bioihbjkbjnl/mcl2 huggingface dataset:
Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome
Condition: Infertility; Polycystic Ovarian Syndrome; Intrauterine Insemination
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The study null hypothethesis is: intrauterine insemination (IUI) does not improve pregnancy
      rates in women with polycystic ovary syndrome. Infertile women with pcos will receive
      gonadotropins for ovarian stimulation and then randomize to either IUI or timed intercourse
      (TI)
    


Intervention name(s): Intrauterine insemination (IUI)
Intervention type(s): Procedure
Intervention description(s): The male semen is obtained then processed by swim up technique and then introduced into the uterus by special catheter.
Other intervention name(s): IUI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infertility; PCOS; IUI
Effects of Non-Invasive Brain Stimulation on Soldiers' Cognitive and Functional Performance
Condition: Performance Enhancement
Study type: Interventional

Summary: 
      Non-invasive brain stimulation has been shown to alter performance in both clinical and
      healthy populations on cognitive tasks. While the performance alterations have generally been
      shown to result in enhancement, mixed results remain in the literature. Much of the mixed
      results within the literature have been attributed to the use of different stimulation
      parameters, targeting of different brain areas, and using a variety of performance measures
      or assessing different constructs. However, non-invasive brain stimulation is a desirable
      method for enhancing Soldier performance given the ease of administration and minimal side
      effects as compared to other forms of performance enhancement (e.g., pharmaceuticals,
      caffeine). The objective of the current study is to evaluate the effects of non-invasive
      brain stimulation to the left dorsolateral prefrontal cortex in enhancing Soldier cognitive
      skills and performance on military tasks. A double blind within-subjects design will be used
      with healthy, rested Soldiers who will receive non-invasive brain stimulation and perform
      basic cognitive and operationally relevant tasks.
    


Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that stimulates the brain through the application of a low-intensity electrical current, typically ranging from 1 to 2 milliamps (mA), via electrodes placed on an individual's scalp. During the active stimulation sessions, 2 mA of stimulation will be applied for 30 minutes. During the sham stimulation session, 2 mA of stimulation will be applied over the course of 90 sec, the electrodes will remain in place for the 30 minute duration.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A double-blind, randomized, sham-controlled, within-subjects design
Masking: Single (Investigator)
Primary purpose: Basic Science
A Study of How Tutin and Hyenanchin, Two Toxins Found in Honey, Are Absorbed and Processed by the Body
Condition: Tutin Poisoning
MeSH terms: Poisoning
Study type: Interventional

Summary: 
      Honey available in New Zeland can contain the toxins tutin and hyenanchin. Tutin is produced
      by several plants native to New Zealand. Bees collect honeydew contaminated with tutin and
      hyenanchin for honey production.

      Honey contaminated with high levels of tutin has caused cases of poisoning in New Zealand
      since the 1800s, with the most recent outbreak in 2008.

      The study aims to find out how tutin and hyenanchin are absorbed and processed by the body.
      This information will help the FSANZ give guidance on acceptable levels of tutin and
      hyenanchin in honey.

      About 6 healthy men will each take a single dose of honey containing known concentrations of
      tutin and hyenanchin.

      This dose level is similar to what someone who eats a lot of honey would have, if the honey
      contained the maximum level of tutin allowed under the Food Standards Code.

      Blood tests to measure tutin and hyenanchin levels will be taken at certain times after
      dosing, and any side effects will be recorded.
    


Intervention name(s): Honey substance
Intervention type(s): Other
Intervention description(s): Honey substance containing 5.1 mg/kg tutin and 23 mg/kg hyenanchin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Randomized, Placebo-controlled Study to Evaluate Effects of E5555 on Renal Function Parameters and OCT2 Activity
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a drug-drug interaction study to evaluate the effects of steady-state exposure of
      E5555 and its main metabolites on the pharmacokinetics (PK) of metformin, an organic cation
      transporter-2 (OCT2) substrate. In addition, the study will also investigate the effects of
      E5555 on several renal function parameters.
    


