bioihbjkbjnl/mcl2 huggingface dataset:
CoPPer Study - Complications of Polycystic Ovary Syndrome (PCOS) Pregnancy: Evaluating Risk
Condition: Pregnancy Complications; Delivery Complications; Neonatal Complications
MeSH terms: Polycystic Ovary Syndrome; Pregnancy Complications
Study type: Observational

Summary: 
      The CoPPer study is a follow-up study of women diagnosed with Polycystic Ovary Syndrome
      (PCOS). Women will be included pre-conceptional and followed-up until after delivery. The
      investigators will design a multivariate prediction model of pregnancy outcome in women with
      PCOS with the intention to define intervention strategies for the future.
    

Detailed description: 
      Background of the study:

      PCOS is a heterogeneous condition in which metabolic disturbances such as insulin resistance
      are common. Pregnancies in women with PCOS are reported to have an increased chance of being
      complicated by gestational diabetes, pregnancy induced hypertension and pre-eclampsia.
      Subsequently their offspring are reported to have a lower birth weight and higher risk of
      admission to a neonatal intensive care unit. However, the cause of increased complication
      rate is not yet identified.

      There is evidence that intra-uterine conditions as well as pre- and periconception factors
      influence not only neonatal outcome, but also long-term health of the child. Therefore early
      detection and treatment of pregnancy complications is important for both mother and child.

      In order to identify high risk PCOS pregnancies, the specific effects of PCOS on pregnancy in
      comparison to the background effects need further investigation.

      Preconceptional risk assessment of PCOS women is needed to improve antenatal health care and
      pregnancy outcome of PCOS pregnancies in the future.

      Objective of the study:

      To design a multivariate prediction model of pregnancy outcome in women with PCOS with the
      intention to define intervention strategies for the future.

      Study design:

      Prospective multi-centre follow-up cohort study.

      Method:

      Women with PCOS will be screened and included in the study pre-conceptionally.
      Endocrinological values, glucose tolerance and ultrasound scan etc will be recorded. During
      pregnancy, blood samples will be stored regularly and glucose measurement will be done.
      Post-partum the pregnancy outcome will be recorded.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with PCOS and a wish to conceive who attend to the University Hospital in Utrecht.
      
Biospecimen description: 
      Whole blood, serum and lithium heparine, urine and placenta tissue
    
Keywords: PCOS; Polycystic Ovary Syndrome; Pregnancy Complications; Gestational Diabetes; Pre eclampsia; Prediction Model; Pre conceptional
Analgesic Effect of Erector Spinae Plane Block for Renal Colic Pain
Condition: Renal Colic
MeSH terms: Colic; Renal Colic
Study type: Interventional
Phase: Phase 4

Summary: 
      Plane blocks have become very popular in recent years with the introduction of
      ultrasonography into the regional anesthesia and algology practice. Erector spinae plane
      (ESP) block involves the injection of local anesthetics between erector spinae muscles and
      transverse process of vertebrae and can block the dorsal and ventral rami of thoracolumbar
      spinal nerves.

      The aim of this study was to evaluate the analgesic efficacy of the erector spine plane block
      for reno-ureteral colic.
    


Intervention name(s): 30 ml %0.25 bupivacaine; Dexketoprofen-trometamol
Intervention type(s): Drug; Drug
Intervention description(s): Ultrasound-guided erector spinae plane block; 50 mg Dexketoprofen-trometamol intravenous
Intervention MeSH terms: Dexketoprofen trometamol; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
White Matter Integrity According to BDNF Genotype After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      The aim of this study was to investigate differential plastic changes of fractional
      anisotropy (FA) in the corticospinal tract (CST), the intrahemispheric corticocortical tract
      from the primary motor cortex to ventral premotor cortex (M1PMv) and the corpus callosum (CC)
      from 2 weeks to 3 months after stroke according to BDNF genotype.
    

Detailed description: 
      The aims of this study were to investigate plastic changes in the fractional anisotropy (FA)
      of three motor-related white matter fibers according to the BDNF genotype from 2 weeks to 3
      months after stroke onset; one is a the majority of fibers from M1 to medullary oblongata
      (CST), another is the intrahemispheric connection from M1 to ventral premotor cortex (M1PMv),
      and the other is the interhemispheric connection between bilateral M1s (CC). There were also
      to investigate the relationships between motor impairment and tract-related FA of white
      matter tracts in each BDNF genotype
    

Intervention name(s): observational study
Intervention type(s): Other
Intervention description(s): This study is a longitudinal observational study
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with ischemic stroke who were admitted to Samsung Medical Center and transferred
        to the Department of Physical and Rehabilitation Medicine
      
Biospecimen description: 
      brain-derived neurotrophic factor (BDNF) genotype single nucleotide polymorphism (SNP): a
      methionine (Met) substitution for valine (Val) at codon 66 (Val66Met; rs6265)
A Study to Assess the Safety, Tolerability and PK Profile of FDL176 in Healthy and CF Participants
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 5-part study of FDL176. Part 1 is a double blind, placebo-controlled, dose
      escalation study in healthy male participants. Part 2 is a single dose, open-label study in
      healthy male participants. Part 3 is a single dose, double blind, placebo-controlled study in
      healthy female participants. Part 4 is a randomised, double-blind, placebo-controlled,
      dose-escalation study in healthy male and female participants.Part 5 is a single dose,
      open-label study in male and female participants with CF.
    

Detailed description: 
      This is a 5-part study. Part 1 is a double blind, placebo-controlled, dose escalation,
      first-in-human study to assess the safety, tolerability and PK profiles following single oral
      administration of FDL176 to healthy male participants. Part 2 is a single dose, open-label
      study in healthy male participants to determine the effect of food on the PK profile of
      FDL176. Part 3 is a single dose, double blind, placebo-controlled study in healthy female
      participants to assess the PK, safety and tolerability profiles of FDL176. Part 4 is a
      randomised, double-blind, placebo-controlled, dose-escalation study to assess the safety,
      tolerability and PK profiles following multiple oral administrations of FDL176 to healthy
      male and female participants. Part 5 is a single dose, open-label study in male and female
      participants with CF to determine the PK profile of FDL176.
    

Intervention name(s): FDL176; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CFTR modulator; Placebo for FDL176
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 5-part study. Part 1,3,4: parallel assignment; Part 2: cross over assignment; Part 5: single assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cystic Fibrosis
Creation of an Algorithm for the Personalisation of Pedalling Exercises
Condition: Aging
Study type: Interventional

Summary: 
      The aim of the EXO-MODE project is to develop an innovative algorithm for the personalisation
      of Concentric and / or Eccentric training programmes adapted to the individual to improve the
      efficiency and tolerance. This algorithm will make it possible to personalise trainings
      programmes according to the different profiles of subjects, determined on the basis of their
      personal characteristics (age, sex, comorbidities), their exercise capacity and muscle
      performance, their level of motivation and their perception of the workload, and of the
      principal objective of the training programme. The final goal is to develop a tool to allow
      elderly populations to exercise more easily and more effectively.
    


Intervention name(s): pedalling exercises
Intervention type(s): Other
Intervention description(s): pedalling exercises on a bicycle ergometer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluation of PSMA Antagonist Produced by Two Different Methods
Condition: Metastatic Prostate Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Patients with metastatic prostate cancer will undergo two protocol 68Ga-PET scans within
      24-48 hours with 68Ga-PSMA-cyclotron and 68Ga-PSMA-generator radiotracers. The goal of the
      study is to evaluate repeatability and equivalence across the different 68Ga-PSMA production
      methods. This research study is being conducted to assess whether the PET/CT imaging results,
      as generated from the two different 68Ga production methods, are equivalent.
    

Detailed description: 
      Patients with metastatic prostate adenocarcinoma will be enrolled in the study and will
      undergo two 68Ga-Prostate Specific Membrane Antigen- Positron Emission Tomography (PSMA-PET)
      scans within 24-48 hours. The difference between the two scans is that the radiotracer used
      in each scan will be produced with a different method (68Ga-PSMA-cyclotron and
      68Ga-PSMA-generator produced). The first scan will occur after a baseline clinical
      evaluation, which will include a history, physical, and baseline lab draw. After each scan,
      blood draws will be obtained.

      The purpose of this study is to evaluate equivalence of two processes to create
      68Ga-HBED-PSMA and compare dosimetry, biodistribution and whole body excretion/ metabolism.
      Furthermore, the research team will perform dynamic analysis of the PET scans to investigate
      repeatability of whole-body 68Ga-PSMA-generator Ki Patlak imaging against that of
      conventional whole-body 68Ga-PSMA- SUV imaging and evaluate equivalence of whole-body
      68Ga-PSMA Ki Patlak imaging between the two processes to create 68Ga-HBED-PSMA
      (68GA-PSMA-cyclotron vs. 68Ga-PSMA-generator). Patients will afterwards receive standard of
      care treatment and follow up imaging.
    

