bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of a Novel Carpal Tunnel Tissue Manipulation Device in Treating Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      A single-center, prospective, non-randomized study to evaluate the safety and efficacy of a
      novel carpal tunnel tissue manipulation device in treating symptoms and decreased physical
      function in subjects previously diagnosed with mild to severe carpal tunnel syndrome (CTS).
    

Detailed description: 
      A single-center, prospective, non-randomized study to evaluate the safety and efficacy of a
      novel carpal tunnel tissue manipulation device in treating symptoms and decreased physical
      function in subjects previously diagnosed with mild to severe carpal tunnel syndrome.
    

Intervention name(s): Carpal Tunnel Tissue Manipulation Device (CTMD)
Intervention type(s): Device
Intervention description(s): This piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece for a duration of 2-14 hours.
Other intervention name(s): Wrist-Aid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Function and Scoliosis Surgery
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      The purpose of the study is to examine the changes in function and performance biomechanics
      in patients undergoing spinal fusion corrective surgery for adolescent idiopathic scoliosis
      (AIS).
    

Detailed description: 
      Methods will consist of movement studies, questionnaires, and chart review. The recruited
      subjects will be followed at the usual clinical schedule of pre-op, 6-week, 3 -, 6- and
      12-month post-operative follow-up visits. After signing informed consent, age at time of
      surgery, height, weight, body composition, leg length will be recorded to be used during data
      processing. Chart review will further yield data on Cobb angle, Lenke Scoliosis
      classification, instrumentation used during surgery, and level of spinal fusion. All subjects
      will be asked to complete assessments of activity level (Marx Score, Tegner Activity Score),
      general health (EQ-5D), and a validated scoliosis survey (Scoliosis Research Study
      questionnaire SRS-22). Movement studies will consist of the Lower Quarter Y Balance Test
      (YBT-LQ), and Functional Movement Screen (FMS), and measures of forward flexion, right and
      left lateral bending, and right and left trunk rotation. These measures will be assessed
      preoperatively and at postoperative follow-up visits.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that are undergoing spinal fusion surgery to treat idiopathic scoliosis.
      
Keywords: Adolescent Idiopathic Scoliosis; Functional Movement Screen; Y Balance Test
A Study of Lasmiditan in Healthy Participants When Co-administered With Topiramate
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability and blood concentrations of lasmiditan and
      topiramate together compared to lasmiditan and topiramate separately. Information about any
      side effects that may occur will be collected.

      Participants will be admitted to the Clinical Research Unit (CRU) one day prior to the start
      of the study and will remain through Day 14.

      This study is expected to last approximately 25 days, not including screening. Screening is
      required within 28 days prior to the start of the study.
    


Intervention name(s): Lasmiditan; Placebo; Topiramate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Other intervention name(s): LY573144
Intervention MeSH terms: Topiramate; Lasmiditan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

        -  Compare disease-free survival in women with human epidermal growth factor receptor 2
           (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer
           treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without
           trastuzumab (Herceptin) vs trastuzumab, docetaxel, and carboplatin.

      Secondary objective:

        -  Compare overall survival of participants treated with these regimens.

        -  Compare the toxic effects (including cardiac) of these regimens in these participants.

        -  Compare quality of life of participants treated with these regimens.

        -  Compare pathologic and molecular markers for predicting efficacy of these regimens in
           these participants.

        -  For substudy: Compare peripheral levels of shed HER2-neu extracellular domain with
           fluorescence in situ hybridization in predicting outcome in participants treated with
           these regimens.
    


Intervention name(s): Doxorubicin; Cyclophosphamide; Docetaxel; Herceptin; Carboplatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Taxotere; Trastuzumab
Intervention MeSH terms: Cyclophosphamide; Carboplatin; Docetaxel; Doxorubicin; Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Affect-regulatory Characteristics of Deceptive Placebos
Condition: Social Anxiety; Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The study tries to identify whether specifically framed expectations, induced with an active
      placebo nasal-spray, have effects on affective regulation processes and rumination.
    

