bioihbjkbjnl/mcl2 huggingface dataset:
Active Schools: Skelmersdale
Condition: Physical Activity; Sedentary Lifestyle
Study type: Interventional

Summary: 
      The aim of AS:Sk is to improve physical activity levels and health-related outcomes of
      children from the Skelmersdale area of West Lancashire through a school-based physical
      activity multi-component intervention.
    

Detailed description: 
      The multi-component intervention is the third and final phase of the AS:Sk project. It will
      be implemented and evaluated in four of the seven participating schools. The remaining three
      schools will act as controls and will not implement any physical activity intervention during
      the period of the research project. Schools will be randomly assigned to either intervention
      or control conditions. The multi-component intervention will involve multiple areas of the
      schools' curricula, environments, or policies being targeted. Decisions regarding these
      intervention components will be influenced by what was deemed effective, and feasible within
      phase 2 of the project. Phase 2 included a four week trial of three different single
      component physical activity interventions across all participating schools. Phase 3 will be
      implemented for at least eight weeks and if successful, it would then be rolled out in the
      control schools at the end of the project. Participants from both intervention and control
      schools will take part in the measures for evaluation in this third and final phase of the
      project.
    

Intervention name(s): Multicomponent physical activity intervention
Intervention type(s): Other
Intervention description(s): School-based multicomponent intervention
Intervention model: Single Group Assignment
Intervention model description: Control vs Intervention clusters of schools
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Children; Schools
Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of MT921 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability of
      MT921 in Healthy Subjects
    


Intervention name(s): MT921; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Formulated as an injectable solution; normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Modulation of Muscle Protein Synthesis With Diet and Exercise in Old Aged Women
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Observational

Summary: 
      In this study will measure differences in how muscle responds to both exercise and protein
      supplements in healthy women aged 60-69. We are studying two different protein supplements- a
      standard Whey Protein and a Leucine enriched supplement. Each patient would receive either
      one of these.
    

Detailed description: 
      One of the factors that plays an important role in the loss of functional performance and, as
      such, the capacity to maintain a healthy, active lifestyle is the progressive loss of
      skeletal muscle mass with ageing (i.e., sarcopenia). Indeed, sarcopenia is a more robust
      predictor of functional status and mortality in the elderly than chronological age or indeed,
      any other co-morbidity. Sarcopenia is an incipient process whereby lean muscle mass
      contributing up to ~50% of total body weight in young adults declines to ~25% when reaching
      the age of 75-80 y. Adequate nutritional intake, and in particular dietary protein, is
      important for offsetting age-related declines in muscle mass. The aim of this project is to
      seek the most effective nutrition with which to counteract sarcopenia, specifically in women.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy females aged 60-70
      
Biospecimen description: 
      Blood samples for Glucose and RNA analysis Muscle biopsies for protein synthesis
    
Keywords: Muscle Protein Synthesis; Muscle Protein Breakdown
Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)
Condition: Variegate Porphyria
MeSH terms: Porphyria, Variegate; Porphyria, Erythropoietic; Porphyrias
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to evaluate the impact of afamelanotide on the severity of skin
      disease in patients with Variegate Porphyria (VP). The secondary objectives are to evaluate
      the safety and tolerability of afamelanotide in patients with VP and evaluate the impact of
      afamelanotide on the quality of life of patients with VP.
    


Intervention name(s): Afamelanotide 16 MG
Intervention type(s): Drug
Intervention description(s): Eligible patients will receive one dose of afamelanotide 16mg every 28 days (up to six doses), as a controlled-release formulation.
Intervention MeSH terms: Afamelanotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Compliance of Clinical Pathways in Elective Laparoscopic Cholecystectomy: Evaluation of Different Implementation Methods
Condition: Gallstones
MeSH terms: Gallstones
Study type: Observational

Summary: 
      Compliance to the clinical pathway, postoperative complication and total cost of the
      hospitalisation of patients undergoing elective cholecystectomy for symptomatic
      cholecystolithiasis were collected over two different periods: using a clinical pathway in
      form of a paper based check-list (group 1, n=118) or a clinical pathway integrated into the
      paper based medical treatment and nursing documentation (group 2, n=123). Outcome measures
      were compliance of the clinical pathway and total costs per case.
    

