bioihbjkbjnl/mcl2 huggingface dataset:
Collaborative Tinnitus Research at Washington University
Condition: Subjective Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this trial to see if repetitive transcranial magnetic stimulation (rTMS) to the
      hearing area of the brain can lessen the perception of tinnitus. rTMS uses a strong magnet
      and when placed against the scalp generates a small electrical field within the brain.
      Depending on the frequency of the stimulation, this electrical field can either decrease or
      increase the electrical excitability of the brain. In this study, low-frequency stimulation
      will be used, which is thought to decrease nerve activity. It is this electrical excitability
      of the brain that is thought to be responsible for tinnitus.

      The hypothesis of this study is that rTMS can decrease the perception of tinnitus.
    

Detailed description: 
      This will be a cross-over randomized trial. The order of the treatments received will be
      randomly selected and the participant will not be told which treatment they are receiving.
      Subjects will fall into one of the four treatment groups described below:

        1. 2 weeks of active rTMS treatment followed by washout and then by 2 weeks sham

        2. 2 weeks of sham followed by washout and then 2 weeks of active rTMS treatment

        3. 4 weeks of active rTMS treatment followed by washout and then 4 weeks of sham

        4. 4 weeks of sham followed by washout and then 4 weeks of active rTMS treatment

      For the washout period between the two interventions, we will plan a minimum of 2 weeks to
      avoid the problem of carryover effects. Prior to starting the next intervention after the
      washout period, we will re-assess subject's tinnitus severity. To ensure no carryover effect,
      the washout period will be extended for those subjects whose tinnitus severity, as defined by
      the THI, is more than 20 points different than their baseline THI score.
    

Intervention name(s): rTMS
Intervention type(s): Device
Intervention description(s): Stimulation Settings:
Frequency -- 1Hz on 330 sec (5 min 30 sec.) per train for the first 5 trains with the last train 350 sec. (5 min. 50 sec.) in duration Off -- 90 sec (1 min. 30 sec.) Intensity -- 110% of motor threshold Duration -- 42½ minutes (total 2000 pulses in 6 trains)
Other intervention name(s): Neuronetics 2100 device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tinnitus; subjective tinnitus; therapy; repetitive transcranial magnetic stimulation; clinical trial
Oxygen Toxicity in the Resuscitation in Extremely Premature Infants
Condition: Birth Asphyxia; Premature Birth
MeSH terms: Premature Birth; Asphyxia Neonatorum; Asphyxia
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators hypothesize that using low oxygen concentrations during resuscitation of
      extremely premature infants will avoid oxidative stress derived damage and improve outcome.
    

Detailed description: 
      This is a prospective randomized trial enrolling premature infants of less than 28 weeks
      gestation. Patients are randomly assigned to become resuscitation with an initial oxygen
      inspiratory fraction (FiO2) of 30% or 90%. Main objective is to reach a target saturation of
      85% at 15 min of life.

      Immediately after birth pre-and-postductal pulse oximeters are set and oxygen saturation
      (SpO2) continuously monitored and registered as long as the patient requires oxygen
      supplementation. FiO2 is stepwise adjusted (increased or decreased 10%) every 90 sec
      according to heart rate, SpO2 and responsiveness.

      Blood samples are drawn from umbilical cord and at day 1, 2 and 7 from peripheral vein to
      determine oxidative stress markers (GSH, GSSG), angiogenic factors (VEGF, VEGF receptors,
      Angiopoietin), pro-inflammatory markers (IL8, TNF alfa) and pro-apoptotic markers (Fas
      Ligand; Cytochrome C).

      Urine is collected every day during the first week of life to determine oxidative stress
      markers (8-oxo-dG; O-tyrosine; F2 isoprostanes; Isofurans).

      Babies are followed in the NICU and clinical condition recorded. Serial examinations for ROP
      and Auditory evoked potentials will be performed. Neurodevelopmental outcome is evaluated at
      2 years of postnatal life. Main outcome: Achievement of a target saturation of 85% at 15 min
      of life. Secondary outcomes: acute complications during delivery; chronic complications (BPD,
      ROP, IPVH); mortality in the neonatal period.
    

