bioihbjkbjnl/mcl2 huggingface dataset:
Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules
Condition: Primary Immune Deficiency; Secondary Immune Deficiency
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to assess the impact of immunoglobulin treatment by subcutaneous
      injections every 2 weeks (biweekly) on a cohort of patients with primary and secondary immune
      deficiencies. The full study will consist of safety, efficacy and Quality of Life (QoL)
      evaluations and a pharmacokinetic (PK) sub-study. The primary objectives of the study are to
      determine tolerability and safety of biweekly IgPro20 injection regimen and to compare PK
      outcomes on weekly and biweekly IgPro20 therapy.

      Patients who have received and/or are currently receiving immunoglobulin G (IgG) in
      intravenous (IVIg), or subcutaneous (SCIg) infusions are eligible for inclusion if they meet
      inclusion/exclusion criteria.

      The study consists of two parts. In Part 1 of the study enrolled subjects will receive
      IgPro20 weekly for either 12 weeks (for patients on SCIg infusion prior to the study) or 24
      weeks (for patients on IVIg infusion prior to the study). Part 2 will consist of a biweekly
      treatment with IgPro20 for 52 weeks, for both groups.

      Additionally, study subjects meeting inclusion criteria for the PK sub-study will undergo a
      PK sample collection for 1 week and 2 weeks in study Parts 1 and 2, respectively.
    


Intervention name(s): Subcutaneous Immune Globulin (Human) (Hizentra)
Intervention type(s): Biological
Intervention description(s): Hizentra, Subcutaneous Immune Globulin (Human) (SCIg), is a ready to use, polyvalent human normal Immunoglobulin G (IgG) for subcutaneous administration. Hizentra is a 20% IgG protein solution, is prepared from large pools of human plasma, and is stabilized by L-Proline.
Other intervention name(s): IgPro20; Hizentra
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety of MiSight ® Contact Lenses in Reducing the Progression of Childhood Myopia.
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of the study is to quantify the effectiveness of CooperVision MiSight® (omafilcon
      A) soft (hydrophilic) contact lens in slowing the rate of progression of juvenile-onset
      myopia.
    

Detailed description: 
      Subjects in two parallel groups were randomized and assigned to either the study contact lens
      (omafilcon a) or single vision spectacles.
    

Intervention name(s): omafilcon A; Spectacle
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Covert Saccade Triggers in Bilateral Vestibular Hypofunction
Condition: Reflex, Abnormal; Bilateral Vestibulopathy; Healthy Volunteers
MeSH terms: Bilateral Vestibulopathy; Reflex, Abnormal
Study type: Interventional

Summary: 
      Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability
      during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to
      a severe impairment of their quality of life. However, correcting saccades during rapid head
      movement, called covert-saccades, have been more recently identified. These saccades, which
      occur during the head movement in patients with vestibular hypofunction, present a very short
      latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease
      oscillopsia and visual impairment. The triggering of these covert-saccade is still not known.
      They could be of visual origin but the short latency is unusual. The objective of this study
      is to evaluate the potential role of visual trigger in 12 patients with chronic bilateral
      areflexia, using different visuo-vestibular conditions. The latency of simple visually guided
      saccades will also be tested in the group of patients and a group of 12 healthy controls.
    


Intervention name(s): Covert Saccades and Virtual Reality; Actives versus passives Head Impulses; Visually guided saccades
Intervention type(s): Other; Other; Other
Intervention description(s): During this intervention, patients will undergo head impulse testing while wearing virtual reality Headsets. During the head impulse tests the visual information will be modified in order to create a conflict between head rotation and rotation of the visual scene. Recording of head and eye movement will be done during these head impulses in order to verify if visual information modifies compensatory eye movements during head impulses.; Patients will undergo classic passive head rotation as well as active head rotation in order to compare latencies of covert saccades in both conditions.; Patients as well as healthy control subjects will undergo testing of visually guided saccades in different conditions (step, gap, overlap) in order to compare latencies of covert saccades between both groups.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Saccadic Eye Movements; Bilateral Vestibulopathy; Bilateral Vestibular Hypofunction
The Influence of Warm Bupivacaine on Supraclavicular Plexus Block Characteristics
Condition: Surgery to the Distal One Third of the Upper Limb
Study type: Interventional

Summary: 
      Despite PH adjustment of local anesthetic solution improves the quality of the block in all
      respects with special advantage of early onset of sensory and motor block, adequate level of
      analgesia, and prolongation of duration of block, the effect of warmed bupivacaine should
      have the same effect which have not been evaluated on supraclavicular plexus block for upper
      limb surgery.

