bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Lidocaine Spray and Paracervical Block Application for Pain Relief During First-trimester Surgical Abortion: a Randomized, Double-blind, Placebo-controlled Trial
Condition: Pain Score
Study type: Interventional

Summary: 
      Objective: The investigators sought to investigate the analgesic efficiency of lidocaine
      spray, paracervical block (PCB) with lidocaine and PCB with lidocaine plus lidocaine spray
      combination in patients undergoing first-trimester surgical abortion.

      Methods: A randomized, double-blind, placebo-controlled clinical trial was conducted on 108
      women with the request of pregnancy termination.The subjects were randomly assigned into four
      groups: PCB (n=27), lidocaine spray (n=27), PCB plus lidocaine spray (n=27) and
      placebo(n=27).Intraoperative and postoperative pain scores were measured with a standard
      Visual Analog Scale (VAS).
    


Intervention name(s): Paracervical block; Lidocaine spray; Paracervical block + lidocaine spray
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: abortion; analgesia; paracervical block; lidocaine spray
Breast Tissue Before And After Breastfeeding Or The Use Of A Breast Pump
Condition: To Collect Measurements of the Nipple; To Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After Breastfeeding; To Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After Expressing Milk With 3 Different Electric Breast Pumps.
Study type: Observational

Summary: 
      There will be breast tissue changes after use of a breast pump.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Lactating women.
      
Keywords: Breastfeeding; Breast tissue; Breast pump
A Japan Phase I/II Study of Bortezomib in Relapsed or Refractory Multiple Myeloma Patients
Condition: Refractory; Multiple Myeloma; Relapse
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety/tolerability and determine the Japanese
      recommended dose (RD) of bortezomib administered as a once-daily intravenous bolus twice
      weekly for 2 consecutive weeks(Days 1, 4, 8, and 11) followed by a 10-day rest period (Days
      12 to 21) in Japanese patients with relapsed or refractory multiple myeloma.
    

Detailed description: 
      In Japan, there is no clear treatment guidance for patients with multiple myeloma that
      repeatedly relapsed and became refractory. At present, various therapies including other
      multi-drug combination chemotherapy, hematopoietic stem cell transplantation, corticosteroid
      massive therapy, interferon therapy, thalidomide therapy, radiation therapy and other
      experimental therapies are conducted exploratory as salvage therapies to find the one to
      which the patient shows response. Considering that the antitumor activity of JNJ-26866138
      against relapsed or refractory MM is clear and and the tolerability is acceptable based on
      results of the overseas clinical studies, the development of JNJ-26866138 in Japan is quite
      meaningful. This is a non-randomized, open-label, multicenter dose-escalation study which
      consisting of the two parts: the Phase I part is intended to intravenously administer
      JNJ-26866138 twice daily for 2 weeks (Days 1, 4, 8, and 11) to establish the Japanese RD
      based on the incidence of dose limiting toxicities (DLTs), while the Phase II part is
      intended to evaluate the efficacy and safety of JNJ-26866138 in patients repeatedly treated
      at the Japanese RD.

      Based on the body surface area calculated before treatment in each cycle, the dose is
      calculated for each patient according to the dose level specified by the Patient Enrollment
      Center (0.7mg/m2, 1.0 mg/m2 or 1.3 mg/m2). JNJ-26866138 is intravenously administered once
      daily, twice weekly for 2 weeks (Days 1, 4, 8, and 11), followed by a 10-day rest period
      (Days 12 to 21). This is considered one cycle (21 days), and treatment is repeated up to 6
      cycles in patients expected to show a response.
    

Intervention name(s): bortezomib
Intervention type(s): Drug
Intervention MeSH terms: Bortezomib
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bolus; intravenous; proteasome inhibitor; multiple myeloma; refractory; relapse
DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
Condition: Post Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the efficacy and safety of intravenous administration of Bonviva
      regimens in women with post-menopausal osteoporosis, compared to oral daily administration.
      Patients will also receive daily supplementation with vitamin D and calcium. The anticipated
      time of study treatment is 2+ years, and the target sample size is 500+ individuals.
    


