bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of a Multi-vitamin Supplement in Adult Females
Condition: Health, Subjective
Study type: Interventional

Summary: 
      The investigators are examining how the daily consumption of a multi-vitamin/mineral
      supplement affects the following variables in 21-40 year old women:

        1. blood levels of various micronutrients (assessed from blood draws using mass
           spectrometry-based assays)

        2. blood cell gene expression patterns (assessed from blood draws and real-time PCR assays)

        3. mood (assessed via questionnaires) Blood and questionnaires will be collected prior to
           supplementation, and 12 weeks into supplementation.
    

Detailed description: 
      The investigators are testing the efficacy of a multi-vitamin/mineral/omega-3 complex on
      psychological and physiological measures in pre-menopausal women (21-40 years old) over a
      12-week period.

      This study will be a double-blinded, placebo-controlled intervention. Briefly, subjects will
      be screened for inclusion criteria. Eligible subjects will then undergo a pre-testing battery
      (i.e., T1) and will then be randomly assigned to one of two groups including:

        1. Experimental group (anticipated n=50)

        2. Control group (anticipated n=50) Subjects will then consume 2 capsules per day for 12
           weeks and perform a post-testing battery (i.e., T2) that includes tests performed during
           the pre-testing battery.

      Main outcome (dependent) variables between treatments will include:

        1. blood levels of various micronutrients (assessed from blood draws using mass
           spectrometry-based assays)

        2. blood cell gene expression patterns (assessed from blood draws and real-time PCR assays)

        3. mood (assessed via questionnaires) Blood and questionnaires will be collected prior to
           supplementation, and 12 weeks into supplementation.

      Statistics used to assess differences between conditions over time will include two-way
      repeated measures ANOVAs. When significant group*time interactions are observed, the
      statistical model will be decomposed using LSD post hoc tests.
    

Intervention name(s): Experimental supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects in both arms will consume two pills daily. Prior to and following 12 weeks of supplementation, participants will arrive to the laboratory following an overnight fast in order to donate blood as well as fill out EuroQoL and POMS questionnaires.; Subjects in both arms will consume two pills daily. Prior to and following 12 weeks of supplementation, participants will arrive to the laboratory following an overnight fast in order to donate blood as well as fill out EuroQoL and POMS questionnaires.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded, parallel
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Tramadol in Prevention of Postpartum Depression
Condition: Caesarean Section
MeSH terms: Depression, Postpartum
Study type: Interventional
Phase: Phase 4

Summary: 
      The incidence of postpartum depression in Europe and the United States is about 10%, while in
      China the incidence rate of 15.7-39.8%. Postpartum depression is one of the most common
      diseases of perinatal distress, but the current research of high-quality prevention and
      treatment of postpartum depression is still very lack. The study suggests that the risk of
      postpartum depression in cesarean delivery is significantly higher than that in vaginal
      delivery. Therefore, postpartum depression in cesarean delivery may require more attention
      and treatment.Tramadol is a non-opioid central analgesic that relieves common to severe pain,
      and tramadol has an inhibitory effect on norepinephrine and serotonin systems and has the
      potential to reduce depression and anxiety. Therefore, for the analgesic demand and
      antidepressant demand for maternal who undergoing cesarean section, tramadol may be an
      optimized and effective analgesic for the prevention and treatment of postpartum depression.
    

Detailed description: 
      This study was designed according to a prospective, randomized, controlled clinical trial.
      Randomized subjects were randomly assigned to different analgesic drug-treated groups
      according to the random number induced by SPSS software. All three analgesic treatments were
      routinely used for clinical analgesia; Anesthesia, surgery, postoperative treatment are in
      accordance with clinical practice. The investigators conducted a postoperative questionnaire
      survey and psychological diagnosis for all patients. And blood sample was collected from
      patients before and 48 hours after the surgery.
    

Intervention name(s): Tramadol; Hydromorphone; Ropivacaine (Epidural analgesia)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patient-controlled intravenous analgesia with Tramadol; Patient-controlled intravenous analgesia with Hydromorphone; Patient-controlled epidural analgesia with Ropivacaine.
Intervention MeSH terms: Tramadol; Hydromorphone; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
Condition: Multiple Sclerosis, Primary Progressive
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, parallel group, double-blind, placebo controlled study will evaluate the
      efficacy and safety of ocrelizumab in participants with primary progressive multiple
      sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or
      placebo.
    


