bioihbjkbjnl/mcl2 huggingface dataset:
Splinting to Treat Hand Osteoarthritis
Condition: Hand Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      Osteoarthritis (OA) is the most common form of arthritis and the hand is the most frequently
      affected site.Interphalangeal (IP) joints (the small joints of the fingers) are often
      involved causing pain, progressive loss of hand function and deformity. Deviation, or bending
      to the side, of IP joints (IPJs) with significant functional and cosmetic consequences for
      the individual is common. There are no drugs which can slow the disease process so there is
      reliance on symptomatic treatment such as pain relief and hand therapy. Joint thermoplastic
      splinting (moulded plastic splints that are custom-made) is employed by hand therapists in
      other settings, but to the investigators knowledge no studies have formally investigated the
      effect of splinting in IP OA.

      By resting inflamed tissues and correcting joint alignment, a beneficial role for splinting
      in IP OA is likely. In this study, the investigators want to test whether thermoplastic
      splinting of deviated IP joints due to OA will 1) improve joint alignment 2) ameliorate soft
      tissue inflammation, and whether as a consequence 3) pain and overall hand function will be
      improved.

      Adults with hand OA with 'affected' IP joints (symptoms from OA associated with deviation of
      the joint on X-ray)will be recruited from a specialist hand osteoarthritis clinic. Initially
      this will be for distal IP (DIP) joints. In the intervention group (30 patients), an
      'intervention' joint for splinting will be identified as the most painful deviated DIP joint
      in the past week leading up to enrolment. Up to 3 other 'affected' DIP joints on either hand
      will not be splinted but will be monitored as 'control' joints. In the control group (15
      patients), an affected joint will be monitored but not splinted. Assessment of joint pain,
      hand function by a hand therapist, deformity (by X-ray)and joint inflammation will take place
      at baseline, during and at the end of splinting period of 3 months, and also at 6 months,to
      assess whether any changes are persistent. In this way, the efficacy of splinting of IP
      joints in OA will be assessed.
    


Intervention name(s): Splinting
Intervention type(s): Device
Intervention description(s): Gutter thermoplastic custom-made splint for nominated joint, to be worn at night-time for consecutive nights for 3 months
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hand; osteoarthritis; splint; pain; deformity; function
Quinoa Biscuit & CVD Risk Trial
Condition: Cardiovascular Diseases; Dyslipidemias; Lipid Profile
MeSH terms: Cardiovascular Diseases; Dyslipidemias
Study type: Interventional

Summary: 
      Cardiovascular disease (CVD) is one of the most common chronic diseases in older populations,
      which has been increasing in line with rising overweight and obesity levels in recent years.
      Dietary intake is a major modifiable risk factor for CVD, and one such recommendation is to
      increase the intake of essential (omega-3) polyunsaturated fats in our diets, for example by
      consuming more oily fish. We know, however, from large population level dietary surveys, that
      many individuals within the United Kingdom (UK) population are not consuming enough oily
      fish. Therefore, alternative dietary sources of omega-3 polyunsaturated fats are required to
      help meet consumer needs.

      Quinoa is a traditional Andean seed crop consumed in a similar fashion to staple cereal
      grains in Europe, and the popularity of quinoa has been growing worldwide because of its
      nutritional content and perceived healthiness. Quinoa contains a small amount of fat, but the
      ratio of omega-6 and omega-3 essential fats is more favourable in quinoa than in other plant
      oils. An opportunity therefore exists to incorporate quinoa flour into more frequently
      consumed food products (e.g. biscuits) as an alternative means of increasing consumers
      omega-3 intake.

      The purpose of this study is to investigate the effect of consuming quinoa-enriched biscuits,
      compared to control, on markers of CVD risk over 4-weeks in older adults.
    


Intervention name(s): Quinoa biscuit; Control biscuit
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2x15g biscuits per day for 28 consecutive days (4 weeks).; 2x15g biscuits per day for 28 consecutive days (4 weeks).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Quinoa; Functional food; Cardiovascular disease; Cholesterol; Lipid profile; Randomised Control Trial
Japanese Phase II Study of SB-497115-GR in Hepatitis C Virus Infected Patients
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the ability of SB-497115-GR to raise platelet counts
      in thrombocytopenic patients with hepatitis C virus (HCV) infection (platelet count <80,000
      /μL, suggestive of compensated cirrhosis) to a level desirable to initiate antiviral therapy
      and to assess the ability of SB-497115-GR to maintain platelet counts at a level sufficient
      to minimise dose reductions of pegylated interferon (Peg-IFN) and ribavirin (RBV) therapy
      with the expectation that a lower rate of Peg-IFN dose reduction and omission will translate
      to a higher rate of sustained viral response.
    


Intervention name(s): SB-497115-GR
Intervention type(s): Drug
Intervention description(s): TPO receptor agonist to increase platelet count
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thrombocytopenia; Hepatitis C, chronic
Systemic Lupus Erythematosus Exercise Program
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      This pilot study is a randomized controlled trial to assess the effect of an individualized
      supervised exercise program in patients with systemic lupus erythematosus (SLE) compared to
      treatment-as-usual (TAU).
    

Detailed description: 
      The aim of this study is to evaluate the effect of a 12-week individualized exercise program
      in subjects with SLE in comparison to treatment-as-usual therapy. Several previous studies
      showed that exercise leads to various benefits in treating SLE, including enhanced aerobic
      capacity, reduced symptoms of depression and fatigue. Moreover, it has been shown that
      exercise is well tolerated and does not impair disease activity in SLE negatively. Here, the
      effects of an individual internet-based exercise therapy for 12 weeks will be evaluated.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Participants will obtain an individualized exercise program based on entrance examination on treadmill.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The three study arms (TAU, aerobic exercise, anerobic exercise) will be included in parallel. After 12 weeks, the patients in the control group will be invited to participate in the training group.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Aerobic training; Anaerobic training; Internet-based exercise program
A Trial to Investigate the Effect of Different Supplements on Fluid and Sodium Status in Short Bowel
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome
Study type: Interventional

Summary: 
      Patients with short bowel intestinal failure are recommended to aim for a diet high in energy
      and protein. Some patients have difficulties in achieving recommended intakes and additional
      nutrition may be provided by oral nutritional supplements. There is very little research
      completed on which is the best oral nutritional supplement for patients. The aim of the study
      is to see the effect different oral nutritional supplements have on your stoma or fistula
      output and levels of hydration.
    

Detailed description: 
      After written consent is obtained, patients will be asked to fast from 12.00am on day one. At
      08.00am patients will be asked to pass urine and to empty their stoma bag. After this they
      will be asked to drink 200ml of the ONS which they have been randomised to test on day one
      over a 30 minute period. Urine and intestinal output will be collected into two separate
      containers over the next 6 hours. During this time the patient will not be permitted to eat
      or drink other fluids. After 6 hours the patient will be able to eat and drink normally. The
      urine and intestinal output will be weighed and then an aliquot will be stored in a -20oC
      freezer before being sent for analysis. Day two is a washout day when the patient will be
      able to eat and drink normally. Day three will be the same as day one but the patient will
      have the other ONS that they did not have on day one. No changes will be made to the
      patient's usual anti diarrhoeal and/or anti motility agents or parenteral support during the
      study.
    

Intervention name(s): Vital 1.5; Ensure Plus
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral nutritional supplement; Oral nutritional supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose-response of Ketamine in Patient Controlled Analgesia in Orthopaedic Surgery Patients
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous
      patient-controlled analgesia bolus dosing and effects in patients scheduled for
      posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation
    


Intervention name(s): Oxycodone; S-Ketamine 0.25; S-Ketamine 0.5; S-Ketamine 0.75
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Current clinical practice, used as a control in this study; dosage; dosage; dosage
Other intervention name(s): Oxanest; Ketanest-S; Ketanest-S; Ketanest-S
Intervention MeSH terms: Ketamine; Oxycodone; Esketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Stimulatory Autoantibodies to the Platelet-Derived Growth Factor Receptor (PDGFR) in Patients With Systemic Sclerosis
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Observational

Summary: 
      This study is to determine if subjects with .systemic sclerosis have stimulatory
      autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF
      receptor in skin sites with varying degrees of skin thickening
    

Detailed description: 
      Pilot study to assess whether patients with systemic sclerosis have stimulatory
      autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF
      receptor in skin sites with varying degrees of skin thickening
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects from a tertiary care clinic specializing in scleroderma. Controls recruited by
        subjects being biopsied.
      
Biospecimen description: 
      skin serum
    
Keywords: systemic sclerosis autoantibodies
Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy
      in patients who have developed neutralizing antibodies during previous interferon-beta
      treatment
    

Detailed description: 
      This is a multi-centre, prospective, open label, non-comparative phase IV trial. Eligible
      patients will receive treatment with IFN-beta-1a AVONEX® 30 mcg i.m. once weekly for 12
      months.The patients will be examined clinically and NAb titres will be performed at screening
      and after 12 months. Adverse event source verification will be performed during the
      documentation period.
    

Intervention name(s): low immunogenic interferon-beta-1a
Intervention type(s): Drug
Intervention description(s): dosage and frequency as per Biogen Idec protocol
Other intervention name(s): Avonex
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Neutralizing antibodies; Safety; Low immunogenicity; interferon; interferon-beta-1a
Low-Carb/Time-restricted Feeding Protocol in Insulin-Using Type 2 Diabetics
Condition: Type2 Diabetes
Study type: Interventional

Summary: 
      The current paradigm of Type 2 Diabetes treatment relies heavily on expensive pharmacotherapy
      even though lifestyle factors are at the root of the condition. This study is designed to
      assess the feasibility of a low carbohydrate diet coupled with a time restricted feeding
      intervention to improve participant sensitivity, reducing their need for insulin. 20
      participants will be invited to enroll from the 20 S Park St Clinic in Madison, WI and remain
      on study for up to 6 months.
    

Detailed description: 
      The investigators will perform a prospective cohort study of 20 insulin-using Type 2
      diabetics who have primary care providers at 20 S Park St Clinic. Participants will be
      recruited from the Internal Medicine practices at the clinic. The subjects will meet with Dr.
      Zimmermann (Study Clinician) to review time restricted feeding and low-carbohydrate diets as
      well as a strategy for decreasing insulin doses. Calls from Dr. Zimmermann's clinic nurse
      will occur daily until blood glucose levels stabilize to manage insulin decrease.

      Participants will complete monthly logs of food intake times and meet with a dietician twice
      during the 6-month study. Diabetes medication use will be reviewed, and hemoglobin A1c will
      be measured, at baseline and at 3 and 6 months. The participants' non-diabetic medical care
      will continue to be managed through their primary care physicians (PCPs).

      Specific Aims:

        -  Demonstrate feasibility of the low carbohydrate/time restricted feeding (LC/TRF)
           protocol

             -  Feasibility will be assessed based on participant compliance with time-restricted
                feeding and recommended carbohydrate intake, clinician time and clinic resources

        -  Determine effectiveness of the LC/TRF protocol on diabetes care and quality of life

             -  Effectiveness on diabetes care will be evaluated using changes in A1c, insulin use,
                BMI, patient quality of life, and adverse events including hypoglycemia.
    

Intervention name(s): Low Carbohydrate Diet; Time Restricted Feeding
Intervention type(s): Other; Other
Intervention description(s): Dietary choices are counseled to come primarily from lean meats, eggs, nuts, seeds, vegetables and berries.; Participants will be asked to have 2 meals within an 8 hour period, preferably before 2pm.
Other intervention name(s): Intermittent Fasting
Intervention model: Single Group Assignment
Intervention model description: prospective cohort study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: low carbohydrate diet; time restricted feeding; insulin sensitivity
A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate safety and tolerability of a single dose of MEDI8852
      when given with oseltamivir, the safety and tolerability of oseltamivir alone, and the safety
      and tolerability of a single dose of MEDI8852 alone in adult participants with acute,
      uncomplicated influenza caused by Type A strains.
    

Detailed description: 
      The MEDI8852 phase 2a study will evaluate the safety and tolerability of a single intravenous
      (IV) dose of MEDI8852 administered in conjunction with oseltamivir, the safety and
      tolerability of oseltamivir alone and the safety and tolerability of a single IV dose of
      MEDI8852 alone in adult participants with confirmed acute, uncomplicated influenza caused by
      Type A strains. Enrollment is planned in the United States, South Africa, and Australia.
    

Intervention name(s): Oseltamivir; MEDI8852; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 75 mg capsules orally BID from Day 1 to Day 5.; MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered as a single IV infusion of 750 mg or 3000 mg on Day 1.; Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 1.
Intervention MeSH terms: Oseltamivir; MEDI8852
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Influenza; Influenza A; Flu; Flu A
Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the proposed study is to determine whether BL-7040 demonstrates clinical
      efficacy in patients with inflammatory bowel disease (IBD).
    


Intervention name(s): BL-7040
Intervention type(s): Drug
Intervention description(s): BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.
Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.
BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulcerative Colitis; IBD
TyG Index Levels in Klinefelter Syndrome
Condition: Cardiac Event; Klinefelter Syndrome; Endothelial Dysfunction
MeSH terms: Klinefelter Syndrome; Cardiovascular Diseases; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      It is well known that the frequency of cardiometabolic diseases are increased in patients
      with Klinefelter Syndrome. The triglyceride-glucose index (TyG index) is a simple surrogate
      marker of insulin resistance and is also associated with various cardiometabolic diseases.
      The aim of this study to investigate the TyG index levels and its relationship with insulin
      resistance and endothelial dysfunction in patients with KS.
    

Detailed description: 
      From the patient database of our Endocrinology department we randomly included a total of 30
      patients with KS and 32 healthy controls in the study. All the recorded data in the database
      were registered under the approval of Local Ethical Committee of Gulhane School of Medicine.

      The clinical and laboratory parameters, TyG index, asymmetric dimethylarginine (ADMA),
      homeostatic model assessment of insulin resistance (HOMA-IR) and high-sensitivity C-reactive
      protein (hs-CRP) levels were gathered from the database and the triglyceride-glucose index
      was calculated by the help of pre-measured laboratory parameters.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): this study was designed as retrospective observational study
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A total of 30 male patients with treatment-naive Klinefelter syndrome and 30 control
        subjects without any chronic disease
      
Keywords: Klinefelter Syndrome, TyG Index, Cardiometabolic risk
Efficacy of Balance Training by BBS on Gait Parameters and Balance in Patients With RLAS
Condition: Ankle Sprains
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      This study will be conducted to find out the effect of adding balance training on gait
      parameters, balance, and Sensory Interaction
    

Detailed description: 
      LAS are not benign injuries. As many as 4 in 10 individuals will develop chronic ankle
      instability (CAI) after a first-time sprain, More than half of patients with osteoarthritis
      (OA) of the ankle report a history of a sport-related ankle injury, and 85% of those are LAS.
    

Intervention name(s): Biodex Balance System; specific physical therapy exercise program
Intervention type(s): Device; Other
Intervention description(s): Subjects will receive several unique training modules using biodex; Subjects will receive recommended PT program
Other intervention name(s): BBS
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Fifty subjects (power analysis) of both gender diagnosed with recurrent lateral ankle sprain patients will be assigned randomly into 2 groups.
Group (A) will receive biodex balance training
Group (B)will receive a physical therapy exercise protocol only
Masking: Single (Participant)
Primary purpose: Treatment
Intraocular Pressure Fluctuation in Patients With Glaucoma and in Healthy Patients During Standard Yoga Positions
Condition: Glaucoma; Intraocular Pressure
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      The purpose of the study is to investigate the IOP difference between normal and glaucomatous
      eyes using standard ophthalmic tonometry devices while subjects are performing different
      standard yoga asanas. The IOP of participants will be measured prior, immediately at start of
      the asana, 2 minutes into the asana, and immediately after assuming a sitting position. The
      patient will wait 10 minutes and a final IOP will be taken. Four standard yoga asanas will be
      tested.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Glaucoma Practice and Yoga Studios