Intervention name(s): ibandronate [Bonviva/Boniva]; ibandronate [Bonviva/Boniva]; ibandronate [Bonviva/Boniva]
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2mg iv every 2 months; 2.5mg po daily; 3mg iv every 3 months
Intervention MeSH terms: Ibandronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Prevalence of Depression and Anxiety Among Breast Cancer Patients
Condition: Depression; Anxiety; Breast Cancer
MeSH terms: Breast Neoplasms; Depression; Depressive Disorder; Anxiety Disorders
Study type: Observational

Summary: 
      Depression and anxiety in patients with breast cancer is serious comorbidity that affects the
      quality of life for patients, and their survival rates as they have poorer health outcomes.
      Furthermore, patients' high psychological burden is linked to higher healthcare costs. The
      investigation of the depression and anxiety symptoms prevalence among newly diagnosed breast
      cancer patients will help to navigate the health policy adjustment and psycho-social support
      system requirements. This study aims to investigate the prevalence of depression and anxiety
      symptoms among newly diagnosed breast cancer patients in Almaty, Kazakhstan, and associated
      risk factors.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population will include breast cancer patients with confirmed diagnosis referred to
        the treatment to the Kazakh Institute of Oncology and Radiology and the Almaty Oncology
        Center
      
Keywords: depression; anxiety; breast cancer; prevalence; Beck Depression Inventory; Beck Anxiety Inventory
Hypoalgesic Effect of Neural Mobilization
Condition: Cervicobrachial Neuralgia
MeSH terms: Neuralgia; Brachial Plexus Neuritis
Study type: Interventional

Summary: 
      The purpose of these study is to compare the effectivity of the Cervical Lateral Glide
      physical therapy neural mobilization technique to the complete absence of treatment in a
      group of patients who suffer cervicobrachial pain.
    

Detailed description: 
      The Cervical Lateral Glide (CLG) is a neural tissue mobilization technique capable of
      achieving a hypoalgesic effect during the onset of cervicobrachial pain symptoms. This
      happens through a series of complex physiologic interactions which are not fully understood.
      The CLG Physical therapy technique consists of controlled movements of the cervical and
      brachial plexus neural tissue. Hypoalgesic effect produced by CLG is associated to an
      increase in neural tissue mobility, edema, inflammation and intraneural pressure reduction,
      without any known side effects when applied properly, except for a momentary worsening of
      symptoms (the only known side effect of CLG), which is an important contrast to the wide and
      sometimes severe spectrum of side effects derived from drug therapy used to treat
      cervicobrachial pain.

      It is believed that the hypoalgesic effect offered by neural tissue mobilization is a
      consequence of descending nervous system pain modulation activity and an improvement in the
      distinct biomechanical properties of the involved neural tissue.Despite the increase in
      scientific interest in evidence based options to treat pain and neural tissue mobilization
      techniques there is a current lack of enough controlled double blind clinical trials that
      measure the effectiveness of neural tissue mobilization techniques such as the CLG and its
      specific effect over cervicobrachial pain. For this reason the present investigation
      consisted in the application of a treatment protocol based on CLG neural tissue mobilization
      in a controlled double blind clinical trial with the aim to assess its clinical effectiveness
      in treating pain symptoms
    

Intervention name(s): Cervical Lateral Glide neural mobilization
Intervention type(s): Procedure
Intervention description(s): Non-surgical non-invasive Cervical Lateral Glide neural mobilization procedure was applied by a physical therapist continuously during 2 minutes in 5 different occasions with 1 minute of rest between each 2 minute application of the Neural Mobilization technique. The intervention was applied during a period of 6 weeks. The correct linear alignment of patient's cervical spine was determined through the baseline use of a Universal Goniometer Device in each application of Cervical Lateral Glide neural mobilization.
Other intervention name(s): Cervical Lateral Glide Neural Tissue Mobilization; Cervical Lateral Glide Neurodynamics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Perfusion Index (PI) and Pleth Variability Index (PVI) in Patients With Interscalene Blocks in Orthopedic Surgery
Condition: Perfusion Index and Pleth Variability Index; Interscalene Blocks; Orthopedic Surgery
Study type: Observational

Summary: 
      The purpose of this study is to:

        1. To describe effects of interscalene nerve blocks on perfusion index (PI) and pleth
           variability index (PVI) (Radical 7, Masimo Cooperation, Irvine, CA) before and after
           induction of general anesthesia.

        2. To compare effects of fluid-bolusing on PI and PVI of the anesthetized and
           non-anesthetized limb.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients scheduled for surgery of the shoulder and the upper arm.
      
Keywords: PI; PVI; Interscalene block
Evaluation of the Safety Use of the InsuPatch Device in Daily Life Conditions
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is an open-label, randomized, two-period crossover study. Up to one hundred and
      twenty (120) subjects with type 1 diabetes mellitus (T1DM) who use the MiniMed paradigm
      insulin pump, who meet the inclusion/exclusion criteria and who provide written Informed
      Consent will be enrolled in the study. The aim of the study is to examine the safety of the
      InsuPatch device in a home use setting. Mild Hypoglycemia,hyperglycemia and Adverse events
      will be compared between two phases of the study : 3 months with the use of the device and 3
      months without the use of the device.
    

Detailed description: 
      The primary objective of this study is to show that safety parameters are similar, when
      delivering insulin subcutaneously in subjects with type I diabetes using the InsuPatch device
      along with the Medtronic Minimed Paradigm insulin infusion pump and the Medtronic Minimed
      Quick-Set® infusion set compared to subcutaneous insulin delivered with the above mentioned
      equipment, without the InsuPatch device.

      The participation of each subject in this study will be up to seven months and will include
      three phases: one week Run in phase , 3 months with device use and 3 months without device
      use. Study will include 4 clinic visits and bi weekly calls. During the entire study the
      subjects will be requested to preform at least 5 blood glucose self measurements and record
      results in a logbook.At each visit blood will be drawn for HBA1C test.
    

Intervention name(s): InsuPatch
Intervention type(s): Device
Intervention description(s): Heaters for single use and a permanent control unit.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MiniMed Paradigm insulin pump; insulin Lispro; Insulin Aspart; Quick-set infusion set
Phase 1 Thorough QT Study in Young Healthy Volunteers
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      A reduction in the postoperative need for opioids to enhance the recovery process and
      increase patient postoperative satisfaction.
    

Detailed description: 
      Providing extended pain relief without the use of indwelling catheters is the basis for
      developing SKY0402. A formulation of bupivacaine, given as a single injection after surgery,
      that could provide adequate, continuous, and extended pain relief would greatly simplify
      postoperative pain management, reduce the need for repeated administration, and minimize
      break-through episodes of pain.
    

Intervention name(s): SKY0402; Moxifloxacin 400mg; Placebo injection; Placebo tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subects received either 300mg or 450mg
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; postoperative
Evaluation of Diabetic Foot Wound Healing Using Hydrogel/Nano Silver-based Dressing vs. Traditional Dressing
Condition: Diabetes Mellitus
MeSH terms: Diabetic Foot
Study type: Interventional

Summary: 
      Background: The wound dressings perform a crucial role in the cutaneous wounds' management
      due to their ability to protect wounds and promote dermal and epidermal tissue regeneration.
      Objective: the aim of the present study to evaluate the effectiveness of using hydrogel/nano
      silver-based dressing vs. traditional dressing on diabetic foot wound healing.

      Approach: Sixty patients with type-2 diabetes hospitalized for diabetic foot wound treatment
      were recruited from selected Surgical departments at Kasr Al-Aini university hospital.
    

Detailed description: 
      Data Collection: The patients of group-I wounds were cleaned using normal saline; then, the
      wounds were closed firmly with hyderogel\nano silver dressing. The dressing was changed every
      two days according to dressing manufacture instruction. When the dressing was opened after
      three days, the wound was assessed for granulation tissue, wound, and discharge size.

      The patients of group II wounds were dresses using a traditional method, cleaned by normal
      saline, use of betadine antiseptic; then they were secured with clean linen gauze. The
      dressing was changed once daily. The wound healing process of the two groups was then
      assessed for three consecutive weeks.
    

Intervention name(s): Hydrogel/nano silver-based dressing
Intervention type(s): Procedure
Intervention description(s): compare the effectiveness of using hydrogel/nano silver-based dressing vs. traditional dressing on diabetic foot wound healing.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Diabetic foot ulcer
Risk of Malignancy Index and Assiut Scoring Model for Adnexal Malignancy
Condition: Risk Malignant Index
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      The presence of an adnexal mass is a frequent reason for a woman to be referred to a
      gynaecologist. The discrimination between benign and malignant adnexal masses is central to
      decisions regarding clinical management and surgical planning in such patients. Patients with
      malignant tumours should be referred to a gynaecological oncologist, as the quality of
      cytoreductive surgery and surgical staging/lymph node dissection are important prognostic
      factors in ovarian cancer. These specialized surgical procedures require the specific skills
      and experience provided by gynaecologic oncology surgeons. Furthermore, appropriate and
      timely referral to a gynaecologic oncologist has been proven to increase survival in patients
      with ovarian cancer.Conversely, patients believed to have a benign mass requiring surgery are
      able to have this performed by a general gynaecologist. A standardized method for
      preoperative identification of probable malignant masses would allow optimization of
      first-line treatment for women with ovarian cancer. A risk of malignancy index would be
      valuable for the selective referral of relevant patients to specialized oncology centres.
      Currently, clinical examination, ultrasound assessment, and assays of tumour markers are part
      of the standard work-up for an adnexal mass. Although none of these indicators alone is very
      sensitive or specific for detecting malignancy, an index developed by Jacobs et al.
      incorporates information about the patient's menopausal status and serum Cancer antigen A-125
      levels, and ultrasound characteristics of the mass to predict the risk of malignancy with
      greater sensitivity and specificity than any one factor alone.Some of the potential
      advantages of risk malignant index include rapid triage of patients through the referral
      system and fewer operations for benign masses being performed by gynaecologic oncologists.
    


Intervention name(s): ultrasound; cancer antigen 125 level; Doppler
Intervention type(s): Radiation; Diagnostic Test; Radiation
Intervention description(s): for assessment of adnexal masses size and pattern; for prediction of malignancy; for detection of blood flow
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients has any adnexal mass by ultrasound
Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation
Condition: Sufentanil; Remifentanil; Fentanyl; Bronchoscopy; Narcotrend; Conscious Sedation
Study type: Interventional
Phase: Phase 4

Summary: 
      The best opioid for bronchoscopy is still unclear.This randomized double-blind prospective
      study was conducted on a total of 60 patients who were randomly allocated into 3 groups:
      Group S received sufentanil 0.1 mcg/kg, Group F received fentanyl 1 mcg/kg and Group R
      received remifentanil target-controlled infusion with effect-site target concentration of
      1ng/ml. Patients in all groups received midazolam to achieve moderate levels of sedation as
      assessed by the Narcotrend (NT; between B1 and C2). Adverse events, patient tolerance and
      physician satisfaction were analized.
    


Intervention name(s): Sufentanil; Fentanyl; Remifentanil; Midazolam
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients in Group S received sufentanil 0.1 mcg/kg.; Patients in Group F received fentanyl 1 mcg/kg.; Patients in Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml.; Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).
Intervention MeSH terms: Midazolam; Fentanyl; Sufentanil; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Effectiveness of Toothbrushing Techniques in Plaque Removal and Caries Lesion Control
Condition: Caries
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effectiveness of cross-toothbrushing technique
      compared with anteroposterior and biofilm removal and control of caries lesions in first
      permanent molars.
    

Detailed description: 
      220 children between 5-7 years with at least one permanent molar erupting will be selected,
      with a maximum score of ICDAS 3. These children will be randomly allocated into two groups
      according to the technique adopted. The teeth will be evaluated by ICDAS, laser fluorescence
      (DIAGNOdent), QLF and subtraction radiography at baseline and after 15 days, 3, 6, 9,12,18,24
      months.
    

Intervention name(s): modified toothbrush with multilevel filaments; cross toothbrushing
Intervention type(s): Behavioral; Behavioral
Intervention description(s): After the allocation of patients in this group they were instructed to brush their first molars erupt with the brushing technique anteroposterior.; Children allocated to the group multi-bristled brush will be modified compared to the results of the group cross toothbrushing technique
Other intervention name(s): stages, oral b; buccal-lingual technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: caries; primary molars; plaque; toothbrushing
A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects
Condition: Bleeding
Study type: Interventional
Phase: Phase 2

Summary: 
      "This is a single-center, randomized, double-blind, and placebo-controlled trial designed to:
      1) demonstrate the degree to which administered andexanet doses can reverse Factor Ten A
      (FXa)-inhibitor induced anticoagulation; and 2) evaluate the safety and PK/PD of andexanet in
      healthy Japanese subjects taking direct FXa inhibitors at therapeutic doses."
    


Intervention name(s): Andexanet alfa; Apixaban; Rivaroxaban; Edoxaban; Placebo
Intervention type(s): Biological; Drug; Drug; Drug; Drug
Intervention description(s): fXa inhibitor antidote; factor Xa inhibitor; factor Xa inhibitor; factor Xa inhibitor; Placebo
Other intervention name(s): 200 mg/vial for IV injection; Eliquis; Xarelto; Savaysa, Lixiana
Intervention MeSH terms: Rivaroxaban; Apixaban; Edoxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment