osteoarthritis (idiopathic or
      post-traumatic), inﬂammatory arthritis (rheumatoid,psoriatic, etc.), a-vascular necrosis,
      tumors, or congenital deformities. Osteoarthritis and rheumatoid arthritis are the causes of
      the overwhelming majority of total joint arthroplasties.

      A successful Total knee arthroplasty(TKA) surgery includes: an accurate alignment( the
      mechanical axis in axial and rotational planes), as well as significant pain relief which
      improves function and quality of life. Incorrect alignment can lead to abnormal wear,
      premature mechanical loosening of the components and patellofemoral problems.

      The common techniques for Total knee replacement are:

        1. Conventional method TKR

        2. CT/MRI-based preoperative navigated TKR

        3. Image-free intraoperative navigated TKR In our research we focus on the 3rd method using
           the Orthopilot navigation system Aesculap®, Tutlingen, Germany. This system is an active
           PC based guiding system that helps the surgeon decide on the accurate alignment and
           orientation of the implant and cutting surfaces of the bone and thus avoid incorrect
           alignment.

      We aim to compare between pre-operative and post-operative lower limb alignment (mechanical
      axis) in Aesculap based TKA using serview CT. Furthermore, we will try to examine the
      existence of a correlation between the CT scans and the Orthopilot navigation system output
      and assess the clinical outcome of the patient postoperatively.

      Our Hypothesis is that the intra-operative navigation system is accurate and correlated to CT
      images results, moreover, allows the surgeon to achieve a good mechanical axis and high
      clinical outcome,
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing navigated total knee replacement
Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer（NSCLC）
Condition: Advanced Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the effectiveness and safety of utidelone injection in patients with advanced or
      metastatic NSCLC as a phase II trial
    


Intervention name(s): utidelone injection
Intervention type(s): Drug
Intervention description(s): utidelone monotherapy in patients with advanced NSCLC by utidelone
Other intervention name(s): UTD1 injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Vonoprazan in Adults With Helicobacter Pylori
Condition: Helicobacter Pylori
Study type: Interventional
Phase: Phase 1

Summary: 
      Helicobacter Pylori (H Pylori) is a bug found in the digestive system. It can cause soreness
      and redness in the stomach (gastritis). It can also cause ulcers in the stomach and other
      parts of the digestive system. Vonoprazan is a medicine to treat people with H Pylori. It is
      taken together with other medicines to fight infections caused by H Pylori.

      The main aim of this study is to learn if vonoprazan changes how the other medicines are
      processed by the body. It will be compared with another medicine called esomeprazole. Other
      aims are to check for side effects from the study medicines.

      At the first visit, the study doctor will check who can take part. Participants who take part
      will be picked for 1 of 2 treatments by chance.

        -  Vonoprazan taken with bismuth, clarithromycin, and amoxicillin

        -  Esomeprazole taken with bismuth, clarithromycin, and amoxicillin

      Both treatments will last for 14 days. Participants will stay in the clinic throughout their
      treatment.

      After treatment, the clinic staff will telephone the participants 2 days later for a
      check-up. The participants will visit the clinic 4 weeks later for a final check-up.
    

Detailed description: 
      This is a study in healthy participants with Helicobacter pylori (HP positive) to evaluate
      the safety, tolerability and PK of a quadruple therapy with bismuth, clarithromycin,
      amoxicillin, and vonoprazan versus quadruple therapy with bismuth, clarithromycin,
      amoxicillin, and esomeprazole.

      The treatment phase consists of quadruple therapy twice daily (BID) with bismuth potassium
      citrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg), and vonoprazan (20 mg)
      (Group B) or quadruple therapy BID with bismuth potassium citrate (600 mg), clarithromycin
      (500 mg), amoxicillin (1000 mg), and esomeprazole (20 mg) (Group A) from Days 1 to 14.
      Participants will be discharged on Day 15 after all procedures have been performed.

      This single-center will be conducted in China. Participants will remain confined to the study
      site from check-in (Day -1) through Day 15 and will followed up through call on Day 17 and
      return on Day 42 for a follow-up assessment.
    

Intervention name(s): Clarithromycin; Amoxicillin; Bismuth potassium citrate; Esomeprazole; Vonoprazan
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Clarithromycin tablets.; Amoxicillin capsules.; Bismuth potassium citrate tablets.; Esomeprazole tablets.; Vonoprazan tablets.
Other intervention name(s): TAK-438
Intervention MeSH terms: Amoxicillin; Clarithromycin; Potassium Citrate; Esomeprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Drug Therapy
Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions
Condition: Asthma
MeSH terms: Malnutrition
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this study was to prove the bioequivalence of Montelukast Tablet under fed
      conditions
    


Intervention name(s): Montelukast; Singulair
Intervention type(s): Drug; Drug
Other intervention name(s): Singulair; Montelukast
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Atypical Antipsychotic Therapy on Health Outcomes and Costs Among Patients With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      The primary objective is to examine changes in pre/post-augmentation healthcare costs and
      resource utilization in patients diagnosed with major depressive disorder (MDD) who augment
      their current antidepressant therapy with an atypical antipsychotic.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The population is identified as patients diagnosed with MDD who are treated with
        antidepressants and subsequently augment with atypical antipsychotic therapy.
Physiological Characteristics of High Altitude Climbers
Condition: Hypoxia; Exercise; Sport Performance
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Climbing at high altitude and tolerating hypoxic environment require specific physiological
      adaptations. Large intersubjects differences exist regarding the ability to adapt to high
      altitude and hypoxia. The present study aims to characterise the physiological responses to
      hypoxia in a group of elite climbers by comparison to sea level athletes. We hypothesised
      that elite climbers would show better physiological responses to hypoxia and more preserved
      performances compared to sea level.
    


