bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, randomized, 2-treatment, 2-period, crossover single-dose study in
      approximately 134 healthy adult participants. Participants will be randomized into 2
      sequences of treatment as described in the following table of Intervention Groups and
      Duration.
    


Intervention name(s): PF-06881894 by on-body injector; PF-06881894 by prefilled syringe
Intervention type(s): Combination Product; Combination Product
Intervention description(s): PF-06881894 given by on-body injector (OBI), 6 mg administered as a single SC injection; PF-06881894 given by prefilled syringe (PFS), 6 mg administered as a single SC injection
Other intervention name(s): on-body injector
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: on-body injector; OBI; febrile neutropenia; pegfilgrastim
The Efficacy and Safety of Using Tranexamic Acid by Different Means to Reduce Blood Loss During Total Knee Replacement
Condition: Blood Loss
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      We will investigate the efficacy and safety of using tranexamic acid by intravenous,
      intra-articular and combinational administration to reduce blood loss during total knee
      replacement. We hypothesize a combined intra-articular and single intravenous dose protocol
      of tranexamic acid may achieve a higher therapeutic concentration at the intra-articular and
      extra-articular bleeding site with little or no systemic absorption and subsequent systemic
      side effects.
    

Detailed description: 
      A randomized, double-blind, single-center, controlled and parallel-assigned study comparing
      the efficacy and safety of intravenous, intra-articular and combinational administration of
      tranexamic acid to reduce blood loss during total knee replacement. Subjects will be
      monitored for occurrence of any complications, particularly deep venous thrombosis and
      thromboembolism during the hospital stay and for 3 months postoperatively.
    

Intervention name(s): Tranexamic acid
Intervention type(s): Drug
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tranexamic Acid; Antifibrinolytic; Blood transfusion; Total knee arthroplasty
Can Tranexamic Acid Reduce Bleeding After Post Partum Hemorrhage in Cesarean Section Delivery
Condition: Post Partum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate the effect of early administration of tranexamic
      acid (TXA) on post partum hemorrhage caused by uterine atony after cesarean section delivery.

      This was a randomised, placebo controlled trial including 74 patients. The investigators
      included ASA1 parturients with correct haemostatic status undergoing cesarean section under
      spinal anesthesia. The randomization begins after the inefficacy of oxytocin injections and
      starting up sulprostone perfusion at the request of the surgeon. TXA Group received 10 mg/kg
      of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the
      2 following hours. Placebo Group received same volumes of normal saline. The investigators
      compared blood loss and transfusions in both groups.
    


Intervention name(s): Tranexamic Acid; saline serum
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours; The Placebo group received normal saline with the same volumes
Other intervention name(s): exacyl; normal saline; NaCl 0.9%
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: post partum hemorrhage; transfusion; tranexamic acid
Oral Administration of Colostrum to Premature Babies: Impact on the Oral Microbiota
Condition: Changes in the Oral Microbiota
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Oropharyngeal administration of mother's colostrum to premature infants has been proposed as
      a stimulus to the oropharyngeal lymphatic tissues to decrease the incidence of pneumonia and
      sepsis, particularly in intubated babies. We propose to study the impact of this intervention
      on the composition of the oral microbiota.
    


Intervention name(s): Colostrum
Intervention type(s): Other
Intervention description(s): Mother's own colostrum (0.2 ml) will be administered into the mouth of the infant every 2 hours for 48 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effective Ways of Recruiting Lapsed Blood Donors: a Stratified Randomized Pilot Study
Condition: Blood Donor
Study type: Interventional

Summary: 
      Blood donor recruitment is an important issue in every country, since the blood supply
      pressure become more and more intense. Donor retention is even more important, because it is
      easier to recruit an old customers than a new one. Therefore, figuring the most effective
      ways of recruiting lapsed blood donors and understanding the reasons of not donating blood
      again is critical and vital for the development of blood donation.
    