Intervention name(s): Ocrelizumab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Two IV infusions of 300 mg in each treatment cycle of double blind treatment period; two IV infusions of ocrelizumab 300 mg for Cycle 1 and single IV infusion of ocrelizumab 600 mg for subsequent cycles in OLE phase.; Two IV infusions of placebo matched to ocrelizumab in each treatment cycle of double blind treatment period.
Intervention MeSH terms: Ocrelizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Prospective, Randomized Controlled Study to Evaluate the Effect of Artificial Intelligence Assisted Optical Diagnosis of Advanced Adenomas
Condition: Advanced Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      This study is a clinical validation of our developed a computer-aided optical dignosis of
      advanced adenoma using non-magnified NBI image. This study is a randomized clinical trial
      comparing endoscopists' optical recognition of advanced adenoma for sending to histological
      examination with our computer-aided system. The hypothesis of the study is that the developed
      computer-aided system increases the percent of sending actual advanced adenoma Intelligence
      Assisted Optical Diagnosis of Advanced Adenomas
    

Detailed description: 
      Colorectal polyp diagnosis is based on endoscopic resection and histological analysis. An
      accurate optical diagnosis could avoid histological lesion of smaller lesions, reducing the
      costs associated with histological diagnosis. However, it should be noted this policy could
      only be applied in diminutive polys considering high proposition of advanced adenomas in
      polyps more than 5 mm. In addition, optical diagnosis criteria of advanced adenomas have not
      been validated for finding advanced adenomas among adenoma polyps. If as many as advanced
      adenomas as possible could be differentiated from non-advanced adenomas and be further sent
      for histological examination, this policy could be generalized to small polyps.

      Considering this situation, the investigators tried to develop computer-aided optical
      dignosis of advanced adenoma using non-magnified NBI image with preliminary, satisfied
      results. In this study, the investigators next validate the investigators' developed
      computer-aided system for detecting advanced adenomas by comparing endoscopists' optical
      detection of advanced adenomas with or without the investigators' computer-aided system.
    

Intervention name(s): AI system of optical detection of advanced adenomas
Intervention type(s): Device
Intervention description(s): AI system of optical detection of advanced adenomas
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of Sarcopenic Obesity on Weight Loss Outcomes and Quality of Life After Laparoscopic Sleeve Gastrectomy
Condition: Sarcopenic Obesity; Body Composition
MeSH terms: Obesity
Study type: Observational

Summary: 
      The purpose of this study is to assess the impact of sarcopenic obesity (SO) on weight loss
      outcomes and improvement of quality of life after laparoscopic sleeve gastrectomy.
    

Detailed description: 
      Sarcopenic obesity is a state in which a lack of muscle mass and strength coexists with an
      increase in fat mass, and it may affect the health outcome of people with obesity after
      laparoscopic sleeve gastrectomy (LSG).No studies have reported differences in weight loss
      outcomes between patients with SO and those with non-sarcopenic obesity (NSO) after LSG.
      Therefore, this study aimed to systematically evaluate the differences in weight loss and
      quality of life (QOL) evaluation between patients with SO and NSO after LSG and provide
      high-level evidence-based medical evidence for the impact of SO on weight loss in the obese
      population and refinement of follow-up strategies.
    

Intervention name(s): Laparoscopic sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): Laparoscopic sleeve gastrectomy was performed in all patients with or without SO.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This retrospective monocentric study included 260 obese patients who underwent LSG between
        January 2015 and July 2022 at the Department of Gastric Surgery, Fujian Medical University
        Union Hospital. All patients underwent a thorough multidisciplinary evaluation (an
        endocrinologist, dietician, and bariatric surgeon), and a psychiatric evaluation was
        obtained if considered necessary. All patients completed routine preoperative
        investigations, including upper gastrointestinal endoscopy, chest radiography, abdominal
        computed tomography (CT), abdominal ultrasound examination, and nutritional assessment.
        Preoperative QOL was measured using the Moorhead-Ardelt questionnaire at the same visit.

        All patients in this study were operated on by the same surgical team of surgeons with more
        than 60 LSG experiences.Postoperative treatment was performed based on the patient's
        condition.
      
