bioihbjkbjnl/mcl2 huggingface dataset:
Effects of IV Tranexamic Acid on the Thromboelastogram in Patients Undergoing Total Hip or Knee Arthroplasty
Condition: Status Post Total Hip and Knee Arthroplasty
Study type: Observational

Summary: 
      Blood management is an important part of successful total joint replacement. Loss of blood
      and transfusion can lead to poor outcomes for patients. The use of tranexamic acid (TXA) has
      become a standard component to many blood management programs. It is used to treat or prevent
      excessive blood loss during surgery and in various medical conditions such as excessive
      bleeding or hemorrhage. A normal body process prevents blood clots that occur naturally from
      growing and causing problems. When this process becomes overactive it can result in excessive
      bleeding, leading to increased blood transfusions. The proposed study seeks to evaluate the
      relationship between TXA and thromboelastogram (TEG) results.
    


Intervention name(s): Effects of IV TXA on TEG in patients undergoing THA or TKA
Intervention type(s): Procedure
Intervention description(s): Subjects will undergo surgery per standard of care. All subjects will have 3 additional vials of blood drawn to evaluate TEG.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults undergoing primary total hip and knee arthroplasty
Pulp Capping in Primary Molars Using TheraCal (LC)
Condition: Deep Caries; Indirect Pulp Capping; Direct Pulp Capping; Reversible Pulpitis; Decayed Teeth; Vital Pulp Therapy
MeSH terms: Pulpitis; Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized clinical trial that aims to evaluate clinical and radiographic success rates of
      indirect pulp capping and direct pulp capping in primary molars with reversible pulpitis
      using a light-cured tri-calcium silicate base material (TheraCal (LC)).
    

Detailed description: 
      Participating primary molars will be randomly allocated to one of the following groups:
      Indirect pulp capping group or Direct pulp capping group. A light-cured tri-calcium silicate
      base material (TheraCal (LC) ) will be used in the two groups as a dressing material.
      Patients will be recruited from the outpatient clinic of the pediatric dentistry department,
      Faculty of Dentistry Ain Shams University. The participant will be recalled for follow-up
      assessments at 3, 6,9, and 12 months.
    

Intervention name(s): Light cured tri-calcium silicate base material
Intervention type(s): Drug
Intervention description(s): TheraCal (LC) (BISCO Inc., Schamburg, IL, USA) was introduced in (2011), are available commercially as flowable cement applicable via syringe
Other intervention name(s): TheraCal (LC)
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Simple parallel randomization was performed by using computerized random numbers
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IPC , DPC
Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications
Condition: Hypospadias
MeSH terms: Hypospadias; Postoperative Complications
Study type: Interventional
Phase: Phase 3

Summary: 
      Hypospadias is a congenital abnormality of the penis that is caused by incomplete development
      of the anterior urethra. This pathology is one of the most common genital anomalies in
      paediatric urology .The incidence is reported to be 1 out of 250 live male births and is
      increasing regularly. The hypospadias surgeries present a high risk of post operative
      complications requiring re-interventions.

      A great part of the post operative complications is related to imperfect healing issues. If
      androgen stimulation seems to be deleterious, at the opposite, oestrogen could impact
      positively on the skin healing process. This point leads to the hypothesis that local
      transcutaneous oestrogen stimulation on the ventral and dorsal penile faces decreases the
      number of skin healing post-operative defects.

      The objective of the study is to assess the effect of oestrogen (applied once daily for 2
      months prior to surgery) on the post-operative complications.
    


Intervention name(s): promestriene; Placebo; Urethroplasty; Wrist X ray; Blood test
Intervention type(s): Drug; Drug; Procedure; Radiation; Procedure
Intervention description(s): Promestriene cream 1%, 1g per day during 2 months, cutaneous application; Placebo of promestriene cream, 1g per day during 2 months, cutaneous application; Onlay-tube-onlay urethroplasty performed by a physician expert of this technique (at least 5 years of practical ability); Wrist X ray to follow the degree of bone maturation; Hormonal dosage: Oestradiol, testosterone, FSH-LH and AMH
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Severe hypospadias; local oestrogen; promestriene; Onlay-tube-onlay urethroplasty; post-operative complications; fistula dehiscence
A Comparison of Paliperidone and Risperidone for Treatment of Patirnts With Methamphetamine-Associated Psychosis
Condition: Methamphetamine Dependence
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or
      environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical
      presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms),
      response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic
      neurotransmission) of both conditions. Both paliperidone and risperidone are second
      generation antipsychotics，but have same pharmacological effects of antipsychotic treatment
      and paliperidone may have more efficacy and safty.This study was designed to examine the
      acute efficacy, safety, and tolerability of paliperidone and risperidone for patients with
      MAP.
    

