bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Effectiveness of Obstetric Lubricant Gel in Labor in Nulliparous and Primiparous Women: A Randomized Controlled Study
Condition: Parturition; Obstetric; Injury Pelvic Floor
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesized that the application of lubricant gels at the beginning of the
      active phase of the labor may reduce duration of the delivery and episiotomy rates. The aim
      of this study is to investigate and confirm this hypothesis through a randomised controlled
      trial.

      All participants in the study received standard routine antepartum care in the delivery room.
      Obstetric lubricant gel was applied to patients in the study groups, which had 47 nulliparous
      and 50 primiparous patients. Perinatal outcomes were compared between the groups.
    

Detailed description: 
      The participants were divided into two groups based on their parity: nulliparous and
      primiparous. Initially, each group had 110 participants. Nulliparous and primiparous groups
      were randomly assigned to two groups as study and control groups using a computer-generated
      random number table. In this randomized controlled trial, participant allocation was carried
      out using a computer program to ensure a randomized and unbiased selection process. The
      randomization procedure was conducted in a double-blind manner, with the study investigators
      remaining unaware of the allocation until the conclusion of the study. All participants in
      the study received standard routine antepartum care in the delivery room. Among all patients,
      25 participants were lost to follow-up during the study. Consequently, obstetric lubricant
      gel was applied to patients in the study groups, which included 47 nulliparous and 50
      primiparous patients. Perinatal outcomes were compared between the groups
    

Intervention name(s): Natalis Obstetric Lubrican Gel
Intervention type(s): Combination Product
Intervention description(s): The obstetric lubricant gel was applied to the vaginal canal with a special applicator at the beginning of the active phase of the labor. The gel used in the study was highly viscose and isotonic with a slight acid pH of 6.0 - 6.7 and contained hydroxyethylcellulose, propylene glycol, glycerin. The gel box contained a sterile syringe (15 ml) and a flexible applicator.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The participants were divided into two groups based on their parity; nulliparous and primiparous. At the outset, each group had 110 participants. Nulliparous and primiparous groups were randomly assigned to two groups as study and control groups by using a computer generating random number table. Obstetric lubricant gel was applied to patients in the study groups. Perinatal outcomes and durations of the labor were compared between study and control groups.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: birth; parturition; obstetric lubricant gel; duration of second stage of labor; labor
Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
Condition: Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
MeSH terms: Mucocutaneous Lymph Node Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with
      a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with
      Kawasaki disease refractory to initial therapy with Intravenous Immunoglobulin (IVIG). The
      pharmacokinetics of TA-650 is also examined.
    


Intervention name(s): TA-650; Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Intervention type(s): Drug; Drug
Intervention description(s): TA-650 at 5 mg per kg body weight on the day of TA-650 administration (day 0) is administered by intravenous infusion slowly over at least 2 hours.; VGIH at 2 g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infliximab; REMICADE; TA-650; intravenous immunoglobulin; Kawasaki disease; IVIG
The Effect of Ultra-low-dose Naloxone on Remifentanil-induced Postoperative Hyperalgesia - A Randomized Controlled Study
Condition: Pain
MeSH terms: Hyperalgesia
Study type: Interventional

Summary: 
      High-dose remifentanil infused intraoperative ironically results in postoperative
      hyperalgesia. Ultra-low dose nalxone is demonstrated to prevent these opioid-induced
      hyperalgesia in animal model. In this clinical trial in patients undergoing general
      anesthesia with remifentanil, we evaluate the effects of ultra-low-dose naloxone on
      remifentanil-induced hyperalgesia
    

Detailed description: 
      We enrolled adult patients undergoing thyroidectomy under general anesthesia with desflurane
      and remifentanil. Remifentanil was administered via target-controlled infusion and anesthetic
      depth was maintained keeping the BIS between 40 and 60. Patients were randomized into one of
      three groups depending on intraoperative doses of remifentanil and naloxone: effect-site
      concentrations of remifentanil 1 ng/ml (control group), 4 ng/ml (remifentanil group), and 4
      ng/ml combined with infusion rate 0.8 ng/kg/min of naloxone (remifentanil and naloxone
      group). Postoperative mechanical pain thresholds, pain intensity, and analgesic consumption
      were examined during 48 h of postoperative period. The primary outcome was mechanical pain
      threshold measured on the peri-incisional area 24 h after surgery.
    

