bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Threatened Miscarriage
Condition: Pregnancy
MeSH terms: Abortion, Spontaneous; Abortion, Threatened
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to determine whether the dydrogesterone therapy is associated with
      reduction in miscarriage in women with first trimester threatened miscarriage. The hypothesis
      is that the dydrogesterone therapy will significantly reduce the risk of miscarriage in women
      with threatened miscarriage.
    


Intervention name(s): Dydrogesterone; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Duphaston
Intervention MeSH terms: Dydrogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Threatened miscarriage; Dydrogesterone; Randomized controlled trial
Outcomes of an Intraoperative Bispectral Index Monitor
Condition: Anesthesia
Study type: Observational

Summary: 
      This pilot study is being conducted to determine whether the intraoperative presence of a
      Bispectral Index Monitor (BIS), a non-invasive monitor, affects the perioperative and
      postoperative indices and outcomes. The BIS monitor is an adhesive sensor that is applied to
      the forehead to monitor EEG waves. This monitor is not a Standard of Care Monitor, yet in
      adult and pediatric studies it has been shown to decrease time to emergence, decrease
      volatile anesthesia requirement, decrease recovery time and in some cases, decrease
      post-operative morbidity (REFS). The effect on intra-operative and post-operative parameters,
      when BIS is present but not specifically designated to be used as a monitor to guide
      anesthesia delivery, has not been specifically examined. This will be the first pediatric
      study which applies BIS on all patients and randomizes the anesthesiologists to either be or
      not be privy to seeing the BIS values during intra-operative period.
    

Detailed description: 
      The BIS monitor is an adhesive sensor that is applied to the forehead to monitor EEG waves.
      In adult and pediatric studies, the BIS monitor has been shown to decrease time to emergence,
      decrease volatile anesthesia requirement, decrease recovery time and in some cases, decrease
      post-operative morbidity (REFS). The effect on intra-operative and post-operative parameters,
      when BIS is present but not specifically designated to be used as a monitor to guide
      anesthesia delivery, has not been specifically examined. This will be the first pediatric
      study which applies BIS on all patients and randomizes the anesthesiologists to either be or
      not be privy to seeing the BIS values during intra-operative period.
    

Intervention name(s): BIS™ Complete 2--Channel Monitor
Intervention type(s): Device
Intervention description(s): monitor depth of anesthesia
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        60 patients ages 2-12 scheduled for day surgery at Boston Children's Hospital
Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial
Condition: Bronchopulmonary Dysplasia (BPD)
MeSH terms: Bronchopulmonary Dysplasia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase I/II open-label study to determine the lowest, safe, effective dose of
      budesonide given with calfactant as the vehicle.
    

Detailed description: 
      This is a phase I/II open-label study to determine the lowest safe, effective dose of
      budesonide given with calfactant as the vehicle; the investigators will perform an unblinded
      dose escalation study. The investigators will administer four dosing levels of budesonide
      suspended in calfactant beginning with 0.025 mg/kg of budesonide administered to 8 extremely
      low gestational age newborns (ELGANs) who are intubated at 3-10 days of age. Daily doses (at
      the same dosage) will be administered to infants who remain intubated for a potential of 5
      total doses in each patient. Subsequent groups of 8 infants each will receive 0.05 mg/kg,
      0.10 mg/kg, and 0.15 mg/kg of budesonide in calfactant (up to 5 total doses in each patient).
      A total of up to 32 infants will be enrolled in the trial. The investigators will evaluate
      the clinical, laboratory and safety data from each group of treated infants to 28 days of age
      before moving to the next dosing level of budesonide.
    

Intervention name(s): Budesonide in Calfactant
Intervention type(s): Drug
Intervention description(s): Budesonide in Calfactant
Other intervention name(s): pulmicort respule; calfactant; budesonide; 0186-1986-04; infasurf
Intervention MeSH terms: Budesonide; Calfactant
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bronchopulmonary dysplasia; Pulmonary; Surfactant; Steroids; Extremely low gestational age
Double-Blind Trial of a Probiotic Supplement to Reduce the Symptoms of Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The investigators intend to explore the hypothesis that symptoms of schizophrenia may be
      reduced by the administration of a probiotic supplement when used in addition to standard
      antipsychotic medications.
    

Detailed description: 
      The primary aim of the current study is:

        1. To evaluate the safety and efficacy of a supplemental probiotic therapy, containing the
           microorganisms Lactobacillus rhamnosus GG and Bifidobacterium lanimalis subsp. lactis
           (BB12), for individuals with schizophrenia who have residual psychotic symptoms of at
           least moderate severity.

           Secondary aims of the study are:

        2. To assess the effect of probiotic treatment on patients' gastrointestinal functioning

        3. To study the effect of probiotic treatment in lowering the levels of antibodies to
           casein and gliadin.

        4. To investigate the association between the efficacy of probiotic therapy and initial
           levels of antibodies to gliadin and casein.
    