Detailed description: 
      Methods:A Multiple-Center, Randomized, Double-Blind.
    

Intervention name(s): paliperidone; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): Paliperidone group,6mg/pill,6mg-12mg/day non-forced titration method,last 2-4weeks; Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks
Other intervention name(s): Paliperidone Extended-Release Tablets; Invega; Risperdal H20070057
Intervention MeSH terms: Risperidone; Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Methamphetamine-Associated Psychosis; Aripiprazole; Risperidone
Effect of Motor Imagery Training on Ataxic Children After Medulloblastoma Resection
Condition: Cerebellar Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia
Study type: Interventional

Summary: 
      Background: after resection of medulloblastoma in children they suffer from signs and
      symptoms of ataxia which impedes their activities of daily living.

      purpose: to investigate the effect motor imagery training on balance, severity of ataxia and
      gait parameters on children after resection of medulloblastoma.

      Methods: Fifty children surfing from cerebellar ataxia after medulloblastoma resection were
      selected from tumors hospital of Cairo University, their age ranged from seven to nine years
      old, they were randomly assigned into two matched control and study groups. The control
      groups received the selected physical therapy program while, the study group received motor
      imaginary training in addition to the selected physical therapy program. Both groups were
      evaluated by ataxic rating scale, pediatric berg balance scale and kinematic gait analysis by
      kinovea software.
    

Detailed description: 
      Motor imagery is an effective method to enhance motor performance applied in rehabilitation
      programs it did not impose a physical load on patients, was confirmed through clinical
      evidence from meta-analysis. Motor imagery means thinking in motor task with executing it to
      activate motor cortical areas as 25% of the brain neurons are mirror neurons and fire by
      thinking.
    

Intervention name(s): motor imaginary training; physical thertapy training
Intervention type(s): Other; Other
Intervention description(s): Each child shown a video of 5 minutes of illustrating normal movements while the child resting in semi-reclined sitting in quiet room in front the screen. Children then asked to close their eyes and imagine practicing the task like the illustrative video. Repetition of the exercises depend on the children ranging from 5 to 10 repetitions per exercise.; The Control group received the selected physical therapy program for one hour, three times weekly for three successive months including facilitation of balance and protective reactions from standing position, standing on one leg, weight shifting from standing, squat to standing, strengthening exercises for trunk muscles and for upper and lower extremities musculatures, gait training activities for correction of gait pattern including.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Impact of Rituximab in Patients With Primary Breast Diffuse Large B Cell Lymphoma (DLBCL)
Condition: Lymphoma, Large B-Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Observational

Summary: 
      The purpose of this study is to investigate the impact of rituximab in primary breast DLBCL
      using a matched pair analysis following strict matching criteria in patients with primary
      breast and nodal DLBCL treated with rituximab plus cyclophosphamide, doxorubicin,
      vincristine, and prednisone (R-CHOP) regimen.
    

Detailed description: 
      Primary breast lymphoma represents 1.7% to 2.2% of all extranodal non-Hodgkin's lymphoma.
      Histologically, the diffuse large B cell lymphoma (DLBCL) is the most predominant subtype of
      PBL. Previous studies in the pre-rituximab era have identified the worse outcomes in primary
      breast DLBCL compared with nodal DLBCL. Few clinical studies have been reported for
      investigating the efficacy of rituximab in patients with primary breast DLBCL. For clarifying
      this, a large randomized trial comparing survival in patients with primary breast DLBCL is
      required. However, the rarity of primary breast DLBCL makes large trial virtually difficult
      in single center or study group. Additionally, retrospective studies for evaluating the role
      of rituximab in primary breast DLBCL had bias according to the difference of treatment period
      between CHOP and R-CHOP era. Thus, in attempt to clarify the impact of rituximab on survival
      and patterns of progression in patients with primary breast DLBCL, the investigators
      performed this matched pair analysis following strict matching criteria in patients with
      primary breast DLBCL, who were identified from our previous nation-wide survey, and nodal
      DLBCL, who were selected from the data registry of Korean Society of Hematology Lymphoma
      Working Party, treated with R-CHOP regimen.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The primary breast DLBCL group was identified from the nation-wide surveys in the
        university hospital, general hospital, and cancer institute of Korea. And, the nodal DLBCL
        group, as a matching control group, was selected from the data registry of Korean Society
        of Hematology Lymphoma Working Party.
      
Keywords: Diffuse large B cell lymphoma; Breast; Rituximab
Comparative Bioavailability Study of Two Prototypes of Trazodone Controlled-release Products and Two Marketed Reference Products in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study were:

        -  to compare the pharmacokinetic profiles of two prototype controlled-release (CR)
           trazodone hydrochloride (HCl) 300 mg tablets versus two reference products: Trittico® AC
           (2 x 150 mg CR tablets) and Desyrel® (3 x 100 mg IR (immediate-release) tablets) under
           fasting condition;

        -  to assess the controlled release properties of the two prototype formulations;

        -  to select a prototype formulation for further development;

        -  to validate the blood sampling schedule for future pivotal pharmacokinetic studies;

        -  to determine the appropriate sample size for pivotal studies based in the intra-subject
           variability.
    


Intervention name(s): Trazodone HCl; Trazodone HCl; Trazodone HCl; Trazodone HCl
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The dosage of trazodone.HCl during this treatment phase was a single oral dose of 300 mg (one CR tablet) at 07:30 (after an overnight fast of at least 10 hours) on clinic days.; The dosage of trazodone.HCl during this treatment phase was a single oral dose of 300 mg (one CR tablet) at 07:30 (after an overnight fast of at least 10 hours) on clinic days.; The dosage of trazodone.HCl during this treatment phase was 2 oral doses of 150 mg each: one controlled-release (CR) tablet at 07:30 (after an overnight fast of at least 10 hours) and 19:30 (after a fast of at least 2 hours) on clinic days.; The dosage of trazodone.HCl during this treatment phase was three oral doses of 100 mg each: one immediate-release (IR) tablet at 07:30 (after an overnight fast of at least 10 hours), 15:30 and 23:30 (both dosages after a fast of at least 2 hours) on clinic days.
Other intervention name(s): Oleptro
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy subjects
Post-COVID 19 Patients Undergoing Surgery
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational [Patient Registry]

Summary: 
      More and more patients are undergoing elective surgery after SARS-CoV-2 infection, and little
      is known about the residual pulmonary changes in these patients after infection and
      postoperative pulmonary complications. So, we propose an observational study comparing
      postCOVID-19 patients with normal population (control group) undergoing surgery.
    

Detailed description: 
      The most common lung complications of severe COVID-19 are pneumonia and hypoxemic respiratory
      failure/ARDS. Manifestations of lung inflammation or fibrosis were also observed in late
      stages of COVID-19 causing respiratory sequelae. Fibrous lesions may form during the healing
      of pulmonary chronic inflammation or proliferative diseases, with gradual replacement of
      cellular components by scar tissues indicating a poor outcome of COVID-19. Ultrasound allows
      to stratify the severity of lung damage and combined with the clinic, can help estimate the
      patient's prognosis and support therapeutic decision-making. On the other hand, pulmonary
      inflammatory processes and fibrosis are responsible for a decrease in respiratory
      distensibility or pulmonary compliance. Pulmonary parenchyma distensibility is known as
      static distensibility or compliance and it´s calculated by mechanical ventilators during
      general anesthesia.

      There are no studies that determine the results of lung ultrasound and pulmonary compliance
      in preoperative and intraoperative period respectively in postCOVID patients, and the
      postoperative complications of postCOVID patients are poorly understood.
    

Intervention name(s): scheduled surgery
Intervention type(s): Procedure
Intervention description(s): Patients undergoing scheduled surgery with lung ultrasound before surgery and determination of lung compliance during general anesthesia
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The written consent forms are obtained from all the subjects who agreed to participate in
        the study. Patients who suffered Covid-19 prior to surgery without previous moderate-severe
        pulmonary pathology, that at the time of surgery present negative PCR and absence of clinic
        due to SARS-CoV-2, are included in the Post-COVID 19 group. The "control group" includes
        patients over the age of 18 who did not have COVID-19 and without moderate-severe pulmonary
        pathology prior to surgery.
      
Keywords: Post-COVID patients; pulmonary sequelae; postoperative complications
Effects of SIMEOX on Static Hyperinflation in Patients With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This study will investigate the effects on the SIMEOX technology on static hyperinflation in
      patients with chronic obstructive pulmonary disease (COPD).
    

Detailed description: 
      This is a crossover study assessing the short-term effects of SIMEOX and PEP device on static
      hyperinflation in patients with COPD.

      Patients will perform lung function tests (to assess the residual volume and functional
      residual capacity) before, after and 30 minutes after a 20-min long session of SIMEOX or PEP
      (depending of randomization).
    

Intervention name(s): SIMEOX; PEP
Intervention type(s): Device; Device
Intervention description(s): SIMEOX is a device generating a succession of gentle depression at the mouth.; A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The visits include sessions (test 1 and 2) with SIMEOX or a positive expiratory pressure device (PEP) (chosen according to the subject's randomization) lasting 20 minutes, each followed by a rest period of 30 minutes.
Lung function tests will be performed before, after and 30 minutes after performing the devices (SIMEOX and PEP).
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effects of Diltiazem, a Moderate CYP3A4/A5 Inhibitor, on the Pharmacokinetics and Pharmacodynamics of E5555 and Its Metabolites in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of diltiazem on the pharmacokinetics
      (PK) and pharmacodynamics (PD) of E5555 and its metabolites in healthy subjects.
    

Detailed description: 
      This is an open-label, 2-arm study to evaluate the effects of diltiazem given in conjunction
      with E5555 on the PK of diltiazem and its metabolites. This is a Phase 1 study of 24 healthy
      male and female subjects that will be conducted at a single site. The planned duration of
      treatment for each subject is approximately 15 days including 1 day in Treatment Period 1 and
      14 days in Treatment Period 2.
    

Intervention name(s): E5555 100 mg and diltiazem; E5555 300 mg and diltiazem
Intervention type(s): Drug; Drug
Intervention description(s): E5555 single 100 mg oral dose in Treatment Period 1 Day 1 and in Treatment Period 2 Day 8. Diltiazem 360 mg orally each day for 14 days (Days 1-14) in Treatment Period 2.; E5555 single 300 mg oral dose in Treatment Period 1 and in Treatment Period 2 Day 8. Diltiazem 360 mg orally each day for 14 days (Days 1-14) in Treatment Period 2.
Intervention MeSH terms: Diltiazem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of Aminocaproic Acid in Scoliosis Surgery
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      This study will evaluate the pharmacokinetics of antifibrinolytic drug epsilon-aminocaproic
      acid (EACA) in children undergoing Posterior spinal fusion surgery (PSF) at The Children's
      Hospital of Philadelphia (CHOP) who receive EACA at the standard dose reported in the
      literature for this population and currently in use at CHOP.
    

Detailed description: 
      Posterior spinal fusion surgery (PSF) can be associated with significant blood loss, and
      perioperative transfusion is common. Various strategies have been employed to decrease
      intraoperative blood loss and reduce transfusion in children undergoing PSF. The
      intraoperative administration of the antifibrinolytic drug epsilon-aminocaproic acid (EACA)
      is one such strategy that has been shown to be effective in this regard. This study will
      evaluate the pharmacokinetics of EACA in children undergoing PSF at CHOP who receive EACA at
      the standard dose reported in the literature for this population and currently in use at
      CHOP.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and Adolescents scheduled to have posterior spinal fusion surgery at The
        Children's Hospital of Philadelphia
      
Keywords: Pediatrics; Scoliosis; Pharmacokinetics; Hemorrhage; Orthopedic Surgery
Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to define the absorption, breakdown and excretion of a single
      dose of radiolabelled SB-649868 and its breakdown products by measuring their concentration
      in blood, urine and faeces over a 7-10 day period. "Radiolabelled" means that the test drug
      has a radioactive component to help us track the drug. The safety and tolerability of the
      test drug will also be assessed.
    


Intervention name(s): 14C-SB649868
Intervention type(s): Drug
Intervention description(s): SB-649868 will be provided as powder in a bottle which will be reconstituted into a solution prior to dosing via a hard gelatin capsule. Each subject will receive one unit dose of SB-649868 30 milligram reconstituted powder presented in a size 00 capsule once. The capsule will be swallowed with 160 milliliters of water.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Distribution,; SB-649868,; Healthy,; Excretion,; Sleep disturbances; Volunteer,; Metabolism,; Absorption,