bioihbjkbjnl/mcl2 huggingface dataset:
Occlusal Adjustment as Treatment for Chronic Orofacial Pain
Condition: Temporomandibular Joint Disorders; Orofacial Pain
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Facial Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether occlusal adjustment by selective grinding
      and/or occlusal addition is an effective treatment of chronic temporomandibular joint
      disorders.
    

Detailed description: 
      Temporomandibular disorders (TMD) are very common disorders in daily dentistry and oral and
      maxillofacial practice. The key symptoms are jaw joint pain and limited mouth opening. Other
      than trauma, the causes remain unknown; consequently, there are no treatments based on
      specific etiologies. In our experience, patients can usually receive beneficial occlusal
      adjustments if these are carefully planned and performed in two steps: (1) elimination of
      premature contacts, which reduces loads in the temporomandibular joints, and (2)
      individualized remodeling of lateral anterior guidance to facilitate unilateral alternate
      chewing. The study will use stratified blocking randomization to blindly assign patients to
      the real or placebo treatment groups in order to evaluate the null hypothesis (H0) that
      "Occlusal adjustment of sufficient quality has no effect on chronic pain and/or limited mouth
      opening in TMD patients."
    

Intervention name(s): Occlusal adjustment; Placebo occlusal adjustment
Intervention type(s): Procedure; Procedure
Intervention description(s): modification of occlusal surfaces; Simulated modification of occlusal surfaces
Other intervention name(s): Selective grinding; Occlusal reshaping; Occlusal equilibration; Occlusal therapy
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Temporomandibular Joint Disorders (TMD); Orofacial pain; Limited mouth opening; Craniomandibular dysfunction syndrome; Axiography; Gnatography; Preferred chewing side; Occlusal adjustment; Selective grinding; Handedness; Bruxism; TMD; Costen's Syndrome; Myofascial pain; TMD treatment; Pain
Closed-loop Control of Glucose Levels in the Context of Exercise in Adults With Type-1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Recent developments of continuous glucose sensors and insulin infusion pumps have motivated
      the research toward closed-loop strategies to regulate glucose levels in patients with type 1
      diabetes. In a closed-loop strategy, the pump(s) infusion rate is altered based on a
      computer-generated recommendation that relies on continuous glucose sensor readings. In this
      study, we aim to compare the effectiveness of dual-hormone (insulin+glucagon) closed-loop
      strategy to open-loop conventional continuous subcutaneous insulin infusion pump (CSII)
      therapy in regulating glucose levels during an evening exercise and on a night following an
      exercise in adults with type 1 diabetes.
    


Intervention name(s): Conventional continuous subcutaneous insulin infusion therapy; Dual-hormone closed-loop
Intervention type(s): Device; Device
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Low Molecular Weight Heparin vs Unfractionated Heparin at Cardiac Surgery
Condition: Coronary Disease; Coronary Artery Bypass Grafting
MeSH terms: Coronary Disease
Study type: Interventional

Summary: 
      Because the impairment of platelet function may cause excess peri-operative bleeding,
      pre-operative aspirin discontinuation and heparin bridging are common at cardiac surgery. We
      aimed to evaluate the impact of a low-molecular-weight-heparin (LMWH), enoxaparin, and
      unfractionated heparin (UFH) on coagulation parameters and peri-operative bleeding in
      patients undergoing elective coronary artery bypass grafting (CABG) surgery after aspirin
      discontinuation.

      The specific hypothesis of this study was that a 12 h interval is sufficient not to cause
      excess peri-operative bleeding, and is therefore an optimal compromise between antithrombotic
      efficacy and haemorrhagic safety.
    

Detailed description: 
      Since LMWH provide many pharmacokinetic advantages compared with UFH, and since they are a
      valid substitution for UFH in a number of settings, such as non-ST elevation acute coronary
      syndromes and prevention of venous thromboembolism, LMWH may provide a useful bridge to
      revascularization after aspirin discontinuation in patients undergoing CABG surgery.
      Obstacles to the spreading of this practice are mainly the absence of solid evidence of
      equivalence (or superiority) as to efficacy in this setting, and the proof of equal safety,
      namely the absence of excess bleeding because some studies have suggested an increased number
      of haemorrhagic complications after LMWH, particularly with the use of higher doses. This
      might here be a problem, as patients are here generally at high risk of thrombotic events and
      for this reason need higher doses than for prevention of venous thromboembolism.
    