Intervention name(s): Stress test
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: elite climbers; near infrared spectroscopy
Study Using Pregnenolone to Treat Bipolar Depression
Condition: Bipolar Disorder; Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary purpose of this study is to determine if pregnenolone supplementation is associated
      with greater improvement in depressive symptoms of patients with bipolar disorder. Also the
      study will explore possibilities of improving anxiety and manic symptoms as well as the
      patient's cognition.
    

Detailed description: 
      Determine if pregnenolone supplementation is associated with greater improvement in
      depressive symptoms than placebo in persons with Bipolar Depression (BPD), depressed phase.
      In our pilot study, pregnenolone showed a strong signal on depression scores.

      Secondary

        1. Determine if pregnenolone supplementation is associated with greater improvement in
           anxiety symptoms in persons with BPD, depressed phase. Data from prior studies suggests
           that pregnenolone may decrease symptoms of anxiety. Anxiety is a common and clinically
           important feature of BPD. Therefore, we will examine anxiety symptoms in this trial.

        2. Determine if pregnenolone supplementation is associated with improvement in manic
           symptoms as compared to placebo in persons with BPD, depressed phase. Our pilot study
           suggested that pregnenolone may be associated with improvement in manic symptoms.
           Although the current study targets bipolar depression we will also examine manic
           symptoms.
    

Intervention name(s): Pregnenolone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.; Inactive ingredient matching the active medication in appearance.
Other intervention name(s): 3β-hydroxypregn-5-en-20-one; Sugar pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Potential Role of sRAGE, KL-6, and SP-D as Prognostic Factors in Children With COVID-19
Condition: SARS CoV 2 Infection; Alveolar; Injury; Children; Pneumonia, Viral
MeSH terms: Pneumonia; COVID-19; Pneumonia, Viral
Study type: Observational [Patient Registry]

Summary: 
      COVID-19 causes a wide spectrum of clinical illness, from upper respiratory symptoms to
      severe respiratory failure and death. Several plasma biomarkers -such as IL-6, C-reactive
      protein (CRP), D-dimer, the neutrophil-to-lymphocyte ratio, and ferritin, among others- have
      been studied as markers of disease severity and prognosis. Besides, as alveolar damage
      biomarkers such as Surfactant protein D (SP-D), Krebs von den Lungen-6 (KL-6), and soluble
      Receptor for Advanced Glycation end products (sRAGE) can be used in lung diseases as well as
      COVID-19 pneumonia. The investigators hypothesized that serum SP-D, KL-6 and sRAGE levels
      increases in the setting of COVID-19 pneumonia. In this prospective study the investigators
      aimed to determine the clinical value of serum KL-6, SP-D and sRAGE levels as a prognostic
      marker in children with COVID-19 patients. In the literature review, it has been determined
      that there is no study conducted or published in pediatric patients for this purpose, and it
      is aimed that our study will be a pioneer study on this subject.
    

Detailed description: 
      It aimed to determine the clinical value of serum KL-6, SP-D and sRAGE levels as a prognostic
      marker in children with COVID-19 patients.. This study was planned as a case-control study
      with patients hospitalized in the Haseki Training and Research Hospital Pediatric Infection
      Ward. A total of 150 children, including at least 30 patients in each group were included in
      the study. The study group was divided into three groups according to COVID-19 WHO clinical
      progression Scale: uninfected (Group 1), mild (Group 2) and moderate (group 3). In order to
      investigate the relationship between disease severity and alveolar damage, serum KL-6, SP-D
      and sRAGE levels and high sensitive C-reactive protein were measured. These biomarkers levels
      were compared between three groups.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents diagnosed as diagnosed SARS-CoV-2 infection and whose parents sign
        the informed consent from to participate the study
      
Biospecimen description: 
      3-5 cc serum was obtained from participants. serum samples were stored at -80° C
    
Keywords: soluble receptor for Advanced Glycation end products; Krebs von den Lungen-6; Surfactant protein D; Children; SARS CoV 2 Infection; Pneumonia
The Th17/Treg Cells and IL-23/IL-17 Axis and Early Enteral Nutrition in Sepsis
Condition: Sepsis; Immune System Disorder; Enteral Feeding
MeSH terms: Sepsis; Toxemia; Immune System Diseases
Study type: Interventional

Summary: 
      The investigators aim to evaluate the roles of Th17/Treg cells and IL-23/IL-17 axis in the
      mechanisms of early enteral nutrition (EEN) correcting immune imbalance of sepsis by means of
      improving the intestinal flora disturbance. The results of this study would lay the
      foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and
      provide a new idea to the early treatment of sepsis
    


Intervention name(s): enteral nutrition
Intervention type(s): Other
Intervention description(s): early enteral nutrition group or delayed enteral nutrition group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF Therapy
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, randomized, open-label clinical trial to evaluate the efficacy and
      safety of total glucosides paeony capsules in maintaining clinical remission in patients with
      ankylosing spondylitis which achieved clinical remission after anti-TNF therapy. Patients
      will be divided into two groups randomly, one group receive non-steroid anti-inflammatory
      drugs(NSAID) mono-therapy and the other group receive total glucosides paeony capsules plus
      NSAID therapy for 24 weeks. The primary clinical endpoint is the proportion of patients which
      disease activity reaches relapse criteria. The investigator's hypothesis the proportion of
      relapse in total glucosides paeony capsules plus NSAID group would be lower than the NSAID
      mono-therapy group.
    


Intervention name(s): Total Glucosides Paeony Capsules
Intervention type(s): Drug
Intervention description(s): Total Glucosides Paeony Capsules, oral, 0.3 gram per capsule, 3 capsules tid, 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Totally Implantable Venous Access Devices: Quality of Life and Body Image
Condition: Neoplasms Undergoing Chemotherapy
Study type: Interventional

Summary: 
      Our hypothesis is that totally Implantable Venous Access Devices in neoplastic patients
      modify body image and self-representation. Therefore, the purpose of this study is to
      evaluate the efficacy of psychological intervention on patients undergone this surgical
      practice.
    


Intervention name(s): psychological support (interactive/cognitive strategies)
Intervention type(s): Behavioral
Intervention description(s): cognitive/behavioural intervention (6 times starting from hospital admission, in 90 days; for arm of intervention)
metacognitive techniques (6 times starting from hospital admission, in 90 days; for arm of intervention)
psychoeducational intervention (6 times starting from hospital admission; for arm of intervention)
questionnaires: EORTC questionnaires and a written structured interview (3 times: hospital admission,15 days after surgical intervention, 90 days after intervention; in both arms)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cancer, quality of life, body-image, subcutaneous-implant
Beat AML Core Study
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Observational

Summary: 
      In this study, DNA sequencing, computational biology modeling, and ex vivo drug sensitivity
      assays will be utilized to define clinically relevant gene mutations and identify potential
      therapeutics for patients with acute myeloid leukemia (AML).
    

Detailed description: 
      As part of normal clinical care, patients will undergo a peripheral blood draw and bone
      marrow aspiration & biopsy. Blood draws and bone marrow aspirations are performed at the time
      of diagnosis, after treatments , disease progression, and relapse. Under normal clinical
      care, patient specimens are analyzed by cytogenetics (giemsa staining), fluorescence in situ
      hybridization (FISH), and gene mutation profiling. Clinically, treatment can begin before
      these molecular diagnostics are available.

      As part of this repository study, subjects are asked to:

        -  Allow access to banked blood and bone marrow specimens in IRB approved protocol #
           532-2012.

        -  Donate peripheral blood specimens whenever blood is already being drawn for clinical
           purposes such as at times of diagnosis, relapse, refractory disease or disease
           progression. Additional samples may be requested at other standard of care visits in the
           event that initial samples are not viable for DNA sequencing, phenotyping, or functional
           assays for patients with AML, if disease is present.

        -  Donate bone marrow aspirate specimens whenever bone marrow aspiration is already being
           done for clinical purposes such as at times of diagnosis, relapse, refractory disease or
           disease progression. If bone marrow aspirate is being collected for banking protocol
           #532-2012, then an aliquot of the banked specimen will be accessed rather than collect
           an additional bone marrow aspirate for this study.

        -  Undergo skin biopsy and donate the skin biopsy specimen for genomic profiling.

        -  Allow bone marrow, peripheral blood and skin biopsy specimens to be collected for
           genomic profiling and ex vivo drug sensitivity testing.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 50 subjects with newly diagnosed or relapsed/refractory acute myeloid leukemia
        (AML) will be enrolled in this study.
      
Biospecimen description: 
      Perform molecular and cellular studies on blood, skin biopsy, and bone marrow samples done at
      the time of diagnosis, after treatments, disease progression, and relapse.
    
Keywords: leukemia; myeloid; genomics
INCAS - Integrated Care of Asthma in Switzerland
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effect of standardized patient education on
      asthma control. In collaboration with two health insurance companies, pharmacists and
      pneumologists, patients with asthma were recruited. They completed the "Asthma Control Test
      (ACT)" and the "Patient Assessment of Chronic Illness Care (PACIC 5A)" questionnaire to
      assess asthma control and patients' satisfaction with the health care service they received.
      Additionally, patients were offered the possibility to participate in a patient education
      seminar run by the Swiss lung leagues or the Swiss allergy centre (aha!). After one year,
      patients were asked to complete the questionnaires again. Comparisons of intraindividual
      changes and differences regarding ACT and PACIC 5A between patients with and without patient
      education were made.
    


Intervention name(s): asthma patient education
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care