bioihbjkbjnl/mcl2 huggingface dataset:
Impact of a Multidisciplinary Therapeutic Education Program Being Set up for Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2; Patient Education as Topic
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Therapeutic education programs allows in diabetic patients to promote self-care and better
      perception of the disease The multidisciplinary program of therapeutic education regroups in
      one day: individual interview, nutritional workshop, self-monitoring blood glucose workshop,
      physical activity and glycemic objectives workshop.

      At the end of the program, individual and personalized goals are given to the patient.

      This study aims to evaluate this program success rates and the psychological, anamnesis, and
      sociological factors linked to success.
    


Intervention name(s): Treatment adequacy score
Intervention type(s): Other
Intervention description(s): Evaluation of the program rate of success rate by a score evaluating the different criteria that the patient was supposed to modify following the therapeutic education program: practice of a physical activity, reduction of the amount of fat in Diet, practice of self-monitoring blood sugar as a motivational tool and decreased distress related to diabetes
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This initial education program is intended for patients with type 2 diabetes:

          -  who have recently been diagnosed with type 2 diabetes

          -  or who have an HbA1c greater than 7% and unability to lower their blood glucose levels
             despite an optimal management by general practitioner but do not yet require insulin
             treatment
      
Keywords: Diabetes Mellitus, Type 2 +; Patient Education
Lipid Profile of Tenon's Capsule
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      The purpose of this study is to provide data on the lipid profile of the Tenon's capsule in
      Human glaucomatous eyes and to establish possible relationships with the short term outcome
      of filtration surgery.
    


Intervention name(s): trabeculectomies, non penetrating deep sclerectomies
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient suffering from Glaucoma
      
Biospecimen description: 
      Eye Tenon's Capsule
    
Keywords: Glaucoma; Tenon's Capsule; Lipid profile; Assessment of lipid profile in Tenon's capsule in patients with Glaucoma
The Effect of Cognitive-Behavioral Intervention Package on Procedural Pain and Anxiety in Children
Condition: Procedural Anxiety; Procedural Pain
MeSH terms: Pain, Procedural; Anxiety Disorders
Study type: Interventional

Summary: 
      This study investigated the effect of cognitive-behavioral interventions package (CBIP) on
      pain and anxiety related to peripheral venous cannulation (PVC) in children aged 7-12 years.
    

Detailed description: 
      The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and
      Procedural Pain) recommends pharmacological and nonpharmacological methods to effectively
      manage and prevent acute procedural pain in children. Nonpharmacological methods alone or in
      combination with pharmacological methods help reduce pain, and therefore, have become popular
      especially in recent years. For pain management, nonpharmacological methods are easy to use,
      and cost- and time-effective methods with no side effects. Studies have evaluated a large
      number of pharmacological and nonpharmacological interventions for procedural pain management
      in children. However, most of those interventions are not used by healthcare professionals
      because they are expensive, time-consuming or hard to use. Therefore, easy-to-use, practical,
      non-invasive, cost-effective, and reusable nonpharmacological methods can be used especially
      in acute settings. Cognitive-behavioral interventions, one of the non-pharmacological methods
      used to minimize pain and anxiety related to painful medical procedures in children are
      promising.
    

Intervention name(s): Cognitive-Behavioral Interventions Package
Intervention type(s): Behavioral
Intervention description(s): CBIP was developed by researchers in line with the relevant literature according to the developmental characteristics of children. Opinions were obtained from experts in the field of pediatrics or psychiatric nursing regarding CBIP. CBIP consisted of cognitive and behavioral practices to prevent/reduce procedural pain and anxiety.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized into the experimental and control groups using a block randomization method. The variables of age (7-9 and 10-12 years), gender (girls and boys), and fear of procedure (yes and no) were used for block randomization.
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Anxiety; Children; Procedural pain; Cognitive-behavioral interventions
Effects of a 60-min Repeated Trunk Flexion Protocol on Trunk Neuromuscular Properties.
Condition: Occupational Exposure
Study type: Interventional

Summary: 
      An interventional study on the effects of repeated trunk flexion exposure on trunk
      neuromuscular properties.
    

Detailed description: 
      An interventional study will include 16 healthy young adults. All participants will complete
      a 60-min protocol of intermittent trunk flexion. Measurements of trunk neuromuscular
      properties will be performed prior to and following the 60-min protocol.
    

Intervention name(s): Repeated trunk flexion
Intervention type(s): Other
Intervention description(s): A 60-min intermittent trunk flexion protocol. Participants will sit on a standard height sit, with their knees bent at approximately 90° with their hands crossed on their chest. They will perform 40 sets of 60 s of maintaining a flexed position, interspersed with 30 s of rest. Participants will achieve the flexed position by tilting the pelvis posteriorly and leaning forward. During rest, participants will sit up straight without leaning on the support.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bending, load, stiffness, elastography, deformation
Efficacy of the Myofunctional Therapy on Oral Dysphagia
Condition: Dysphagia, Oral Phase; Temporomandibular Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Deglutition Disorders
Study type: Interventional

Summary: 
      The aim of the study is to analyze the effects of orofacial myofunctional therapy (OMT) on
      oral dysphagia (OD) in patients with temporomandibular disorders (TMD).
    