Intervention name(s): Resuscitation; Resuscitation
Intervention type(s): Procedure; Procedure
Intervention description(s): Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-88%; Oxygen inspiratory fraction needed to keep oxygen saturation in the preset limits of 90-93%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Asphyxia; Resuscitation; Oxidative stress; Prematurity; Follow up
Validation and Reproducibility of S.P.A.T. With Allergens
Condition: Allergy to House Dust; Allergy Pollen
MeSH terms: Rhinitis, Allergic, Seasonal; Hypersensitivity
Study type: Interventional

Summary: 
      To improve accuracy and take out human error opportunities, Hippo Dx developed S.P.A.T., an
      automated skin prick test. This study will provide a comparison between manual and automated
      skin prick test in allergic and non-allergic individuals with a panel of common inhalant
      allergens.

      The primary endpoint is to compare the accuracy of S.P.A.T. to detect sensitization to common
      aeroallergens compared to a manual skin prick test (SPT).

      It is a prospective monocentric study that will include 120 study participants.
    


Intervention name(s): Skin Prick Automated Test; Skin Prick Manual Test
Intervention type(s): Device; Diagnostic Test
Intervention description(s): skin prick test to detection sensitisation to aeroallergens; skin prick test to detection sensitisation to aeroallergens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Ottawa Nutritional Guidelines for Nausea and Vomiting
Condition: Nausea Gravidarum
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting
      During Pregnancy (A Randomized Control Trial)
    

Detailed description: 
      Studying the Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and
      Vomiting During Pregnancy (A Randomized Control Trial) using no pharmacological agents and
      life style modification in addition to acupressure to treat nausea and vomiting of pregnancy
    

Intervention name(s): Acupressure and nutritional advices
Intervention type(s): Behavioral
Intervention description(s): Teaching using booklets and application of acupressure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
To Investigate the Effect of Montelukast on Behavior Problems in Children With Asthma
Condition: Asthma, Behavior Problem, Montelukast
MeSH terms: Asthma; Problem Behavior
Study type: Observational [Patient Registry]

Summary: 
      The purpose of the study to investigate whether montelukast lead to behavior problems in
      children with asthma.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We planned to include who who treated for asthmatic children and healthy controls in the
        study.
Heart Valve Prosthesis-Patient Mismatch
Condition: Heart Valve Diseases
MeSH terms: Heart Valve Diseases
Study type: Observational

Summary: 
      The purpose of this study is to determine the frequency of prosthesis-patient mismatch after
      mitral valve replacement and its effect on clinical outcomes.
    

Detailed description: 
      Mitral valve replacement (MVR) is associated with higher short and long term mortality than
      aortic valve replacement or mitral valve repair. The suboptimal results of MVR underline the
      importance of identifying and preventing prosthesis- patient mismatch. The effective orifice
      area (EOA) of prosthetic valves used for MVR is often too small in relation to body size,
      thus causing a mismatch between valve EOA and transvalvular flow. As a consequence, normally
      functioning mitral prostheses often have relatively high gradients that are similar to those
      found in patients with mild to moderate mitral stenosis. Residual pressure gradients across
      mitral prostheses delay the regression of left atrial and pulmonary arterial hypertension.
      Pulmonary hypertension may cause rightsided failure and is an important risk factor for
      morbidity and mortality in patients with cardiovascular diseases. However data about the
      frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on
      clinical outcome is inconclusive. Predetermined outcomes will be evaluated in the clinical
      course of this condition.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Tertiary care clinic
      
Keywords: Heart valve prosthesis
Virtual Reality and Pain
Condition: Pain, Postoperative; Pain; Anxiety Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Determine the impact of VR-Biofeedback, VR-distraction, and 360 video on pain and medication
      utilization in patients undergoing surgery; determine the role of anxiety and pain
      catastrophizing on changes in pain following VR-BF in patients undergoing surgery.
    


Intervention name(s): VR-Biofeedback; VR-Distraction; 360 Video
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will be instructed to use the Mindful Aurora application; Participants will be instructed to use one of three applications; Participants will be instructed which video to view
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 90 participants assigned to one of three groups (30 participants for each group). VR- Biofeedback, VR-Distraction, 360 Video
Masking: None (Open Label)
Primary purpose: Other
Periodontal and Salivary Evaluation of Type 1 Diabetes Mellitus Patients
Condition: Diabetes Mellitus, Type 1; Periodontal Diseases
MeSH terms: Periodontal Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Diabetes Mellitus is a risk factor for periodontal disease increasing its prevalence,
      extension and severity. Periodontal disease is considered the sixth complication of diabetes.
      There is a global epidemic of diabetes, including an increase of incidence of type 1 diabetes
      in younger patients. Thus, the aim of this observational study was to evaluate the
      periodontal and salivary condition of a sample of patients with type 1 diabetes of a
      brazillian city.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Test Group: Patients diagnosed with Type 1 diabetes mellitus
      
