bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Learn More About the Safety and the Blood Level of BAY1747846 Given as Injection Into the Vein at Increasing Single Doses in Chinese Healthy Male Participants
Condition: Contrast Enhancement in Magnetic Resonance Imaging; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical study was to learn more about BAY1747846 compared to placebo when
      given as an injection into the vein in Chinese healthy male participants:

        -  the safety of BAY1747846 when given at increasing single doses

        -  the level of BAY1747846 in the blood over time when given at increasing single doses.

      To answer the first question, the researchers compared the number and severity of medical
      problems the Chinese participants had after receiving BAY1747846 at increasing doses and
      placebo respectively. Doctors kept tracking of all medical problems that happened in the
      study, even if they did not think they might be related to the study treatments.

      To answer the second question, the researchers determined:

        -  the (average) total level of BAY1747846 in the blood, also called AUC

        -  the (average) highest level of BAY1747846 in the blood, also called Cmax

        -  how BAY1747846 is removed from the blood, also called clearance (CL).
    


Intervention name(s): Gadoquatrane (BAY1747846) 0.03 mmol Gd/kg; Gadoquatrane (BAY1747846) 0.1 mmol Gd/kg; Matching placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.03 mmol Gd/kg by intravenous injection (at 2 mL/s); 0.1 mmol Gd/kg by intravenous injection (at 2 mL/s); 0.9% sodium chloride by intravenous injection (at 2 mL/s)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel-group, consecutive cohort, escalating single-dose study design
Masking: Single (Participant)
Primary purpose: Other
Keywords: Safety; Pharmacokinetics
A Study to Evaluate the Photoallergic Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study is designed to determine the photoallergic potential of PEP005 Gel, 0.01%
      and it's vehicle on normal skin.
    


Intervention name(s): PEP005 (ingenol mebutate) Gel
Intervention type(s): Drug
Intervention description(s): PEP005 (ingenol mebutate) Gel, 0.01%
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peplin; PEP005
Study of the Pharmacokinetics and Pharmacodynamics of Crystalline PX-866 Tablets and Amorphous PX-866 Capsules in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two part study designed to evaluate the PK profile of PX-866 capsules versus
      tablets, and to evaluate the effect of food on the PK of PX-866 tablets only in healthy
      volunteers.
    

Detailed description: 
      This is a two part, Phase 1, open label, cross over study designed to evaluate the PK profile
      of crystalline PX-866 tablets relative to that of amorphous PX-866 capsules and to evaluate
      the effect of administration with food on the PK of crystalline PX-866 tablets in healthy
      volunteers.
    

Intervention name(s): PX-866
Intervention type(s): Drug
Intervention description(s): Volunteers in part 1 of the study will receive two single dose 8 mg treatments of PX-866 (one each of crystalline PX-866 tablets and amorphous PX-866 capsules) in Periods A and B, separated by at least seven days. Volunteers in part 2 of the study will receive two single dose 6 mg treatments of PX-866 (crystalline PX-866 tablets administered in either fed or fasted state), in Periods C and D, separated by at least seven days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteer; PX-866; PI3K Inhibitor
Antihypertensive Effect of Fermented Milk With Lactococcus Lactis on Prehypertensive Subjects
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The objective of the present work was to evaluate the antihypertensive effect associated with
      the consumption of fermented milk with Lactococcus lactis NRRL-B50571 on prehypertensive
      subjects.
    

Detailed description: 
      A double-blind randomized controlled clinical study of an 8-week intervention with 36
      hypertensive subjects was carried out to evaluate the antihypertensive effect of fermented
      milk with Lactococcus lactis NRRL-B50571. Once obtained the informed consent; volunteers were
      randomized into two groups (n=18) to either receive 150 mL daily: fermented milk with
      Lactococcus lactis NRRL-B50571 (intervention group) or artificially acidified milk as control
      (placebo). Both drinks were consumed daily. Participants were asked not to change their diet
      or lifestyle during the intervention. We applied intention to treat for those participants
      who did not have good adherence and those who withdraw the study. The outcomes between groups
      were analyzed using an independent sample Student t test, with a P value of 0.05 or less (two
      sided) when there was statistical significance; using statistical software.
    

