bioihbjkbjnl/mcl2 huggingface dataset:
Tarsal Tunnel Syndrome and Fibromyalgia
Condition: Tarsal Tunnel Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Tarsal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Widespread pain is observed in patients diagnosed with fibromyalgia, and lower extremity and
      foot pain are also common. In our study, we aimed to evaluate the relationship between foot
      pain and tarsal tunnel syndrome in female patients diagnosed with fibromyalgia.
    


Intervention name(s): Fibromiyalgia and foot pain
Intervention type(s): Diagnostic Test
Intervention description(s): Sensory and motor conduction studies will be performed in the lower extremities. Nerve conduction studies will be performed by another physician unaware of the patient's diagnosisFunctional status will be evaluated by using the Turkish version of the Fibromyalgia Impact Questionnaire (FIQ).Neuropathic Pain will be evalutaed by using the Turkish version of the Neuropathic Pain Questionnaire.
Other intervention name(s): Patients with foot pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Tarsal Tunnel Syndrome, Fibromyalgia, Neuropathic pain, EMG
A Study of the Cardiac Effects of ALXN2050 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, double-dummy, placebo- and positive-controlled parallel
      study to evaluate the effect of ALXN2050 on the QT interval in healthy adult participants.
    

Detailed description: 
      Participants randomized to the treatment arm will receive ALXN2050 in a multiple-ascending
      doses fashion over 3 periods (treatment sequence ABC). Participants randomized to the control
      arms will be further randomized to 1 of 2 treatment sequences (treatment sequence DEF or GHI)
      to receive placebo or active control over 3 periods.
    

Intervention name(s): ALXN2050; ALXN2050-matching Placebo; Moxifloxacin; Moxifloxacin-matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ALXN2050 will be administered orally twice daily as powder-in-capsule.; ALXN2050-matching placebo will be administered orally twice daily as placebo powder-in-capsule.; Moxifloxacin will be administered as a single oral dose.; Moxifloxacin-matching placebo will be administered as a single oral dose.
Other intervention name(s): ACH-0145228 (formerly)
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: ALXN2050; Electrocardiogram; QT Interval; Concentration-QT; Factor D Inhibitor
Efficacy Study of Adalimumab to Treat Interstitial Cystitis
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate an investigational treatment for interstitial
      cystitis. Interstitial cystitis is a chronic bladder disease that includes the following
      symptoms: Urinary frequency during the day,urinary frequency at night, urinary urgency and
      bladder discomfort relieved by voiding.

      Presently, there is no cure for interstitial cystitis. The response to current treatments is
      poor. Patients with interstitial cystitis have a poorer quality of life. The cause of
      interstitial cystitis is unknown. This study is evaluating the drug Humira® (adalimumab) for
      improving the symptoms of patients with interstitial cystitis. Humira® is an injectable
      anti-inflammatory medication that has been available for use since December 31, 2002. Humira®
      has been FDA approved for the treatment of rheumatoid arthritis, psoriasis, ankylosing
      spondylitis, and Crohn's disease. These diseases have similar characteristics to interstitial
      cystitis. This study will evaluate an investigational use of Humira® for the treatment of
      interstitial cystitis.
    

Detailed description: 
      Interstitial cystitis (IC) is a chronic disabling bladder syndrome characterized by urinary
      frequency, nocturia, urinary urgency, and pain with bladder filling-relieved by emptying.
      There is no cure for IC and the treatment options are suboptimal. Patients with IC report
      significant negative effects on their physical and mental quality of life. The etiology of IC
      is unknown. Certain aspects of IC suggest that autoimmunity may play a role in initiating or
      sustaining the chronic inflammatory response. Bladder biopsies of patients with IC
      demonstrate an increase number of mast cells. Mast cell activation with the release of tumor
      necrosis factor (TNF) may mediate this bladder inflammation. Humira® (adalimumab) is a
      medication that blocks the effect of TNF. Humira® (adalimumab) is FDA approved for the
      treatment of rheumatoid arthritis, psoriasis, ankylosing spondylitis, and Crohn's disease.
      These diseases are similar to IC. In this study, the hypothesis being tested is that Humira®
      (adalimumab) will show efficacy at reducing the symptoms of IC.
    

Intervention name(s): Adalimumab; inactive drug
Intervention type(s): Drug; Other
Intervention description(s): 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period; 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
Other intervention name(s): Humira; placebo
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Interstitial cystitis; Humira; Adalimumab
A Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label Phase 1 dose escalation study of OMP-59R5 in subjects with previously
      treated solid tumors for which there is no remaining standard curative therapy and no therapy
      with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers.
      Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and
      efficacy. No formal interim analyses will be performed.

      Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon
      enrollment, subjects will receive intravenous (IV) infusions of OMP-59R5 at a assigned dosing
      schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there
      is no evidence of disease progression or if the tumor is smaller, then subjects may continue
      to receive IV infusions of OMP-59R5 every week until disease progression.

      Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose
      escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled
      in a cohort will not be treated on the same day. The dose may be administered at any time
      during the day. Three subjects will be treated at each dose level if no dose-limiting
      toxicities (DLTs) are observed. The first 2 subjects in each cohort will not be started on
      OMP-59R5 on the same day. If 1 of 3 subjects experiences a DLT, that dose level will be
      expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be
      dosed at that level and 3 additional subjects will be added to the preceding dose cohort
      unless 6 subjects have already been treated at that dose level. Subjects will be assessed for
      DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled
      subjects, if appropriate, will occur after all subjects in a cohort have completed their Day
      28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to
      continue to receive weekly doses of OMP-59R5 until disease progression. An additional 14
      subjects will be enrolled at the highest dose level that result in <2 of the 6 subjects
      experiencing a DLT.
    


Intervention name(s): OMP-59R5
Intervention type(s): Drug
Intervention description(s): IV infusion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase 1; dose escalation; histologically confirmed; malignancy metastatic
Prospective Trial of Tranexamic Acid in Cardiac Surgery
Condition: C.Surgical Procedure; Cardiac
Study type: Interventional
Phase: Phase 4

Summary: 
      Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease
      perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is
      still unknown. We use three different doses to find which is the optimum dose of tranexamic
      acid in cardiopulmonary bypass cardiac surgery.
    


Intervention name(s): Tranexamic Acid
Intervention type(s): Drug
Intervention description(s): The loading doses were given in 15 minutes when incision.
Other intervention name(s): SINE; Tranexamic Acid Injection; 120902
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: tranexamic acid; cardiac surgery; cardiopulmonary bypass
Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is an observer-blind, randomized, controlled prospective intervention study of
      Phase I. The primary objective is to evaluate the safety and immunogenicity of the SARS-CoV-2
      protein subunit recombinant vaccine adjuvanted with Alum+CpG1018
    

Detailed description: 
      This trial is observer blinded, comparative, randomized, phase I study. Approximately 175
      subjects will be recruited (18 years and above).

      The investigational product is 0.5 ml in two dose-regimen (for all subjects) with 28 days
      apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine). There
      will be 4 formula of investigational product used with different concentration of Receptor
      Binding Domain (RBD) antigen and adjuvant CpG 1018.
    

Intervention name(s): SARS-CoV-2 protein subunit recombinant vaccine; SARS-CoV-2 inactivated vaccine
Intervention type(s): Biological; Biological
Intervention description(s): candidate vaccine manufactured by PT. Bio Farma; active control manufactured by Sinovac Life Sciences Co.Ltd
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COVID-19 vaccine; healthy population
Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study assessed the efficacy of fingolimod in patients with short duration
      relapsing-remitting multiple sclerosis who had not been previously treated with
      disease-modifying therapies (DMTs), versus patients with the same disease duration who had
      previously received first-line DMTs.
    


Intervention name(s): Fingolimod (FTY720)
Intervention type(s): Drug
Intervention description(s): Hard gelatin capsules containing 0.5 mg of fingolimod.
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Fingolimod; Early multiple sclerosis; Naive patients
Enriched Yogurts With Soluble Fibre or Vegetable Protein on Satiety
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the satiating effects of different functional
      yogurts enriched with soluble fiber or vegetable protein on overweight subjects (BMI ≥25 and
      <30 kg / m2).

      Some studies have shown the contribution of high-fiber foods in the reduction of the
      cardiovascular risk. On the other hand, protein consumption could have a greater satiety
      potential compared to other macronutrients.
    

Detailed description: 
      A randomized, cross-over and double-blind pilot study with 3 study arms is being performed to
      evaluate the satiating properties of different functional enriched yogurts with soluble fiber
      or vegetable protein in a group of healthy overweight subjects.

      The investigators included 12 participants (6 men and 6 women) between 18 and 55 years (BMI
      ≥25 and <30 kg / m2). All volunteers will be randomized into 3 study groups, and participants
      will receive the 3 different study products in order during the 3 experimental phases.
    

Intervention name(s): Control Yogurt; Yogurt Variety 1; Yogurt Variety 2
Intervention type(s): Other; Other; Other
Intervention description(s): 125 g/day; 125 g/day; 125 g/day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Satiety; Vegetable protein; Yogurt; Fiber; Visual Analogue Scale; Cross-over
Aspirin in Asymmetrically Intrauterine Growth
Condition: Intrauterine Growth Restriction Asymmetrical
MeSH terms: Fetal Growth Retardation
Study type: Interventional
Phase: Phase 2

Summary: 
      Intrauterine growth restriction refers to a fetus that has failed to get a specific measures
      by a gestational age. Asymmetric type of Intrauterine growth restriction is known by normal
      sized head with smaller abdomen.It is important to recognize the growth restricted fetuses,
      because these fetuses may have fetal or neonatal complications.

      When blood flow is increased, the oxygen and nutrients will deliver good to the fetus. The
      role of low-dose aspirin therapy in management of intrauterine growth restriction is
      controversial. It has been used, in many studies, in prevention of intrauterine growth
      restriction especially in women at high risk of pre-eclampsia or obstetrical antiphospholipid
      syndrome.
    


Intervention name(s): Aspirin
Intervention type(s): Drug
Intervention description(s): This group were subjected to aspirin 75 mg once daily for 6 weeks.
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mobile App in Addiction
Condition: Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      The sleep and behavior agendas are today very largely underused while they can be of a
      considerable contribution in the follow-up of the patients and the reinforcement of the
      therapeutic alliance. In the management of addictions, sleep disorders are a major
      comorbidity, these two components maintain indeed complex links: it was highlighted a
      bidirectional relationship between the effect of the consumption of addictive substances on
      sleep and conversely, the effect of sleep disorders on the consumption of products, the same
      is true for overexposure to screens.
    

Detailed description: 
      The sleep and behavior agendas are today very largely underused while they can be of a
      considerable contribution in the follow-up of the patients and the reinforcement of the
      therapeutic alliance. In the management of addictions, sleep disorders are a major
      comorbidity, these two components maintain indeed complex links: it was highlighted a
      bidirectional relationship between the effect of the consumption of addictive substances on
      sleep and conversely, the effect of sleep disorders on the consumption of products, the same
      is true for overexposure to screens.
    

Intervention name(s): ASC
Intervention type(s): Device
Intervention description(s): mobile app
Other intervention name(s): mobile application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: mobile app, pilot study, addiction, sleep, ePRO
Validation Study for an Unobtrusive Online Sleep Measurement System
Condition: Apnea; Restless Legs Syndrome; Sleep Fragmentation
MeSH terms: Restless Legs Syndrome; Sleep Deprivation
Study type: Observational

Summary: 
      The purpose of the study is to determine the precision of an unobtrusive sleep measurement
      system. The system measures a force sensor signal under the mattress and analyzes sleep
      quality. The system measures: time in bed, sleep stages, sleep fragmentation, heart rate,
      respiration rate, sleep related breathing disorders, and limb movements.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A group of 20 volunteers - 10 males, 10 females - is recruited so that their ages are
        distributed evenly between 18 and 80.
CPR Audiovisual Tool to Impact ICU Patients' Surrogate Anxiety Level.
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Video or No Video to decrease HCPOA/LAR anxiety and increase knowledge as it pertains to CPR.
    

Detailed description: 
      Designated surrogate decision makers of 30 medical intensive care unit patients will be
      consented and enrolled to receive either a video describing CPR and it's outcomes after
      standard of care code discussions versus standard of care code discussions alone. All
      participants will complete a short questionnaire to determine their knowledge level regarding
      CPR and to assess their anxiety levels. Patients who view the video will also rate their
      comfort level while watching the video on a 5 point Likert scale.
    

Intervention name(s): CPR Video
Intervention type(s): Other
Intervention description(s): A 7.07 minutes' CPR video will be administered to the ICU patients' surrogates in Group B.
After viewing the video, the surrogate will complete the Hamilton Anxiety Rating Scale, a five-question survey about CPR, and a one-question form about comfort using the Likert Scale.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of Three-chamber-bag Versus Compounded Bag
Condition: Parenteral Nutrition for Patients With Proven Insufficient Enteral Resorption
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate the efficacy and safety of a convenient
      3-chamber-bag containing aminoacids, glucose and lipid emulsion (LCT/MCT 20%) compared to a
      conventionally compounded monobag for parenteral nutrition.
    


Intervention name(s): NuTRIflex Lipid peri; compounded monobag
Intervention type(s): Drug; Drug
Intervention description(s): parenteral nutrition; parenteral nutrition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass
Condition: Postoperative Hemorrhage
MeSH terms: Hemorrhage; Postoperative Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      Study has been completed and is in the data analysis and manuscript writing phase of the
      project.
    


Intervention name(s): Heparin; HH or high heparin; heparin concentration HC
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 300u/kg of heparin for CPB ACT performed. If ACT is < 480 seconds a bolus of 5000u heparin will be given. ACT will be repeated and bolus given until ACT is>480 seconds; initial dose of 450u/kg for CPB ACT performed additional bolus given if result is <600 seconds anytime during CPB; will have anticoagulation during CPB assessed with heparin concentration monitoring and heparin dose response (HDR) to determine the optimal dosage of heparin. This group will evaluate the possible benefit of the HDR to determine heparin dosing and monitoring to achieve maximal suppression of thrombin compared to a fixed dose of heparin as the other two groups. Additional heparin doses will be given to maintain a specific heparin concentration according to the HDR. This is a recognized way of managing heparin dosing and anticoagulation for CPB.
All three groups will have heparin neutralized by protamine. Adequacy of heparin neutralization will be based on a difference between the ACT and heparinase-treated ACT values of less than 10%
Intervention MeSH terms: Heparin; Calcium heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heparin management