Intervention name(s): Enoxaparin
Intervention type(s): Drug
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unfractionated heparin; enoxaparin; low molecular weight heparin; bypass surgery; bleeding
Enhancing Medication-based Analgesia in Humans- STUDY 2
Condition: Pain; Cannabis; Opioid Use
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-group, within-subject, double-blind, double-dummy, placebo and
      active-controlled study evaluated whether the FDA-approved cannabinoid cannabidiol (CBD;
      Epidiolex) would enhance analgesia, subjective reports, and cognitive performance when
      compared to the FDA-approved opioid hydromorphone (Dilaudid). This is study 2 is a series of
      studies.
    

Detailed description: 
      This was a human laboratory systematic examination of whether adding the FDA-approved
      cannabinoid cannabidiol (CBD; Epidiolex; oral) to the FDA-approved opioid hydromorphone
      (Dilaudid; oral) would change the experience of hydromorphone as rated by laboratory measures
      of pain, subjective reports of drug effects, and cognitive performance. Subjects are healthy
      individuals with no history of drug use disorder. Study subjects and staff were completed
      blinded to the study drugs and the class of drugs under investigation and were informed that
      subjects may receive opioids, stimulants, cannabinoids, benzodiazepines, over the counter
      medications, and/or placebo. All participants completed all sessions. Sessions lasted up to
      8-hours and were conducted at least 7 days apart on an outpatient basis. Primary outcomes
      were collected from participants prior to dosing and at several hour periods post-dosing.
    

Intervention name(s): Within-subject test of blinded study medications
Intervention type(s): Drug
Intervention description(s): Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.
Intervention model: Single Group Assignment
Intervention model description: Within-subject study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Clinical Trial; Analgesia; Phase II; Abuse potential
Virtual Reality and Active Video Games to Improve Balance in Children With Brain Injury
Condition: Cerebral Palsy; Acquired Brain Injury
MeSH terms: Brain Injuries; Cerebral Palsy; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this pilot feasibility study is to assess the feasibility of using the
      Playstation Xbox 360 and Rutgers V-step via a Kinect Sensor with active video game software
      as a part of a physical therapy intervention to improve obstacle negotiation, gait speed, and
      stair negotiation in ambulatory children with Cerebral Palsy (CP) hemiparesis or spastic
      diplegia, or non-progressive brain injury (BI). Children will be assessed using perceptual,
      balance, functional and gait assessments.
    


Intervention name(s): Active video gaming; Usual care physical therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Children will visit Blythedale for 8 sessions, one 45-session visit per week, in place of one of the child's typical physical therapy sessions. During each session, children will play a video game on the X-Box Kinect system, using the games "Kinect Adventures" and "Kinect Sports". The child will first play a "Kinect Adventures" game, which requires ambulating, ducking, and dodging one's way through an obstacle course.; Children will attend their usual care physical therapy appointments at Blythedale.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized Block Design will be utilized in order to attempt to "match" subjects according to functional level and diagnosis (cerebral palsy or acquired brain injury). Upon signing consent the subjects will be grouped based on their diagnosis. At that time gait speed for the 10 M Walk Test will be utilized to categorize all participants into a "fast" and "slow" group. (subjects performing the 10 M Walk Test at a speed less than .4 m/s will be placed in the "slow" group, and subjects testing at a speed greater than or equal to .4 m/s will be placed in the "fast" group After this determination is made, subjects will be randomized to "control" (usual care), and "intervention" one therapy session replaced with a session utilizing Active video games and the Rutger's V-step. A minimum of 2 subjects per grouping will be sought in order to analyze for differences.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: virtual reality; hemiplegia; diplegia; video gaming; active video games; Playstation X-Box 360; Rutgers V-Step; Microsoft Kinect
Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement
Condition: Beard Enhancement
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for
      beard enhancement.
    


Intervention name(s): 3 % Minoxidil lotion; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Minoxidil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants
Condition: Degeneration; Bone
Study type: Interventional

Summary: 
      The aim of the study is to test in a randomized comparative study the performance of
      Straumann® MembraGel (PEG Membrane) to act as a barrier for guided bone regeneration compared
      to that of a standard collagen membrane (BioGide®) in the bone regeneration around Straumann®
      SLActive bone level titanium implants.

