bioihbjkbjnl/mcl2 huggingface dataset:
Anovaginal Distance, Interobserver Agreement
Condition: Pelvic Floor Disorders
MeSH terms: Pelvic Floor Disorders
Study type: Observational

Summary: 
      Interobserver variation in measuring the anovaginal distance (AVD) with perineal ultrasound
    

Detailed description: 
      Aims: This study describes perineal ultrasound measurement of the AVD in regard to ease of
      learning and interobserver agreement, in order to establish if the method is reliable to use
      in further research about objective postpartum description of perineal tears.

      Methods: To educate the examiners, the method was shown and described by an experienced
      examiner. The examiners then measured the anovaginal distance in one woman repeatedly with
      until similar results (+/- 5 mm ) were achieved. The woman was in the lithotomy position and
      a vaginal ultrasound probe was used. The AVD in another 40 women was then measured and
      documented by two examiners, right after the other, who were blinded to the other´s results.
      The distance was measured between the mucosal margin of the internal anal sphincter and the
      vaginal probe. Interobserver agreement was calculated using Kappa-score.
    

Intervention name(s): anovaginal distance variation
Intervention type(s): Other
Intervention description(s): Kappa calculation
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The examiners whose measurements were compared for interobserver varialility were
        gynecologists working inte the department.

        The study population to perform measurements on was recruited from women visiting the
        gynaecological outpatient clinic of Linköping University Hospital.
      
Keywords: ultrasound anovaginal distance, observer variation
Evaluating the Safety, Tolerability, Pharmacokinetics, and Effect of Food of Lucid-21-302 in Healthy Volunteers
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to determine the safety, tolerability, and pharmacokinetics of single doses
      of Lucid-21-302 in healthy adult volunteers. This study will also investigate the effects of
      food in healthy volunteers.
    


Intervention name(s): Lucid-21-302; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A small molecule inhibitor of hypercitrullination; Product containing excipients with no active ingredients
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: 5 SAD Cohorts. Each SAD cohort will enroll 8 participants randomized 6 active:2 placebo to receive single doses of Lucid-21-302. For SAD cohort with food effect, all 8 participants will receive Lucid-21-302.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Compare Safety and Pharmacokinetic Properties of Surfolase Capsule(Acebrophylline 100mg) and Surfolase CR(200mg)
Condition: Healthy Male
Study type: Interventional
Phase: Phase 1

Summary: 
      Acebrophylline is metabolized by being separated into Ambroxol and 7-theophylline when orally
      administered as a salt composed of an acid-base as a compound that was synthesized by and
      chloride (salifying) the ambroxol to 7-theophylline. Acebrophylline is selectively applied to
      the bronchial or lung tissue and inhibit the activity of phospholipase bronchoalveolar shows
      the expectorant action to raise the surface activity of the alveolar, leukotrienes (LTs) and
      by suppressing the production of prostaglandins (PGs), showed potent anti-inflammatory
      activity, bronchial was celebrated by reducing the bronchial hyperreactivity to normal state
      is allowed to recuperate or extended.

      It was developed to improve compliance improve pharmaceutically Surfolase
      capsule(Acebrophylline 100mg) that intake twice daily 100mg to Surfolase CR(Acebrophylline
      200mg) that intake once daily 200mg
    


Intervention name(s): Surfolase capsule (100mg); Surfolase CR (200mg, T1); Surfolase CR (200mg, T3); Surfolase CR (200mg, T4)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Surfolase capsule one capsule twice one days fasting administration; one tablet once one days fasting administration.; one tablet once one days fasting administration.; one tablet once one days fasting administration.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151
      after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese
      subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and
      elderly male Japanese subjects.
    


Intervention name(s): ASP2151; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Healthy non-elderly and elderly subjects; ASP2151; Safety
Continuous Measurement of Intratracheal Pressure
Condition: Endotracheal Pressure
Study type: Interventional

Summary: 
      Continuous measurement of intratracheal pressure in mechanically ventilated infants using a
      fibreoptic pressure transducer in the endotracheal tube (ETT). Based on the findings,
      tracheal pressure can continuously be monitored in the presence of pediatric ETTs by
      combining ETT coefficients and the flow and airway pressure continuously measured at the
      proximal end of the ETT.
    


Intervention name(s): endotracheal tube pressure measurement probe
Intervention type(s): Device
Intervention description(s): The endotracheal tube pressure measurement probe is inserted into the endotracheal tube prior to intubation for measurement of tracheal pressure at the tip of the endotracheal tube.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: endotracheal tube; endotracheal pressure; airway pressure; pressure drop; calculation; continuous calculation
A Pharmacokinetic Study of MK-0941 After Multiple Daily Doses in Subjects With Type 2 Diabetes (MK-0941-012)(COMPLETED)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to test the pharmacokinetics after twice daily administration of MK-0941 or placebo
      in subjects with type 2 diabetes who have inadequate control on metformin.
    


Intervention name(s): MK-0941; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.; Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Achilles Tendon Elongation and Gait Pattern After Rupture.
Condition: Achilles Tendon Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The objective of this study is to determine if Achilles tendon elongation and gait pattern
      differ between patients treated using an individualized treatment algorithm and patients
      treated as usual (two control groups; patients treated operatively and non-operatively).

      The individualized treatment algorithm is based on ultrasonographic status of tendon overlap
      and Copenhagen Achilles Length Measure (1). Patients are allocated for operative treatment if
      there the tendon overlap is less than 25 % or the tendon is elongated with 7% or more
      compared to the healthy, contralateral achilles tendon.
    


Intervention name(s): Individualized treatment of Acute Achilles tendon rupture.; Non-operative treatment; Operative treatment
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The most proximal border of the calcaneus and the most distal point of the musculotendinous junction of the medial gastrocnemius muscle is identified and marked on the skin. These two points on the un-injured leg defines the original length of the total Achilles tendon [1]. The difference in length between the injure and the un-injured leg determines elongation for the ruptured Achilles tendon. The relative elongation of the ruptured tendon together with overlap of the tendon ends on the cross-sectional area determines the treatment for the patients receiving individualized treatment: 1) patients with 0-6% elongation of the tendon and a minimum of 25% tendon are treated non-operatively 2) patients with 7% elongation or more or less than 25% tendon overlap are treated operatively.; Circulated cast below the knee in maximal, unforced plantar flexion over the ankel.; Open surgery with suture of the ruptured achilles tendon prior to circulated cast below the knee in maximal, unforced plantar flexion over the ankel.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bioequivalency Study of Montelukast Chewable 5 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 Chewable Tablet
      under fed conditions
    


Intervention name(s): Montelukast; Singulair
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg Chewable Tablet; 5 mg Chewable Tablet
Other intervention name(s): Singulair; Montelukast
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glucagon-Like Peptide-1 (GLP-1) Suppression of Alpha Cell Secretion in Type 2 Diabetes Mellitus (T2DM)
Condition: Hyperglycemia; Hyperglucagonemia; Glucose Intolerance
MeSH terms: Hyperglycemia; Glucose Intolerance
Study type: Interventional

Summary: 
      The incretin hormone glucagon-like peptide-1 (GLP-1) has known insulinotrophic and
      glucagonostatic properties. However, inpatients with type 2 diabetes mellitus (T2DM)it is
      shown, that the beta cell sensitivity towards GLP-1 is decreased, when comparing to healthy
      controls. Further, these patients have decreased GLP-1 response to a meal.

      The aim of this study is to elucidate if the diabetic hyperglucagonemia, seen in these
      patients both during fasting and in a postprandial condition, is coursed by a decreased
      sensitivity to GLP-1 in the diabetic alpha cell.

      Ten T2DM patients and ten matched healthy control subjects will be examined on two separate
      days. Day 1: increasing GLP-1 infusions and Day 2: saline. During both days plasma glucose
      (PG) will be clamped at fasting level (FPG).

      Patients with T2DM will be submitted til a Day 3, here PG will be normalized over-night by an
      adjustable insulin infusion, on the following day the GLP-1 infusion of Day 1 will be
      repeated.

      The hypothesis is that these patients have decreased alpha cell sensitivity to GLP-1 as is
      the case with the beta cell sensitivity. This decreased sensitivity, the investigators
      speculate, contributes the defect suppression og glucagon and thereby to the increased PG
      levels seen in T2DM. Further the investigators will elucidate if this sensitivity can be
      increased by normalizing the diabetic PG to a normal FPG level.
    