Intervention name(s): Text message; Telephone
Intervention type(s): Other; Other
Intervention description(s): Text messages would be sent via the messaging platform of Guangzhou Blood Center. The feedback of sending status (received, failed to receive, or unknown) would be marked on every number. Four to six months follow-up, blood donation rate would be checked.; Status (response, no answer, line issue, wrong number or refused to be interviewed) of every donor in this groups would be marked. Four to six months follow-up, blood donation rate would be checked.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Bioequivalence Study of SAL001 and FORSTEO in Healthy Chinese Adults
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, open label, single-dose, the original drug controlled,
      crossover design, two sequence, two periods, Phase Ⅰclinical study.

      64 qualified subjects will be randomly assigned to two administration sequences (sequence A
      and sequence B) at the ratio of 1∶1, with 32 subjects in each sequence. Each period will be
      given subcutaneous injection once, and the washout period will be 72 hours, and each subject
      will be given subcutaneous injection twice. Sequence A: the test drug (SAL001) is injected in
      the first period, and the reference drug (FORSTEO) is injected in the second period. Sequence
      B: the reference drug (FORSTEO) is injected in the first period, and the test drug (SAL001)
      is injected in the second period.

      If the geometric mean ratio (GMR) 90% confidence interval of the major pharmacokinetic
      indexes (AUC0-t, Cmax) for SAL001 and FORSTEO is between 80.00% and 125.00%, the two drugs
      are considered to be bioequivalent.
    


Intervention name(s): SAL001; FORSTEO
Intervention type(s): Biological; Biological
Intervention description(s): administrated once by subcutaneous injection; administrated once by subcutaneous injection
Intervention MeSH terms: Teriparatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Teriparatide; Bioequivalence
STATE Trial: SusTained Attention Training to Enhance Sleep
Condition: Insomnia
Study type: Interventional

Summary: 
      This study is a validation study to document the acceptability of the Tonic and Phasic
      Alertness Training (TAPAT) training program in older adults with chronic late-life insomnia.
      The goal of this study is to employ a computerized attention-training program, TAPAT,
      designed for chronic late-life insomnia in a randomized, controlled trial to assess
      feasibility and initial efficacy in this population.
    


Intervention name(s): Computerized Plasticity-Based Adaptive Cognitive Training; Commercially available computerized training
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study Testing Professional, Peer, and Mentor Health Coaches for Weight Loss
Condition: Obesity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Participants will be randomly assigned to 1 of 3 types of health coaches, Peers, Mentors, or
      Professionals. The aim of this study is to examine the feasibility and preliminary efficacy
      of health coaching for weight loss.
    


Intervention name(s): peer coach; mentor; Professional
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive behavioral weight loss treatment and be coached by a peer between treatment visits.; Participants will receive behavioral weight loss treatment and be coached by a mentor between treatment visits.; Participants will receive behavioral weight loss treatment and be coached by a behavioral weight loss interventionist between treatment visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial Biomarkers
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out whether ubiquinol is well tolerated, can affect the
      symptoms of Parkinson's Disease and change the energy levels in the brain. Subjects will be
      randomized to taking ubiquinol or placebo and will have a neurological evaluation, magnetic
      resonance spectroscopy (MRS) and blood test for biological markers taken during the study.
    

Detailed description: 
      Multiple lines of evidence have implicated abnormal energy metabolism and deficient
      mitochondrial function in Parkinson's disease, presenting a unique target for therapy. A
      pilot study of ubiquinol in PD was therefore undertaken to determine its effects upon
      physiologic measures of mitochondrial metabolic function. The incorporation of a neuroimaging
      biomarker is particularly important, since changes would demonstrate our ability to achieve
      Central Nervous System (CNS) access from this an formulation, accompanied by a meaningful
      neurophysiologic effect. Hydrogen Proton Magnetic Resonance Spectroscopy Imaging (1H MRSI) is
      a technique that provides insight into the metabolism of several endogenous brain compounds,
      most notably N-acetyl-L-aspartate (NAA), choline-containing compounds (Cho), and creatine and
      phosphocreatine (Cr). A number of studies of mitochondrial function have now firmly
      established the utility of 1H MRSI in probing potential mitochondrial energy metabolism
      dysfunction, in primary mitochondrial disorders, but also in PD. This pilot study is
      therefore designed to test whether oral ubiquinol affects cerebral indices of mitochondrial
      dysfunction, as measured by 1H MRSI in patients with Parkinson's disease, and to gather
      preliminary information on the safety and tolerability of ubiquinol in individuals with PD.
    

Intervention name(s): Ubiquinol; Placebo
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Ubiquinol caplets 600mg/day; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson Disease; ubiquinol; CoQ10; magnetic resonance spectroscopy; lactate; glutathione
Quetiapine Efficacy in Bipolar Depression Study
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Observational

Summary: 
      To reassure the clinical study data on Seroquel antidepressant efficacy in patients who are
      diagnosed as bipolar depression
    


Time perspective: Prospective
Keywords: Bipolar depression; quetiapine; observational; Naturalistic
Management of Recurrent Implantation Failure
Condition: Recurrent Implantation Failure (RIF)
MeSH terms: Recurrence
Study type: Interventional

Summary: 
      This is the first study to investigate, whether pregnancy and implantation rates would
      improve in patients with recurrent implantation failure (RIF), if all embryos were to be
      frozen and transferred in a consecutive natural cycle.
    

Detailed description: 
      There is growing evidence that elective frozen-thawed embryo transfer in a non-stimulated
      cycle (freeze-all policy) would eliminate the risk of controlled ovarian stimulation and
      resulting in better endometrial receptivity and lower uterine contractility as compared with
      fresh intracytoplasmic sperm injection (ICSI) cycles.

      RIF refers to women who fail to achieve a clinical pregnancy, in a minimum of three embryo
      transfer cycles with at least four good-quality embryos were transferred in a woman < 40
      years. It affects approximately 10% of ICSI cases. Many management protocols aimed to enhance
      ICSI outcome in cases of RIF, however, none of them examined the effect of freeze all policy
      in this category of patients.
    

Intervention name(s): Freeze all policy
Intervention type(s): Other
Intervention description(s): Cryopreservation of human blastocysts for freeze all group has been employed using vitrification. The blastocysts were transferred after thawing in a frozen-thawed cycle.
Other intervention name(s): Frozen-thawed embryo transfer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Recurrent implantation failure; Freeze all policy; endometrial receptivity; implantation; clinical outcome
The Role of Genetic Factors in the Development of Atopic Dermatitis in the Kazakh Population
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      This is a GWAS study that aims to identify possible candidate genes associate to atopic
      dermatitisby exploring single nucleotide polymorphism (SNP) in a group of atopic dermatitis,
      in the Kazakh population. The investigators hypothesize that the careful phenotyping of the
      subject sand matching with increase the power to find SNP significantly associate with atopic
      dermatitis
    

Detailed description: 
      A genome-wide association study (GWAS) is an approach used in genetics research to associate
      specific genetic variations with particular diseases. The method involves scanning the
      genomes from many different people and looking for genetic markers that can be used to
      predict the presence of a disease. Once such genetic markers are identified, they can be used
      to understand how genes contribute to the disease and develop better prevention and treatment
      strategies.
    

Intervention name(s): DNA analysis
Intervention type(s): Genetic
Intervention description(s): GWAS
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        KAZAKH POPULATION
      
Biospecimen description: 
      Blood
    
Keywords: GWAS
Workplace-Sponsored Diet and Exercise Program to Reduce Obesity
Condition: Obesity; Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effectiveness of an environmental worksite intervention to
      reduce obesity among hospital employees.
    

Detailed description: 
      BACKGROUND:

      Obesity is a significant public health problem in the United States, prompting policy makers
      and researchers to call for action against the epidemic. Obesity and associated health
      conditions affect all age groups and both genders, yet disproportionately affect racial and
      ethnic minorities. Health consequences of obesity include high blood pressure, high
      cholesterol, hyperinsulinemia, type 2 diabetes, heart disease, stroke, gallbladder disease,
      arthritis, sleep disturbances, breathing problems, and certain types of cancer. Hospitals are
      important worksite environments that employ large numbers of people in diverse job categories
      from diverse educational and socioeconomic backgrounds.

      DESIGN NARRATIVE:

      The purpose of this study is to promote weight loss among those who are overweight and obese,
      and prevent weight gain among those of normal weight through an environmental intervention
      targeted to all employees at six hospitals in central Massachusetts. The hospitals will be
      matched according to size, and within each matched pair randomly assigned to either the
      intervention or control group. The intervention will promote active living, in which physical
      activity is incorporated into each participants' daily routine. Participants will also follow
      a healthy diet, characterized by higher intakes of fruits, vegetables, fish, poultry,
      legumes, and whole grains. Participants will consume less high fat foods and refined grains,
      and reduce their total caloric intake through smaller portion sizes.
    

Intervention name(s): Diet; Physical Activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will also follow a healthy diet, characterized by higher intakes of fruits, vegetables, fish, poultry, legumes, and whole grains. Participants will consume less high fat foods and refined grains, and reduce their total caloric intake through smaller portion sizes.; The intervention will promote active living, in which physical activity is incorporated into each participants' daily routine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Trial of Oxaloacetate in Alzheimer's Disease (TOAD)
Condition: Alzheimer's Disease (AD)
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if oxaloacetate (OAA) is safe and tolerable at
      doses of up to 2 grams per day in people with Alzheimer's disease (AD).
    

Detailed description: 
      Alzheimer's disease (AD) is a progressive brain disorder that causes memory and thinking
      problems. The exact cause of AD is unknown. Researchers believe mitochondria (the part of
      your cells that produce energy) might be linked to symptoms of AD. Some studies have shown
      that the brains in patients with Alzheimer's disease have reduced mitochondrial activity,
      have fewer mitochondria present in the nerve cells, and have reduced ability to utilize
      glucose (sugar) for energy.

      Oxaloacetate (OAA) is a natural chemical that has been shown to have an effect on brain
      mitochondrial activity and brain energy in non-human animals.

      This study is divided into two parts. In the first part of the study, researchers will test
      whether a dose of 1 gram per day of OAA, taken for approximately 4 weeks in 15 people with AD
      is safe and tolerable. After all 15 participants in part 1 have completed their
      participation, and it is determined that the study drug was safe at this dose, the second
      part of the study will begin. In part 2, researchers will test a dose of 2 grams per day of
      OAA, taken for approximately 4 weeks in 15 people with AD, to assess safety at this dose.

      Participants will be in this study for about 10 weeks.
    

Intervention name(s): Oxaloacetate (OAA) 1g; Oxaloacetate (OAA) 2g
Intervention type(s): Drug; Drug
Intervention description(s): Pills to be taken orally in 500mg dose two times per day; Pills to be taken orally in 1000mg dose two times per day.
Other intervention name(s): Oxobutanedioic acid; Oxaloacetic acid; Oxalacetic acid; 2-Oxosuccinic acid; Ketosuccinic acid; Oxobutanedioic acid; Oxaloacetic acid; Oxalacetic acid; 2-Oxosuccinic acid; Ketosuccinic acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: energy metabolism; oxaloacetate
Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
Condition: Intraventricular Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The overall objective of this Phase III clinical trial is to obtain information from a
      population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of
      current clinical practice and national demographics of ICH regarding the benefit (or lack
      thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS).
      This application requests funding for five years to initiate a Phase III randomized clinical
      trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The
      investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue
      plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+
      placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH)
      and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd
      or 4th ventricles by intraventricular blood clot).
    


Intervention name(s): Alteplase; Normal saline
Intervention type(s): Drug; Other
Intervention description(s): 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses; 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses
Other intervention name(s): Cathflo Activase; rt-PA
Intervention MeSH terms: Tissue Plasminogen Activator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intraventricular hemorrhage thrombolysis