Intervention name(s): 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron
Intervention type(s): Drug
Intervention description(s): 68Ga-PSMA-generator vs. 68Ga-PSMA-cyclotron; single dose each, approximately 100-300 mBq.
Other intervention name(s): Prostate specific membrane antigen imaging (PSMA)
Intervention MeSH terms: Gallium 68 PSMA-11
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Prostate Cancer
Autologous Serum Skin Testing in Patients With Atopic Dermatitis Autologous Serum Skin Testing in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis, Serum Skin Test
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      Recently, IgE-type autoantibodies against self proteins have been detected in the serum of
      the atopic dermatitis patients. The role of this IgE autoantibodies involved in the
      pathogenesis of atopic dermatitis is not known, yet. But, there may be a correlation between
      the severity of the disease and the serum levels of this autoantibodies. The autologous serum
      skin testing is applied to both atopic dermatitis patients and healthy control and the
      results are estimated in this study.The investigators detected 70% positive autologous serum
      skin testing in atopic dermatitis patients and test positivity was higher in patients with
      atopy history, moderately severe disease calculated by SCORAD index and high serum IgE
      levels.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        90
      
Keywords: Atopic dermatitis, autologous serum skin testing, IgE autoantibodies
Evaluation of the Effect of Adding Dexamethasone to 2% Lidocaine
Condition: Pulpitis - Irreversible
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      This randomized, double-blind clinical trial aimed at the evaluation of the effect of adding
      dexamethasone to 2% lidocaine, given as inferior alveolar nerve block in the endodontic
      management of symptomatic irreversible pulpitis. One hundred and twenty four patients
      received one of the three IANB injections before the endodontic treatment: 2% lidocaine with
      1:80 000 epinephrine; 2% lidocaine with 1:80 000 epinephrine mixed with 2mg dexamethasone;
      and plain 2% lidocaine mixed with 2mg dexamethasone. The anesthetia was considered successful
      if the patients experienced no pain or faint/weak/mild pain during root canal access
      preparation and instrumentation (HP VAS score <55 mm). The effect of intraligamentary
      injections on maximum heart rates was also recorded.
    


Intervention name(s): Lidocaine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Inferior alveolar nerve block
Other intervention name(s): dexamethasone
Intervention MeSH terms: Dexamethasone; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Technology-assisted Case Management in Adults With Type 2 Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to help low income patients achieve and maintain better
      self-management skills and improve blood sugar levels, using a 2-in-1 blood glucose and blood
      pressure monitoring system and nurse case management. Patients must be served at a Federally
      Qualified Health Center (FQHC) in coastal South Carolina.
    

Detailed description: 
      The long-term goal is to develop a practical and sustainable system of diabetes management
      that will help low income patients achieve and maintain goals within established treatment
      guidelines regardless of geographic location. This randomized clinical trial will employ the
      innovative FORA system, an inexpensive, off-the-shelf, state-of-the-art technology comprised
      of a 2-in-1 Blood Glucose and Blood Pressure monitor, coupled with nurse case management
      (TACM) to optimize diabetes care for low income, rural adults with type 2 diabetes (T2DM).
      The target population will be low income patients served in Federally Qualified Health Care
      Centers (FQHCs) with poorly controlled T2DM residing in coastal South Carolina. Two hundred
      patients will be randomly assigned to two groups of 100 patients each; Group A (Usual Care)
      and Group B (Technology-assisted Case Management, TACM). Each patient will be followed for 6
      months, with study visits at baseline, 3, and 6 months. The primary outcome will be
      Hemoglobin A1c (HbA1c) at 6 months post-randomization while the secondary outcomes will be
      blood pressure control and quality of life (qol) at 6 months post-randomization.
    

Intervention name(s): Technology-Assisted Case Management
Intervention type(s): Behavioral
Intervention description(s): The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time. Patients will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. They will be asked to perform glucose testing and blood pressure measurement using the FORA system once daily. They will be asked to upload the measurements daily as soon as possible after the test is performed. The nurse case manager will have access to a secure server to which the uploaded measurements are stored in real time. Medications are titrated under supervision of a primary care and endocrinology physicians
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 2 diabetes; nurse case management; telemedicine
Effects of Exogenous Ketones in Healthy Young Adults
Condition: Healthy Young Adults
Study type: Interventional

Summary: 
      Exogenous ketone supplements in the form of beta-hydroxybutyrate can be utilized as an
      alternate energy source (in place of glucose) for all cells except red blood cells. Exogenous
      ketone administration has been shown to be beneficial in terms of reducing oxidative stress,
      improving neuronal energy supplies, and maintaining normal blood glucose levels. The purpose
      of this study is to determine the effects and safety of supplementing with exogenous ketones
      for 6-weeks in healthy college-aged males and females. The results of this proposed study
      will determine whether exogenous ketone supplementation can be useful in promoting better
      body composition, energy levels, and blood cholesterol, glucose, and insulin levels.
    

Detailed description: 
      A total of 22 subjects, male and female, were randomized to either a ketone salt group or a
      placebo group. Both the participants and investigators were blinded, as the supplements were
      coded by an external lab. Data was collected at baseline and again in 6-weeks. Participants
      consumed 2 servings of the assigned supplement daily for 6 weeks. Measures included body
      composition, blood pressure, questionnaires, blood work (comprehensive metabolic panel,
      complete blood count, and lipid panel), and a urinalysis. Also, blood ketone levels were
      assessed before and periodically after consuming the supplemental drink (30 and 60 minutes
      post drink). These measures were performed at both baseline and 6-weeks later.
    

Intervention name(s): Ketone Salts
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will take 2 servings of ketone salts daily for 6 weeks
Other intervention name(s): Exogenous Ketone Salts, Pruvit Keto OS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blinded, 2-groups (condition and placebo)
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: exogenous ketone salts; ketosis; safety; comprehensive metabolic panel; complete blood count; lipid panel; insulin
A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children
Condition: Virus Diseases
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and reactogenicity of a single IM dose of
      the GSK3390107A (ChAd3 EBO-Z) vaccine, overall and in children aged 1 to 5, 6 to 12, and 13
      to 17 years, separately.

      Considering the risk of exposure to Ebola and the potential (based on animal data) for the
      investigational GSK3390107A (ChAd3-EBO-Z) vaccine to afford at least partial protection, all
      children in the study will receive the investigational GSK3390107A (ChAd3 EBO-Z) vaccine. The
      children in the Group GSK3390107A+Nimenrix will receive the investigational GSK3390107A
      (ChAd3-EBO-Z) vaccine at Day 0 of the study, whereas the children in the Group
      Nimenrix+GSK3390107A will receive Nimenrix at Day 0 (as a control). At Month 6, the children
      in the Group Nimenrix+GSK3390107A will receive the investigational GSK3390107A (ChAd3-EBO-Z)
      vaccine (provided that no safety concerns are raised), whereas the children in the Group
      GSK3390107A+Nimenrix will receive Nimenrix.
    


Intervention name(s): GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A); Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): A single dose administered intramuscular; A single dose administered intramuscular
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Protection against Ebola Zaire virus
Stretching Isquiotibials in Water and on Land in Healthy Adutls
Condition: Muscle Relaxation
Study type: Interventional

Summary: 
      Comparison of therapeutic intervention to gain range of motion at the hip joint within
      therapeutic in water and on land. Stretching is a therapeutic maneuver used to increase the
      length of shortened soft tissue structures and thereby gain range of motion; for that,
      innumerable procedures within Physiotherapy use it for the benefit of patients. The work in
      question is justified by the need to seek the means that can promote a better performance in
      the application of the stretching procedure, called Proprioceptive Neuromuscular
      Facilitation, in a universe of pre-selected volunteers. It is a relevant and feasible study,
      hoping that its results may benefit future patients, with better results and faster
      responses. What is the medium that leads to better results in a program using the
      proprioceptive neuromuscular facilitation technique? Hypotheses: a - Probably the heated
      aquatic environment, in a range of 32 ° to 36 ° C, will promote a better result, since the
      heat increases the collagen's distensibility. b - Perhaps the heat, by increasing the
      excitability threshold of nerve fibers, triggers the "protective reflex" later, which may
      promote a more vigorous elongation without the protective response. c - Possibly the
      relaxation promoted in the aquatic environment, could influence the gains obtained in the
      swimming pool.
    

Detailed description: 
      Comparison of therapeutic intervention to gain range of motion at the hip joint within
      therapeutic in water and on land.
    

Intervention name(s): Flexibility training
Intervention type(s): Other
Intervention description(s): Flexibility training was carried out over a period of six weeks, with two sessions per week, totaling 12 sessions.
Other intervention name(s): streching training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Clinical Trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Passive; Stretching; Water; Proprioceptive Neuromuscular Facilitation (PNF)