Keywords: laparoscopic sleeve gastrectomy; weight loss; sarcopenic obesity; Fat-free mass; Quality of life
ASPIRE Pilot: Comparing Self-collected HPV Testing With Visual Inspection With Acetic Acid Screening for Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      Cervical cancer remains a public health burden, particularly in developing countries such as
      sub-saharan Africa where the infrastructure for organized screening programs does not exist.
      As a result, other screening modalities (visual inspection with acetic acid) are the standard
      of care in such regions. It is now known, persistent infection with an oncogenic Human
      papillomavirus (HPV) type is a necessary precursor of cervical cancer and evidence is showing
      HPV testing is a potential, safe and effective alternative to cytology testing (The Pap
      smear). This study is evaluating the feasibility and acceptance of HPV self-collection vs.
      VIA in a cohort of women from Kisenyi, Uganda.
    


Intervention name(s): HPV self-colleciton; visual inspection with acetic acid (VIA); 3-5% acetic acid
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Women will self-collect a cervical sample that will be provided to an outreach worker and then labelled and sent to laboratories in Kampala for HPV testing. Women who test positive for HPV will be contacted by phone and provided with follow-up instructions.
Other intervention name(s): Women will self-collect a cervical-vaginal specimen per instructions. Sample will then receive high-risk HPV DNA testing.; VIA conducted per standard of care.
Intervention MeSH terms: Acetic Acid; Retinol acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Cervical Cancer; Cervical Cancer Screening; Low Resource setting; HPV; Self-Collection; VIA
Effect-site Concentration of Remifentanil for Smooth Removal of the Double-lumen Endotracheal Tube
Condition: Remifentanil Concentration for Smooth Emergence
Study type: Interventional
Phase: Phase 4

Summary: 
      Smooth emergence is important for patient safety and satisfaction. Coughing during emergence
      is associated with detrimental effects like laryngospasm, sore throat, hoarseness, negative
      pressure pulmonary edema and bleeding at surgical site 1. Especially sore throat and
      hoarseness are most common complications after extubation 2,3 and closely related to patient
      satisfaction 4. Using double lumen tube (DLT) increase the incidence of hoarseness and airway
      injury than using single lumen tube for it has large size5,6. Various technique and drugs
      have been proposed for reducing coughing during extubation including smooth emergence 1,7-11
      and this is closely correlate with reducing sore throat and hoarseness 12. One of the
      proposed technique, the use of short acting opioids are prefered13-15 because it can be
      maintained during emergence with less respiratory depression. Remifentanil is a potent short
      acting opioid and several studies choose remifentanil combined with other anesthetic agents
      1,15,16. There is a study about the EC50 and EC95 of remifentanil in effect site Target
      controlled infusion(TCI) for preventing cough during emergence after thyroidectomy with
      propofol-remifentanil anesthesia 15 but no study about the proper dose of remifentanil for
      smooth DLT extubation.

      The purpose of this study was to evaluate the EC50 and EC95 of remifentanil in effect-site
      TCI for preventing cough during extubation of DLT in total TIVA with propofol and
      remifentanil.
    


Intervention name(s): Remifentanil titration
Intervention type(s): Drug
Intervention description(s): Initial concentration being 1.5ng/ml for the first patient The smooth emergence was defined as extubation without cough-a strong and sudden contraction of the abdomen. The predetermined concentration was decreased by 0.5 ng/ml for the next patient if the patient did not cough during emergence and similarly, if the patient coughed anytime during emergence, it was considered failed smooth emergence and predetermined concentration was increased by 0.5 ng/ml.
Intervention MeSH terms: Remifentanil
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Study of Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis
Condition: Digital Arthrosis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Among the risk factors for lower limb osteoarthritis, if obesity is probably the most
      studied, digital osteoarthritis received increasing interest in recent years. Recent
      publications have highlighted a link between obesity and digital osteoarthritis, but also a
      very probable link between digital osteoarthritis and structural progression of knee
      osteoarthritis. Few data including hip exist and need to be confirmed on larger scale
      studies. We have with "Khoala" a national multiregional cohort of symptomatic gonarthrosis
      and coxarthrosis representative of the general population (which is rarely the case in the
      literature) including X ray, clinical and biological follow-up (hips and / or knees).
    


Intervention name(s): Hand X-rays
Intervention type(s): Radiation
Intervention description(s): Hand X-rays to assess the digital arthrosis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effectiveness of School-based Health and Nutrition Education to Improve Health and Dietary Practices of Primary School Children From Jimma Zone
Condition: Behaviour
Study type: Interventional

Summary: 
      School based Health and Nutrition Education (SHNE) is a key component of school health and
      nutrition programs that can address several health and nutrition issues in Ethiopia.
    


Intervention name(s): school based health and nutrition education
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Nutrition; Food; Security; School; Health
Sarcosine (N-Methylglycine) Monotherapy for Schizophrenia
Condition: Schizophrenias; Psychoses; Psychotic Disorders; Schizophrenic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The etiology of schizophrenia remains unclear. Schizophrenia patients reveal positive
      symptoms, negative symptoms, and cognitive impairments. In addition to dopamine system
      hyperactivity, hypofunction of N-methyl-D-aspartate (NMDA) receptor plays a role in the
      pathophysiology of schizophrenia. Consequently, enhancing NMDA receptor neurotransmission has
      been considered as a novel treatment approach. To date, there have been several trials on
      NMDA enhancers reported. For example, sarcosine (N-methylglycine, a glycine transporter I
      inhibitor) showed therapeutic effects not only in chronically stable patients but also in
      acutely exacerbated ones when added-on to antipsychotics. In addition, sarcosine yields
      excellent safety profiles, in comparison to current antipsychotics.

      It remains unclear whether NMDA enhancers, such as sarcosine, can serve as monotherapy for
      schizophrenia. The aims of this project are to examine the efficacy and safety of sarcosine
      monotherapy for acutely-ill schizophrenic patients, and to compare the effects of 2
      grams/day, effective dose, with 1 gram/day, ineffective lower dose.
    

Detailed description: 
      In the study, 20 schizophrenic patients are recruited into the 6-week trial and randomly
      assigned into the two groups (1 g/d and 2 g/d) with a double-blind manner. Clinical
      manifestation (Positive and Negative Syndrome Scale; Scale for the Assessment of Negative
      Symptoms), side effects and quality of life are evaluated every two weeks during the trial.
      The efficacies of two groups are compared, and the characteristics of better responders are
      analyzed.
    

Intervention name(s): Sarcosine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Physiotherapy After Botulinum Toxin Injection and Serial Casting
Condition: Cerebral Palsy; Cerebral Palsy, Spastic
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The effects of different physiotherapy programs on children with cerebral palsy who have been
      received botulinum toxin injection and serial casting application will be determined.
    

Detailed description: 
      CP children who underwent botulinum toxin injection to medial gastrocnemius muscle and serial
      casting application in last two months will be included in the study. The effects of
      traditional physiotherapy and downhill backward treadmill training plus to traditional
      physiotherapy on muscle morphology, activity, walking, quality of life and selectivity will
      be determined.
    

Intervention name(s): backward downhill walking; routine physiotherapy
Intervention type(s): Procedure; Procedure
Intervention description(s): Children in the intervention group will take backward downhill walking program plus to routine physiotherapy.; Children in one of the groups will take routine physiotherapy programme
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups of children with Cerebral palsy are going to be involved at the same time. One of the groups will be enrolled in the routine physiotherapy intervention. The other group will be enrolled to the routine physiotherapy intervention + backward downhill walking.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebral palsy; botulinum toxin; serial casting; physiotherapy; muscle morphology
The Effectiveness of Titanium-Prepared Platelet-Rich Fibrin on Angiogenic Biomarkers in Gingival Crevicular Fluid
Condition: Chronic Periodontitis; Intrabony Periodontal Defect
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      This study investigates the effect of titanium-prepared platelet-rich fibrin (T-PRF)
      treatment on the angiogenic biomarkers in gingival crevicular fluid (GCF) in infrabony
      defects of patients with chronic periodontitis. In each patient, the infrabony defect of one
      side of arch was designated as control group (allograft), while the infrabony defect on the
      contralateral side of same arch was designated as test group (allograft+T-PRF).
    

Detailed description: 
      Platelets are the cells initiating the wound healing and also supporting it by secreting
      various growth factors actively. These growth factors released by platelets act the increase
      of connective tissue healing, bone regeneration and repair, fibroblast mitogenesis, wound
      angiogenesis and the activation of macrophages by stimulating cell proliferation signals.

      Titanium-prepared, platelet-rich fibrin (T-PRF), is a new platelet concentrate, is formed in
      titanium tubes may be more efficient to activate platelets in comparison with glass tubes.The
      titanium tubes is utilized to refrain any inverse effects of glass tubes and also silica.
    

Intervention name(s): T-PRF; Allograft
Intervention type(s): Procedure; Procedure
Intervention description(s): Flap Surgery; Flap Surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Angiogenesis; Bilateral infrabony defect; Flap surgery; Titanium-prepared, platelet-rich ﬁbrin