bioihbjkbjnl/mcl2 huggingface dataset:
Fear of Movement, Functionality and Quality of Life in Elite Athletes With an Ankle Instability History
Condition: Ankle Sprains
MeSH terms: Ankle Injuries
Study type: Observational

Summary: 
      Ankle sprain is frequently experienced by individuals participating in different sports
      activities. Ankle sprains have been shown to result in a decrease in level of physical
      activity and persistence of some symptoms for a long time. In this case, it is predicted that
      ankle sprains may affect the quality of life as well as functionality. Also, ankle sprain
      history may result in increased fear of movement, which may delay return to sports. This
      study aimed to examine the relationship between foot and ankle functionality, fear of
      movement and quality of life of elite athletes with a history of ankle sprain.
    


Intervention name(s): Questionnaires
Intervention type(s): Behavioral
Intervention description(s): Assessing the behavioral metrics (quality of life, functionality and fear of movement) with appropriate measurement tools
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Athletes who are participating in sportive activities regularly
      
Keywords: Quality of life; Fear of movement; Functionality; Ankle sprain
A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
Condition: Falciparum Malaria
MeSH terms: Malaria, Falciparum
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine bioequivalence of amodiaquine suspension ( Pfizer)
      and the WHO approved reference product Flavoquine® tablet ( Sanofi Aventis).
    


Intervention name(s): Flavoquine®, Camoquin® Suspension; Flavoquine®, Camoquin® Suspension
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A 15.3 mL (50 mg/5 mL) AQ suspension single dose. Treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis) single dose.; Treatment A 15.3 mL (50 mg/5 mL) AQ suspension single dose. Treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis) single dose.
Other intervention name(s): amodiaquine; amodiaquine
Intervention MeSH terms: Amodiaquine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amodiaquine suspension; Flavoquine tablets; Bioequivalence study
Healthy Habits Program for High Cardiovascular Risk Patients: Randomized Controlled Clinical Trial
Condition: Health Behavior; Motor Activity; Food Habits
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of a program to improve habits in
      a population with cardiovascular disease, comparing two different educational techniques
      (cognitive behavioral therapy group vs. informational workshops).
    


Intervention name(s): Cognitive Behavioral Therapy; Informational Workshop
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in this arm will be invited to attend 8 weekly group meetings and 3 monthly follow-up meetings. In each meeting a coordinator will explore the experiences of the participants and encourage them to look for strategies to solve problems associated with changing habits. In the meetings we will use a therapeutic education approach with motivational interviewing techniques and problem solving in order to increase self-efficacy and motivation to adopt healthy habits. There will be periodic reminders and telephone contacts with patients before the meetings to assess the achievement of objectives.; Participants will be invited to participate in 4 weekly group meetings and an additional reinforcing meeting in the 5th month. In each meeting, workshop techniques will be used, together with educational materials as brochures, pictures, etc. The informational material will focus on the benefits of lifestyle changes in diet and physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Therapy; Health Education; Secondary Prevention; Cardiovascular Disease
A Personal Microbiome-dependent Glucose Response in Healthy Young Volunteers
Condition: Blood Glucose, High
Study type: Interventional

Summary: 
      Individuals eating identical meals present high variability in post-meal blood glucose
      response making comparisons challenging. This study evaluates in 40 healthy and fasted
      participants whether the postprandial glucose response upon a standardized breakfast is
      dependent on gut microbial richness. Gastric emptying rate, intestinal transit time, insulin,
      appetite hormones and measures of the intestinal microbiome and fermentation will also be
      analyzed in the context of postprandial glucose metabolism.
    

Detailed description: 
      Elevated blood glucose levels constitute a major risk factor for pre-diabetic and diabetic
      patients. Postprandial glucose tests have been used for decades to monitor and compare
      glucose responses. Yet, individuals eating identical meals present high variability in
      post-meal blood glucose response making comparisons challenging. A recent landmark study
      showed that the inter-individual variation of postprandial glucose responses was associated
      with multiple person-specific factors including faecal microbiome factors. Gut microbial
      richness has for a long time been considered a hallmark of gut health and stability.
      Furthermore, microbial richness has been associated with colonic transit time, which together
      with the gastric emptying rate appear to be major determinants of the initial glycaemic
      response to carbohydrate-containing meals. Therefore, the aim of the study is to investigate
      whether postprandial glucose responses are associated with gut microbial richness, as well as
      secondary measures including gastric emptying rate, intestinal transit time and gut microbial
      composition and fermentation.

      In an acute-meal study, 40 healthy fasted participants will consume a standardized breakfast
      including one tablet of paracetamol (for estimating gastric emptying rate) and 300 mL of
      juice.
    

Intervention name(s): Standardized breakfast
Intervention type(s): Other
Intervention description(s): One tablet of paracetamol (500 mg) and a glass of water (150 mL) is consumed followed by a breakfast consisting of white bread, butter, jam, and juice (300 mL) and
Intervention model: Single Group Assignment
Intervention model description: Acute meal test
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glucose tolerance; Gut microbiota; Microbial richness; Gastric emptying; Metabolomics
Using the Norm Range to Predict the Effect of Food Portion Size Reductions on Compensation Over 5 Days
Condition: Portion Size
Study type: Interventional

Summary: 
      Reducing food portion size is a potential strategy to reduce energy intake. However it is
      unclear at what point consumers compensate for reductions in portion size by increasing
      energy intake from other items. This could result in no overall benefit of reducing food
      portion sizes. The investigators tested the hypothesis that reductions to the portion size of
      components of a main meal will only result in significant compensatory eating when the
      reduced portion size is no longer visually perceived as 'normal'. In a crossover experiment,
      participants were served different sized portions during lunch and dinner over 5 days: a
      'large-normal', a 'small-normal', and a 'smaller than normal' portion. Intake from all other
      meal components consumed in the laboratory were measured.
    


Intervention name(s): portion size
Intervention type(s): Behavioral
Intervention description(s): Smaller than normal portion size - the intervention is the main meal component size perceived as 'smaller than normal' that participants are provided with during lunch and dinner in the laboratory.
Small-normal portion size - the intervention is the main meal component size perceived as 'small-normal' that participants are provided with during lunch and dinner in the laboratory.
Large-normal portion size - the intervention is the main meal component size perceived as 'large-normal' that participants are provided with during lunch and dinner in the laboratory.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
VNRX-5024 Safety and PK in Healthy Adult Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part dose-ranging study to evaluate the safety and pharmacokinetics of escalating
      doses of VNRX-5024. Subjects will be enrolled in one of three dose cohorts. They will receive
      a single dose on Day 1 in Part 1 and will proceed into the multiple dose Part 2 of the study
      after safety assessments and PK samples are collected. In the multiple dose part of the
      study, subjects will receive multiple doses of VNRX-5024 for 10 days.
    


Intervention name(s): VNRX-5024; Placebo for VNRX-5024
Intervention type(s): Drug; Drug
Intervention description(s): Part 1: one dose
Part 2:
Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours [q12h] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours [q8h] dosing for 9 days with a single morning dose on Day 10); Part 1: one dose
Part 2:
Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours [q12h] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours [q8h] dosing for 9 days with a single morning dose on Day 10)
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Intravesical Gemcitabine Instillation Followed by Transurethral Resection for the Treatment of Patients With Superficial Bladder Cancer at Low Risk.
Condition: Superficial Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether neoadjuvant intravesical Gemcitabine is
      enough active in patients with a solitary, low risk superficial bladder cancer.After
      diagnostic urethrocystoscopy or bladder sonography, all patients will receive intravesical
      gemcitabine once a week during 6 weeks. Two weeks after finishing antiblastic therapy, all
      patients will be submitted to a new cystoscopy, with TUR or cold biopsies of the site of the
      initial lesion.
    


Intervention name(s): Gemcitabine
Intervention type(s): Drug
Intervention MeSH terms: Gemcitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Performance Evaluation of the AutoLap System
Condition: Patients Scheduled for Hernia Repair, Cholecystectomy, Right Colectomy, Nissen Fundoplication and Sigmoid Resection
MeSH terms: Hernia
Study type: Interventional

Summary: 
      The main objectives of this study are to evaluate the safety and performance of the AutoLap
      system in Laparoscopic Cholecystectomy procedures.
    


Intervention name(s): active laparoscope positioner (AutoLap)
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: laparoscopic Cholecystectomy; Gallbladder removal; laparoscope holder
MRI Imaging of Labeled Human Islets Transplanted Into the Liver
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of the study is to determine whether human islets labeled by iron contrast agents
      could be imaged using magnetic resonance after transplantation into the liver of Type 1
      diabetic recipients.
    