Detailed description: 
      Healthy volunteers are informed that a new application method for an antidepressant,
      specialized on positively influencing the experience of aversive emotional states would be
      tested. They will randomly be assigned to a no treatment control group (not taking a placebo)
      or to one of the two treatment groups: Participants will be taking the antidepressant (which
      is in fact an active placebo) which will either protect them from experiencing intense
      emotional reactions and rumination (anticipatory group) or help them to regulate emotional
      states quicker as well as to distance themselves from ruminative thoughts (reactive group).
      Then, an aversive emotional state is induced by an autobiographical recall of events which
      made the participants feel inadequate, bashful, and ashamed. Currently experienced shame as
      well as state rumination are assessed before and after the negative recall task.
    

Intervention name(s): Active Placebo labelled as antidepressant
Intervention type(s): Other
Intervention description(s): Participants receive an active nasal spray that is in fact a placebo with a specific framing in regards to its affect-regulatory characteristics, respectively.
Intervention MeSH terms: Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer
Condition: Urine Detectable Acute and Chronic Diseases
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      The Dip Home-Based Dipstick Analyzer (henceforth HBDA) is composed of a kit and a smartphone
      application. The device will be provided to the subject in a simulated home-use environment.
      All subjects will be asked to complete the urine test by following the application guidance,
      including providing a urine sample and scanning the urine strip after placing it on the
      Color-Board.

      The user will also complete a questionnaire to collect information regarding the use of the
      HBDA device. Following the usability test performed by the lay user, the subject's urine
      sample will be tested by the professional user using the comparator device. The use of the
      HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable
      usability criteria for specific, critical steps will be evaluated.
    


Intervention name(s): Dip Home-Based Dipstick Analyzer; Urine analysis predicate device for professional user
Intervention type(s): Diagnostic Test; Device
Intervention description(s): The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures six urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.; Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Atopic Dermatitis Biomarker Identification Trial in Omalizumab Usage
Condition: Atopic Dermatitis; Atopic Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims at evaluating the therapeutic potential of omalizumab in atopic dermatitis,
      and to work out biomarkers predictive of treatment response.
    


Intervention name(s): Omalizumab (Xolair®)
Intervention type(s): Drug
Intervention MeSH terms: Omalizumab
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: Atopic dermatitis (atopic eczema)
Enhanced External Counterpulsation on Delayed Onset Muscle Soreness
Condition: Muscle Tightness
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      This study will evaluate the effects of Enhanced External Counterpulsation on delayed onset
      muscle soreness. The primary outcomes will be duration of delayed onset muscle soreness, WBC
      count, CRP count, CPK count, and pain tolerance.
    


Intervention name(s): Enhanced External Counterpulsation
Intervention type(s): Device
Intervention description(s): Enhanced External Counterpulsation
Other intervention name(s): Lumenair Enhanced External Counterpulsation Therapy System, Vasomedical
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Minimum Alveolar Concentration of Sevoflurane With Nitrous Oxide Inducing Isoelectric EEG
Condition: Middle Aged Patients; General Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      In order to investigate the effect of a combination effect of sevoflurane and nitrous oxide
      on cerebral electrical activity, the investigators determined the MAC of sevoflurane combined
      with nitrous oxide inducing isoelectric electroencephalogram (EEG) in 50% of the subjects
      (MACie) in middle aged subjects.
    

Detailed description: 
      Anaesthesia was induced by sevoflurane in oxygen. Cisatracurium 0.15 mg kg-1 was administered
      after loss of the lash reﬂex, then ventilated manually until the amplitude of T1 decreased to
      0. Intubation was performed and switched to mechanical ventilation with a fresh gas flow of 2
      L min-1. Anesthesia was maintained by sevoflurane or sevoflurane+60% nitrous oxide
      respectively. The surgical incision was performed at least 30 min after tracheal intubation,
      provided that the predetermined end-tidal sevoflurane concentration had been constant for at
      least 30 min and that the difference between inspired and end-tidal concentrations was less
      than 10%.