Intervention name(s): Fermented milk; Acidified milk
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571; 150 mL daily of artificially acidified milk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; Fermented Milk; Clinical Study; Randomized; Double-blind
A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Self-Administered Subcutaneously (SC) by Healthy Subjects
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, parallel-group, open-label, single-dose study of belimumab in
      healthy subjects to estimate the relative bioavailability, tolerability and safety of a
      single dose of belimumab 200 milligram (mg) when self-administered SC by healthy subjects
      using a prefilled syringe or autoinjector. This study will also assess the usability and
      reliability of the injection devices. A total of approximately 80 subjects (40 per group)
      will be randomly assigned in a 1 to 1 ratio to receive 200 mg belimumab SC as a single 1.0
      milliliter (mL) injection of the liquid formulation (200 mg/mL) on Day 0 via the assigned
      injection device. Subjects will continue to be followed for 70 days after the administration
      of belimumab.
    


Intervention name(s): Belimumab 200 mg/mL
Intervention type(s): Drug
Intervention description(s): Clear to opalescent, colorless to pale yellow sterile solution sterile solution for SC injection in a single-use liquid formulation of Belimumab 200 mg/mL will be supplied in 1mL long glass prefilled syringe or autoinjector device.
Intervention MeSH terms: Belimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Phase 1; Healthy Subjects; Comparability; Belimumab
Preoperative Educational Videos on Maternal Stress Whose Children Received Congenital Heart Disease Surgery: During COVID-19 Panic
Condition: COVID-19; Educational Videos; Maternal; Uncertainty; Anxiety; Depression; Congenital Heart Disease; Children
MeSH terms: COVID-19; Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      During COVID-19 panic, we examined if educational digital video disk can reduce maternal
      uncertainty, anxiety and depression if their children undergo congenital heart disease
      surgery and when surgical or post-surgical complications occur. Compared to only routine
      education, adding digital video disk could decrease mothers' uncertainty and anxiety more
      after education, and until the day of discharge. Compared to only routine education, adding
      digital video disk could decrease mothers' uncertainty and anxiety more on the discharge day
      if their child had surgical or post-surgical complications.
    

Detailed description: 
      Aims and objectives: During COVID-19 panic, we examined if educational digital video disk can
      reduce maternal uncertainty, anxiety and depression if their children undergo congenital
      heart disease surgery and when surgical or post-surgical complications occur.

      Background: Mothers experience uncertainty, anxiety and depression if their children undergo
      conditions mentioned above. Such stress would be more during COVID-19 panic. Design: A
      randomized control-group pretest-posttest design. The CONSORT checklist is used. Methods:
      During COVID-19 panic, in a teaching hospital, 120 mothers whose children underwent first
      elective surgery for congenital heart disease were randomly divided into group 1: 60 mothers
      receiving routine education plus digital video disk before surgery; and group 2: 60 mothers
      receiving routine education. Between groups, mothers' uncertainty, anxiety and depression
      levels were compared (1) before education, (2) after education (before surgery) and (3) on
      the discharge day. Among mothers whose children had surgical or post-surgical complications,
      the effect of watching the digital video disk on uncertainty, anxiety and depression at
      discharge day was evaluated.
    

Intervention name(s): Preoperative educational videos plus routine education; Preoperative routine education
Intervention type(s): Other; Other
Intervention description(s): Mothers receiving routine education plus digital video disk before their children receiving congenital heart disease surgery. The content was the same as the routine education but was presented audio-visually, and the video was easy to understand by the general public.; Mothers receiving routine education before their children receiving congenital heart disease surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants
Condition: No Evidence of Disease; Prostate Carcinoma
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized phase I trial studies the side effects and the best dose of
      Se-methyl-seleno-L-cysteine or selenomethionine in preventing prostate cancer in healthy
      participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The
      use of Se-methyl-seleno-L-cysteine or selenomethionine, two different types of selenium
      compounds, may prevent prostate cancer from forming.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the individual toxicity profiles of Se-methyl-seleno-L-cysteine (methyl
      selenocysteine; MSC) and selenomethionine (SeMet) administered to cohorts of men daily for
      twelve weeks, with dose escalation with each successive cohort.

      SECONDARY OBJECTIVES:

      I. To measure the pharmacokinetics of selenium, according to form (MSC vs SeMet): MSC and
      SeMet impacts on plasma, albumin, and urinary concentrations of selenium over 48 hours on
      dosing days 1 and 84.

      II. To evaluate the pharmacodynamics of selenium by form (MSC vs SeMet): plasma, albumin, and
      urinary Selenoprotein P (Sepp1) concentrations and glutathione peroxidase (GPx) activity over
      48 hours on dosing days 1 and 84.