Detailed description: 
      Islet transplantation represents approved therapeutic approach in selected Type 1 diabetic
      recipients with syndrome of hypoglycaemia unawareness. Existing imaging methods are not
      sufficient to provide adequate information about amount and fate of islets transplanted into
      the liver. Labeling of islets with superparamagnetic contrast agent ferucarbotran
      significantly shortens T2 relaxing time and therefore increase the contrast between islets
      and liver tissue in magnetic resonance imaging. In consequence, islets transplanted into
      liver could be easily detectable like hypotensive areas dispersed throughout the liver. MRI
      examination will be done on 1, 2, 4 weeks and 3, 6 and 12 months.
    

Intervention name(s): Transplantation of labeled islets
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cohort will be selected from residents of Czech republic
      
Keywords: islet transplantation; magnetic resonance; Type 1 DM
Rehabilitation in Multiple Sclerosis: Influence of Exercise on Development of Insulin Resistance, Muscle Power and Aerobic Capacity
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Insulin Resistance; Sclerosis
Study type: Interventional

Summary: 
      the purpose of this study is to investigate the development of insulin resistance in multiple
      sclerosis patients + explaining the effects of a combined training programme on insulin
      resistance, muscle power and aerobic capacity in multiple sclerosis patients
    


Intervention name(s): Training
Intervention type(s): Behavioral
Other intervention name(s): 24 weeks combined exercise programma (supervised)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: combined training; insulin resistance
Ultrasonographic Assessment of Optic Nerve Sheath Diameter in Children Receiving Caudal Block
Condition: Orchiopexy; Inguinal Hernioplasty; Hydrocelectomy; Diverticulectomy; Fistula Repair; Penoplasty
MeSH terms: Fistula
Study type: Interventional

Summary: 
      The recent study revealed that high-volume caudal block caused reduction in cerebral blood
      flow velocity and cerebral oxygenation. It was supposed to be associated with increased
      intracranial pressure. Ultrasonography of optic nerve sheath diameter shows a good level of
      diagnostic accuracy for detecting intracranial hypertension. The aim of this study is to
      evaluate the effect of caudal block on intracranial pressure in pediatric patients undergoing
      urologic surgery. Eighty patients, aged 6 months to 4 years, receiving caudal block before
      urologic surgery will be divided into high dose group (n=40) and low dose group (n=40).
      Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine
      for caudal block. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15%
      ropivacaine for caudal block. The primary endpoint is the optic nerve sheath diameter after
      caudal block measured by optic nerve ultrasonography.
    


Intervention name(s): 1.0 ml/kg of 0.15% ropivacaine; 1.5 ml/kg of 0.15% ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block before their surgery. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block before surgery.; Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block before their surgery. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block before surgery.
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
A Phase 2A Trial of EPI-743 for Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of EPI-743 in patients with Parkinson's
      disease.
    


Intervention name(s): EPI-743 400mg; EPI-743 200mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ubiquinone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Evaluating Skin Irritation, Phototoxicity and Safety After Administration of LEO 90105 on Intact Skin of Healthy Japanese Male Subjects
Condition: Healthy
MeSH terms: Dermatitis, Phototoxic
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the trial is to investigate skin irritation, phototoxicity and safety of LEO
      90105 and its components by patchtest (48 hours closed patch test and photo patch test) in
      healthy Japanese male subjects.
    


Intervention name(s): LEO 90105
Intervention type(s): Drug
Intervention description(s): Ointment
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Frozen Embryo Transfer in PCOS Patients
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Polycystic ovarian syndrome (PCOS) is condition characterized by being complex, familial and
      polygenetic metabolic condition with heterogeneous involvement of several genes in the
      hypothalamic-pituitary-gonadal axis. PCOS is the most incident endocrine-metabolic syndrome
      that is characterized by hyperandrogenemia, menstrual irregularities, and/or small cysts in
      one or both ovaries and could be considered as the main cause of female infertility.

      Assisted reproductive technologies (ART) were defined by the American Center for Disease
      Control as any fertility-related treatments where eggs or embryos are manipulated. In vitro
      fertilization involves the transfer of fresh embryos, however, the freeze-all strategy that
      entails cryopreservation of all embryos to be transferred subsequently in un-stimulated cycle
      to guard against the negative effects of controlled ovarian stimulation on the endometrium
      and to minimize the risk of ovarian hyper-stimulation syndrome. Intracytroplasmatic sperm
      injection (ICSI) is a common procedure used to improve reproductive results, even among
      couples without male factor infertility.