Detailed description: 
      60 subjects with TMD, according to the Research Diagnostic Criteria, will be included in the
      study after voluntary consent form will be filled out. Subjects will randomly be divided into
      3 groups according to the order.

      Home Exercise (n=20) will be the Group 1, Home Exercise combined with Manual Therapy (n=20)
      will be the Group 2, and Orofacial Myofunctional Therapy combined with Home Exercise and MT
      treatment (n=20) will be the Group 3.

      Group 1 will include educational training program about parafunctional activities of TMD
      disorders and active exercises for masticatory and neck muscles with 10 repetitions, 3 times
      a day, and for 10 weeks.

      Group 2 will receive home exercise training program and manual therapy program which is
      planned to last 30 minutes; will be applied twice a week, for 10 weeks.

      Group 3 will include stretching and strengthening of the tongue muscles, tongue rotation
      exercises, effortful swallowing, strengthen the hyoidal muscles, which is planned to last 40
      minutes, will be applied twice a week, for 10 weeks.
    

Intervention name(s): Home Exercise; Manual Therapy Combined with Home Exercise; Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Educational training program about oral dysphagia in patients with temporomandibular disorders.; Manual therapy program combined with educational training program about oral dysphagia in patients with temporomandibular disorders.; Orofacial Myofunctional Therapy program with combination of Manual therapy and educational training program about oral dysphagia in patients with temporomandibular disorders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Oral Dysphagia; Temporomandibular Disorders; Quality of Life; Pain
Immuno-monitoring of Patients With Metastatic Melanoma (AJCC Stadium IV) Under Chemotherapy
Condition: Immuno-monitoring
MeSH terms: Melanoma
Study type: Observational

Summary: 
      This pilot clinical trial aims at evaluating immuno-modulating effects of palliative
      treatment with specifically dosed standard chemotherapeutics in patients with metastatic
      melanoma (AJCC stage IV) by assessing myeloid-derived suppressor cells' (MDSCs) count and
      activity.
    


Intervention name(s): Immuno-monitoring
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Metastatic melanoma patients (AJCC stage IV)
Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19)
Condition: SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of administration of plasma containing
      antibodies to the SARS-CoV-2 virus (i.e., convalescent plasma) and if it is able to prevent
      disease or lessen the severity of disease in individuals who are at high risk of developing
      COVID-19 due to a recent exposure. This study will also measure the level of anti-SARS-CoV-2
      antibodies in patient's blood after the administration of the convalescent plasma.
    

Detailed description: 
      People who become infected with a virus such as SARS-CoV-2 usually develop an immune response
      and produce antibodies against the virus. Antibodies are natural proteins made by the body's
      immune system that attack viruses and other germs. These antibodies are found in plasma,
      which is the yellow, clear part of the blood. There have been other studies using plasma to
      treat other types of viruses that showed some positive results. Human plasma containing
      antibodies to the SARS-CoV-2 virus is an option for prevention and treatment of COVID-19.
      This type of treatment, known as passive antibody therapy, could be rapidly available when
      there are sufficient numbers of people who have recovered from infection and can donate
      antibody-containing plasma. In contrast to vaccination strategies, which begin to provide
      protection weeks after administration, antibody-containing plasma would provide its
      protective benefits immediately. Additionally, passive antibody therapy may be the only way
      to provide immunity for some immunocompromised patients who do not respond to vaccines.

      This research will evaluate the safety of administration of plasma containing antibodies to
      the SARS-CoV-2 virus (i.e., convalescent plasma). The research will also measure the level of
      anti-SARS-CoV-2 antibodies in patient's blood after the administration of the convalescent
      plasma.
    

Intervention name(s): Anti-SARS-CoV-2 Human Convalescent Plasma
Intervention type(s): Biological
Intervention description(s): 1-2 unit (200-250 mL per unit) of plasma with anti-SARS-CoV-19 titers of ≥1:320.
The total volume (mL) infused will be based on weight (5 mL/kg) with a maximum volume of 500 mL.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: convalescent; COVID-19; Coronavirus; plasma
Impact of Decision Aids on Bariatric Surgery Choice
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Sleeve gastrectomy, Roux-en-Y gastric bypass, laparoscopic gastric banding, and bioenteric
      intragastric balloon insertion are common types of bariatric surgeries. These treatment
      strategies have diverted outcomes in body weight loss, metabolic diseases control, surgical
      complications, and life quality improvement. Thus, shared decision making (SDM) is necessary
      to aid patients to choose an appropriate treatment that suits thier needs. Investigators have
      developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to
      evaluate its impact on obese patients. The measurements include a battery of interview-based
      questionnaires and evaluations of decision regret and knowledge improvement. Investigators
      expect the DAs would benefit the intervention group in the aspects of knowledge,
      communication and anxiety status during and after their treatment sessions.
    