      III. To store plasma and formed elements (red cells plus platelets) for future analysis of
      methyl selenol and other key selenium species, when those assays become available.

      OUTLINE: This is a dose-escalation study. Participants are randomized to 1 of 3 treatment
      arms.

      ARM I: Participants receive Se-methyl-seleno-L-cysteine orally (PO) on days 1-84.

      ARM II: Participants receive selenomethionine PO on days 1-84.

      ARM III: Participants receive placebo PO on days 1-84.

      After completion of study treatment, patients are followed up on day 112.
    

Intervention name(s): Selenium; Placebo; Laboratory Biomarker Analysis; Pharmacological Study; Methylselenocysteine
Intervention type(s): Dietary Supplement; Other; Other; Other; Drug
Intervention description(s): Given PO; Given PO; Correlative studies; Correlative studies; Given PO
Other intervention name(s): Se; PLCB; pharmacological studies; L-Se-Methylselenocysteine; Methylselenocycteine; MSC; Se-Methyl-seleno-L-cysteine; SeMSC
Intervention MeSH terms: Selenium; Selenomethylselenocysteine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Electroacupuncture as an Adjunct to Non-Surgical Periodontal Therapy
Condition: Periodontal Diseases; Periodontal Inflammation; Periodontitis; Acupuncture; Electroacupuncture; Periodontal Pocket
MeSH terms: Periodontitis; Periodontal Diseases; Periodontal Pocket; Inflammation
Study type: Interventional

Summary: 
      The aim of this randomized, single-masked, controlled clinical trial study was to determine
      if the administration of electro acupuncture improves the outcomes obtained in combination
      with non-surgical periodontal therapy.

      Participants will get non-surgical periodontal therap with/without electro acupuncture.

      Researchers will compare EA and control groups to see if there is any relationship between
      acupuncture application clinical periodontal parameters,serum and saliva cytokine levels.
    

Detailed description: 
      Periodontitis is a prevalent complex chronic inflammatory oral disease that can result in the
      progressive destruction of tooth supporting tissues and eventual loss of teeth. Although
      pathogenic bacteria are the triggers and provokers of periodontal inflammation, the main
      determinant of the destruction is the host immunoinflammatory response. The host response is
      modified by many genetic and environmental factors as well as various systemic diseases.

      Electroacupuncture (EA) has effects on both the immune system and inflammatory processes. The
      effect of acupuncture on the regulation of cytokine production has been mentioned in the
      literature. .

      No study has been found in the literature about the effects of EA on the host modulation in
      periodontitis patients. In this study, the investigators aimed to examine the effect of
      electroacupuncture application on the host modulation at periodontitis.
    

Intervention name(s): Electroacupuncture
Intervention type(s): Procedure
Intervention description(s): LI-4, LI-11, GV-14, GV-20 acupuncture points were needled bilaterally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontitis; Acupuncture; Electroacupuncture; IL-6; IL-10; TNF-α; Cytokine; non-surgical periodontal therapy
A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, multicenter, randomized, controlled, open-label trial of the safety and
      efficacy of Nutropin AQ administered subcutaneously (SC) daily in prepubertal children with
      CF and growth restriction.
    


Intervention name(s): Nutropin AQ [somatropin (DNA origin) injection]
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: Growth restriction in children with cystic fibrosis
Single Doses of ZP4207 Adm. sc to Hypoglycemic TD1 pt. to Describe the PK and PD of ZP4207 as Comp. to Marketed Glucagon
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial is a single-centre, randomized, double-blind, parallel trial in Group 1 and
      cross-over trial in Groups 2-4 with single doses of ZP4207 administered s.c. to hypoglycemic
      Type 1 diabetic patients to evaluate the pharmacokinetics and pharmacodynamics of ZP4207 as
      compared to marketed glucagon.
    


Intervention name(s): ZP4207; GlucaGen
Intervention type(s): Drug; Drug
Intervention description(s): Parallel trial in Group 1 and cross-over trial in Groups 2-4 with single doses of ZP4207 administered s.c. to hypoglycemic Type 1 diabetic patients; Parallel trial in Group 1 and cross-over trial in Groups 2-4 with single doses of GlucaGen administered s.c. to hypoglycemic Type 1 diabetic patients
Other intervention name(s): analogue af human glucagon; glucagon
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is in two stages:

      Stage 1 purpose is to assess safety, tolerability, and efficacy of multiple TAB08 doses in
      patients with active Rheumatoid Arthritis in which methotrexate (MTX) treatment is not enough
      effective.

