bioihbjkbjnl/mcl2 huggingface dataset:
Live Birth Rate Between PPOS and GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response
Condition: IVF; GnRH Antagonist; PPOS
Study type: Interventional
Phase: Phase 3

Summary: 
      Progestin can inhibit the pituitary LH surge during ovarian stimulation and various studies
      show progestin-primed ovarian stimulation (PPOS) is effective in blocking the LH surge in
      IVF. More and more centers in China are using PPOS because this regimen appears simpler and
      cheaper.A randomized trial to compare the effectiveness of PPOS and GnRH antagonist protocol
      in IVF in terms of the live birth rate is urgently needed.

      Trial objectives: To compare the live birth rate between the PPOS protocol and the antagonist
      protocol used for ovarian stimulation during IVF

      Eligible women will be randomised into one of the two groups:

      Antagonist group : Women will receive antagonist (Cetrorelix or Ganirelix 0.25mg) once
      subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.

      PPOS group: Women will receive oral medroxyprogesterone 10 mg daily or duphaston 10mg bd
      daily from Day 3 till the day of ovulation trigger.

      There will be no fresh transfer. Only one blastocyst will be allowed to replaced in the first
      FET and a maximum of two blastocysts will be replaced in the subsequent FET cycles.

      The primary outcome is the live birth rate of the first frozen-thawed transfer cycle.
    


Intervention name(s): Progesterone; GnRH Antagonist
Intervention type(s): Drug; Drug
Intervention description(s): oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger; GnRH antagonist (Cetrorelix or Ganirelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger
Other intervention name(s): medroxyprogesterone; duphaston; Cetrorelix; Ganirelix
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone; Cetrorelix; Progesterone; Dydrogesterone; Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sequential High-dose Dexamethasone and Response Adopted PAD or VAD Induction Chemotherapy Followed by High-dose Chemotherapy With Autologous Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Complete Response (CR) plus near CR rate of VAD (Vincristine, Adriamycin, Dexamethasone)
      induction chemotherapy followed by ASCT in patients with newly diagnosed MM was about 50% and
      CR plus near CR rate of PAD (Bortezomib, Adriamycin, Dexamethasone) induction chemotherapy
      followed by ASCT in patients with newly diagnosed MM was about 60%. If the CR with near CR
      rate of sequential high-dose dexamethasone and response adopted PAD or VAD induction
      chemotherapy followed by ASCT is more than 60%, this combination will be accepted as active
      regimen that may be worth for investigating in phase III trial. But, if the CR with near CR
      rate of this regimen is lower than 50%, this has not a merit than VAD induction chemotherapy.

      Based upon the above assumption, this trial was designed by using Simon's optimal two-stage
      testing procedure. Assuming a target level of interest, p1=0.6, and a lower activity level,
      p0=0.5. Initially 61 patients will be accrued. If 33 or more CR + near CR rate were observed,
      the trial will be continued. Accrual will be planned to a total of 190 patients. If total 106
      or more patients were assessed as CR with near CR, sequential high-dose dexamethasone and
      response adopted PAD or VAD induction chemotherapy regimen will be accepted as active
      regimen. This design provides probability 0.05 of accepting drugs worse than p0 and
      probability 0.20 of rejecting drugs better than p1. If we assume that drop-out rate is 10%,
      total accrual patient will be 210.

      Patient characteristics and toxicity will be evaluated by descriptive methods. Progression
      free survival and overall survival (median value, 95% confidence interval) will be calculated
      by Kaplan-Meier method.
    


Intervention name(s): high dose dexamethsone
Intervention type(s): Drug
Intervention description(s): high dose dexamethasone : 40mg/day , D1-D4, D9-D12, IV or PO, repeat every 21days for 2cycles
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Capsular Outcomes of Pediatric Cataract Surgery With Primary Intraocular Lens Implantation
Condition: Capsular Contracture, Implant; Pediatric Cataract
MeSH terms: Contracture; Cataract; Implant Capsular Contracture
Study type: Observational

Summary: 
      Lens capsular often changes after pediatric cataract surgery，causing complications such as
      anterior capsulerhexis shrinkage, visual axis opacification (VAO), zonular dehiscence and so
      on. The aim of study was to prospectively investigate the capsular outcomes of pediatric
      cataract surgery with primary intraocular lens (IOL) implantation.
    