      The warmed bupivacaine used in supraclavicular plexus block may reduce sensory and motor
      block onset and prolong the duration of analgesia when compared to bupivacaine at operating
      room temperature.
    

Detailed description: 
      The aim of this study is to compare the effect of warm bupivacaine 0.5% at 37◦C versus
      bupivacaine 0.5% at operating room temperature at 23◦C on ultrasound-guided supraclavicular
      plexus block characteristics as regard sensory block onset time, motor block onset time,
      duration of sensory and motor block , effective duration of analgesia, total analgesics
      requirement, complications and side effects.
    

Intervention name(s): Warm bupivacaine at (37°c); Bupivacaine at operating room temperature (23°c)
Intervention type(s): Drug; Drug
Intervention description(s): Bupivacaine 0.5%, 30 mL, warmed to 37◦C for 20 minutes. The empty syringes and needles, in their packaging, will be held at the same temperature before initiating the block.; Bupivacaine 0.5%, 30 ml held in crash shelf of the operating room temperature at 23◦C. The empty syringes and needles will be held in the same temperature before use.
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children
Condition: Dehydration
MeSH terms: Dehydration
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous
      (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the
      rehydration of pediatric patients with mild to moderate dehydration.
    

Detailed description: 
      Pediatric patients (2 months to 10 years of age), presenting to the emergency department (ED)
      with mild to moderate dehydration and requiring parenteral rehydration, were treated with
      HYLENEX-augmented subcutaneous (SC) rehydration. An initial volume of 20 mL/kg of isotonic
      fluid was to be administered by continuous SC infusion over the first hour, and additional SC
      rehydration could be continued as clinically indicated. The preferred anatomic site for the
      SC infusion was the anterior thigh, unless there was an overriding preference for an
      alternate site.

      The duration of HYLENEX-augmented SC rehydration was to be a minimum of 1 hour and a maximum
      of 72 hours. The investigator or designee performed a clinical assessment of the subject's
      hydration status at baseline and at the end of SC infusion or at discharge from the ED. Other
      assessments of effectiveness and safety were made directly during the rehydration period and
      ED stay, and by telephone on Days 3 and 7 after discharge from the ED.
    

Intervention name(s): hyaluronidase (human recombinant)/rehydration fluid
Intervention type(s): Drug
Intervention description(s): Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
Other intervention name(s): HYLENEX recombinant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dehydration; fluid therapy; pediatrics; emergency medicine; hyaluronoglucosaminidase; hyaluronidase; hypodermoclysis; clysis; subcutaneous hydration; subcutaneous rehydration; hyaluronan; rHuPH20
Skin Sensitization Test (Modified Draize-95 Test)
Condition: Skin Sensitisation
Study type: Interventional

Summary: 
      Skin Sensitization Test (Modified Draize-95 Test) to Support a Low Dermatitis Potential Claim
      for a Blue Non Sterile Powder Free Nitrile Examination Gloves. This study is a RIPT (Repeat
      Insult Patch Test) to evaluate whether residual chemical additives at the level that may
      induce Type IV allergy in the nonsensitized general user population are present in a finished
      Blue Non Sterile Powder Free Nitrile Examination Glove.
    


Intervention name(s): Blue Non Sterile Powder Free Nitrile Examination Gloves
Intervention type(s): Device
Intervention description(s): Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.
Intervention model: Single Group Assignment
Intervention model description: Blue Non Sterile Powder Free Nitrile Examination Gloves Dose: Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.
Positive control: 0.4% sodium lauryl sulfate (SLS) Dose: 0.2 ml
Negative control: Blank patch Dose: Not applicable
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Modified Draize-95 Test; Skin Sensitisation; Repeat Insult Patch Test
Uterocervical Angle in Induction of Labor
Condition: Labor Induction, Third Trimester
Study type: Observational

Summary: 
      To evaluate the performance of uterocervical angle (UCA) in the prediction of labor
      induction.
    

Detailed description: 
      Induction of labor is a common procedure in obstetrics. In recent years, uterocervical angle
      (UCA) emerged as a new ultrasound parameter in the prediction of labor. Dziadosz et al
      concluded that the performance of UCA was even better than the cervical length in their
      cohort. A wide UCA during second trimester shown to have an increased risk of preterm labor
      and narrow angle was less likely to have labor.

      The investigators are aimed to investigate predictive role of both cervical length and UCA in
      the labor induction in third trimester of pregnancy.The investigators focused on nulliparous
      women who are taking dinoproston for the cervical preparation and aim to measure their UCA.
    

Intervention name(s): uterocervical angle
Intervention type(s): Other
Intervention description(s): uterocervical angle is the angle between lower segment of uterus and cervix
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant population undergoing labor induction in the third trimester
      
Keywords: uterocervical angle, labor induction
AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study
Condition: Walled Off Pancreatic Necrosis
MeSH terms: Pancreatitis, Acute Necrotizing; Necrosis
Study type: Interventional

Summary: 
      To demonstrate safety and effectiveness of lumen-apposing metal stents for resolution of
      walled off pancreatic necrosis (WONs) in patients with WONs with solid component >30%.
    

Detailed description: 
      This study is a prospective, single arm, multi-center trial. Treatment of up to 40 patients
      will take place at up to 6 clinical centers. Patients who meet all eligibility criteria will
      receive the AXIOS stent for up to 60 days stent indwell and 6 months follow-up after stent
      removal.
    

Intervention name(s): AXIOS
Intervention type(s): Device
Intervention description(s): Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic necrosis
Effect of Peppermint Water on Breast Crack
Condition: Breast Diseases
MeSH terms: Breast Diseases
Study type: Interventional

Summary: 
      To evaluate the effectiveness of a topical preparation of peppermint water in comparison with
      that of expressed breast milk for the prevention of nipple cracks in primiparous
      breastfeeding women.
    

Detailed description: 
      One hundred and ninety-six primipara participants, who are breastfeeding after delivery at 38
      or more week gestation, were assigned randomly to 2 groups, with one of 2 regimens
      (peppermint water, an old household remedy, and no treatment only using breast milk) to right
      and left sides. Each group was followed for a maximum of 3 visits within 14 days and until
      the 6 weeks postpartum by telephone call. The aerial parts of Mentha piperita were purchased
      from Hakim Momen Tabrizi Company, and the identity was confirmed by morphological
      characterization in comparison with the herbarium specimen retained in the School of
      Pharmacy, Tabriz University of Medical Sciences. Also, a voucher specimen has been generated
      in that herbarium.
    

Intervention name(s): peppermint water
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: peppermint water; nipple crack; lactating women
Single-dose Study to Evaluate Safety, Tolerability, and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus; Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled, double-blind study to evaluate safety, tolerability
      and pharmacodynamics of REMD-477 in subjects who have Type 1 diabetes and are currently
      receiving insulin treatment. This proof of concept study will determine whether glucagon
      receptor blockade using a single dose REMD-477 can improve short-term glucose homeostasis in
      people with Type 1 diabetes.
    

Detailed description: 
      The study will be conducted at two sites in the United States, and approximately 20 subjects
      with type 1 diabetes will be enrolled. Eligible subjects will be admitted to the clinical
      research unit, to carefully monitor blood glucose; and establish the baseline insulin
      requirement for maintaining targeted normoglycemia (postabsorptive: 90-120 mg/dL; and
      postprandial: <180 mg/dL).

      The patients will then be subjected to a hyperglycemic period (250-300 mg/dL) by a stepwise
      reduction in insulin infusion. After receiving a single SC dose of REMD-477 or matching
      placebo in a double-blinded fashion, all subjects will be assessed for the post-treatment
      24-hour insulin requirement needed to maintain targeted normoglycemia (postabsorptive: 90-120
      mg/dL; and postprandial: <180 mg/dL); and to be monitored closely for safety, tolerability
      and targeted glycemic control, for a 48-hr period. After the in-patient residency period,
      subjects will return to the clinic for weekly out-patient safety follow-up visits for 8
      weeks.
    

Intervention name(s): REMD-477; Placebo Comparator
Intervention type(s): Biological; Biological
Intervention MeSH terms: Volagidemab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients
      who have advanced soft tissue sarcoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the anticancer activity of exatecan mesylate, in terms of objective response
           and duration of response, in patients with advanced soft tissue sarcoma.

        -  Determine the safety of this drug in these patients.

      OUTLINE: This is a multicenter study. Patients are stratified according to histological
      diagnosis (leiomyosarcoma vs other histologies).

      Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5. Courses repeat every
      21 days in the absence of disease progression or unacceptable toxicity.

      Patients are followed every 6 weeks until disease progression. After disease progression,
      patients are followed every 12 weeks for survival.

      PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per stratum) will be accrued for this
      study.
    

Intervention name(s): exatecan mesylate
Intervention type(s): Drug
Intervention MeSH terms: Exatecan
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult angiosarcoma; adult fibrosarcoma; adult leiomyosarcoma; adult liposarcoma; adult neurofibrosarcoma; adult synovial sarcoma; stage IV adult soft tissue sarcoma; recurrent adult soft tissue sarcoma; adult malignant fibrous histiocytoma; adult malignant hemangiopericytoma; adult rhabdomyosarcoma; stage IV uterine sarcoma; recurrent uterine sarcoma; uterine leiomyosarcoma
Diaphragmatic Mobility and Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the influence of diaphragm mobility on exercise
      capacity and dyspnoea in patients with chronic obstructive pulmonary disease (COPD).
    

Detailed description: 
      Chronic Obstructive Pulmonary Disease (COPD) is characterized by progressive obstruction of
      the airways which is partially irreversible. COPD patients commonly present increased
      resistance to airflow, air trapping, and pulmonary hyperinflation that alters the chest wall
      placing the respiratory muscles in mechanical disadvantage, thereby increasing both
      respiratory drive and the sensation of dyspnoea. Furthermore, to prevent dyspnoea, COPD
      patients reduce their daily living activities leading to loss of physical condition, social
      isolation, depression and anxiety,whilst compromising their quality of life.

      Forced expiratory volume in one second (FEV1) is the main parameter used to establish the
      severity of pulmonary impairment and disease progression.

      Nevertheless, some studies have suggested that FEV1 does not adequately reflect the clinical
      manifestations of the disease and is only weakly associated with the severity of dyspnoea,
      health related quality of life (HRQOL) features, and the ability to perform activities of
      daily living.

      Moreover, FEV1 appears not to be a predictor of mortality in COPD patients. Pulmonary
      hyperinflation has been related with adaptation in diaphragm muscle maintaining the muscle's
      capacity to generate power whilst reducing its displacement. The importance of the diaphragm
      in lung mechanics associated with hyperinflation has been the subject of frequent discussion
      owing to widespread use of lung volume reducing surgery which results in increased movement
      range of the diaphragm muscle. However, to date, the relationship between diaphragm mobility
      and functional capacity in COPD patients remains unknown.

      The objective of the present study was to evaluate the influence of diaphragm mobility in the
      exercise capacity and dyspnoea of patients with COPD.
    

Sampling method: Non-Probability Sample
Study population: 
        Sixty patients with moderate or severe COPD were evaluated.
      
Keywords: COPD; pulmonary emphysema
A Study of SB751689 in Japanese Postmenopausal Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety and tolerability, PK and PD of SB751689 following single and 5-day
      multiple oral doses of 100, 200, and 400 mg in Japanese postmenopausal subjects.
    


Intervention name(s): SB751689
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pharmacodynamics; Japanese; safety; Pharmacokinetics
Snuff Use, Smoking, Periodontitis and Mortality: 30-year Cohort Study From Sweden
Condition: Tobacco Use; Periodontitis
MeSH terms: Periodontitis
Study type: Observational [Patient Registry]

Summary: 
      Smoking and dual using associated with poor periodontal health.
    

Detailed description: 
      Aim: To investigate how snuff use, smoking and risk behaviour affect periodontal health and
      mortality in a Swedish cohort, hypothesizing that they indeed have a poor impact and increase
      the risk of death.

      Material and methods: Study cohort of 1080 subjects aged 31 to 40 years (528 men and 552
      women) from Stockholm area was clinically examined in 1985 and followed for mortality until
      2015. Associations between periodontal health parameters, snuff use, smoking and age of death
      were analysed by classifying all subjects into four groups: "dual-users" (current snuffers
      and current smokers); "pure snuffers" (current non-smoking snuffers); "pure smokers" (current
      non-snuffing smokers) and "non-users" (non-snuffers, non-smokers). SPSS was used for
      analyses.
    

Intervention name(s): Qestinnaires
Intervention type(s): Behavioral
Intervention description(s): Questionnaires
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Swedish national database sample
      
Keywords: mortality; oral hygiene; periodontitis; smokeless tobacco; tobacco