      Stage 2 purpose is to assess efficacy parameters (ACR criteria) of at least one selected
      TAB08 dose in extended patient population with active Rheumatoid Arthritis in which
      methotrexate (MTX) treatment with at least 10 mg/week is not enough effective.
    

Detailed description: 
      Stage 1 is designed as standard phase 1 study with one arm and sequential dose cohorts with
      ascending doses. Each patient in each dose cohort will be administered TAB08 several times.
      After last TAB08 administration each patient will undergo investigational-treatment-free
      follow-up period.

      At Stage 2 at least one TAB08 dose, selected during Stage 1 will be studied during longer
      timeframe in extended patient population.
    

Intervention name(s): TAB08
Intervention type(s): Drug
Intervention description(s): Weekly intravenous administration in escalating doses.
Other intervention name(s): Theralizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pain Control in Hip Arthroscopy: Comparing Lumbar Plexus Versus Peri-capsular Injection
Condition: Nerve Block; Hip Arthroscopy
Study type: Interventional

Summary: 
      Comparison of lumbar plexus nerve block versus pericapsular injection for pain control during
      hip arthroscopy
    

Detailed description: 
      The purpose of this study is to compare two different methods of pain control during and
      after hip arthroscopy surgery. It is not clear which of many different pain control methods
      are ideal to reduce pain for patients; consequently, the investigators are performing this
      study to compare the two main choices for pain control commonly used in order to identify if
      either is superior to the other.
    

Intervention name(s): Lumbar Plexus BLock; Pericapsular injection
Intervention type(s): Procedure; Procedure
Intervention description(s): Peripheral nerve block; Injection around the area undergoing surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial
Condition: Premature; Infant, Light-for-dates
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      To test the hypothesis that progressive feeding without minimal enteral feeding (MEF)
      compared to progressive feeding preceded by a 4-day course of MEF will result in an increased
      number of days alive on full enteral feeding in the first 28 days after birth in extremely
      preterm infants receiving human milk.
    

Detailed description: 
      Qualifying participants will be randomly assigned to one of two study groups: 1) Early
      progressive feeding without MEF or 2) Progressive feedings preceded by 4 days of MEF.
      Regardless of study group assignment, donor human milk will be offered if not enough of the
      mother's expressed breastmilk during the intervention phase of the trial.

      Intervention group: Progressive feeding of 20-24 ml/kg/d on day 1 of feeding, followed by
      daily increments of 24-25 ml/kg/d as tolerated until full enteral feeding achieved.

      Control group: MEF with feeding volumes of 20-24 ml/kg/d for 4 days followed by progressive
      feeding (daily increments of 24-25 ml/kg/d) as tolerated until full enteral feeding achieved.

      Both groups will receive fast progressive feeding (>/= 24 ml/kg/day)

      If parent agrees, stool "dirty" diapers will be collected 5 times (at birth, 1, 2, 3 and 4
      weeks of life).
    

Intervention name(s): Progressive Feeding without MEF; Progressive Feeding with MEF
Intervention type(s): Other; Other
Intervention description(s): This group will receive feeding volumes of 20-24ml/kg/d of day 1 of feeding followed by the study intervention of daily volume increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.; This group will receive minimal enteral feeds (MEF) with volumes of 20-24ml/kg/d for 4 days followed by daily increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: premature infant; early progressive feeding
Oligosecretary Myeloma: Prevalence and Its Clinical Significance
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Observational

Summary: 
      In this study, the investigators aim to investigate the prevalence and clinical course of
      oligosecretary myeloma.
    

Detailed description: 
      Oligosecretary myeloma is a subgroup of multiple myeloma (MM) characterized by low levels of
      serum and urine monoclonal (M) protein below thresholds of measurable disease (a serum M
      protein ≥ 1g/dL, a urine M protein ≥ 200mg/day). Patients with oligosecretary myeloma do not
      have established methods for disease monitoring and clinical informations regarding
      oligosecretary myeloma are still largely unknown.

      In this study, we aimed to investigate the prevalence and clinical course of oligosecretary
      myeloma.
    

Intervention name(s): oligosecretary
Intervention type(s): Other
Intervention description(s): not abvailable
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        a subgroup of multiple myeloma (MM) characterized by low levels of serum and urine
        monoclonal (M) protein below thresholds of measurable disease (a serum M protein ≥ 1g/dL, a
        urine M protein ≥ 200mg/day)
      
Keywords: oligosecretary multiple myeloma