Detailed description: 
      To investigate the capsular outcomes from a case series of children who underwent cataract
      surgery and primary IOL implantation at the Eye Hospital of Wenzhou Medical University
      between 2016 and 2019. Took Digital retro-illumination photographs of pediatric eyes at
      baseline and 6 months, 12 months, and the last visit postoperatively. Compare the capsular
      outcomes of the posterior capsule opening (PCO) area and visual axis transparent area at
      those time points, and analysis the correlations between the PCO area and influential
      factors, such as age at surgery, axial growth, and follow-up duration.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients （age：0.5~8.0 years）with congenital cataract
      
Keywords: capsular outcome; pediatric cataract; posterior capsulorhexis
Use of Topotecan in Patients With Refractory Acute Leukemia
Condition: Non-Hodgkin's Lymphoma; Leukemia
MeSH terms: Leukemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to identify the highest tolerated doses in drugs used to treat
      aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy
      treatment. The drugs being used in this study include drugs frequently used in treating such
      diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be
      effective (topotecan).
    

Detailed description: 
      The purpose of this study is to identify the highest tolerated doses in drugs used to treat
      aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy
      treatment. The drugs being used in this study include drugs frequently used in treating such
      diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be
      effective (topotecan).
    

Intervention name(s): Topotecan; Mitozantrone; Etoposide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Etoposide; Mitoxantrone; Topotecan
Keywords: Multiple Myeloma; Lymphoma; Leukemia; Etoposide; Drug Therapy; Clinical Trials
Pilot Study for Noninvasive Spectroscopic Detection of Adipose Tissue Inflammation in Obesity
Condition: Obesity
MeSH terms: Obesity; Inflammation
Study type: Observational

Summary: 
      This study will test the potential of two techniques using light properties of adipose tissue
      to diagnose crown-like structures and inflammation to be compared with pathologic examination
      of adipose tissue biopsies from ongoing clinical studies.
    

Detailed description: 
      Adipose tissue (fat) inflammation is emerging as an important harbinger of disease
      development including Type 2 diabetes, heart disease and potentially cancer. The hallmark
      feature of adipose tissue inflammation is the crown-like structure, a dying fat cell
      surrounded by immune cells attempting to clear the damage. Current methods for detecting
      adipose tissue inflammation rely on invasive procedures such as fat biopsies. We propose
      developing methods that use the light reflection properties of inflamed adipose tissue as a
      potential non-invasive method to detect adipose tissue inflammation.
    

Intervention name(s): Fat Biopsy
Intervention type(s): Procedure
Intervention description(s): Fat biopsy
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy Volunteer and obese subjects
      
Biospecimen description: 
      Adipose tissue
    
Keywords: Obesity; Healthy Volunteers
Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery
Condition: Postoperative Pain; Nerve Block
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Effect of perineural dexamethasone on the duration of popliteal nerve block after ankle/foot
      surgery
    

Detailed description: 
      This study is proposed to explore the effect of perineural dexamethasone on the duration of
      popliteal nerve block for analgesia after ankle surgery.

      After ankle or foot arthrodesis patients need a good analgesia. Nevertheless early
      mobilisation and discharge are important for the healing process after surgery. Peripheral
      nerve blocks have provided a safe, effective method to control early postoperative pain when
      symptoms are most severe. Perineural dexamethasone added to local anesthetic prolongs the
      duration of analgesia of the perineural nerve block.

      The perineural use of dexamethasone is still off-label. There is a ongoing discussion of
      which has better benefits, intravenous or perineural dexamethasone.

      There are multiple research where the intravenous and perineural dexamethasone use has
      compared, but there is still a limited amount of research of low dose perineural
      dexamethasone versus intravenous dexamethasone.

      In this study investigators compare different doses of perineural dexamethasone added to
      ropivacaine 2 mg/ml 20ml. After arthrodesis under spinal anaesthesia the patients receive
      popliteal block ropivacaine 2 mg/ml 20 ml and dexamethasone of different doses. Groups 1 to 4
      has dexamethasone doses 0, 2mg, 3mg or 4 mg.

      After the popliteal nerve block investigators follow postoperative pain, opiate consumption,
      mobilisation and long term quality of life.

      Investigators goal is to find a dexamethasone dose which is as low as possible but at the
      same time covers the need for a good pain relief and fast recovery postoperatively.
    