Intervention name(s): E5555; E5555
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Oral E5555 400 mg/matching placebo, oral metformin 500 mg, iohexal 20 mL intravenous (IV), and para-aminohippuric acid (PAH) 7 mg/kg IV.; Drug: Oral E5555 100 mg/matching placebo, oral metformin 500 mg, iohexal 20 mL intravenous (IV), and para-aminohippuric acid (PAH) 7 mg/kg IV bolus.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment With Copper in Patients With Mild Alzheimer´s Dementia
Condition: Alzheimer´s Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The efficacy of 8 mg of copper daily regarding cognitive function, content of beta amyloid
      protein in the CSF and volumetric changes in the brain will be examined in a first
      double-blind, placebo-controlled human clinical trial conducted in 70 patients with mild
      Alzheimer´s dementia.
    


Intervention name(s): copper; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): intake of copper orotate 8 mg per day per os, once daily for one year, vs. placebo under observation of the cognitive status; placebo
Intervention MeSH terms: Copper
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: efficacy of treatment with copper in patients with mild Alzheimer´s disease; cognitive status over time; CSF and volumetric data over time (1 year)
Safety Study of Replagal® Therapy in Children With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety of Replagal in children with Fabry disease
      who who have not previously been treated with enzyme replacement therapy (ERT).
    

Detailed description: 
      In 2008, a change in the agalsidase alfa drug substance manufacturing process was made. There
      are no changes to the drug product formulation, manufacturing site, manufacturing process, or
      container closure.

      An agalsidase alfa bioreactor manufacturing process (agalAF1) utilizing animal component-free
      media replaced the previous roller bottle (RB) process.

      This study will evaluate the safety of Replagal AF, manufactured using the new bioreactor
      process at a dose of 0.2 mg/kg infused IV over 40 minutes, every other week (EOW) in children
      with Fabry disease who are 7 years to less than 18 years of age and who are naive to ERT.
    

Intervention name(s): Replagal (agalsidase alfa)
Intervention type(s): Biological
Intervention description(s): 0.2 mg/kg administered over 40 minutes every other week (EOW)
Other intervention name(s): agalsidase alfa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: agalsidase alfa; Replagal; Enzyme Replacement Therapy
Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Observational

Summary: 
      The purpose of this study is to collect safety information following routine vaccination with
      Synflorix™ among infants in Korea.
    

Detailed description: 
      Rationale for the protocol amendment: The therapeutic indication for Synflorix in Korea has
      been updated. The protocol is being amended to reflect this update.
    

Intervention name(s): Synflorix™ Data collection
Intervention type(s): Other
Intervention description(s): Safety monitoring: recording of adverse events during using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants and children who receive at least one dose of Synflorix as a part of routine
        practice at a private clinic or hospital.
      
Keywords: Pneumococcal vaccine; Safety; Synflorix; Pneumococcal diseases
A Clinical Trial to Compare Pharmacokinetics of the "CDFF0318" and "Champix Tab. 1mg"
Condition: Smoking Cessation; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics
      after Administration of the "CDFF0318" and "Champix Tab. 1mg (Varenicline tartrate)" in
      Healthy Male Volunteers
    


Intervention name(s): CDFF0318, Champix
Intervention type(s): Drug
Intervention description(s): CDFF0318: Varenicline salt changed Champix: Varenicline tartrate
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine
Condition: Seasonal Influenza; Hand, Foot and Mouth Disease
MeSH terms: Influenza, Human; Enterovirus Infections; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the Immunogenicity and safety of the simultaneously
      vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV)
    

Detailed description: 
      Main subjects:

      The seroconversion rate for each antigen when EV71 is administrated with SIV

      Secondary subjects:

      The positive rate of antibody for each antigen when EV71 is administrated with SIV The safety
      for each antigen when EV71 is administrated with SIV
    

Intervention name(s): EV71 +SIV; EV71; SIV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Give 2 doses of EV71 +SIV, get 2 blood samples before the first dose and 28-43 days after the last dose.; Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last; Give 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunogenicity; Safety; Enterovirus 71 Vaccine; seasonal influenza vaccine
Vitamin B12 Supplementation Study
Condition: Vitamin B12 Deficiency
MeSH terms: Vitamin B 12 Deficiency
Study type: Interventional

Summary: 
      We hope to learn the clinical and functional signs of sub-clinical vitamin B12 deficiency and
      its response to supplementation in non-anemic, non-pregnant, and non-lactating women in Rural
      Mexico. Vitamin B12 is important in hematopoiesis, neuro-cognitive functions and genetic
      integrity. However vitamin B12 is only found in animal source foods therefore a large segment
      of the population in developing countries and those practicing vegetarianism are at risk of
      deficiency of the vitamin. This information will help decide weather supplementation with
      vitamin B12 is necessary in such populations for public health reasons.
    


Intervention name(s): Vitamin B12; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 500 microgram daily supplement of vitamin B12 1000 mg injection vitamin B12 given at the start of the study; placebo given as a daily supplement 1000 mg injection of vitamin B12 given at the end of the study
Other intervention name(s): sugar pill
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: B12 deficiency; methylmalonic acid; homocystein; vitamin B12 supplementation intervention
A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
Condition: ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy,
      safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult
      participants presenting with acute STEMI (ST segment elevation myocardial infarction).

      The study will enrol participants presenting with acute STEMI who are planned for primary
      percutaneous coronary intervention (pPCI). For all participants, an end of study CMR will be
      performed at 10-12 weeks (70-84 days following Dose 1). A subset of participants will also
      undergo an index and an end of study CTA.
    


Intervention name(s): MEDI6012; Placebo
Intervention type(s): Biological; Other
Intervention description(s): MEDI6012; Placebo
Other intervention name(s): MEDI6012 300 mg will be administered on Day 1 and MEDI6012 150 mg on Day 3 by IV push in Cohorts A and B. In Cohort B, MEDI6012 100 mg will be administered on Days 10, 17, 24, and 31 by IV push.; Placebo matched to MEDI6012 will be administered on Day 1 and Day 3 by IV push in Cohorts A and B, and on Days 10, 17, 24, and 31 by IV push in Cohort B.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery
Condition: Postoperative Pain; Spine Deformity; Spine Injury; Spine Fracture; Spine Malformation
MeSH terms: Pain, Postoperative; Spinal Injuries; Spinal Fractures
Study type: Interventional

Summary: 
      Major spine surgery causes severe postoperative pain. The primary objective of this
      randomized controlled study is to compare the effect of ultrasound (US)-guided superficial
      erector spinae plane (ESP) block on 48-hour postoperative cumulative opioid requirements with
      standard (opioid-based) analgesia.
    

Detailed description: 
      46 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo spine surgery,
      were randomized and divided into two groups. (23 patients in each of the control and
      superficial ESP groups). Superficial ESP block was performed for SESP group and standard
      (opioid-based) analgesia performed in the control group. Postoperative analgesia was provided
      by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative
      numeric rating scale values were the primary outcome measure. 24-hour total morphine
      consumption was secondary outcome measure.
    

Intervention name(s): superficial erector spina plane block; Standard (opioid-based) analgesia
Intervention type(s): Procedure; Procedure
Intervention description(s): The investigators performed superficial erector spina plane block to that patient group for postoperative analgesia; The investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia
Intervention MeSH terms: Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Postoperative pain; Superficial Erector Spinae Plane Block; Spine Surgery; Local anesthetic
The Effect of Combining Aprepitant With Ondansetron in High-risk Patients for Postoperative Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      PONV (Postoperative nausea and vomiting) is one of most common complications after general
      anesthesia. Female sex, history of PONV, motion sickness, nonsmoker status, use of volatile
      agents, duration of anesthesia, opioid administration and laparoscopic surgery are known as
      risk factors for developing PONV. In consequence, patients undergoing laparoscopic
      gynecologic surgery are at high risk for developing PONV. Most of these patients use fentanyl
      based IV-PCA. And it also causes PONV.

      So, we should prevent PONV in these patients by using multimodal or combination therapy.

      Aprepitant is a NK1 receptor antagonist.And it is used to prevent chemotherapy induced nausea
      and vomiting. Many studies using aprepitant to prevent PONV are in progress.

      In this study, we investigate the effect of combining aprepitant with ondansetron in
      high-risk patients for PONV.
    


Intervention name(s): Aprepitant; placebo
Intervention type(s): Drug; Drug
Intervention description(s): We administrate aprepitant with small amount of water to aprepitant group in pre treatment room. (Before patient get in the operating room)And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery.; Patient in placebo group will be given Placebo in the PTR. And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery.
Other intervention name(s): Emend
Intervention MeSH terms: Aprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Project JAY THA Registration Study
Condition: Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis; Avascular Necrosis; Developmental Dysplasia of the Hip; Femoral Neck Fracture
MeSH terms: Arthritis; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Necrosis; Femoral Neck Fractures
Study type: Interventional

Summary: 
      This is a prospective, randomized, multicenter clinical study in Chinese subjects to compare
      the safety and efficacy of the Delta PLUS Femoral Head and SL-TWIN Stem with BIOLOX forte
      ball head and SL-PLUS Stem in total hip arthroplasty
    

Detailed description: 
      As the incidence of joint disease continues to increase, an ever growing percentage of the
      affected population will undergo total hip arthroplasty (THA). This recent upward trend for
      THA procedures appears to be directly related to the prevalence of certain health factors.
      Specifically, longer life spans, rising obesity rates, and increasing physical activity
      levels in relatively younger populations are all examples of factors that may significantly
      contribute to hip degeneration. While strategies such as weight reduction, lifestyle change,
      or drug therapy may offer temporary relief from the symptoms of joint degeneration, THA
      remains the standard of care for subjects experiencing significant losses in quality of life
      due to advanced hip disease.

      There has been an increase in imported hip prostheses during the past decade, so that
      surgeons now have more choices of implants. However, the high cost of imported prostheses has
      become a barrier to the development of hip replacement in China and caused many patients
      requiring immediate hip replacement to have to delay or miss their surgery. The development
      and promotion of high-quality domestic joint implants and surgical instruments is the key to
      the development of joint replacement technique in China.

      The primary objective of this study is to demonstrate non-inferiority of subjects implanted
      with the Delta PLUS Femoral Head + SL-TWIN Stem compared to a randomized concurrent control
      group of subjects implanted with the BIOLOX forte ball head + SL-PLUS Stem in terms of mean
      Harris Hip Score (HHS) at 1 year.
    

Intervention name(s): Delta PLUS Femoral Head + SL-TWIN Stem; BIOLOX forte ball head + SL-PLUS Stem
Intervention type(s): Device; Device
Intervention description(s): Subject will undergo total hip arthroplasty with Delta PLUS Femoral Head & SL-TWIN Stem; Subject will undergo total hip arthroplasty with BIOLOX forte ball head & SL-PLUS Stem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-2
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      DEFEND-2 is a Phase 3 confirmatory study for the Phase 3 DEFEND-1 study. The study objective
      is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in
      insulin secretion as compared with placebo. Insulin secretion will be assessed using mixed
      meal-stimulated C-peptide.

      Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3
      otelixizumab, 1/3 placebo). These study agents will be administered as an addition to
      insulin, diet, and other standard of care treatments.
    

Detailed description: 
      The following visits are required:

        -  Screening Visits: 2 to 3 appointments will be conducted to determine eligibility. At 2
           of these visits participants will drink a liquid meal and have blood tests done over the
           post-meal period. Participants will also be required to wear a continuous glucose
           monitor for a short period of time.

        -  Dosing Visits: 8 outpatient visits on consecutive days, each lasting about 2-4 hours.

        -  Follow-up Visits: weekly for the first month, then every 2 weeks for 3 months, followed
           by monthly visits through 1 year. There will be 3 visits in the second year.

        -  The total duration of the study is 2 years.

        -  Glucose test strips and glucose monitors will be provided to participants for the
           duration of the study. Frequent glycemic monitoring will occur through lab testing and
           blood glucose self-monitoring to help facilitate tight glycemic control in all subjects.
           Subjects will be asked to intermittently record their insulin doses using a telephone or
           web based system and continuous glucose monitoring will be performed every 6 months.
    

Intervention name(s): Otelixizumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): infusion; Infusion
Other intervention name(s): ChAglyCD3; TRX4; monoclonal antibody; anti-CD3
Intervention MeSH terms: Muromonab-CD3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: new onset type 1 diabetes; juvenile diabetes; T1DM; Type 1 diabetes