Detailed description: 
      Data of patients undergoing elective cholecystectomy for symptomatic cholecystolithiasis were
      collected over two different periods: a clinical pathway in form of a paper based check-list
      (check-list group, n=118, or in form of a clinical pathway integrated into the paper based
      medical treatment and nursing documentation (integrated clinical pathway group, n=123. A
      standardized clinical pathway for elective laparoscopic cholecystectomy in form of a check
      list was initially established in 2008 and evaluated during a 6-month period (August 2011
      until January 2012) at the University of Tuebingen. The integrated clinical pathway was
      evaluated during a 6-month period after an introduction phase of 2 months (November 2012
      until April 2013). The contents of both clinical pathways were identical, especially
      concerning the standardization of perioperative fluid management, perioperative monitoring,
      nutrition, analgesia, reserve medications, preoperative and postoperative examinations,
      detailed laboratory blood testing, nursing standards and planned discharge.

      Primary outcome measure was the compliance to the clinical pathway defined as an adherence of
      more than 80% to the presetted pathway items.
    

Intervention name(s): clinical pathway
Intervention type(s): Other
Intervention description(s): implementation of a standardized clinical pathway
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients undergoing elective laparoscopic cholecystectomy
      
Keywords: cholecystectomy, check list
Effect of Apelin on Insulin Sensitivity in Type 2 Diabetic Volunteers
Condition: Diabetes
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      Preclinical studies have demonstrated in mouse models that (PYR1)-apelin-13 exerts a
      glucose-regulating action in vivo. The (PYR1)-apelin-13 effect on insulin sensitivity in
      healthy overweighed volunteers has been previously assessed in a phase I clinical trial
      (APELINS study; NCT02033473). The APELINS-2 clinical trial aims to expand the initial proof
      of concept to the population targeted by future innovative insulin-sensitizing therapies:
      patients living with type 2 diabetes.
    

Detailed description: 
      Insulin sensitivity is measured using the hyperinsulinemic euglycemic glucose clamp method.
      The hypothesis of the investigators is that a continuous (pyr1)-apelin-13 infusion improves
      insulin sensitivity of type 2 diabetic patients compared to placebo infusion.

      This study could bring new elements for understanding the pathophysiology of insulin
      resistance and type 2 diabetes mellitus in humans and could lead to the development of
      innovative therapies in type 2 diabetes mellitus.
    

Intervention name(s): apelin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Assessing the difference between the insulin sensitivity measured during hyperinsulinemic euglycemic clamps in the presence of a 2 hours continuous infusion of (PYR1)-apelin-13 (30nmol/kg) versus a 2 hours continuous infusion of placebo (vehicle alone).; 2 hours continuous infusion of placebo (vehicle alone) to compare with 2 hours infusion of apelin
Other intervention name(s): [pyr1]-apelin-13 infusion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Type 2 diabetic volunteers
Symptom Clusters in Children With Leukemia
Condition: Childhood Leukemia
MeSH terms: Leukemia; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to examine the phenotypic and genotypic characteristics and
      their associations with symptom clusters experienced during treatment for childhood leukemia.
    

Detailed description: 
      A repeated measures research design will evaluate phenotypic and genotypic treatment-related
      symptom associations experienced by children and adolescents 3-17 years of age with a
      diagnosis of leukemia.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children between 3-18 years of age undergoing treatment for leukemia.
      
Biospecimen description: 
      A baseline CSF sample will be obtained prior to intrathecal chemotherapy. CSF biomarkers will
      be obtained at the initiation of post-induction, 4 and 6 months into post-induction therapy,
      and at the start of maintenance therapy.A saliva sample will be obtained for genotypic
      analysis at one of the four data collection times.
Pilot Study of the Use of ULTRABRAID PLUS SUTURE in the Repair of Tears of the Rotator Cuff
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The primary objective of this study is to obtain safety data on the use of the ULTRABRAID
      PLUS SUTURE, and to assess the preliminary effectiveness of the use of the ULTRABRAID PLUS
      SUTURE in comparison to the ULTRABRAID SUTURE in patients undergoing rotator cuff repair.
    