Intervention name(s): Dexamethasone Sodium Phosphate; Ropivacaine Hydrochloride Inj 2 mg/ml; Sodium Chloride 9mg/mL
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dexamethasone injection; Ropivacaine injection; Sodium Chloride injection
Other intervention name(s): Oradexon; Saline
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ropivacaine; Dexamethasone 21-phosphate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Drug-Drug Interaction Study of N91115 +/- Rifampin in Healthy Adult Subjects
Condition: Drug Interaction Potentiation
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study is designed to assess the effects of Rifampin on the pharmacokinetics of
      N91115 in healthy subjects.
    

Detailed description: 
      This study will assess the effects of multiple oral dose administration of rifampin on the
      steady state plasma pharmacokinetics (PK) of N91115 in healthy subjects.

      Eligible subjects (n=15) will receive oral doses of N91115 twice daily (approximately every
      12 hours) on Study Days 1 through the morning of Day 13. On Study Days 8 through 12, rifampin
      administered 600 mg once daily will be added to the N91115 regimen. Study subjects will be
      monitored for safety while housed in the clinical research unit (CRU) until discharge on Day
      14. Pharmacokinetics will be followed from Study Day 1 through Study Day 14. A follow-up
      phone call will be made on Day 20 (1 day). Participation of an individual subject may last up
      to approximately 48 days from the time of screening until the end-of-study follow-up call.
    

Intervention name(s): N91115; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg BID; 600 mg QD
Other intervention name(s): Cavosonstat; Rifadin
Intervention MeSH terms: Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: N91115; Rifampin; drug interaction; Cavosonstat
Media Impact on Preschool Behavior
Condition: Aggression; Prosocial Behavior
MeSH terms: Aggression
Study type: Interventional

Summary: 
      This study tests the hypothesis that modifying the media diet of preschool children so that
      they watch more prosocial programming and less violent programming will result in decreased
      aggression and increased prosocial behavior.
    


Intervention name(s): media diet; nutritional intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): advice and tips and tools for healthy non violent TV viewing; advice on healthy eating
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: TV; Violence; DVDs; Behavior; Preschool children
Unannounced Meal Handling of Advanced Closed Loop Insulin Delivery in Monitored Condition
Condition: type1diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The study will follow participants for the periods of 3 months while using an advanced hybrid
      closed loop algorithm in free living conditions . Each period will have a different meal
      handling protocols. The objective is to identify the mitigation of the algorithm with
      different meal handling approaches.
    


Intervention name(s): Advanced hybrid closed loop system
Intervention type(s): Device
Intervention description(s): Free living follow-up of meal handelling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Eltoprazine on Cognitive Impairment Associated With Schizophrenia (CIAS) in Adults
Condition: Cognitive Impairment; Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if eltoprazine (as an adjunct to anti-psychotic
      medication) improves one or more aspects of cognitive impairment in adult schizophrenic
      patients.
    

Detailed description: 
      Schizophrenia is a common and highly disabling psychiatric disorder with population
      prevalence around 1%. The manifestations of schizophrenia fall into three major domains: 1)
      "positive" symptoms, such as delusions, hallucinations, and disorganization of behavior; 2)
      "negative symptoms," including social withdrawal, lack of motivation, and reduced expression
      of affect; and 3) cognitive dysfunction. Cognitive deficits are seen in most patients with
      schizophrenia.

      Eltoprazine has agonist effects on both 5-HT1A and 5-HT1B receptors, which suggests that this
      drug may be useful for normalizing prefrontal cognitive abilities, reducing aggression and
      impulsivity, and improving cognitive function in schizophrenia.

      This study will compare the effects of Eltoprazine (as an adjunctive treatment to
      anti-psychotics) with Placebo in Adults with a DSM IV/DSM IV TR diagnosis of schizophrenia,
      in potentially improving one or more dimensions of cognitive impairment associated with
      schizophrenia.
    

Intervention name(s): Eltoprazine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of eltoprazine, dosed orally, for 8 weeks; Placebo to match eltoprazine
Other intervention name(s): eltropazine hydrochloride
Intervention MeSH terms: Eltoprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CIAS; Cognition; Schizophrenia; Eltoprazine
Trial of Perioperative Chemotherapy (Gemcitabine and Cisplatin) and Adjuvant Chemoradiotherapy (With Weekly Low Dose Gemcitabine) in Patients With Lung Cancer With Positive Nodes
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test feasibility, toxicity and efficacy of two different
      adjuvant treatment schedules in Stage II-IIIa Non-small cell lung cancer patients with
      positive lymph nodes.
    


Intervention name(s): gemcitabine; cisplatin; radical surgery; chemoradiotherapy
Intervention type(s): Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Gemcitabine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cornea Ectasia Excimer Laser Treatment
Condition: Corneal Ectasia
MeSH terms: Dilatation, Pathologic
Study type: Observational

Summary: 
      To evaluate efficacy, safety, objective and subjective quality of vision after treatment of
      cornea ectasia with transepithelial topographic guided laser simultaneous Central Corneal
      Remodeling (CCR) and Cross-linking (CXL).
    

Detailed description: 
      Background To evaluate efficacy, safety, objective and subjective quality of vision after
      treatment of cornea ectasia performed with transepithelial topographic guided laser
      simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL).

      Methods In this retrospective study 8 eyes of 8 patients (mean age 31.50±14.73 years)
      affected by cornea ectasia underwent simultaneous CCR and CXL. Preoperative and 6 month
      postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity
      (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of
      vision were evaluated preoperatively and 6 months postoperatively using corneal morphological
      irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39
      questionnaires.
    

Intervention name(s): topographic guided trans epithelial excimer laser
Intervention type(s): Procedure
Intervention description(s): In this retrospective study 8 eyes affected by cornea ectasia of 8 patients (mean age 31.50±14.73 years) underwent simultaneous CCR and CXL. Preoperative and 6 month postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of vision were respectively evaluated through preoperative and 6 month postoperative corneal morphological irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39 questionnaires.
Other intervention name(s): corneal cross linking
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Eight eyes (2 right and 6 left eyes) of 8 patients, 5 male and 3 female (mean age
        31.50±14.73, range 19 to 66 years), affected by cornea ectasia were enrolled in this study.
Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age
Condition: Infections, Papillomavirus; Papillomavirus Vaccines
MeSH terms: Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      HPV infection has been established as a necessary cause of cervical cancer. GSK Biologicals
      has developed an HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) which targets the 2 most common
      oncogenic HPV types (HPV-16 and HPV-18), found in > 70%, approximately, of all cervical
      cancers. Recently, Merck's HPV vaccine Gardasil® [quadrivalent human papillomavirus
      (HPV-6,11,16,18 L1 VLP) recombinant vaccine] has been approved by the FDA for prevention of
      genital tract cancers and pre-cancers and genital warts in females. Although the GSK HPV
      vaccine and Gardasil® have different compositions and are expected to have different efficacy
      profiles, each vaccine targets prevention of HPV-16 and 18 genital tract cancers and
      pre-cancers. Therefore, a comparison of the immunogenicity of the two vaccines is warranted.
      This Phase 3b study is designed to compare the immunogenicity of the GSK vaccine (HPV-16/18)
      to Gardasil® in healthy adult females 18-45 years of age.

      The Protocol Posting has been updated as the study will be extended by 3 additional years.
    

Detailed description: 
      This Protocol Posting has been updated following Protocol Amendment 25, November 2010
    

Intervention name(s): GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM); Gardasil ® (Merck & Co. Inc); Placebo; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Three doses administered intramuscularly at months 0, 1 and 6; Three doses administered intramuscularly at months 0, 2 and 6; One dose administered intramuscularly at month 1 to maintain blinding; One dose administered intramuscularly at month 2 to maintain blinding
Other intervention name(s): Cervarix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccines; Cervical cancer; Immunogenicity; Humans; Safety; Viral infections; Human papillomavirus (HPV); Comparative study; Human papillomavirus vaccine; Adults
IUD Insertion During Cesarean Section
Condition: Contraception
Study type: Interventional

Summary: 
      Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical
      Trial
    


Intervention name(s): IUD during CS; IUD after puerperium
Intervention type(s): Device; Device
Intervention description(s): IUD insertion during CS; IUD after puerperium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Effectiveness Study of a Swedish Youth Mentoring Program
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This study aims to investigate the effectiveness of a one-to-one, adult-to-youth primary
      preventive mentoring program in Sweden. Outcome domains and criteria for inclusion and
      exclusion of study participants are elaborated in collaboration with the providing NGO, and
      the program is given as customary.
    


Intervention name(s): Youth Mentoring program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Youth mentoring; Effectiveness; Sweden; low-risk youth