bioihbjkbjnl/mcl2 huggingface dataset:
Balanced Salt Solution VS. Normal Saline Solution in Septic Shock
Condition: Shock, Septic; Sepsis
MeSH terms: Sepsis; Shock, Septic; Shock
Study type: Interventional
Phase: Phase 3

Summary: 
      The Purpose of this study is to determine the impact of balanced salt solution versus
      chloride rich solution on clinical outcomes in paediatric severe sepsis or septic shock
    

Detailed description: 
      The surviving sepsis campaign guideline recommended the isotonic crystalloids as the first
      choice of initial fluid resuscitation. The isotonic crystalloids are including chloride-rich
      solution (eg.NSS) and balanced salt solution. Retrospective study showed normal saline can
      induced hyperchloremic metabolic acidosis and acute kidney injury. However, no randomized
      controlled trial compare efficacy between the balanced salt solution and chloride rich
      solution.
    

Intervention name(s): Ringer acetate; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Ringer acetate 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status; NSS 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status
Other intervention name(s): NSS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Severe sepsis, Balanced Salt Solution, Normal Saline
Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children
Condition: Malnutrition; Developmental Disabilities
MeSH terms: Malnutrition; Developmental Disabilities
Study type: Interventional

Summary: 
      This study seeks to evaluate the impact of an intensive home-based education intervention
      targeting severely stunted Guatemalan children for catch up growth and improved development.
      Half of the children in the study will receive standard of care, which includes micronutrient
      supplementation and a food ration. The other half of children in the study will receive, in
      addition to the above, home-based dietary assessment and individualized parental nutrition
      education.
    


Intervention name(s): Home-based nutrition education; Standard-of-care nutrition support
Intervention type(s): Behavioral; Dietary Supplement
Intervention description(s): Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.; Subjects will be provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The aim of the study is to investigate reliability, validity, and responsiveness of the timed
      360° turn test in patients with Multiple Sclerosis.
    

Detailed description: 
      At baseline, the timed 360° turn test, Berg Balance Scale, Timed Up and Go test, Functional
      Reach Test, Four Square Step Test, and One-legged Stance Test is applied to the Multiple
      Sclerosis group. The timed 360° turn test is repeated after seven days from the first
      application in patients with Multiple Sclerosis. Healthy controls are going to perform only
      the timed 360° turn test.
    

Intervention name(s): The timed 360° turn test
Intervention type(s): Other
Intervention description(s): The timed 360° turn test: Each participant turns around in place in a standing position for both sides.
Berg Balance Scale: It has 14 items, each of which is scored from 0 (i.e, severely impaired balance) to 4 (i.e., no balance impairment).
Timed Up and Go test: It requires individual to stand up from an armed chair, walk 3m, turn around, walk back to the armed chair, and sit down again.
Functional Reach Test: It measures the maximum distance an individual is able to reach forward beyond arm's length in the standing position when maintaining a fixed base of support.
One-leg stance test: Individuals were asked to stand on either their left or right leg.
Four square step test: It requires an individual to step over obstacles in various directions including forward, backward, and sideways.
Other intervention name(s): Berg Balance Scale, Timed Up and Go test, Functional Reach Test, One-leg stance test, Four square step test
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with Multiple Sclerosis who apply to Gazi University, Department of Physiotherapy
        and Rehabilitation will be invited to this study.
      
Keywords: The timed 360° turn test; Multiple sclerosis; reliability; validity
Comparison of Antibody Levels in Children and Adolescents After Initiation of Insulin Therapy by Either Insulin Aspart or Soluble Human Insulin
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This trial is conducted in Europe. This is a single-centre, retrospective trial aiming at
      comparing the antibody levels in children and adolescents.
    


Intervention name(s): soluble human insulin; isophane human insulin; insulin aspart
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Effects of Proton-pump Inhibitor on Acalabrutinib Capsule When Administered Orally With COCA-COLA in Healthy Participants
Condition: Infectious Disease
MeSH terms: Communicable Diseases; Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to support the clinical development of acalabrutinib in
      participants who need treatment with proton pump inhibitors while taking acalabrutinib.
    

Detailed description: 
      This is an open-label, single-center, randomized study in healthy participants to evaluate
      the effect of proton-pump inhibitors (rabeprazole; PPI) on acalabrutinib 100-mg capsule dosed
      orally with COCA-COLA. Participants will receive a single dose of acalabrutinib alone or with
      rabeprazole, and pharmacokinetic (PK), safety and tolerability will be assessed.
    