Intervention name(s): Shared decision making with decision aids
Intervention type(s): Behavioral
Intervention description(s): For obese patients, we use shared decision making with decision aids to help them choose the suitable types of bariatric surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
A Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 (RG6042) in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease
Condition: Huntingtons Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Study BP40410 is an open-label, adaptive multiple-dose clinical study designed to
      characterize the PK of RO7234292 (RG6042) in plasma and CSF as well as the acute time course
      and recovery profile of CSF mHTT lowering in response to RO7234292 (RG6042) treatment after
      intrathecal (IT) administration of RO7234292 (RG6042) to patients with manifest Hungtington's
      disease (HD).
    


Intervention name(s): RO7234292 (RG6042)
Intervention type(s): Drug
Intervention description(s): RO7234292 (RG6042) will be administered in two IT doses of the same dose level at an interval of 28 days during the treatment period (Day 1 and Day 29). Each dose of RO7234292 (RG6042) will be administered as a single IT bolus injection.
Other intervention name(s): Tominersen
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy
      compared to second choice after failed medical therapy
    


Intervention name(s): Cryoballoon ablation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers
Condition: Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study consists of two parts, ie, single dose part with young healthy subjects (Part 1)
      and single and multiple dose part with elderly healthy subjects (Part 2), to assess the
      safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and
      multiple ascending dose administration to healthy subjects.
    

Detailed description: 
      This is a Phase I, randomised, double-blind, placebo-controlled, single centre study to
      assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following
      single and multiple ascending dose administration to healthy subjects. This study consists of
      two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple
      dose part with elderly healthy subjects (Part 2). The study design allows a gradual
      escalation of dosage levels between sequential cohorts with safety monitoring to ensure the
      safety of the healthy subjects.
    

Intervention name(s): AZD3293; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution; Oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: AZD3293; Healthy volunteers; Young volunteers; Elderly volunteers; Japanese volunteers; Phase 1; Single and multiple ascending dose study
Safety and Efficacy Study to Compare a 4% Dimethicone Foam and Nix Cream Rinse (1% Permethrin) in the Control of Head Lice
Condition: Head Lice
MeSH terms: Lice Infestations
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the efficacy of a dimethicone foam in the control
      of head lice and to compare the efficacy to a permethrin based product.
    


Intervention name(s): 4% dimethicone foam; 1% permethrin
Intervention type(s): Other; Other
Intervention description(s): The dimethicone foam is applied to dry hair and left on the hair for approximately 15 minutes. The product is then removed by washing the hair with baby shampoo. The foam is applied two time, separated by an interval of 7-9 days.; Nix® Cream Rinse is applied as indicated on the product labeling. The cream rinse is applied to wet hair and left on the hair for 10 minutes. The hair is then rinsed with tepid water to remove the product, toweled dry, and combed with a detangling comb. The product is applied two times, separated by an interval of 7-9 days.
Other intervention name(s): Oxykal, Neo-paraderma; Nix cream rinse
Intervention MeSH terms: Permethrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
EU/LA Pearl Index Study - Transdermal Contraceptive Patch
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the present study is to prove efficacy and safety of a new contraceptive patch.
    


Intervention name(s): Ethinylestradiol/Gestodene (BAY86-5016)
Intervention type(s): Drug
Intervention description(s): 7-day patch containing 0.55 mg ethinylestradiol (EE) and 2.1 mg gestodene (GSD) in a 21-day regimen
Intervention MeSH terms: Ethinyl Estradiol; Gestodene; Femovan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fertility control; Contraception
Carbamazapine for Inherited Erythromelalgia Patients With NaV1.7 Mutations
Condition: Erythromelalgia
MeSH terms: Erythromelalgia
Study type: Interventional
Phase: Phase 4

Summary: 
      This research study is designed to investigate brain response using fMRI scan, and behavioral
      responses, to treatment with the drug carbamazepine (CBZ) in patients with the painful sodium
      channelopathy inherited Erythromelalgia (IEM). This study is designed to identify the central
      nervous system (CNS) regions that are activated during ongoing or evoked pain attacks, and
      the altered CNS response to CBZ treatment. This will advance our understanding of how IEM
      affects the brain. We also hope to validate a pharmacogenic approach to the study of IEM by
      use of an FDA approved drug. We hope, but cannot be sure, that subjects will directly benefit
      from this study.
    


Intervention name(s): Carbamazepine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.
Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days.
Other intervention name(s): Tegretol
Intervention MeSH terms: Carbamazepine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment