bioihbjkbjnl/mcl2 huggingface dataset:
Investigating the Impact of a Shared Decision-Making Tool
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this research study is to learn more about how the use of a Shared
      Decision-Making Tool (SDMT) will impact a patient's decision-making to pursue treatment for
      knee osteoarthritis.
    

Detailed description: 
      The main purpose of this study is to determine the impact of the SDMT on patient decision-
      making regarding various treatment modalities for knee osteoarthritis. If the SDMT is found
      to be beneficial, it can be implemented to help engage patients in their care and support
      more efficient implementation of treatment suggestions. This subsequently will improve
      patient's quality of life. Getting patients who have not taken advantage of preventive care
      or healthy lifestyles to change is paramount to making the medical experience in America more
      equal for all its citizens and reducing total societal costs. Building provider-patient
      communication tools that resonate with all stakeholders should inform patients as they work
      to make health decisions that reflect their individual beliefs.
    

Intervention name(s): Shared Decision-Making Tool; Video; Standard of Care
Intervention type(s): Other; Other; Other
Intervention description(s): The Shared Decision-Making Tool (SDMT) is designed to provide a personalized, patient- centered framework for clinical discussions regarding treatment options for knee osteoarthritis. The tool functions through patient input of information such as pain severity and current symptoms, alongside other demographic information such as age, race, and comorbidities, to offer a series of outcomes to better illustrate how the patient's specific disease presentation will progress. Ultimately, using the SDMT may impact patient behavior if patients change their treatment preferences after utilizing the tool. This can empower them to seek additional support over time and maintain communication with their orthopedist to ensure they are on a healthier path.; Short video that describes knee osteoarthritis and possible treatment options.; Standard of care counseling for a patient presenting with knee osteoarthritis.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized control trial in which participants will be assigned to one of two arms. Patients in the control arm of the study will watch a short video and then receive standard of care counseling with an orthopaedic surgeon. Patients in the treatment arm of the study will watch a short video and then receive standard of care counseling with an orthopaedic surgeon that includes discussion of the SDMT. All patients will complete pre- and post-visit surveys designed to measure the severity of their knee osteoarthritis and their willingness to proceed with different treatment modalities.
Masking: Single (Participant)
Primary purpose: Other
Vitamin D Supplementation to Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000
      IU per week will result in improved metabolic control in patients with type 2 diabetes.
    

Detailed description: 
      The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000
      IU per week will result in improved metabolic control in patients with type 2 diabetes.

      We will include 70 patients with type 2 diabetes. They will be treated with 40.000 IU
      cholecalciferol per week (or placebo) for 6 months. Metabolic control will be evaluated with
      measurements of glycated hemoglobin, home glucose measurements, and fasting blod glucose and
      serum insulin. Only subjects using insulin at bedtime combined with metformin during the day
      will be included.
    

Intervention name(s): Cholecalciferol (vitamin D); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cholecalciferol capsule 20.000 IU twice per week for 6 months; Placebo capsule twice a week, identical to the cholecalciferol capsules
Other intervention name(s): vitamin D
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; insulin; glycated hemoglobin; cholecalciferol; vitamin D
Peer Mentors for Adolescents in HIV Affected Families
Condition: Adolescent Behavior; Health Behavior; HIV Seronegativity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effectiveness of a peer mentoring program designed for youths
      ages 9 to 15 whose parents or guardians are HIV infected. The program will focus on the
      youths' mental health, school performance, alcohol and drug use, personal and social
      behaviors, and behaviors that might expose them to HIV. The study is expected to enroll
      predominantly minority youth.
    

Detailed description: 
      This study will conduct an efficacy trial of peer mentoring for a high-risk, predominantly
      minority population of 9- to 15-year-old youths whose parents are HIV infected. The study
      will also determine mechanisms (mediating variables) through which peer mentoring improves
      outcomes for the mentees, for example, consistency and continuity of relationship,
      teaching/role modeling, emotional support/empathy, advocacy, and behavioral reinforcement.
      After the conclusion of the efficacy trial, the study will continue through naturalistic
      longitudinal research for an additional 2 years in order to examine the long-term outcomes of
      peer mentoring.