Intervention name(s): Acalabrutinib; Rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single oral dose of acalabrutinib on day 1 as per the arms they are randomized.; Participants will receive twice daily oral dose of 20 mg rabeprazole on days -3, -2, and -1.
Intervention MeSH terms: Acalabrutinib; Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is open-label, randomized, single-dose study. The participants will be divided in 2 treatment arms as follows:
Arm A (only acalabrutinib)
Arm B (acalabrutinib + rabeprazole)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Bioavailability
Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy
Condition: Pregnancy Related
Study type: Interventional

Summary: 
      this study is to investigate the response of pulmonary function to deep breathing exercise in
      twin pregnancy
    

Detailed description: 
      Physiological changes during pregnancy impose numerous changes on the respiratory system that
      can affect the health of both mother and foetus. Regarding the importance of the normal
      breathing in the health of mother and foetus.

      Many investigators have studied pulmonary function tests during normal pregnancy, most of
      them found a significant decrease in pulmonary function test parameters during all pregnancy
      trimesters. Others showed that the PFTs parameters are normal in the first trimester but
      there was significant decrease in them in the second and third trimesters, or in the third
      trimester only.

      Study Design: Randomized control trial Sixty twin pregnant women during the third trimester i
      (27th weeks gestation),aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will
      participate in this study. They will be assigned into two equal groups; control group and
      study group ( study group only will make deep breathing exercise inform of diaphragmatic and
      costal breathing 3times a day for 15 repetitions each exercise for 9 weeks, pulmonary
      function test will be applied for both groups at 27th week gestation and at 36th weeks
      gestation.
    

Intervention name(s): deep breathing exercise inform of diaphragmatic and costal breathing
Intervention type(s): Other
Intervention description(s): deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks,
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Education, Counseling, and Drug Therapy to Reduce Symptoms of Metabolic Syndrome
Condition: Metabolic Syndrome X; Prediabetic State; Insulin Resistance; Obesity; Metabolic Diseases
MeSH terms: Metabolic Syndrome; Insulin Resistance; Metabolic Diseases; Prediabetic State; Syndrome
Study type: Interventional

Summary: 
      This study will determine the effects of a supplement in reducing symptoms of metabolic
      syndrome, a collection of symptoms that increase the risk for developing heart disease,
      stroke, and diabetes.
    

Detailed description: 
      Metabolic syndrome is a serious condition involving abnormal glucose and lipid metabolism and
      obesity; these symptoms are associated with a two- to fourfold increased risk for
      cardiovascular disease and diabetes. The dietary supplement being investigated in this study
      is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing
      energy, and improving insulin function.

      This study will last 12 weeks. Participants will be randomly assigned to one of three arms.
      Participants in Arm 1 will receive the supplement; participants in Arm 2 will have a 50%
      chance of receiving either the supplement or placebo; participants in Arm 3 will receive
      placebo. Participants will take their assigned pills 3 times daily for 12 weeks. A follow-up
      visit will occur at the end of the 12 weeks; there will be a debriefing visit shortly after
      the follow-up visit. Participants in all 3 arms will receive weekly education and counseling
      sessions on healthy lifestyle changes to encourage weight loss. Blood collection will occur
      at study start and at the end of 12 weeks for assessment of fasting blood glucose, insulin,
      cholesterol, and levels of certain hormones. Participants will also be asked to complete
      questionnaires at study entry and at Week 12; the questionnaires will assess depression,
      stress, self-absorption, optimism, food cravings, hunger, the degree to which participants
      seek pleasure from activities, and participants' thoughts about their ability to make
      behavioral changes.
    

Intervention name(s): Dietary supplement for weight loss; Education and counseling for weight loss
Intervention type(s): Drug; Behavioral
Intervention description(s): The dietary supplement being investigated in this study is a natural product designed to reduce metabolic syndrome by decreasing hunger, increasing energy, and improving insulin function.; Hour and a half weight loss education session weekly for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blood Glucose; Cholesterol; Weight Loss; Insulin; Complementary Therapies
Study to Assess the Absorption, Distribution, Metabolism and Excretion of AZD1656 in Type 2 Diabetes Mellitus (T2DM)
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the absorption, distribution, metabolism and
      excretion of AZD1656 after administration of a single oral dose of 14C-labelled AZD1656
      solution in male Type 2 Diabetes Mellitus patients.
    