Detailed description: 
      The primary objective of this two-arm, randomized, single-blind pilot study is to obtain
      safety data on the use of the ULTRABRAID Plus Suture and to assess the preliminary
      effectiveness of the use of the ULTRABRAID Plus Suture in comparison to the ULTRABRAID Suture
      in subjects undergoing rotator cuff repair. The primary endpoint of the 6-month postoperative
      analysis is to assess rotator cuff integrity at 6 months, defined as the proportion of
      subjects with a re-tear of the rotator cuff as measured by high-resolution ultrasound.

      Secondary endpoints include:

      rotator cuff integrity at the other time points, as well as between arms (1, 3, 6 weeks and
      3, 12 months); difference in tissue thickness and muscle atrophy using high-resolution
      ultrasound between baseline (preoperative) and all postoperative time points (1, 3, 6 weeks
      and 3, 6, 12 months); difference in tendon echogenicity and vascularity using Doppler
      ultrasound between baseline (preoperative) and all postoperative time points (1, 3, 6 weeks
      and 3, 6, 12 months); difference in Constant Shoulder Assessment score and Western Ontario
      Rotator Cuff (WORC) Index between baseline (preoperative) and all postoperative time points
      (1, 3, 6 weeks and 3, 6, 12 months); rehabilitation:

        -  time to active-assisted rehab exercises

        -  time to isometric rehab exercises

        -  time to discontinuation of an arm sling lab results (C-Reactive Protein [CRP],
           Erythrocyte Sedimentation Rate [ESR] and Butyric Acid Levels) at 1, 3, and 6 weeks
           postoperatively; adverse event (AE) rates (all categories).
    

Intervention name(s): ULTRABRAID PLUS SUTURE; ULTRABRAID SUTURE
Intervention type(s): Device; Device
Intervention description(s): Rotator Cuff Repair with ULTRABRAID PLUS SUTURE; Rotator Cuff Repair with ULTRABRAID SUTURE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Rotator Cuff Tear; Supraspinatus Tear
Influence of Physical Exercise on Semen Quality
Condition: Sexual Abstinence
Study type: Observational

Summary: 
      Our study addresses a previously selected population or by physical activity but not for
      semen quality semen donor candidates donation program within the clinic.

      Total physical activity was analyzed according to the universally accepted international
      physical activity questionnaire (IPAQ) The existence of confounding factors associated She
      purge age, snuff, weight, BMI, alcohol, drugs, type of sport and associated blood parameters
      determinations will be made to exercise.
    

Detailed description: 
      The level of physical activity recommended great unknown and its influence from the
      therapeutic point of view to improve semen quality.

      For it will be held:

        -  3 groups of physical activity are established, according to their score in the IPAQ:
           High, minimum of physical activity between > 1500 MET week Moderate: minimum of physical
           activity of between 600- 1500 MET week Low : until < 600 MET week

        -  Implementation of a double analysis: Seminal and hormonal

        -  Standardization of confounding factors associated with the individual
    

Intervention name(s): International Physical Activity Questionnaire (IPAQ)
Intervention type(s): Other
Intervention description(s): all candidates for sperm donors clinic IVI IVI Bilbao and Valencia were will provide the international physical activity questionnaire (IPAQ) attached to analyze the total physical activity. This will be self-completed questionnaire beforeSperm donation. (Appendix 1) Age, snuff, weight, BMI, alcohol, drug use and the type of sport that practices will be analyzed: Additionally a tab for each donor collecting the existence of associated factors be drawn. (Appendix 2)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Candidates for sperm donors in the donation program which aims clinic It is performed in
        432 cases. For that, our study addresses a population previously selected either by
        physical activity or by semen quality
Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start vs. Corifollitropin-alfa Standard Start in Expected Poor, Normal and High-responders Undergoing IVF
Condition: Fertility Disorders
Study type: Interventional

Summary: 
      To compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard
      CF-alfa protocols (day 2) in patients undergoing IVF. The primary analysis will be also
      performed in specific subgroups of patients: expected poor-responders, expected normal
      responders and expected hyper-responders
    

Detailed description: 
      The investigators hypothesize that:

        1. CF-alfa late start (day 4) will show comparable efficacy in terms of number of retrieved
           oocytes versus standard CF-alfa (day 2) protocol. In certain groups of patients, CF-alfa
           late start might show differences in terms of efficacy such as in poor-responder
           patients.