Keywords: Saliva
Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis
Condition: Multiple Sclerosis; Healthy
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The purpose of this study is to assess effects of B cell depletion on the immune system in
      patients with relapsing forms of multiple sclerosis (MS) treated with ocrelizumab. This will
      be done by collecting blood from patients starting treatment with ocrelizumab before the
      first infusion and before the infusions at 6 and 12 months. The effects on the immune system
      will be assessed by performing transcriptome profiling of immune cells, measuring serum
      levels of microRNAs, and analyzing serum autoantibody immune signatures using antigen arrays.
      In addition, blood will be collected once from a group of healthy individuals to serve as
      controls.
    


Intervention name(s): Blood sampling (MS); Blood sampling (controls)
Intervention type(s): Other; Other
Intervention description(s): Blood samples will be collected before initiation of Ocrelizumab treatment and after 6 and 12 months of treatment.; Blood samples will be collected once at enrollment.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with relapsing form of MS starting treatment with ocrelizumab at Partners MS
        Center
      
Biospecimen description: 
      Serum, plasma, and peripheral blood mononuclear cells.
Study of Osteopathic Manipulation in the Management of Angina
Condition: Angina Pectoris
MeSH terms: Angina Pectoris
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effectiveness of osteopathic manipulation in
      decreasing angina pectoris symptoms.
    


Intervention name(s): Osteopathic manipulation
Intervention type(s): Procedure
Intervention description(s): Participant will be evaluated and treated for somatic dysfunction utilizing osteopathic manipulation once a week for 3 weeks, then once every 3 weeks for three more visits; a total of 6 interventions in 3 months.
Other intervention name(s): osteopathic manipulative medicine; structural exam; viscero-somatic reflexes; circulatory-respirtatory model; musculoskeletal model
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: angina pectoris, osteopathic manipulation
Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This study will evaluate the safety and acute performance of the Globe® Mapping and Ablation
      System with the GPS™ Module intended to conduct electroanatomic mapping and ablation
      treatment of subjects with atrial fibrillation (AF).
    


Intervention name(s): Globe Mapping and Ablation System
Intervention type(s): Device
Intervention description(s): Prospective, non-randomized, open-label clinical study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Safety of Mebeverine + Simethicone in Patients With Functional Bowel Disorders
Condition: Functional Bowel Disorder
MeSH terms: Intestinal Diseases; Gastrointestinal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The parallel three-group study of efficacy and safety was planned to investigate the
      reduction in abdominal pain and bloating during treatment with the fixed-dose combination of
      Mebeverine + Simethicone versus Duspatalin® and Espumisan® as a monotherapy (Protocol No.
      MESI3001).
    


Intervention name(s): Mebeverine+Simethicone; Mebeverine; Simethicone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): fixed-dose combination, film-coated tablets, 135 mg + 80 mg; Duspatalin®, coated tablets 135 mg; Espumisan® capsules 40 mg
Intervention MeSH terms: Mebeverine; Simethicone; Alverine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mebeverine+Simethicone; Duspatalin; abdominal pain; bloating/flatulence; functional bowel disorder; fixed dose combination; NRS11
Safety and Pharmacokinetics of CBX129801 in Patients With Type 1 Diabetes
Condition: Type 1 Diabetes; Diabetes Mellitus; Peripheral Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess safety and tolerability and determine the
      pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of
      CBX129801 (long-acting synthetic C-peptide) in type 1 diabetes patients.
    

Detailed description: 
      This study will be conducted in two parts (Part 1 and Part 2). Part 1 will be conducted in
      three sequential dose cohorts with dose level escalated for each successive cohort. In Part 2
      of the study, a dose regimen determined from the pharmacokinetic data from Part 1 will be
      administered in up to 40 additional subjects to achieve a target plasma concentration range
      that represents the most commonly observed physiological C-peptide levels in healthy,
      non-diabetic individuals.
    

Intervention name(s): CBX129801; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection; Subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      Propofol has been used in adult populations to treat migraines as an abortive agent.
      Investigators plan to investigate its efficacy as an abortive agent in the pediatric
      population when administered as a safe low-dose infusion. Goals of the study are to:

        1. Evaluate efficacy of low-dose propofol infusion as an abortive agent in pediatric
           migraine headaches

        2. Evaluate effective and safe dosing limits in pediatric populations

        3. Evaluate duration of effect reached from a low-dose propofol infusion as an abortive
           agent

      Endpoints for the study will be:

        1. Number of enrolled patients

        2. Safety endpoints reached, including: cardiopulmonary depression, excessive somnolence
           Risks of the study are minimal due to the use of sub-anesthetic dosing of propofol under
           the guidance and supervision of a board certified pediatric anesthesiologist with the
           appropriate monitoring equipment and readily available emergency equipment.
           Investigators hope to demonstrate more rapid improvement and decreased side-effect as
           compared to standard care.
    


Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): Intravenous propofol infusion at 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes.
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Peanuts Second Meal Glycemic Response
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Nut consumption is associated with reduced risk of Type 2 diabetes. The aim of this study was
      to assess the effects of peanut (whole or peanut butter) to breakfast meals on glycemic,
      insulinemic and selected gut hormone responses, appetite, and food intake over two
      consecutive meals in obese women with high Type 2 diabetes risk. Fifteen women participated
      in a randomized crossover trial where 42.5g of whole peanuts (P), peanut butter (PB), or no
      peanuts (control-C) were added to a 75g available carbohydrate-matched breakfast meal.
      Postprandial concentrations of blood glucose, insulin, non-esterified free fatty acids
      (NEFA), glucagon-like peptide-1 (GLP-1), peptide YY (PYY), cholecystokinin (CCK), appetitive
      sensations and food intake were assessed after breakfast treatments and a standard lunch (75g
      available carbohydrate).
    


Intervention name(s): Whole peanuts without skins, Peanut butter, or no peanuts (control)
Intervention type(s): Dietary Supplement
Intervention description(s): In accordance with the Food and Drug Administration qualified health claim regarding daily nut intake, 42.5 g of whole peanuts or peanut butter were added to a 75g available carbohydrate-matched breakfast meal each test session.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peanut; Blood glucose; Insulin; Non-esterified free fatty acids; Glucagon-like peptide-1; Peptide YY; Cholecystokinin; Appetitive; Food intake
Twelve Step Based Self-help Groups for Substance Related Disorders
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The Twelve Step groups are the most available and widespread self-help groups for patients
      with alcohol or drug related disorders. In a public health perspective, self-help groups
      (SHGs) may be considered as a supplement to professional treatment and provide aftercare soon
      as professional treatment has ended.

      There is a need to investigate if U.S. findings and procedures concerning referrals from the
      health services to Twelve Step Groups (TSGs) can be replicated and accommodated to a cultural
      setting which is unfamiliar with these groups. There is also a particular need in the
      Norwegian treatment system to develop alternative treatment strategies for patients
      undergoing detoxification to improve their chances of long-term recovery, due to deficient
      formal follow-up alternatives.

      We plan to carry out a RCT-study. One hundred and sixty patients entering a detoxification
      treatment center (Addiction Unit, Sørlandet Hospital, Kristiansand, Norway) will be assigned
      to two different groups: One given standard information about TSGs (brief advice) and one
      given intensive referral (motivational sessions and contact with TSG volunteers). A follow up
      assessment is planned at 6 months to determine whether intensive referral results in more TSG
      attendance, and if this mediates less substance use and better functioning outcomes.

      This study introduces a new concept in the Norwegian health care system and relies on a
      systematic cooperation with user organizations (SHGs) and user volunteers. Thus the study
      focuses strongly on user resources.
    


Intervention name(s): Brief motivation to participate in TSG
Intervention type(s): Behavioral
Intervention description(s): The intensive intervention will consist of a boost motivational session on follow-up alternatives and particularly on attending TSGs. Efforts will be made to connect the patients with TSG volunteers via the AA/NA contact telephone. The patients are encouraged to invite AA/NA contact persons to visit them on the ward. The patient will then have the possibility to be followed to a meeting after treatment. The patients in the intensive referral group will get a phone call four weeks after discharge. The focus of this call will be on continued motivation to attend TSGs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Substance use disorders; Self-help groups; Twelve Step groups