      Participants are randomized to either the peer mentoring program or a control condition (a
      recreation program). Surveys are conducted at entry into the study, at 6 months, 1 year, and
      then annually for 2 years. Youths will also participate in focus groups. The surveys and
      focus groups will assess the youths' psychological functioning, academic adjustment, alcohol
      and drug use, HIV risk behaviors, delinquent/violent behaviors, peer relationships, prosocial
      activities, and coping/problem-solving skills. The study will also evaluate family outcomes,
      including parent/guardian functioning and improved permanency planning.
    

Intervention name(s): Peer mentoring program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: health behavior; adolescent behavior; peer mentoring
Tolerability and Immunogenicity Study of FLUVAL P H1N1 Flu Vaccine of Omninvest in Children and Adolescents
Condition: Novel 2009 Influenza H1N1; Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      This is a single-blind, reference drug controlled study to assess safety and tolerability of
      FLUVAL P H1N1 monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn
      phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children and adolescents. To
      assess, as secondary objective, the efficacy (immunogenicity) of the vaccine by serology
      testing.
    

Detailed description: 
      Primary Objective:

        -  To assess tolerability/safety (incidence of adverse events 21-28 days following
           vaccination) of the study drug.

      Secondary Objectives:

        -  To assess the efficacy (immunogenicity) of the study drug by serology testing of blood
           samples taken at Day 21-28 after immunization in groups and age groups.

        -  To assess long term (180-210 days following vaccination) tolerability/safety (incidence
           of adverse events) of the study drug.
    

Intervention name(s): Vaccination with Fluval P monovalent influenza vaccine; Vaccination with Fluval AB; Vaccination with Fluval AB Novo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant.
Dose: 0.25 ml /total 3 μg HA/ in age group 3-12 years, and 0.5 ml /total 6 μg HA/ in age group 12-18 years, single dose.; Vaccination with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant.
Dose: 0.25 ml /total 3x7.5 μg HA/ in age group 3-12 years, 0.5 ml /total 3x15 μg HA/ in age group 12-18 years, single dose.; Vaccination with Fluval AB Novo trivalent influenza vaccine with 6 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant.
Dose: 0.25 ml /total 3x3 μg HA/ in age group 3-12 years, 0.5 ml /total 3x6 μg HA/ in age group 12-18 years, single dose.
Other intervention name(s): Fluval P; FL-P-K-01/09; Fluval AB; 5609; Fluval AB Novo; FL-K-13/09
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza; Pandemic vaccine; Seasonal vaccine; Prevention; Influenza vaccine; Influenza in humans; Pandemic influenza in humans; Influenza vaccine for children; Influenza vaccine for adolescents; Seasonal vaccine for children; Seasonal vaccine for adolescents
Correlation of Peritoneal Fluid CA-125 Levels With Postoperative Tumor Histology
Condition: Endometrial Carcinoma
MeSH terms: Carcinoma; Endometrial Neoplasms
Study type: Interventional

Summary: 
      In this prospective study, we aimed to investigate whether serum and abdominal washing fluid
      CA-125 levels correlated with postoperative histopathological parameters in patients with
      endometrial carcinoma.
    

Detailed description: 
      Endometrial cancer was diagnosed with histopathological examination of the samples obtained
      by dilatation and curettage. Preoperative serum CA-125 levels were determined in all
      patients. Serum and abdominal washing fluid CA-125 levels were measured with a double
      antibody sandwich immunoenzymatic method, using Beckman Coulter DXI (Ireland) analyzer. In
      addition to routine preoperative investigations, MRI was done in patients who were thought to
      have an extension outside the uterus.

      During surgery, abdominal exploration was performed first, and then an abdominal fluid sample
      was obtained for cytological examination and measurement of CA-125 level. One hundred
      milliliters of normal saline was used as the abdominal washing liquid to obtain the sample
      for CA-125 measurement. Subsequently, total abdominal hysterectomy and bilateral
      salpingo-oophorectomy (TAH + BSO) were performed.
    