      Brain electrical activity was measured using Narcotrend Monitor and S/5 Compact Anaesthesia
      Monitor, which displayed unprocessed EEG and burst suppression ratio, respectively. The
      design of the experiment is referred to the "Dixon up-and-down" method. To avid anaesthesia
      awareness, the first subject was designed to receive end-tidal sevoflurane concentration of
      2.5 %. The presence or absence of isoelectric EEG (Entropy Module) of the preceding patient
      determined the end-tidal concentration of sevoflurane given to the next patient (with an
      increment size of 0.2%). The isoelectric EEG was considered as significant when the
      isoelectric state last for more than 1 min. The maximal burst suppression rate was recorded
      if isoelectric EEG was not reached.
    

Intervention name(s): Sevoflurane+Nitrous oxide; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): 60% nitrous oxide +40% oxygen+ Sevoflurane; 100% oxygen+ Sevoflurane
Intervention MeSH terms: Nitrous Oxide; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anaesthesia; middle aged; minimal alveolar concentration; sevoflurane; nitrous oxide; isoelectric EEG
RN624 In Adult Patients With Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared
      with placebo and compared with naproxen in the treatment of adult patients with chronic low
      back pain.
    


Intervention name(s): Naproxen; Placebo; PF-04383119 (RN624)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral naproxen 500 mg twice daily for Weeks 1-12.; Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12.; Single IV infusion of 200 micrograms/kg RN624 on Day 1
Intervention MeSH terms: Naproxen; Tanezumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval
      dosing (EID) in participants who have previously been treated with natalizumab standard
      interval dosing (SID) for at least 12 months, in relation to continued SID treatment. The
      secondary objectives is to evaluate relapse-based clinical efficacy measures, disability
      worsening, additional Magnetic resonance imaging (MRI)-lesion efficacy measures and safety of
      EID in participants who have previously been treated with natalizumab SID for at least 12
      months, in relation to continued SID treatment.

      Part 2: The primary objective is to evaluate participant preference for subcutaneous (SC)
      versus intravenous (IV) route of natalizumab administration. The secondary objectives is to
      evaluate treatment satisfaction, drug preparation and administration time, safety and
      immunogenicity, efficacy and characterize pharmacokinetic (PK) and pharmacodynamic (PD) drug
      preparation and administration time of SC versus IV routes of natalizumab administration.
    

Detailed description: 
      This study will be conducted in 2 parts. At the end of part 1, participants who provide
      consent and are eligible, and newly enrolled participants, will enter part 2, an Open Label
      Extension comprising a crossover analysis.

      Those participants who completed part 1 and cannot participate, or elect not to participate,
      in Part 2 (Open label extension) will enter a 12-week follow-up.
    

Intervention name(s): Natalizumab
Intervention type(s): Drug
Intervention description(s): Natalizumab 300 mg SC injection or IV infusion.
Other intervention name(s): BG00002
Intervention MeSH terms: Natalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study on B-blockers to Prevent Decompensation of Cirrhosis With HTPortal
Condition: Portal Hypertension Gastropathy; Esophageal Varices; Spontaneous Bacterial Peritonitis; Hepatic Encephalopathy; Ascites
MeSH terms: Peritonitis; Hypertension, Portal; Hepatic Encephalopathy; Esophageal and Gastric Varices; Brain Diseases; Hypertension; Ascites
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled study on the
      effectiveness of treatment with beta-blockers to prevent decompensation of cirrhosis with
      portal hypertension.
    


Intervention name(s): propranolol; carvedilol; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GPVH ≥ 10 mmHg - responders: propranolol.; GPVH ≥ 10 mmHg nonresponders: carvedilol.; placebo propranolol / carvedilol
Intervention MeSH terms: Propranolol; Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      A follow-up study to assess resistance and durability of response to 3 experimental drugs
      ABT-450/r, ABT-267, and ABT-333 in participants who have participated in AbbVie Phase 2 or 3
      clinical studies with these agents for the treatment of chronic hepatitis C virus (HCV).
      Studies include: M11-646 (NCT01716585), M11-652 (NCT01464827), M12-746 (NCT01306617), M12-998
      (NCT01458535), M13-098 (NCT01715415), M13-099 (NCT01704755), M13-386 (NCT01563536), M13-389
      (NCT01674725)' M13-393 (NCT01685203), M13-961 (NCT01767116), M14-002 (NCT01833533), and
      M14-103 (NCT01911845).
    


Intervention name(s): ABT-450/ritonavir; ABT-333; ABT-267
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug.; Drug is not administered -- this study is follow-up for participants previously receiving the drug.; Drug is not administered -- this study is follow-up for participants previously receiving the drug.
Other intervention name(s): ABT-450 also known as paritaprevir; dasabuvir; ombitasvir
Intervention MeSH terms: Ritonavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Chronic Hepatitis C; Hepatitis C virus; Direct Acting Antiviral; Sustained Virologic Response; Hepatitis C; Persistence of treatment-emergent substitutions
Nervous System Symptoms Associated With COVID 19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      This study aim to prospectively evaluate the neuropsychiatric symptoms of patients infected
      with the SARS-CoV-2 virus by a standardized neuropsychiatric examination : the global CASE
      scale (Clinical Assessment Scale in Autoimmune Encephalitis), and the prevalence of
      disturbances of consciousness, focal neurological deficit, cognitive impairment, headache,
      anosmia, sleep disturbances, impaired autonomic nervous system and peritraumatic stress.
    


Intervention name(s): NEURO +; NEURO -
Intervention type(s): Other; Other
Intervention description(s): The participants will undergo several questionnaires after their classic clinical evaluation allowing to determine the Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score :
The dissociative peri-traumatic experiences questionnaire (Birmes et al., 2005)
the Peri traumatic distress inventory (Jehel et al., 2005)
and the Shortness, Trembling, Racing, Sweating (STRS) (Bracha et al., 2004)
Neuro + patients will also have a Brain MRI, cerebrospinal fluid analysis, EEG, as well as an ambulatory sleep recording and electromyography depending on the symptoms observed.; The participants will undergo several questionnaires after their classic clinical evaluation allowing to determine the Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score :
The dissociative peri-traumatic experiences questionnaire (Birmes et al., 2005)
the Peri traumatic distress inventory (Jehel et al., 2005)
and the Shortness, Trembling, Racing, Sweating (STRS) (Bracha et al., 2004)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: This is an observational, prospective, cross-sectional and monocentric cohort study
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Nervous system; coronavirus; SARS-CoV-2; Nervous system symptoms
Metabolomics of Thyroid Hormones
Condition: Central Hypothyroidism; Hypothyroidism; Hyperthyroidism
MeSH terms: Hypothyroidism; Hyperthyroidism
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study is to develop a metabolome signature of thyroid hormone status. The
      metabolome signature could be useful in diagnosis and treatment of thyroid dysfunction
      diseases, especially in cases where TSH cannot be reliably used.
    

Detailed description: 
      Primary Hypothyroidism is a frequent endocrine disorder, where the thyroid gland does not
      produce sufficient amounts of thyroid hormones. The substitution therapy is guided by
      measurement of the pituitary gland hormone thyrotropin (TSH). Patients with central
      hypothyroidism in whom pituitary insufficiency leads to hypothyroidism, TSH cannot be used to
      guide therapy. So far there are no reliable methods for therapy control in patients with
      central hypothyroidism.

      The measurement of small endogenous metabolites might give investigators a metabolomics
      profile. This could help to discriminate between euthyroid, hypothyroid and hyperthyroid
      state and therefore could be used for diagnosis and therapy control of thyroid dysfunction
      diseases.
    

Intervention name(s): Indirect calorimetry; Dual energy X-ray Absorptiometry (DXA); Blood sampling
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Resting energy expenditure; Body composition; fT4, fT3, TSH, HDL, LDL, triglycerides, cholesterol, HbA1c, Glucose Thyroid panel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers will be recruited by means of advertisements (online or in the
        newspaper).

        Patients will be recruited from the endocrinology outpatient clinics of the Department of
        Endocrinology, Diabetes and Metabolism, University Hospital Basel and patients referred
        from practicing endocrinologists.
      
Biospecimen description: 
      Serum and plasma
    
Keywords: Hypothyroidism; Metabolomics; Thyroid Hormones; Hyperthyroidism