Intervention name(s): AZD1656
Intervention type(s): Device
Intervention description(s): Oral single dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type II diabetes mellitus; absorption; distribution; metabolism; excretion; 14C-labelled
Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
Condition: Chronic Kidney Disease; Secondary Hyperparathyroidism; Vitamin D Insufficiency
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will investigate how the levels of a repeat dose of CTAP101 changes in the body
      over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances
      (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency
      and secondary hyperparathyroidism (SHPT).
    


Intervention name(s): Cohort 1 CTAP101 Capsules- 60µg; Cohort 1 CTAP101 Capsules - 90µg; Cohort 1 Matching Sugar Capsule; Cohort 2 CTAP101 Capsules - 30µg; Cohort 2 Matching Sugar Capsule
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 60µg of CTAP101 capsules given once daily for 42 days.; 90µg of CTAP101 capsules given once daily for 42 days.; Placebo capsules given once daily for 42 days.; 30µg of CTAP101 capsules given once daily for 42 days.; Placebo capsules given once daily for 42 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parathyroid Diseases; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism, Secondary; Vitamin D; Hyperparathyroidism; Kidney Diseases; Kidney Failure; Renal Insufficiency, Chronic
Use of Platelet-Rich Plasma (PRP) and Platelet-Poor Plasma (PPP) to Prevent Infection and Delayed Wound Healing
Condition: Elective Foot and Ankle Surgery.
MeSH terms: Infections
Study type: Interventional

Summary: 
      The purpose of this study is to see if applying PRP and PPP to surgical sites and the closing
      incision helps prevent infection and slow wound healing.
    

Detailed description: 
      This will be a prospective, randomized study with patients blinded to either receiving
      platelet-rich plasma (PRP) and platelet-poor plasma (PPP) treatment or no treatment. We
      hypothesize that the antimicrobial properties of PRP and barrier properties of PPP (acting
      like a tissue sealant) will serve to inhibit deep incisional surgical site infection and help
      prevent delayed wound healing within 60 days of surgery. Thus, the incidence of infection and
      delayed wound healing will be lower in patients receiving PRP and PPP compared to patients
      who do not receive PRP and PPP. However, due to clinical equipoise, we do not know for
      certain that PRP and PPP is truly effective. The cost of preparing PRP and PPP is
      substantial, and involves a blood draw that would not otherwise be done. Thus, it is
      important to know if this treatment is effective or not.
    

Intervention name(s): PRP and PPP
Intervention type(s): Biological
Intervention description(s): Autogenous PRP and PPP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Infection; delayed wound healing; platelet-rich plasma
Partnership to Improve Nutrition and Adiposity in Prenatal Clinical Care: a Pilot and Feasibility Study
Condition: Pregnancy
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study will pilot and assess feasibility of a prenatal intervention for obese pregnant
      women based on the Diabetes Prevention Program (DPP). Intervention group participants will
      meet with a clinic dietitian for 15 minutes at every prenatal appointment to complete a
      DPP-based curriculum and receive breastfeeding education. Control group participants will
      receive usual prenatal care. Outcomes include reach and dose of the intervention, gestational
      weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks
      postpartum.
    

Detailed description: 
      This study will pilot and test feasibility of a prenatal lifestyle intervention designed to
      limit gestational weight gain and prevent gestational diabetes. The intervention is based on
      the Diabetes Prevention Program lifestyle intervention, will include prenatal breastfeeding
      education and online peer group support, and will be integrated into the participants'
      regular prenatal appointments. Women (n=24) will be enrolled in early pregnancy. After
      baseline assessments (demographics, maternal diet, physical activity, mental health), women
      randomized equally to the intervention or usual care conditions. Further data collection will
      occur at approximately 24 weeks gestation, 36 weeks gestation, and 6 weeks postpartum, and
      clinical data (weight, pregnancy and obstetric complications) will be abstracted from medical
      records at the end of the study. Outcomes include reach and dose of the intervention,
      gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6
      weeks postpartum. The investigators hypothesize that the intervention will reduce gestational
      weight gain, improve maternal dietary intake, increase total energy expenditure, and increase
      breastfeeding exclusivity in the first 6 weeks postpartum.
    

Intervention name(s): Dietary and Lifestyle Counseling
Intervention type(s): Behavioral
Intervention description(s): Dietary and lifestyle education; Peer group support.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Gestational weight gain
HB0034 in Patients With Generalized Pustular Psoriasis (GPP)
Condition: Generalized Pustular Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of
      HB0034 in adult patients with generalized pustular psoriasis (GPP ).
    

Detailed description: 
      This is an open-label, multicenter, phase Ib exploratory study to evaluate the safety,
      tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients presenting
      moderate-severe generalized pustular psoriasis (GPP ) flare.
    

Intervention name(s): HB0034
Intervention type(s): Drug
Intervention description(s): HB0034, a single dose
Other intervention name(s): HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Non-Alcoholic Steatohepatitis (NASH) on the Pharmacokinetics of 99mTechnetium-Mebrofenin
Condition: Non-alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the effect of NASH (non-alcoholic steatohepatitis) on
      the disposition of 99mTechnetium(Tc)-mebrofenin and to relate changes in 99mTc-mebrofenin
      disposition to differences in the bile acid profile and Fibroscan Fibrosis Score of healthy
      subjects compared to patients with NASH.
    

Detailed description: 
      This will be an open-label, clinical study in male and female patients with NASH (n=10) and
      healthy volunteers (n=10) of any race and ethnicity investigating the effect of liver disease
      on the pharmacokinetics of 99mTechnetium-mebrofenin. The use of the gamma emitter 99m Tc-
      labeled mebrofenin will allow real-time assessment of hepatic exposure. To determine the
      differences between healthy subjects and patients with NASH, blood and hepatic concentrations
      will be analyzed by non-compartmental analysis. Additionally, serum bile acid samples and
      fibroscan data will be collected to determine whether the bile acid profile and/or fibroscan
      readings are different between healthy subjects and patients with NASH. Changes in
      99mTc-mebrofenin will be correlated with the patient specific bile acid profile and fibroscan
      data. This study will increase our understating of the effect of liver disease on the
      disposition of medications that undergo transporter-mediated hepatic clearance.
    

Intervention name(s): Technetium Tc 99M Mebrofenin
Intervention type(s): Drug
Intervention description(s): Each subject will be injected with ~2.5 mCi of Technetium Tc 99M Mebrofenin
Other intervention name(s): Choletec
Intervention MeSH terms: Technetium Tc 99m mebrofenin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Gut and Oral Microbiome of GDM Patients During Pregnancy
Condition: Gestational Diabetes; Pregnancy Related
MeSH terms: Diabetes, Gestational
Study type: Observational

Summary: 
      The study aimed to clarify the characteristics of the intestinal and oral microbiome of
      Gestational Diabetes Mellitus(GDM) patients during the whole pregnancy, try to clarify the
      relationship between the microbiome and GDM.
    

Detailed description: 
      The aims of the study are to reveal the possibly natural change of the gut and oral
      microbiome of GDM patients during pregnancy, and to explorer whether GDM happened during
      pregnancy are associated with the maternal gut and oral microbiomes. As a perspective cohort
      study, the researchers will recruit pregnant women in early pregnancy（before 13 gestational
      weeks）and following the pregnancies till delivery. The stool samples and saliva samples of
      the recruits will be collected in 9~14,24~28 and 32~37 gestational weeks separately. The
      investigators will also perform oral examination between 24~28 weeks and sample subgingival
      plaque for test. Overall, all samples will be examined use 16S rRNA gene sequencing to
      analyze microbiome. And part of the samples of GDM patients will be analyzed using
      metagenomics. Combine with the pregnancy outcomes, the differences of gut and oral microbiome
      between GDM patients and healthy women will be expected, as well as the natural change during
      pregnancy.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        pregnant women who can ensure a regular prenatal check in the PUMCH OB clinic.
      
Biospecimen description: 
      stool samples were collected from objects in 3 time points：the first trimester(9-14
      gestational weeks), the second trimester(24-28 gestational weeks) and the third
      trimester(32-37 gestational weeks). All the samples were collected at home by the
      participants using a PSP Spin Stool DNA kit, and the genomic DNA was extracted. The
      researchers only amplified the hypervariable V4 region of the bacterial 16S rRNA genes.
    
Keywords: Gastrointestinal Microbiome; pregnancy; gestational diabetes mellitus