Intervention name(s): Probiotic Supplement; Identical-appearing Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic Supplement 1 tablet by mouth daily; Probiotic identical placebo 1 tablet by mouth daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective; Probiotic supplements; Gliadin; Casein
Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This is a prospective, multicenter, feasibility study on the safety and efficacy of renal
      denervation in patients with resistant hypertension.
    

Detailed description: 
      Demonstrate the safety and efficacy of the St. Jude Medical Radiofrequency (RF) Renal
      Denervation System in the treatment of patients with resistant hypertension.

      Safety Marker

        -  All adverse events

      Efficacy Marker

        -  Office blood pressure
    

Intervention name(s): St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)
Intervention type(s): Device
Intervention description(s): Catheter-based RF ablation in renal artery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Catheter-based renal artery ablation; Hypertension; Resistant to Conventional Therapy
Efficacy and Safety of Gabapentin/B-complex Versus Pregabalin in Diabetic Peripheral Neuropathy Pain Management
Condition: Diabetic Peripheral Neuropathic Pain
MeSH terms: Neuralgia; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter, randomized, open-label, parallel, Phase 4 clinical trial to compare
      efficacy and safety of gabapentin/B-complex versus pregabalin in diabetic peripheral
      neuropathy pain (DPNP) management.
    

Detailed description: 
      Primary Objective:

      To compare the efficacy of gabapentin/B-complex versus pregabalin administered for 12 weeks
      in the treatment of pain in mild to moderate diabetic peripheral neuropathy (DPN) of acute or
      chronic presentation.

      Secondary Objectives:

      To determine the safety and tolerability of gabapentin/B-complex versus pregabalin
      administered for 12 weeks in the treatment of pain in mild to moderate DPN of acute or
      chronic presentation.

      Subjects will be randomized in a 1:1 ratio to receive gabapentin/B-complex or pregabalin.

      The duration of treatment per subject will be 12 weeks.
    

Intervention name(s): Gabapentin/B-complex; Pregabalin
Intervention type(s): Drug; Drug
Intervention description(s): Gabapentin/B-complex (Gavindo®) tablet will be administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed will be 3600 mg/day. The total duration of treatment will be 84 days (12 weeks).; Pregabalin (Lyrica®) capsule will be administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed will be 600 mg/day. The total duration of treatment will be 84 days (12 weeks).
Other intervention name(s): Gavindo®; Lyrica®
Intervention MeSH terms: Pregabalin; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gabapentin/B complex; Pregabalin; Pain; Neuropathic; Gavindo; Lyrica
Erector Spinae Plane Block and Oblique Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many
      indications has been identified by case reports in the literature. As the investigators have
      considered that erector spinae plane block could be efficacious for providing postoperative
      analgesia in laparoscopic cholecystectomy, the investigators have implemented the application
      of this blockade into practice at the clinic.Oblique subcostal transverse abdominis plane
      block (OSTAP) is another regional anesthesia technic used for postoperative analgesia in
      laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect
      of ultrasound-guided erector spinae block and OSTAP in laparoscopic cholecystectomy.
    


Intervention name(s): ESP Block; OSTAP block; Standard Pain Followup and Monitorization
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to T9 spinous process. The erector spinae muscles will be identified superficial to the tip of T9 transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 17-gauge 8-cm needle will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 40 mL of bupivacaine/lidocaine mixture will be injected.; The bilateral OSTAP will be performed at the end of the surgery. A total of 40 ml local anesthetic mixture (Bupivacaine and lidocaine) will be injected bilaterally with interfascial plane between the external oblique and transversus abdominis muscles; Numeric Rating Scale (NRS) pain score will be recorded from 20th minute in recovery room followed by 1.-3.-6.-12.-18.-24.hours. Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 6 and over in the postoperative collection room. It is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 6 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 6 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Controlled randomized study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Selenium and Ischemic Stroke Outcome
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      Selenium is a trace element essential to human health.Selenium protection against cellular
      damage by oxygen radicals is accomplished through selenoproteins. Ischemic stroke is
      associated with the generation of oxygen free radicals resulting in a condition of oxidative
      stress. Supplementing stroke patients with antioxidant nutrients may improve survival.
    


Intervention name(s): Selenium; normal saline
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 4 vials selenase stat and 2 vials daily for 5 days; Normal saline infusion like intervention group
Other intervention name(s): selenase; Selenium selenite; Sodium chloride 0.9%
Intervention MeSH terms: Selenium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a feasibility/pilot study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women
Condition: HIV Infections; Cachexia
MeSH terms: Infections; Wasting Syndrome; Cachexia
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Determine whether physiologic testosterone replacement can increase fat-free
      mass, therefore contributing to weight maintenance, improved muscle function, and quality of
      life in HIV-infected women.

      II. Examine the mechanism of testosterone-induced increase in fat-free mass.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are
      randomized to one of three arms.

      Arm I: Patients receive two placebo transdermal patches applied twice a week (every 3-4
      days).

      Arm II: Patients receive one testosterone transdermal patch and one placebo transdermal patch
      applied twice a week (every 3-4 days).

      Arm III: Patients receive two testosterone transdermal patches applied twice a week (every
      3-4 days).

      Patients receive 12 weeks of treatment in the absence of adverse reaction or health
      deterioration. Patients are followed on day 1, every 2 weeks during treatment, and at the end
      of the recovery period. Quality of life is assessed before treatment begins and at weeks 6
      and 12.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): testosterone
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: cachexia; disease-related problem/condition; human immunodeficiency virus infection; immunologic disorders and infectious disorders; nutrition; quality of life; rare disease; viral infection
Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine the safety, tolerability and
      pharmacokinetics of ABT-308 in healthy volunteers and patients with mild to moderate
      controlled asthma.
    


Intervention name(s): ABT-308; ABT-308; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single IV doses; Multiple SC doses x 3; Single IV dose; Multiple SC doses x 3
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Adverse events; Pharmacokinetics
Trial of Sodium Valproate in Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the use of sodium valproate is effective in
      slowing the disease progression in Amyotrophic Lateral Sclerosis.
    

Detailed description: 
      Amyotrophic lateral sclerosis (ALS) is a devastating disease characterized by progressive
      degeneration of motor neurons leading to muscle weakness.

      The pathogenesis of ALS is unknown, but there is convincing evidence that several molecular
      mechanisms play a role. Previous studies investigated the role of the Survival Motor Neuron
      (SMN) gene in ALS. Recent data suggest that SMN genotypes producing less SMN protein increase
      susceptibility and severity of ALS. This leads to the hypothesis that the clinical expression
      of ALS is influenced by the total SMN protein level in affected patients. In a population of
      ALS patients in the Netherlands we found that SMN genotypes producing less SMN protein appear
      to increase susceptibility and severity of ALS. It was shown that the HDAC inhibitor sodium
      valproate (SVP) increases levels of SMN protein in vitro. From these results and from data
      suggesting neuroprotective properties of SVP, it is hypothesised that SVP could extend
      survival of patients with ALS. In addition, sodium valproate significantly prolonged the
      disease duration in the animal model for ALS, the SOD1 transgenic mouse. Given that SVP is a
      FDA-approved compound with well-known pharmacokinetic and toxicity profiles, it is an
      attractive candidate for a clinical trial in ALS patients.
    

Intervention name(s): Sodium Valproate
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ALS; Sodium Valproate; randomised trial; Amyotrophic Lateral Sclerosis (ALS)
Epirubicin or Not in Patients With TOP2A (Topoisomerase (DNA) II Alpha (170kD)) Normal Early Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The Danish Breast Cancer Cooperative Group (DBCG) wishes to clarify if recurrence-free and
      overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin
      and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast
      cancer.
    

Detailed description: 
      In DBCG trial 89D we in more than 1,200 patients showed that substitution in CMF chemotherapy
      of methotrexate with epirubicin improves survival for patients with primary and operable
      breast cancer. In a retrospective evaluation we have also shown that approximately 20% of all
      patients in 89D have tumors with numerical changes of the TOP2A gene, and that only patients
      with abnormal TOP2A benefit from epirubicin. In the current trial the DBCG wishes to clarify
      if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide
      compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A
      normal and operable breast cancer.
    

Intervention name(s): Epirubicin, cyclophosphamide and docetaxel; docetaxel, cyclophosphamide
Intervention type(s): Drug; Drug
Intervention description(s): Epirubicin 90 mg/m2 iv day 1 every 3 weeks plus Cyclophosphamide 600 mg/m2 iv day 1 every 3 weeks times 3 followed by Docetaxel 100 mg/m2 iv day 1 every 3 weeks times 3; Docetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times six
Other intervention name(s): Ellence; Taxotere; Taxotere
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epirubicin; docetaxel; Adjuvant chemotherapy; DNA Topoisomerases, Type II
Erector Spinae Plane Block for Postoperative Pain in Percutaneous Nephrolithotomy Patients: a Retrospective Study
Condition: Percutaneous Nephrolithotomy
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      To evaluate the ability of Erector spina Plane block decrease postoperative pain and
      analgesia requirements in patients undergoing Percutaneous Nephrolithotomy.
    

Detailed description: 
      Erector spina Plane block was performed with guided ultrasound at T10 Transverse process
      level would lead to adequate postoperative analgesia ,in Percutaneous Nephrolithotomy
      surgeries.
    

Intervention name(s): Erector Spinae Plane block ( Group I); non- blocked Group (GROUP II)
Intervention type(s): Procedure; Procedure
Intervention description(s): ESP Block was performed preoperative to all patients in ESP block group. Patients in all groups were provided with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.; This group was received no intervetion. Patients in all groups were provided with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A number of 60 patients undergoing PCNL between January 2019 and December 2019 were
        included in our study. Patients included in the study were those who were operated from the
        stone diseases.
      
Keywords: Erector spinae block; percutaneous; nephrolithotomy; stone; ultrasound
Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      A prospective evaluation of the visual parameters in a series of patients bilaterally
      implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).
    


Intervention name(s): ReSTOR
Intervention type(s): Device
Intervention description(s): Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ReSTOR Aspheric +3 IOL