bioihbjkbjnl/mcl2 huggingface dataset:
Vapocoolant Spray Used Prior to Intravenous (IV) Insertions
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this study is to determine if by offering a vapocoolant (cold spray)
      to hospital outpatients prior to an intravenous catheter (IV) insertion will increase patient
      satisfaction of IV insertion as well as determine if pain of insertion is decreased.
    

Detailed description: 
      This is a single blind interventional study with a post design using a convenience sample of
      patients undergoing a Nuclear Medicine Stress Test. The patient selection and intervention
      will be randomized in order to ensure a high validity study. The interventional treatment
      used will be a ethyl chloride mist spray manufactured by the Gebauer Company. The placebo
      spray that will be used is manufactured by BioLogic Aqua Research Technologies International
      Inc. The spray is called Nature's Tears Mist and is a sterile water. The patient's for this
      study are required to have intravenous cannulation (IV) access. This is a painful and
      invasive procedure in which a vapocoolant may confer benefit for the relief of pain.
    

Intervention name(s): Gebauer Ethyl Chloride; Nature's Tears
Intervention type(s): Drug; Drug
Intervention description(s): Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds.; Sterile water mist will be administered 1-2 sprays prior to intravenous access
Other intervention name(s): Ethyl Chloride Mist Spray Can; Sterile Water
Intervention MeSH terms: Ethyl Chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Vapocoolant applied prior to IV access
Evaluation of Phenotypic and Genetic Properties in Male Subjects Affected by Hypohidrotic Ectodermal Dysplasia - A
Condition: Hypohidrotic Ectodermal Dysplasia
MeSH terms: Ectodermal Dysplasia; Ectodermal Dysplasia 1, Anhidrotic; Hyperplasia
Study type: Observational

Summary: 
      The overall purpose of this study is to learn more about Hypohidrotic Ectodermal Dysplasia
      (HED) and to help in identifying treatment opportunities. Several evaluations will be
      conducted in this study: 1) the number of skin sweat glands you have and their ability to
      produce sweat; 2) your ability to grow hair; 3) the structure of your face compared to faces
      of people affected by HED; 4) molds of your teeth to see if and how they are different than
      people affected by HED.
    


Sampling method: Non-Probability Sample
Study population: 
        HED Affected Members of the UCSF Craniofacial Clinic, HED Affected Members of the National
        Foundation for Ectodermal Dysplasia
      
Biospecimen description: 
      Whole blood, serum
    
Keywords: X-Linked Hypohidrotic Ectodermal Dysplasia; Hypohidrotic Ectodermal Dysplasia; XLHED; HED
Genetic Testing to Understand and Address Renal Disease Disparities
Condition: Hypertension; Chronic Kidney Disease; Genomics
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypertension
Study type: Interventional

Summary: 
      In this genomic medicine implementation pilot project, the investigators aim to conduct a
      randomized trial in a network of community health centers and primary care facilities to
      study processes, effects and challenges of incorporating information for apolipoprotein L1
      (APOL1)-attributable genetic risk for end stage kidney disease in patients of African
      ancestry with hypertension .
    

Detailed description: 
      CKD is most commonly associated with diabetes (40%) and hypertension (28%), and affects 26
      million American adults. African ancestry populations with hypertension (HTN) have 2- to
      3-fold higher risk of developing CKD, and a 5-fold increased risk to progress to end stage
      renal disease (ESRD) when compared with whites. HTN is a risk factor for progression of CKD
      and for increased cardiovascular risk with CKD. Thus targeting blood pressure control as a
      modifiable risk factor may both reduce CVD in people with CKD and reduce progression of CKD
      to end stage disease. Recent discoveries demonstrate that testable alleles of the APOL1 locus
      on chromosome 22 have a major effect on and explain almost all of the excess risk for
      hypertension-associated CKD and its progression to ESRD in African ancestry populations.

      We will use community-engaged approaches to enroll patients of African Ancestry with HTN from
      a network of community health centers and primary care facilities in Harlem and the Bronx and
      randomize them on a 7 to 1 ratio to receive APOL1 genetic testing and EMR-enabled provider
      clinical decision support incorporating APOL1 genomic risk information.
    

Intervention name(s): Immediate Genetic Testing
Intervention type(s): Other
Intervention description(s): Participants will receive the APOL1 genetic test. Trained research staff will meet with participants to communicate results and lifetime ESRD risk attributable to variations in the APOL1 gene. Primary care providers will receive APOL1 genetic risk information via a best practice alert in the participant's EMR upon commencement of a patient encounter and through results filed in the participant's genetics results section of their EMR.
Other intervention name(s): Genetic Risk Communication
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hypertension; Chronic Kidney Disease; End Stage Renal Disease; APOL1; Genomics; Genetics; Community-engaged
The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated
      craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion
      (Zyban). We compare cue-induced reactivity to smoking videos in smokers who were successfully
      treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic
      activity in response to smoking and neutral cues in Positron Emission Tomography using FDG.
    

Detailed description: 
      Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated
      craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion
      (Zyban)for 2 months. We compare cue-induced reactivity to smoking videos in smokers who were
      successfully treated with Bupropion to smokers who are still smoking. We measured the brain's
      metabolic activity after exposure to videotapes showing smoking and neutral scenes in
      Positron Emission Tomography using FDG. There were 2 scanning sessions, one with a smoking
      videotape and one with a neutral video separated by a week. So far we have compared the
      brain's metabolic activity in 6 abstinent smokers and 6 still smokers.
    

Intervention name(s): Bupropion (Zyban)
Intervention type(s): Drug
Intervention description(s): 1 tablet a day increasing to 2 tablets a day after a week
Intervention MeSH terms: Bupropion
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: craving; nicotine; imaging; FDG; PET; smoking; Bupropion
A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study
      to evaluate the efficacy and safety of AK111 for the treatment of moderate to severe plaque
      psoriasis.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study
      to evaluate the efficacy and safety of AK111 in subjects with moderate to severe plaque
      psoriasis. The study will consist of 4 periods: up to 4 weeks screening period, 12 weeks
      placebo-controlled period,12 weeks crossover treatment period,44 weeks long-term treatment
      period.
    

Intervention name(s): AK111/Placebo
Intervention type(s): Biological
Intervention description(s): After loading dose, investigational drug was administered subcutaneously up to 60 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AK111; efficacy; safety
Effects of Ligands on Human Hair Follicles Grafted Onto SCID Mice
Condition: Alopecia
MeSH terms: Alopecia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if immunophilin ligands may have the potential to
      reverse hair loss.
    

Detailed description: 
      Preliminary experiments in C57BL/6J mice showed that immunophilin ligand FK506 and its
      non-immunosuppressive analogs, GP11046 and GP11511 were capable of promoting telogen to
      anagen transition. Since GP11046 and GP11511 possess the neurotrophic properties of FK506
      without its immunosuppressant capability, the neural action of these immunophilin ligands may
      play an important role in the hair cycle. This finding has significant clinical implications
      in that immunophilin ligands may have the potential to reverse alopecia. To further
      investigate this possibility we propose to explore the response of transplanted miniaturized
      scalp hair follicles to topically applied immunophilin ligands.
    

Intervention name(s): FK506, GP11046, GP11511
Intervention type(s): Drug
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bone Turnover and Parenteral Nutrition
Condition: Bone Turnover Rate Disorder
Study type: Observational

Summary: 
      Evaluation of changes in biochemical markers of bone metabolism. Fat profile. Evaluation of
      the overall body development. Assessment of parenteral nutrition protocols.
    

Detailed description: 
      Osteopenia is very common in premature infants, particularly in preterm infants born at
      extremely low birth weight This is probably related to inadequate calcium and phosphorus
      intake, which is considerably less than the accretion of these minerals during the last
      trimester of pregnancy In addition, severe morbidity during the neonatal period (e.g.
      bronchopulmonary dysplasia [BPD]), chronic drug therapy (e.g. diuretics and systemic
      steroids), the need for total parenteral nutrition and prolonged immobility increase the risk
      of bone demineralization.

      Total parenteral nutrition is associated with osteopenia in preterm infants. Insufficient
      calcium and phosphate are likely causes; aluminum contamination is another possible
      contributing factor as this adversely affects bone formation and mineralization.

      The DHA+ARA-supplemented formulas supported normal growth and bone mineralization in
      premature infants who were born at <33 wk gestation. Smof lipid emulsion has a high density
      of this fatty acids, while Intra lipid does not contain any traces of DHA. Evidence has shown
      that long-chain polyunsaturated fatty acids (LCPUFA), especially the ω-3 fatty acids such as
      eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are beneficial for bone health and
      turnover.
    

Intervention name(s): MCT/ω-3-PUFA; Soybean Based
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): lipid emulsion; lipid emulsion
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Very Low Birth Weight preterm neonates with gestational age <32 weeks
      
Biospecimen description: 
      plasma
    
Keywords: preterms; parenteral; lipid
Evaluating the Efficiency of Newly Designed Prefabricated PMMA Crowns for Restoring Primary Teeth in Comparison to Stainless Steel and Zirconia Crowns
Condition: Decay, Dental
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Evaluation of PMMA pediatric crowns
    

Detailed description: 
      The aim of the present study is to evaluate the PMMA crowns regarding the following aspects:

      I. Clinical evaluation of PMMA crowns regarding wear of opposing teeth when compared to
      zirconia crowns and stainless steel crowns after 6 months, and 12 months.

      II. Color stability of PMMA crowns and zirconia crowns after 6 months, and 12 months.

      III. Gingival health of restored teeth after 6 months, and 12 months. IV. Patient's
      satisfaction regarding the appearance and clinical performance of PMMA crowns when compared
      to stainless steel crowns and zirconia crowns through a given questionnaire.
    

Intervention name(s): PMMA crowns
Intervention type(s): Other
Intervention description(s): New type of pediatric crowns
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of tDCS on Heart Rate Variability in Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Chronic low back (CLBP) pain is an important public health and socioeconomic problem
      worldwide and, despite the volume of research in the area, it remains a difficult condition
      to treat. There are some evidences that altered heart rate variability (HRV) parameters are
      associated with different clinical disorders, such as chronic low back pain. For instances,
      diminished parasympathetic activity has been explored as a potential therapeutic target.
      Considering the dynamic interaction between brain and heart, neuromodulatory strategies
      targeting this relationship could exert a positive influence on cardiac autonomic system and
      pain modulation systems.

      Transcranial direct current (tDCS) stimulation is a noninvasive neuromodulation technique
      that has been presenting recent advances in the treatment of chronic pain. However, tDCS
      application focusing on brain-heart interaction has not been extensively explored, especially
      on chronic pain conditions.

      This study aims to investigate the effects of tDCS on HRV in chronic low back pain patients.
      Sixty patients will be randomized into two distinct groups to receive either tDCS (anodal) or
      tDCS (sham) in a single session protocol. The primary clinical outcome (HRV parameter) will
      be collected before, during and post-tDCS. The data will be collected by a blind examiner to
      the treatment allocation.
    


Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, randomised, double-blind, 4-way crossover, 4-treatment, euglycaemic
      clamp study in subjects with Type 1 Diabetes Mellitus (T1DM). Each subject will be randomly
      allocated to one of four treatment sequences. Each sequence comprises one single dose of each
      of four IMPs. IMP1 and IMP2 are BioChaperone lispro formulations. They have the same
      composition and correspond to different development stages of a unique product which is
      BioChaperone insulin lispro; between them, improvements were made to prepare industrial
      production. Comparators (IMP3 and IMP4) are US-approved Humalog® and EU-approved Humalog®.
      All IMPs will be dosed at 0.2 U/Kg of insulin lispro on 4 dosing visits separated by a
      washout period of 5 to 15 days.

      The trial will compare the characteristics of BioChaperone insulin lispro fully liquid (IMP2)
      formulation to US-approved Humalog and EU-approved Humalog.
    


Intervention name(s): Administration of BioChaperone insulin lispro reconstituted with Humalog® (IMP1); Administration of Ready-to-use BioChaperone insulin lispro (IMP2); Administration of US-approved Humalog® (IMP3); Administration of EU-approved Humalog® (IMP4)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administration of IMP1 during a 12-hour euglycaemic clamp.; Administration of IMP2 during a 12-hour euglycaemic clamp.; Administration of IMP3 during a 12-hour euglycaemic clamp.; Administration of IMP4 during a 12-hour euglycaemic clamp.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Shoulder Disorders in Patients With Parkinson's Disease
Condition: Parkinson's Disease; Shoulder Pain
MeSH terms: Shoulder Pain; Parkinson Disease
Study type: Observational

Summary: 
      Parkinson's disease (PD) is a multisystem neurodegenerative disorder that is increasingly
      recognized in our ageing population. It is characterized by cardinal clinical features
      including bradykinesia, tremor, rigidity, and postural instability. For most people with PD,
      the most serious concern is with the motor system: stiffness, slowness of movement, impaired
      handwriting and coordination, poor mobility and balance. However, more than half of all
      people with PD have experienced painful symptoms. Most people experience aching, stiffness,
      numbness and tingling at some point in the course of the illness. Defazio et al reported that
      pain may begin at clinical onset of PD or thereafter as a non-motor feature of PD.5 Aching
      muscles and joints are especially common in PD. Rigidity, lack of spontaneous movement,
      abnormalities of posture and awkward mechanical stresses all contribute to musculoskeletal
      pain in PD.
    

Detailed description: 
      One of the most common musculoskeletal complaints is shoulder pain or shoulder disorders,
      including frozen shoulder, bursitis, and rotator cuff lesions. Actually, shoulder pain or
      shoulder disorder can be the first sign of PD. The prevalence and severity of shoulder
      disorders in Parkinson's disease are not totally clear. In a retrospective study, Stamey
      found shoulder pain was present in 11% of patients with PD.

      Over the past ten years ultrasound (US) has become popular in the evaluation of shoulder
      disorders. It allows for the detailed assessment of a wide range of changes involving
      different anatomic structures of the shoulder joint, including rotator cuffs, biceps tendon,
      and subdeltoid bursa. Koh et al found among 33 PD patients, 22 patients had abnormal US
      findings on the dominant side, and all 22 patients with abnormal US finding had a tendon tear
      and 9 patients had frozen shoulder. However, there were no control group in Koh' s study, and
      diagnosis of frozen shoulder with US findings is still controversial.

      The purposes of this study are to evaluate patients with PD with a combination of physical
      examination and US study of the shoulder, and to compare the frequency and type of shoulder
      lesion in US between patients with PD and normal subjects. The investigators also plan to
      test the correlation between shoulder disorders or US abnormality and the severity of PD.
    

Intervention name(s): Ultrasonography
Intervention type(s): Other
Intervention description(s): Ultrasonography is applied for normal subjects and patients with Parkinson's disease
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with PD will be recruited consecutively from a neurology clinic. A group of sex-
        and age-matched normal subjects with be recruited from the public.
Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus
      Nerve Stimulation (VNS) device in 15 adult patients with active moderate-to-severe rheumatoid
      arthritis who have had an incomplete response or intolerability to at least two different
      mechanisms of action.
    

Detailed description: 
      This is a two-stage study where Stage 1 is open label, and Stage 2 is randomized and sham
      controlled where the sites and subjects are blinded to treatment. Three subjects will be
      enrolled in Stage 1 of the study. And 12 subjects will be enrolled in Stage 2. Subjects will
      be treated for a total of 12 weeks.

      Subjects will be asked to visit the clinic at day 0, week 1-6, week 8 and week 12. During
      these visits, the following activities will be conducted: standard patient and physician
      assessments of RA activity, blood sample collection for RA biomarkers, and a hand MRI.

      Subjects who complete the study will have the option to enroll in a long-term extension
      study. Subjects that do not participate in the extension study can opt to either have their
      device permanently inactivated and left in place or have the device surgically explanted.
    

Intervention name(s): SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Intervention type(s): Device
Intervention description(s): Active Implantable Vagus Nerve Stimulation device.
Other intervention name(s): SetPoint System
Intervention MeSH terms: Anti-Inflammatory Agents; Cholinergic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Device Feasibility