      Furthermore the clinical evaluation and comparison of complementary parameters describing the
      bony and soft tissue environments at the surgical sites during the study period to evaluate
      effectiveness and performance of the membranes.
    

Detailed description: 
      At the primary endpoint of the study - 6 month post-operative - the vertical bone gain will
      be measured for changes.

      The changes will be evaluated by measuring the distance between the implant shoulder and the
      first visible bone contact on the implant. The measurement will be taken on the medial and
      distal aspect on the implant at site of interest. Measurements will take into account
      distortion based on changes on the radiograph from the true dimension of the implant.

      Intra-oral photographs will be taken at each study visit to document the initial appearance
      of the soft tissue and the subsequent healing of the soft tissue post-implant placement. The
      photographs will be taken buccal and occlusial at study site of interest.

      The physical appearance of soft tissue (form, colour, tissue biotype, surface aspect) will be
      clinically assessed by visual inspection.

      In addition changes in the high of the keratinized gingiva will be assessed in mm. This will
      be measured mid-crestal in buccal direction to the mucogingival border by a periodontal
      probe.

      Changes in gingival recession will be measured at the implant leading visit and the yearly
      follow-up visit 18, 30 and 42 month post surgery. The distance between the margin of the
      gingiva and the edge of the crown will be assessed at accessible buccal, palatal, distal and
      medial sites.

      A measurement of vertical defect height will be performed evaluating the distance of the
      implant shoulder to the first bone to implant contact at surgery visit and 6-month later.
    

Intervention name(s): barrier membrane; MembraGel; Bio-Gide® membrane
Intervention type(s): Device; Device; Other
Intervention description(s): The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).; Device application at surgery; Device application at surgery
Other intervention name(s): Straumann® MembraGel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GBR; GTR; Dental Implant surgery
He Purongo Mo Nga Kai Hei Arai i Te Matehuka - Dietary Diabetes Prevention Study for Maori
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      High protein diets are popular among Maori, especially on the East Coast of the North Island.
      The purpose of this study was to compare the metabolic effects of a moderate carbohydrate,
      high protein diet (MCHP) with a high carbohydrate-high fibre (HCHF) diet on insulin
      sensitivity in Maori at increased risk of developing diabetes and cardiovascular disease.
    

Detailed description: 
      This was a 6-month pilot intervention study of self-identifying Maori participants in a
      randomised control trial conducted in Dunedin and Invercargill. The study consisted of three,
      two month phases and was conducted over a period of six months. Participants meeting all the
      inclusion criteria were randomised into three groups: moderate carbohydrate-high protein
      (MCHP), high carbohydrate-high fibre (HCHF) or a control group. Those randomised to the
      experimental diets were recommended an energy intake based on their current BMI levels. The
      aim of phase one was to achieve weight loss with weekly advice and support from the research
      team. The aim of phase two was for weight maintenance with continued weekly advice and
      support. Phase three consisted of a weight maintenance phase without support. Those in the
      control group were instructed to follow their own self selected diet plan.

      Outcome was determined by examining surrogate clinical endpoints. The clinical endpoints
      included the following recorded measurements of anthropometric measurements, bioelectrical
      impedance measurements, profile of mood state questionnaires, activity questionnaires, and
      three day diet records were collected at 0, 2, 4 and 6 month periods. Biochemical measures of
      lipid profile, fasting insulin and glucose, liver functions and uric acid levels were also
      conducted.
    

Intervention name(s): moderate carbohydrate, high protein diet (MCHP); high carbohydrate-high fibre (HCHF) diet
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Maori; insulin sensitivity; cardiovascular risk; diabetes prevention; diet modification
Balance Training Vs Pilates Training
Condition: Balance Training
Study type: Interventional

Summary: 
      Many pathologies present balance disturbances, however, other types of therapies such as
      Pilates are increasingly used within the Physiotherapy profession. It is therefore necessary
      to know the effects that this type of exercise has compared to the traditional method of
      balance training in order to make good use of this type of therapy.

      The objective of the study will be to know if there are differences between both types of
      training on the balance of the participants.
    