Intervention name(s): GLP-1 infusion
Intervention type(s): Other
Intervention description(s): physiological effect of GLP-1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: glucagon; GLP-1; hyperglycemia
Autologous Cord Blood Cells for Prevention of BPD in Preterm
Condition: Safety Issues; BPD - Bronchopulmonary Dysplasia; Neonatal Death
MeSH terms: Bronchopulmonary Dysplasia; Perinatal Death
Study type: Interventional
Phase: Phase 2

Summary: 
      To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary
      dysplasia in very preterm neonates
    

Detailed description: 
      We did a randomized, double-blind, placebo-controlled trial to assess effect of one
      intravenous dose of cord blood MNCs compared with placebo in reducing incidence of BPD in
      very preterm neonates.We enrolled preterm neonates less than 32 weeks of GA at neonatal
      intensive care units (NICUs) in Guangdong Women and Children Hospital within the first 24
      postnatal hours. Patients were randomly assigned by 1:1 to receive either (5×107cells/kg
      ACBMNC or normal saline intravenously within 24 hours after birth according to a
      computer-generated schedule. The primary endpoint was efficacy at 36 GA or discharge home and
      all analyses were done by intention to prevent.MNCs viability was also tested before
      transfusion
    

Intervention name(s): Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy; 0.9% Sodiun Chloride
Intervention type(s): Other; Drug
Intervention description(s): Evaluate Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates; 0.9% Sodiun Chloride in control group
Other intervention name(s): Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ACBMNC; very premature infants; BPD
Redistribution of Fat and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)
Condition: Human Immunodeficiency Virus
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      The purpose of this study is to learn whether HIV-infected patients have blood abnormalities
      which could lead to heart attack or stroke, and to find out what factors may contribute to
      these abnormalities.
    

Detailed description: 
      This research is being done to learn whether HIV-infected patients have abnormalities in
      their blood vessels that could eventually lead to heart attack or stroke (atherosclerosis),
      in how fat is distributed in their body and in how their body handles fat and sugars. If
      there are abnormalities, this study will also try to find out what factors may contribute to
      those abnormalitites.

      People who participated in FRAM 1 may join FRAM 2.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        men or women 18-65 years old, previous FRAM 1 participant, HIV positive
      
Keywords: Human Immunodeficiency Virus; FRAM 1
Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Condition: Chronic Rhinosinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to evaluate the safety and efficacy of multiple doses of etokimab in adults with
      chronic rhinosinusitis with nasal polyps.
    

Detailed description: 
      This study is a randomized, placebo controlled, double-blind, multi-dose study to assess the
      efficacy of two different dose regimens of etokimab compared to placebo in adults with
      moderate-to-severe chronic sinusitis with nasal polyposis (CRSwNP).

      During the screening period, all subjects will undergo evaluation for eligibility. A
      centralized reader will be used to confirm the diagnosis of CRSwNP as assessed by nasal
      endoscopy, computed tomography (CT) scan of sinuses, and symptom scoring to reduce the risk
      of interpretation variation.

      Participants will also be provided mometasone furoate nasal spray (MFNS) for use during the
      trial and are required to undergo a minimum run-in period of 20 days prior to Day 1 with
      approximately 80% compliance.

      Participants will be randomly assigned on Day 1 to one of the three treatment arms in a 1:1:1
      ratio.
    

Intervention name(s): Etokimab; Placebo; Mometasone Furoate Nasal Spray
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection; Mometasone Furoate Nasal Spray (MFNS) was used from 4 weeks prior to Day 1 (Run-in period) through the end of the study. Participants used 2 actuations (50 μg/actuation) in each nostril BID, total daily dose of 400 μg. Participants intolerant to BID intranasal corticosteroids (INCS) could use the lower dose regimen of 1 actuation in each nostril BID, total daily dose of 200 μg.
Other intervention name(s): ANB020
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ANB020; Etokimab; CRSwNP
PFN-A Augmentation for Intertrochanteric Femoral Fractures
Condition: Intertrochanteric Fracture
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Interventional

Summary: 
      This study evaluates the potential negative effect of cement augmentation in the femoral head
      on viability of the head. Half of the participants will have the standard intramedullary nail
      (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail
      plus cement augmentation.
    

Detailed description: 
      Cement augmentation is believed to increase the bone implant interface and therefore decrease
      the risk of implant cut-out of the femoral head. The cement used in previous studies has
      produced heat and thermal necrosis on bone cells. The cement used in this study (TraumaCemV+)
      is manufactured specially for this implant and for the augmentation of this implant.
      TraumaCemV sets under low temperature (40 degrees Celsius) and we do not anticipate any heat
      necrosis. The volume effect of the cement could theoretically also damage the blood flow in
      the femoral head. There have been no negative effects in big series of patients operated with
      this technique.

      The aim of this study is to quantify the viability of the femoral head with the use PET-CT
      (Positron Emission Tomography with simultaneous Computed Tomography) including a radioactive
      isotope (Fluorine-18) and the use of threedimensional computed tomography.
    

Intervention name(s): Cement augmentation; PFN-A Nail
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Augmentation; PET-CT; Positron Emission Tomography; Fluorine-18
Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the capacity of a 6-week treatment with
      neuromuscular electrical stimulation to improve walking in individuals whose mobility has
      been compromised by multiple sclerosis.
    

Detailed description: 
      Participants will be randomly assigned to one of two study arms. Those in one arm will
      receive a treatment with narrow stimulus pulses (0.4 ms) and those in the other arm will
      receive wide stimulus pulses (1 ms). The electrical stimulation will be delivered with a
      Vectra Genisys System.
    

Intervention name(s): Narrow pulse; Wide pulse
Intervention type(s): Device; Device
Intervention description(s): Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses.; Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Walking; Mobility; Neuromuscular electrical stimulation; Multiple sclerosis
Psychological Symptoms Among Adolescents Enrolled in a Bariatric Surgery Program
Condition: Obesity
Study type: Observational

Summary: 
      This study will examine the interaction of psychological factors and serious overweight to
      determine if particular patterns of psychological symptoms are helpful in predicting outcomes
      of weight loss surgery.

      Patients from the Center of Adolescent Bariatric Surgery (CABS) program at the Morgan Stanley
      Children's Hospital of New York Presbyterian will be asked to participate in a longitudinal
      prospective study of psychopathology among severely obese adolescents. Additionally, the
      psychological symptoms of this group will be compared to other treatment-seeking obese
      adolescents.

      The investigators hypothesize that:

        1. Adolescents receiving bariatric surgery will demonstrate significant reductions in body
           weight, eating pathology, and other symptoms after receiving bariatric surgery.

        2. Adolescents enrolled in the bariatric surgery program will report more psychological
           problems than other treatment-seeking obese adolescents.
    

Detailed description: 
      With increasing rates of overweight and obesity among children and adolescents in the United
      States, there is an urgent need for effective weight loss treatments for younger patients.
      Recently, bariatric surgery has been considered as a treatment for seriously overweight
      adolescents because of the potential for substantial decreases in weight and subsequent
      improvements in physical health. This study will examine the interaction of psychological
      factors and serious overweight to determine if particular patterns of psychological symptoms
      (psychological phenotypes) are helpful in predicting outcomes of bariatric surgery. Patients
      from the Center for Adolescent Bariatric Surgery (CABS) program at the Morgan Stanley
      Children's Hospital of New York Presbyterian will be asked to participate in a longitudinal
      prospective study of psychopathology among severely obese adolescents. The final aim of this
      project is to compare psychological symptoms between obese adolescents seeking bariatric
      surgery, other treatment-seeking obese adolescents, and normal-weight comparison adolescents.
      We will evaluate the effect of psychiatric symptoms on adherence to postsurgery follow-up
      appointments and weight loss. This research will be broadly applicable to the study of
      interactions between psychological factors and compliance with treatment for youth with
      chronic health conditions.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescent Surgical Candidates, Obese Comparison Subjects, Normal-Weight Comparison
        Subjects
      
Keywords: Adolescents; Bariatric Surgery; Psychological Symptoms; Cognitive Behavioral Therapy; Telemedicine; Longitudinal