Intervention name(s): abdominal fluid CA-125 levels test
Intervention type(s): Diagnostic Test
Intervention description(s): One hundred milliliters of normal saline was used as the abdominal washing liquid to obtain the sample for CA-125 measurement. Serum and abdominal washing fluid CA-125 levels were measured with a double antibody sandwich immunoenzymatic method, using Beckman Coulter DXI (Ireland) analyzer. I
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Endometrial carcinoma, CA-125, lymphovascular invasion
Clinical Study to Investigate the Effects of a Food Supplement Santa Herba Extract on Weight Loss in Overweight Women
Condition: Weight Loss
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      Aim of the study is to investigate the effect of a 12-week supplementation of Santa Herba
      Extract on body weight in overweight and obese subjects. Additionally appetite related marker
      as well as marker of white adipose tissue browning will be evaluated.
    


Intervention name(s): Santa herba; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Santa herba dry extract; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner); Maltodextrin; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: lipid profile; 12,13-diHOME
Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects
Condition: Healthy Volunteers; Non-smokers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed as a 2-part, open-label study to assess the effect of pracinostat with
      itraconazole (part 1) and pracinostat with ciprofloxacin (part 2) on the bioavailability of
      pracinostat. Secondarily to evaluate the safety and tolerability of pracinostat administered
      with itraconazole or ciprofloxacin.
    


Intervention name(s): Pracinostat; Itraconazole; Ciprofloxacin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Itraconazole; Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluation of Maintaining Visual Performance in Participants Who Engage in Electronic Visual Tasking While Using Restasis®
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy of Restasis® in participants with dry eye disease who
      engage in electronic visual tasking.
    


Intervention name(s): Cyclosporine 0.05% Ophthalmic Emulsion
Intervention type(s): Drug
Intervention description(s): Cyclosporine 0.05% Ophthalmic Emulsion (RESTASIS®) 1 drop instilled in each eye twice a day.
Other intervention name(s): RESTASIS®
Intervention MeSH terms: Cyclosporine; Cyclosporins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Botox Treatment Into the Upper One Third of the Face an Area on Mood and Self -Appearance Satisfaction
Condition: Mood
Study type: Interventional
Phase: Phase 1

Summary: 
      Botox treatment into the upper one third of the face (glabella, forehead lines and/or lateral
      canthal lines) to analyze mood and self -appearance satisfaction in a Post Covid period on
      non-naïve Botox patients
    

Detailed description: 
      A historical period that will never happen again provides us a unique opportunity to evaluate
      the impact Botox Cosmetic has on the mood and self appearance satisfaction after a societal
      crisis such as the COVID19 pandemic.

      Many regular users of Botox Cosmetic will have exceeded their normal treatment interval and
      their glabellar wrinkles will likely have returned to baseline. Many will want to get treated
      as soon as stay at home orders are rescinded and clinics are permitted to open back up. It
      would not be surprising that these patients also are experiencing a decrease in their mood
      secondary to weeks of social isolating and distancing. Many can expect to have a rebound
      elevation in their happiness and overall mood following the modified return to normalcy.

      Botox Cosmetic has been studied as a mood elevating drug by reducing the animation of a
      glabellar furrow via the facial feedback mechanism hypothesis. This has been shown in
      patients who are not diagnosed with a major depressive disorder. Following a natural
      disaster, does the administration of Botox Cosmetic, in patients who are frequent Botox
      Cosmetic users, synergistically amplify the elevation in mood beyond what would be achieved
      had they not had their Botox Cosmetic treatment. Perhaps regular Botox Cosmetic users have a
      secondary gain desire for Botox Cosmetic beyond wrinkle reduction but also as a mood
      elevator.
    

Intervention name(s): Botulinum Neurotoxin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): glabella, forehead lines and/or lateral canthal lines; Saline solution (preservative free)
Intervention MeSH terms: Botulinum Toxins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of Citrus Extract on Gastrointestinal Health
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, parallel, double-blind, placebo-controlled trial aims to determine the
      effects of daily administration of citrus extract over a period of 8 weeks on
      gastrointestinal health in patients with irritable bowel syndrome.
    