        2. CF-alfa late start (day 4) will obtain similar results in terms of vital pregnancy rates
           with a similar safety profile with respect to COS performed using CF-alfa standard
           administration (day 2) in expected normal, poor, or high responders.

        3. Oocytes and embryos obtained using CF-alfa late start will have comparable morphological
           features and development potential than those obtained with CF-alfa standard.

        4. The patients' satisfaction will possibly be higher using CF-alfa late start than with
           CF-alfa standard expecially in those patients who will not have the need to add further
           daily recFSH injections
    

Intervention name(s): Corifollitropin Alfa
Intervention type(s): Drug
Intervention description(s): late start (day 4) vs. corifollitropin-alfa standard start (day 2)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assess Efficacy in Subjects With Traumatic Spinal Cord Injury
Condition: Erectile Dysfunction; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Erectile Dysfunction; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Assess efficacy of Vardenafil in patients with traumatic spinal cord injury
    


Intervention name(s): Vardenafil (Levitra, BAY 38-9456), 10 mg; Placebo; Vardenafil (Levitra, BAY 38-9456), 20 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.; 10/20 mg placebo in sequence in respective arm; 20 mg vardenafil was administered with a glass of water 1 h before starting the test with the stimulator.
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Spinal cord injury; Urodynamic; Erectile dysfunction; Vardenafil
Single Escalating Dose Study Of HSK7653 In Healthy Subjects
Condition: T2DM (Type 2 Diabetes Mellitus)
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD)
      characteristics of single dose of HSK7653 tablets in healthy adult subjects, and to identify
      the metabolites of HSK7653 in healthy adult subjects
    


Intervention name(s): HSK7653; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HSK7653 tablets in six doses beginning at 5 mg and rising to 150 mg; Matching placebo tables in six doses beginning at 5 mg and rising to 150 mg
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Serum Lipid Profiles in ITP: a Retrospective Study
Condition: Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Observational

Summary: 
      The project was retrospectively undertaking by Qilu Hospital of Shandong University in China.
      In order to investigate the correlations between platelet indices, serum lipids and bleeding
      symptoms in ITP.
    

Detailed description: 
      Background: Immune thrombocytopenia (ITP) is an autoimmune hemorrhagic disease characterized
      by increased platelet destruction and impaired thrombopoiesis. Platelet indices changes
      depending on the morphology and volume of platelets. Serum lipids have been found to affect
      platelet formation and activity in certain diseases, thus induce the corresponding variation
      of platelet indices.

      Objectives: To investigate the correlations between platelet indices, serum lipids and
      bleeding symptoms in ITP.

      Methods: The clinical data from 457 ITP patients were retrospectively collected and analyzed,
      including platelet indices, serum lipids, hemorrhage and therapeutic regimen.
    

Intervention name(s): ITP patients
Intervention type(s): Other
Intervention description(s): ITP patients were enrolled in this study based on Chinese consensus of ITP.12 Patients were excluded as (1) receiving platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins, ezetimibe and so on.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A total of 457 ITP patients at Department of Hematology of Qilu Hospital were enrolled in
        this study based on Chinese consensus of ITP.12 Patients were excluded as (1) receiving
        platelet transfusion within 7 days or ITP-related medication within 3 months (2) treated
        with lipid-lowing agents, including statins, fibrates, niacin, bile sequestrant resins,
        ezetimibe and so on.
      
Keywords: immune thrombocytopenia
Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee Surgery
Condition: Pain; Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and efficacy of self-titration to effective analgesia with inhaled
      AeroLEF in patients with moderate/severe acute pain in the post-surgical setting.
    

Detailed description: 
      After elective ACL knee surgery, consented patients will receive a single dose of AeroLEF for
      moderate/severe acute pain. Patients stop dosing if they achieve analgesia, complete the
      maximum available dose, or experience dose-limiting side effects.
    

Intervention name(s): AeroLEF
Intervention type(s): Drug
Intervention description(s): Inhaled AeroLEF (Liposome-Encapsulated Fentanyl 500 mcg/mL)
for nebulized administration as required by the patient.
Up to a 6 mL volume (2 x 3 mL doses) containing 500 mcg/ml fentanyl.
Other intervention name(s): Liposome-Encapsulated Fentanyl
Intervention MeSH terms: Fentanyl
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Post Op pain; Fentanyl; Pain Control; Surgery