Intervention name(s): High dose Remifentanil; Naloxone; Low dose remifentanil; Normal Saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): remifentanil infusion at 4ng/ml of Ce; naloxone infusion; remifentanil infusion at 1ng/ml of Ce; normal saline infusion
Intervention MeSH terms: Remifentanil; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: acute pain; postoperative; surgery
It's Your Game: An Innovative Approach to Preventing Teen Dating Violence
Condition: Adolescent Behavior; Interpersonal Relationships; Domestic Violence; Physical Violence
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate Me & You: Building Healthy Relationships, a
      classroom- and computer-based healthy relationships and dating violence prevention curriculum
      for 6th grade students, in a large, urban public school district in Southeast Texas.
    

Detailed description: 
      The purpose of this three year study is to evaluate Me & You: Building Healthy Relationships,
      a classroom- and computer-based healthy relationships and dating violence prevention
      curriculum for 6th grade students, in a large, urban public school district in Southeast
      Texas. This curriculum was adapted from an existing effective sex education and relationship
      curriculum, It's Your Game…Keep it Real (IYG), which was enhanced to more explicitly address
      teen dating violence (TDV) and encompass multiple levels of the social-ecological model
      (e.g., youth, family, school staff). A randomized two-arm, nested design was conducted among
      6th grade students, where students receiving the curriculum were compared to students
      receiving usual care. Ten middle schools participated in the study, five schools were
      randomly assigned to receive the curriculum and five to receive usual care. Outcomes were
      assessed at baseline, immediately following the intervention, and 12 months after baseline.
      Parental permission and student assent were obtained prior to administration of the surveys.
      The primary hypothesis is that students who receive the curriculum will have significantly
      lower TDV perpetration than those who do not receive the curriculum.
    

Intervention name(s): Me & You: Building Healthy Relationships
Intervention type(s): Behavioral
Intervention description(s): Me & You: Building Healthy Relationships is a classroom- and computer-based healthy relationships curriculum for middle school students. It consists of thirteen 25-minute lessons: 5 classroom, 5 computer-only, and 3 classroom-computer hybrid. The curriculum integrates group-based classroom activities (e.g., role-plays, group discussion, and other skill-building activities) and computer-based activities, some of which are individually tailored. The curriculum was adapted from an existing effective sex education and relationship curriculum, It's Your Game…Keep it Real (IYG), which was enhanced to more explicitly address teen dating violence (TDV).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: adolescent behavior; interpersonal relationships; intimate partner violence; violence/prevention & control; program evaluation; teen dating violence
A Bioequivalence Study of APX001 High-load and Low-load Tablets
Condition: Invasive Fungal Infections
MeSH terms: Mycoses; Invasive Fungal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to learn about the bioequivalence (the biochemical similarity of two medicines that
      share the same active ingredient and desired outcome for patients) of the study medicine
      called APX001 in healthy participants.
    


Intervention name(s): APX001; APX001A
Intervention type(s): Drug; Drug
Intervention description(s): Low-load oral tablet; High-load oral tablet
Other intervention name(s): fosmanogepix; fosmanogepix
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fosmanogepix; candida; aspergillus; scedosporium; fusarium; mucorales; rhizopus
Role of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Inflammation and Lipids
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Inflammation
Study type: Interventional

Summary: 
      The objective of this study is to provide critical information regarding both common and
      distinctive roles of EPA and DHA in systemic inflammation and lipid metabolism.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind, crossover study of the effects of EPA
      and DHA on inflammation and lipid metabolism in 24 men and women with metabolic syndrome. The
      study will characterize the effects of EPA alone and DHA alone, relative to each other and to
      placebo, on plasma biomarkers of inflammation, inflammatory cell activation and gene
      expression, and plasma lipid and lipoprotein levels.
    

Intervention name(s): EPA; DHA; sunflower oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 10 week supplementation; 10 week supplementation; 4-week lead-in
Other intervention name(s): eicosapentaenoic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Yoga Versus Home Exercise Program in Children With Enthesitis Related Arthritis
Condition: Enthesitis Related Arthritis
MeSH terms: Arthritis; Enthesopathy; Arthritis, Juvenile
Study type: Interventional

Summary: 
      The aim of this study is to compare the effectiveness of different exercises programs as
      'Yoga' and 'Home Exercise' in Enthesitis Related Arthritis.
    

Detailed description: 
      Enthesitis is the localized inflammation in the attachments of muscles, ligaments, fascia to
      bone. Enthesitis related arthritis is a sub-form of Juvenile Idiopathic Arthritis (JIA) and
      primarily lower extremities, spine, and sacroiliac joints. In the literature, exercise
      therapy is found beneficial to improve bone density, muscle strength and functionality
      without leading adverse effects in these children.

      Recently yoga has emerged as a new exercise approach which consist of both physical an mental
      components to improve self-awareness and mindfulness. However, the effects of yoga did not
      investigated in JIA patients. The only evidence is a case study which reports improvements in
      pain and stiffness in a child with JIA.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): The children with enthesitis related arthritis will be randomized into one of the exercise groups as yoga or home exercises and will perform the exercise program for 2 times a week for 8 weeks according to their groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: yoga; home exercises; juvenile idiopathic arthritis
A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, cross-over study comprised of 6 periods in healthy subjects.Subjects
      will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed
      by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as
      applicable.
    

Detailed description: 
      This is a single centre, randomised, cross-over study comprised of 6 periods in healthy males
      and females.Subjects will receive Regimens A, B and C in a randomised crossover manner in the
      fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or
      fed state, as applicable.
    

Intervention name(s): FDL169
Intervention type(s): Drug
Intervention description(s): CFTR corrector
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS-APO(a)Rx in Participants With High Lipoprotein(a)
Condition: Elevated Lipoprotein(a)
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      ISIS-APO(a)Rx given to participants with high lipoprotein(a) for 12 weeks.
    

Detailed description: 
      Lipoprotein(a) [Lp(a)] is a genetic variant of low-density lipoprotein (LDL) in which the
      apolipoprotein B (apoB) -100 component of LDL is linked by a disulfide bond to
      apolipoprotein(a) [apo(a)], the distinct protein component of Lp(a) that is mainly
      responsible for its signature structural and functional properties. Lp(a) is now recognized
      as an important genetic risk factor for coronary artery disease, stroke and aortic stenosis.

      The purpose of this study is to determine if ISIS-APO(a)Rx can reduce the production of
      apolipoprotein(a), or apo(a). This study will enroll 50 participants with Lipoprotein(a) ≥50
      and <175 mg/dL and 10 participants with Lipoprotein(a) ≥175 mg/dL.
    

Intervention name(s): ISIS-APO(a)Rx; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.; Normal saline as Placebo, subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
Other intervention name(s): ISIS 494372
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: High Lipoprotein(a)
Impact of Body Weight on the Immediate Health of the Pediatric Population
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Observational

Summary: 
      Objective: Obesity amongst children is a public health issue in the United States and is
      rising at an alarming rate. The purpose of this study is to determine if there is any
      correlation between At Risk body weight (overweight and obese) and immediate health of the
      pediatric population.

      Methodology: As part of routine patient care, we measured length in addition to weight of
      patients 2 years to 18 years of age presenting to the pediatric emergency department. A
      report was run monthly to calculate the BMI of all patients for whom data is available. The
      data were plotted on the year 2000 gender based BMI for age percentile growth charts from
      CDC. A retrospective electronic chart review was conducted for patients At Risk body weight
      (BMI ≥ 85%), and were compared to "control" or healthy (BMI of 25 - 75 %) group for six
      groups of final ED diagnoses of infectious diseases.
    

Detailed description: 
      A. Background and Significance:

      Obesity is a public health issue in the United States. Obesity amongst children is rising at
      an alarming rate. Thirty percent of US children aged 6 to 19 are over weight and 15 % are
      obese1. It is estimated that over 18 million US children are over weight. The long-term
      impact of childhood obesity on such diseases as Diabetes, Asthmaand Hypertension, is well
      studied. The effects of childhood obesity on the current health status of the pediatric
      population have not been studied.

      B. Methodology:

      As part of routine patient care, we measured length in addition to weight of patients 2 years
      to 18 years of age presenting to the pediatric emergency department. A report was run monthly
      to calculate the BMI of all patients for whom data is available. The data were plotted on the
      year 2000 gender based BMI for age percentile growth charts from CDC. A retrospective
      electronic chart review was conducted for patients At Risk body weight (BMI ≥ 85%), and were
      compared to "control" or healthy (BMI of 25 - 75 %) group for six groups of final ED
      diagnoses of infectious disease (ID). Data were entered and analyzed via SPSS 14.0 for
      Windows 2000 software systems.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric Emergency Medicine Patients
      
Keywords: children, obesity, emergency medicine
Ghrelin, Growth Hormone and Cortisol Interaction in Growth Hormone Deficient Patients
Condition: Hypopituitarism
MeSH terms: Hypopituitarism
Study type: Interventional

Summary: 
      In growth hormone deficient patients: Determination of endogenous circulating ghrelin levels,
      ghrelin effects on insulin sensitivity, appetite, energy metabolism, and signal transduction
      in fat and muscle.
    


Intervention name(s): Human acylated ghrelin
Intervention type(s): Drug
Intervention description(s): 5 pmol/kg body weight per min
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Looks at How Food Influences the Amount of BI 1358894 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of BI
      1358894 in healthy male subjects following oral administration of single rising doses.
      Secondary objectives are the exploration of the pharmacokinetics (PK), including dose
      proportionality of BI 1358894 after single dosing.
    


Intervention name(s): Placebo; BI 1358894; BI 1358894 (Test); BI 1358894 (Reference)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Fasting state; Fed state
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Propionyl-L-Carnitine in Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Propionyl-L-carnitine administration may
      ameliorate the illness in patients affected by mild to moderate ulcerative colitis already in
      treatment with one of the standard treatments (corticosteroids excluded).
    

Detailed description: 
      The trial foresees the administration of 2 different dosages of Propionyl-L-carnitine (ST261)
      colon release tablets, 1 g/die and 2 g/die. The primary objective of this trial is to
      evaluate the clinical/endoscopic response defined as a lowering of the Disease Activity Index
      (DAI score) of at least 3 points ot the reaching of remission, the clinical/endoscopic
      remission (DAI score <= 2 with no individual subscore > 1) and histological efficacy of the
      two combined dosages of PLC (i.e. PLC 1 g/die + 2 g/die) in comparison to placebo, defined as
      an improvement of the Histological Index (HI) of at least 1 point at the end of the study (a
      final HI score of <= 1 will be defined as an histological remission).

      The secondary objective is to evaluate the clinical/endoscopic and histological efficacy of
      the two dosages of PLC individually considered in comparison to Placebo, in order to gather
      information on the dosage to be used in subsequent trials. The safety and tolerability of the
      regimens studied will also be objectives of the study.
    

Intervention name(s): Propionyl-L-Carnitine; Propionyl-L-Carnitine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PLC colon release tablet 1 g/die for 4 weeks; PLC colon release tablet 2 g/die for 4 weeks; Placebo PLC colon release tablet 2 g/die for 4 weeks
Other intervention name(s): Dromos; Dromos
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Implantation Rate of Vitrified-warmed Collapsed Blastocysts
Condition: Implantation Rate of Vitrified Blastocysts
Study type: Interventional

Summary: 
      In our centre, the implantation rate of frozen blastocysts (cryopreserved using
      vitrification)was 20,3% (Van Landuyt et al. 2011). This implantation rate is lower when
      compared to data from other observational studies. Retrospective studies have shown that
      artificial shrinkage of the blastocoelic cavity (also called collapse) and dehydration of the
      blastocyst just before vitrification can have a positive effect on the survival after
      warming. This collapse can be induced by using a laser. The study of Iwayama et al. 2010 has
      shown a similar survival rate but an increase in the implantation rate of collapsed
      blastocysts compared to non-collapsed blastocysts.

      The aim of the study is to investigate the effect of artificial shrinkage by laser-induced
      collapse on the implantation potential of vitrified-warmed day 5 or day 6 blastocyst stage
      embryos in a prospective randomised controlled trial.
    


Intervention name(s): Collapse
Intervention type(s): Procedure
Intervention description(s): inducing collapse (= artificial shrinkage) by applying 1 or 2 laser pulses between trophectoderm cells of the blastocyst to be vitrified
Other intervention name(s): artificial shrinkage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: vitrification, blastocyst, artificial shrinkage, collapse