Intervention name(s): Citrus extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Citrus extract; Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Safety of Use of Pandora for Patients Suffering From Gonarthrosis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The knee osteoarthritis is a frequent degenerative condition that mainly affects subjects
      over 60, population often weakened by numerous comorbidities and concomitant treatments,
      justifying the development of new therapies.

      The viscosupplementation is a symptomatic treatment for knee osteoarthritis ; the objective
      of this intra-articular injection of hyaluronic acid is to reduce knee pain and improve
      mobility. In practice, there are two protocols to administer viscosupplementation : in a
      single injection or in three injections performed weekly.

      The present clinical investigation has the objective to evaluate the safety of use of Pandora
      in a single injection or in three injections performed weekly.
    

Detailed description: 
      This clinical investigation is a multicenter, prospective, open study of a class III Medical
      Device.

      This study is designed to evaluate the safety of use of Pandora in its two forms : in a
      single injection or in three injections.

      A descriptive analysis will be carried out to characterize the demographic data, the history
      of the disease and its treatments, the clinical and radiological data of the patients at
      inclusion.

      The security of use of Pandora will be demonstrated by describing the proportion of patients
      with at least one adverse event attributable to the treatment, occurring during the week
      following each injection.

      In total, 20 participants will be enrolled across two study centers in France, 10
      participants in each centers.

      The total duration of subjects participation is 6 months ; overall study duration including
      the enrollment period is expected to take approximately 9 months.
    

Intervention name(s): Intra-articular single injection; Intra-articular three injections
Intervention type(s): Device; Device
Intervention description(s): Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment.
The injection will be performed at Day 1.; Both groups will receive their first injection after a selection visit ; first injection will be planned between 7 days to 30 days after to confirm the enrollment.
The injections will be performed at Days 1, 8 and 15.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Multi-center, Open Clinical Investigation.
Two facilities are participating ; each facility will be in charge and perform a type of viscosupplementation procedure : single injection or three injections.
Subjects will received one or the other viscosupplementation depending of the facility in which they will be included.
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Lyon and Schroth Techniques on Adolescent İdiopathic Scoliosis
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Today, it is known that the conservative treatment of scoliosis is gaining importance. In
      addition, no study has been found comparing the efficacy of two important conservative
      treatment methods, the Schroth and Lyon method, in adolescent idiopathic scoliosis.
      Accordingly, this study was conducted to compare the effectiveness of schroth and Lyon
      exercises in individuals with AIS.
    


Intervention name(s): Schroth Treatment
Intervention type(s): Other
Intervention description(s): Schroth exercises consist of passive and active postural auto-correction exercises done repeatedly and based on kinesthetic and sensorimotor principles. The ultimate goal of the Schroth method is to enable the patient to consciously maintain correct posture in their daily living activities. To achieve this requires repeating corrective movements performed to improve postural motor control. Schroth exercises also include strength and endurance training of postural muscles in order to improve the curve, raise the patient's self-image, and reduce pain. In this study, the Schroth exercises progressed from more to less passive support, from more to less feedback, and from lying to sitting or standing positions, according to the patient's ability to perform the specific exercise
Other intervention name(s): Lyon Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Posterior Cruciate Ligament Reconstruction Using Knot/Press-fit Technique
Condition: PCL TEAR
Study type: Observational

Summary: 
      This study presents an arthroscopic-assisted PCL reconstruction using femoral knot/press-fit
      technique with a periosteum-enveloping graft in tibial tunnel. The investigators evaluated
      the results of patients with PCL ruptures, who undergoing PCL reconstruction using this
      unique technique.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with PCL tear who received surgery
RCT of the Efficacy of the Ketogenic Diet in the Treatment of Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      A study of the efficacy and tolerability of two different ketogenic diets in children with
      drug resistant epilepsy; children resistant to at least two drugs randomised to reveive diet
      after baseline or after further 3m control period; in addition randomised to either MCT or
      classical ketogenic diet.
    


Intervention name(s): Ketogenic diet
Intervention type(s): Dietary Supplement
Intervention description(s): Ketogenic diet
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Epilepsy