      However, there are several points of controversy in the fields of ART traditionally, multiple
      embryo transfer strategy was used to increase the chance for getting a baby, however,
      multiple pregnancy is a common complication for this strategy with subsequent adverse fetal,
      maternal and neonatal outcomes. Also, the developmental stage of embryos at time of transfer;
      cleavage versus blastocyst was a matter of debit, but giving the chance for in-vitro
      maturation to the stage of blastocyst increased the possibility of getting good quality
      embryo to be transferred. However, the exaggeration of prolongation of the in-vitro duration
      appeared as a trend, but recent studies found no advantages for transfer of D7 or D6
      blastocyst over D5 blastocyst transfer (BT).
    


Intervention name(s): fertilized embryo Insertion; fertilized embryo Insertion
Intervention type(s): Procedure; Procedure
Intervention description(s): insertion of single fertilized embryo through IVF; insertion of double fertilized embryo through IVF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Laparoscopic Tubal Preservation Surgery
Condition: Ectopic Pregnancy
MeSH terms: Pregnancy, Ectopic; Cardiac Complexes, Premature
Study type: Observational

Summary: 
      Traditionally, salpingectomy has been the standard procedure for managing ectopic pregnancy.
      We would like to evaluate the safety and efficacy of laparoscopic tubal preservation surgery
      in treating ectopic pregnancies (salpingostomy or salpingotomy) while preserving the
      fertility outcome of the patients, as well as to identify the factors predicting the presence
      of persistent ectopic pregnancy after the surgery.
    

Detailed description: 
      All surgically-treated ectopic pregnancies in women aged 20 and above between 01 January 2009
      and 31 December 2016 were identified. Cases receiving laparoscopic salpingostomy or
      laparoscopic salpingotomy were extracted from the database, patient characteristics and
      surgical outcomes (changes of serumβ-hcg, presence of persistent ectopic pregnancy and
      subsequent management, subsequent pregnancy) were reviewed from their medical records.
      Univariate and multivariate logistic regression analysis were employed to predict the
      presence of persistent ectopic pregnancy after laparoscopic tubal preservation surgery.
    

Intervention name(s): laparoscopic salpingotomy or salpingostomy
Intervention type(s): Procedure
Intervention description(s): A 3-port technique (2 x 5-mm and 1 x 10-mm trocars) was implemented. A diluted solution of vasopressin (20IU in 100 mL saline solution) was initially injected into the mesosalpinx of the affected tube, followed by a linear incision which allowed the removal of the gestational tissue. In case of a ruptured tubal pregnancy, the ectopic mass was evacuated directly from the ruptured site using a combination of forceps and suction device. The tubal lumen was either closed with a single-layer of continuous absorbable suture (salpingotomy) or left to heal by secondary intention (salpingostomy).
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        women diagnosed with ectopic pregnancies and underwent laparoscopic tubal preservation
        surgery (including salpingostomy and salpingotomy)
Motivational Interviewing to Promote Maintenance of Physical Activity in People With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the study is to assess the effectiveness of motivational interviewing in
      promoting maintenance of physical activity in people with Type 2 diabetes (T2D) upon the
      completion of a structured exercise program.

      Participants with T2D who are new graduates of a supervised exercise program will be randomly
      assigned to either standard care (SC) or to standard care and in addition, participate in two
      individual motivational interview (MI) sessions (SC + MI).

      The primary outcome will be change in physical activity behavior assessed by the Godin
      Leisure and Exercise questionnaire. Secondary outcomes will include change in blood glucose
      control (A1C), BMI, six minute walk-test, QoL, and self-efficacy.

      Outcomes will be measured in groups at baseline, end of program, 3 months and 6 months
      post-program.
    


Intervention name(s): Motivational interviewing
Intervention type(s): Behavioral
Intervention description(s): Intervention arm will receive 2 motivational interviewing session aimed at increasing maintenance of physical activity upon the completion of a supervised exercise program. Motivational interviews will occur at the end of the structured program and at 3 months post program completion. Outcomes will be collected at 6 months post-program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Type 2 diabetes, motivational interviewing, physical activity maintenance, physical activity adherence