Intervention name(s): Balance training; Pilates training
Intervention type(s): Other; Other
Intervention description(s): 12 sessions of balance training en 4 weeks, with a duration of 40-45 min each.; 12 sessions of Pilates training en 4 weeks, with a duration of 40-45 min each.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pilates; Balance training; Physiotherapy; Prevention
Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia
Condition: Sickle Cell Anemia; Malaria
MeSH terms: Malaria; Anemia; Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      Malaria is fatal and increases the risk of death among children with sickle cell anemia.
      Chemoprophylaxis significantly improves quality of life in these children. In Uganda
      Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due
      to high levels of resistance throughout the country. Intermittent presumptive treatment with
      sulfadoxine - Pyrimethamine a new approach to malaria prevention, has shown great potential
      in reducing incidence of malaria and anaemia among high risk groups such as pregnant women
      and infants. However no studies have been done in Uganda to determine if presumptive
      treatment with sulfadoxine- pyrimethamine reduces the incidence of malaria in children with
      sickle cell anaemia.

      Hypothesis : Presumptive treatment with sulfadoxine- Pyrimethamine is better than weekly
      chloroquine in reducing incidence of malaria in children with sickle cell anaemia.
    

Detailed description: 
      Malaria is fatal and increases the risk of death among children with sickle cell anemia.
      Chemoprophylaxis significantly improves quality of life in these children. In Uganda
      Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due
      to high levels of resistance throughout the country. Intermittent presumptive treatment with
      sulfadoxine - pyrimethamine a new approach to malaria prevention, has shown great potential
      in reducing incidence of malaria and anemia among high risk groups such as pregnant women and
      infants. However no studies have been done in Uganda to determine if presumptive treatment
      with sulfadoxine- pyrimethamine reduces incidence of malaria among high risk group such as
      children with sickle cell anaemia.

      We calculated a sample size of 110 patients in each group for a power of 95% assuming that
      the incidence of malaria in children receiving weekly chloroquine will be 0.36 and those
      receiving presumptive treatment with sulfadoxine - pyrimethamine the incidence would be 0.16
      according to (schellenberg et al )
    

Intervention name(s): sulfadoxine pyrimethamine
Intervention type(s): Drug
Intervention description(s): Monthly SP
Other intervention name(s): SP
Intervention MeSH terms: Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Sickle Cell anemia; Malaria; Presumptive treatment; Sulfadoxine- pyrimethamine; Children; Uganda
Using PET Scans to Study Brain Receptor Occupancy of BIIB014 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish the extent to which BIIB014, following 8 to 12 consecutive days of dosing at
      selected dose levels, occupies the brain's A2A receptors. Receptor occupancy will be assessed
      by PET scanning using a radiolabelled tracer.
    

Detailed description: 
      Subjects will be enrolled sequentially into cohorts of 2 to 4 subjects. PET scan results will
      determine the actual number of cohorts enrolled and the BIIB014 dose given to each subject.
      Since all enrolled subjects will be receiving BIIB014, this study is being listed as a 1-arm,
      Single Group study (actual study design is dose escalation).

      Participating subjects will be required to reside in the clinical unit for 10 to 14
      consecutive days. Participants will receive 1 oral dose of BIIB014 daily for 8 to 12
      consecutive days. During the study, subjects will undergo 2 PET scans and 1 MRI. Frequent
      blood sample for pharmacokinetic assessments will also be performed.
    

Intervention name(s): BIIB014; [11C]SCH442416
Intervention type(s): Drug; Other
Intervention description(s): oral administration of BIIB014, given once daily for 8 to 12 consecutive days, at various doses as specified in protocol; 11C]SCH442416 is a radiolabelled tracer molecule that specifically binds to adenosine A2A sites and will be used to evaluate receptor occupancy. The target activity will be 370 MBq. [11C]SCH442416 will be administered IV as a bolus injection over 30 seconds following the start of each PET scan.
Intervention MeSH terms: 3-(4-amino-3-methylbenzyl)-7-(2-furyl)-3H-(1,2,3)triazolo(4,5-d)pyrimidine-5-amine; SCH 442416
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy male volunteers
Effects of Traditional Thai Massage on Pain and Pain Related Parameters in Patients With Upper Back Pain
Condition: Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of Thai massage on pain related
      parameters including Pain intensity, 24 hours pain intensity, Pressure pain threshold,
      anxiety, muscle tension, cervical range of motion, pain frequency, patient satisfaction and
      side effect in patients with chronic upper back pain associated with myofascial trigger
      points
    


Intervention name(s): Thai massage
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment