bioihbjkbjnl/mcl2 huggingface dataset:
3D Maternal Fetal Bonding
Condition: Maternal-Fetal Relations; Paternal Behavior; Maternal Behavior
Study type: Interventional

Summary: 
      To determine whether 3D models of fetus' face created from 3D ultrasound will increase
      maternal and paternal attachment, lower stress, anxiety and depression and have improved
      life-style choices during pregnancy. Half of participants will receive 3D model and half will
      receive a picture of 3D ultrasound of their baby.
    


Intervention name(s): 3D printed model; Placebo
Intervention type(s): Other; Other
Intervention description(s): Mother or Mother/Father is given 3D printed model of fetus' face; Mother or Mother/Father is given a picture of 3D ultrasound of fetus
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3D ultrasound and picture of ultrasound or 3D ultrasound and printed model of fetal face
Masking: None (Open Label)
Primary purpose: Health Services Research
Dose Response Bioavailability of Coffee and Green Tea Antioxidants in Humans
Condition: Healthy
Study type: Interventional

Summary: 
      Coffee and green tea are 2 widely consumed beverages. Both contain polyphenol antioxidant
      compounds (chlorogenic acids for coffee and catechins for tea). The bioavailability of
      catechins is somewhat known and has been referenced in the literature. However,
      bioavailability data from tea infusion is non-existent, even though it reflects better how
      consumers drink this beverage. In addition, bioavailability of coffee chlorogenic acids is
      less understood and no dose response study has been reported so far in the literature. Thus,
      there is a great need to understand and reinforce our knowledge on the bioavailability of
      coffee and tea polyphenol compounds.
    


Intervention name(s): Green tea; Coffee
Intervention type(s): Other; Other
Intervention description(s): Infusion (tea bags) from commercially available green tea; Soluble coffee commercially available
Other intervention name(s): Soluble coffee
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
A Prospective Study of Patients With Hypoplastic Left Heart Syndrome (HLHS) Following Stage II Surgical Palliation
Condition: Hypoplastic Left Heart Syndrome
MeSH terms: Hypoplastic Left Heart Syndrome; Syndrome
Study type: Observational

Summary: 
      Hypoplastic left heart syndrome (HLHS) is a severe form of congenital heart disease that
      consists of multiple obstructions to flow through the left heart and aorta, as well as
      hypoplasia of the left ventricle. Most patients require a three-stage surgical protocol
      starting within days of birth. Stage I of this process is the Norwood reconstruction (within
      the first few days of life), Stage II (usually required within 3-8 months) involves creation
      of a direct connection between the patient's superior vena cava and the pulmonary arterial
      confluence (bidirectional Glenn anastomosis), and the last stage is creation of a Fontan
      circulation (typically within the first 2-4 years). This "single ventricle" approach requires
      the right ventricle to perform as the only circulatory pump for the entire body.

      Our long-term goal is to develop regenerative strategies to strengthen and augment the right
      ventricular muscle of the single-ventricle heart following surgical palliation in HLHS
      patients. To determine the safety and feasibility of a cell-based therapeutic intervention at
      the Stage II surgery, we aim to document the natural history of post-surgical care in HLHS
      patients having undergone standard of care with protocol specific follow-up over the course
      of a 6-month period.

      This prospective study will document the natural history in patients with HLHS after planned
      Stage II surgical palliation with a focus on cardiovascular parameters within 6 months
      following surgery in 10 patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with HLHS up to 18 months of age requiring a planned Stage II bi-directional Glenn
        surgery
      
Keywords: Hypoplastic Left Heart Syndrome; Stage II palliative surgery; Glenn procedure; Congenital heart defect; Congenital heart disease; Underdeveloped left ventricle
Compare the Efficacy and Safety of Surfolase CR Tablet With Surfolase Capsule in Patients With Acute Bronchitis
Condition: Acute Bronchitis
MeSH terms: Bronchitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Compare the efficacy and safety of surfolase CR tablet with surfolate capsule in patients
      with acute bronchitis
    


Intervention name(s): Acebrophylline
Intervention type(s): Drug
Intervention MeSH terms: Ambroxol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Clinical Trial to Study the Effects GRC 17536 in Patients With Painful Diabetic Peripheral Neuropathy (Painful Extremities Due to Peripheral Nerve Damage in Diabetic Patients).
Condition: Painful Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent
      injury to peripheral nerves that has major implications on quality of life (QOL), morbidity,
      and costs from a public health perspective. Painful diabetic neuropathy affects approximately
      16% of patients with diabetes. Pharmacological agents used in the management of painful DPN
      mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake
      inhibitors, opioid, and anti epileptic drugs. The available treatment options do not give
      total relief, are not effective in all patients, and only about one-third of patients may
      achieve more than 50% pain relief. Hence newer therapies are required for the treatment of
      DPN. The primary outcome measures will be the change from baseline to end of treatment in the
      mean 24-hour average pain intensity.
    


Intervention name(s): GRC 17356; Matching Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetic neuropathy
Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Chronic Kidney Disease
Condition: Chronic Kidney Disease; Stable Angina
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Angina, Stable
Study type: Interventional
Phase: Phase 4

Summary: 
      Impaired renal function is associated with reduced responsiveness to clopidogrel. There are
      no studies which have shown a means by which to overcome platelet hyporesponsiveness in
      patients with chronic kidney disease (CKD). The purpose of this study was to determine the
      functional impact of cilostazol in patients with CKD undergoing hemodialysis.
    

Detailed description: 
      The aims of this study is to evaluate the effects of platelet responsiveness to clopidogrel
      or cilostazol in CKD patients undergoing hemodialysis. The differences in platelet activation
      markers are also evaluated before and after clopidogrel or cilostazol administration. The
      investigators will perform a prospective, randomized study to compare the degree of platelet
      inhibition and platelet activation markers by adjunctive cilostazol (100 mg twice daily)
      compared to clopidogrel (75 or 150 mg/day) in CKD patients undergoing hemodialysis.
    

Intervention name(s): Clopidogrel, cilostazol
Intervention type(s): Drug
Intervention description(s): Patients with CKD received clopidogrel (75 mg/day)for 14 days Patients with CKD received clopidogrel (150 mg/day)for 14 days Patients with CKD received clopidogrel (75 mg/day)and cilostazol (100 mg twice daily)for 14 days 75mg clopidogrel in patients with normal kidney function for 14 days
Other intervention name(s): Plavix; pletaal
Intervention MeSH terms: Cilostazol; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: platelet; cilostazol; clopidogrel; chronic kidney disease
Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate
Condition: Thermoregulation Impairment
Study type: Observational

Summary: 
      The aim of the study is to investigate whether treatment with glucocorticoids leads to a
      change in heat production of the human body at mild cold conditions.
    

Detailed description: 
      Brown adipose tissue (BAT) is a thermogenic tissue that can convert chemical energy directly
      into heat due to the expression of uncoupling protein 1 (UCP1) protein. Data from preclinical
      studies shows that glucocorticoids (GCs) inhibit the function of BAT. In clinical practice
      GCs are often administered due tue their antiinflammatory properties making the investigation
      of short term (e.g. one week) and long therm (several months) effects practically relevant.
      This study's objective is to evaluate the effect of glucocorticoid treatment on cold induced
      thermogenesis (CIT) in humans.
    

Intervention name(s): Indirect calorimetry; Skin Temperature; Dual energy X-ray Absorptiometry (DXA); Blood Sampling; FDG-PET; Capillary glucose; Biopsy of supraclavicular adipose tissue (optional)
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Resting energy expenditure; Temperature: supraclavicular, infraclavicular, abdominal, mid-thigh, non-dominant lower arm, middle finger tip, left lower leg, left dorsal foot, ear thermometer; Body composition; thyroid-stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), HbA1c, Fibroblast growth factor 21 (FGF21); Dynamic PET scanning of the neck-region; Prior to fluorodeoxyglucose (FDG)-PET in order to avoid hyperglycemia; Ultrasound guided biopsy of the supraclavicular adipose tissue
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients will be recruited via the outpatient clinics (endocrinology, rheumathology,
        ophthalmology, gastroenterology etc.) of the Basel University Hospital.
      
Biospecimen description: 
      Serum and plasma Optional biopsy of supraclavicular BAT
    
Keywords: Glucocorticoids; Brown Adipose tissue; Cold Induced Thermogenesis; Resting Metabolic Rate
Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines
      are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and
      tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical
      trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).
    


Intervention name(s): Surface antigen inactivated influenza vaccine
Intervention type(s): Biological
Intervention description(s): 1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza vaccine
Study to Investigate Relative Bioavailability of up to Five Different Formulations of AZD5069
Condition: Uncontrolled and Persistent Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate relative bioavailability of up to five different formulations of AZD5069
    

Detailed description: 
      An Open-label, Single Centre Relative Bioavailability Study With an Adaptive Design Comparing
      up to 5 Solid Oral AZD5069 Formulations After Single Dose Administration to Healthy
      Volunteers
    

Intervention name(s): Phase IIb formulation; Putative phase III formulation; Slow dissolution variant 1; Slow dissolution variant 2; Test treatment E
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose 45mg AZD5069; Single oral dose 45mg AZD5069; Single oral dose 45mg AZD5069; Single oral dose 45mg AZD 5069; Tablet formulation E, 45 mg (intermediate dissolution variant) of AZD5069
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Relative bioavailability, Healthy volunteers, Neutrophils
A Study Comparing Different Formulations of LY3410738 in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of study is to compare different formulations of LY3410738 under fasting
      condition by looking at the amount of the study drug, LY3410738, that gets into the blood
      stream and how long it takes the body to get rid of it when given in healthy adult
      participants. The study will also access the effect of standard low-fat meal and esomeprazole
      (Proton Pump Inhibitor) on LY3410738. Safety and tolerability of LY3410738 will also be
      evaluated. For each participant, the total duration of the study will be 56 days for Groups 1
      and 2 and up to 61 days for Groups 3 and 4, including screening.
    


Intervention name(s): LY3410738; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Groups 1 and 2 have a randomized, 2-way crossover design and Groups 3 and 4 have a fixed-sequence design.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Formulation, food effect, proton pump inhibitor
Tranexamic Acid in Preventing Postpartum Hemorrhage in High Risk Pregnancies During Elective Cesarean Section
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      postpartum hemorrhage (PPT) represents one of the major causes of maternal mortality .
      Tranexamic acid is used in many studies in management of PPH in combination with ecobolics.
      this study aims to evaluate the possible value of the use of tranexamic acid in prevention of
      postpartum hemorrhage .
    


Intervention name(s): Tranexamic Acid
Intervention type(s): Drug
Intervention description(s): Tranexamic acid (Kepron, Amoun, Egypt) was given slowly intravenously over 10 minutes just before the skin incision of elective cesarean section to group A. Tranexamic acid injection was prepared by diluting 1g (10 mL) tranexamic acid into 20 ml of 5% glucose.
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: tranexamic acid
Effect of Bright Light on Sex Hormones and Ovulation in Humans
Condition: Anovulation
MeSH terms: Anovulation
Study type: Interventional

Summary: 
      The study investigated whether bright artificial light may influence menstrual cycle and
      ovulation conclusively, and what underlying hormonal changes for this effect are.
    

Detailed description: 
      Several studies have shown a shortening of the menstrual cycle following light therapy in
      women with abnormally long menstrual cycles or with winter depression, which suggests that
      bright light may influence sex hormones and ovulation. The study was designed to investigate
      this possibility. Twenty-two women with slightly lengthened menstrual cycles and without
      clinically evident endocrine abnormalities completed a study lasting for two menstrual cycles
      separated by an off-protocol episode of at least 1 menstrual cycle. Bright light therapy was
      administered for a week at home during one experimental cycle, and dim light during another
      cycle (placebo-controlled, crossover, counter-balanced order). Daytime blood sampling and
      ultrasound scan were performed before and after a week of light therapy, on the ~7th and 14th
      days after menstruation onset. Ultrasound examination was repeated further to document
      ovulation. Serum was assayed for thyroid-stimulating hormone, prolactin, luteinizing hormone,
      follicle-stimulating hormone, and estradiol. The preliminary results were reported at the
      SLTBR meeting in June, 2005.
    

Intervention name(s): Light therapy
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Menstrual Cycle; Light Therapy; Sex Hormones; Ovulation
Effect of Nap on Daytime Functioning in Primary School Students
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      Previous studies showed that insufficient sleep has a negative impact on children's physical
      and psychological health. Napping was found to decrease sleepiness and improve daytime
      functioning in adults and adolescents. The effects of napping on children, however, is
      unknown. The current study aims to test the effects of short daytime classroom naps on
      daytime functioning and behaviour in elementary school children.
    

Detailed description: 
      This study is an interventional study testing the effects of short daytime nap on children's
      cognitive functioning and daytime behaviour. Primary school children will be randomised to
      either experimental (nap) or control group (no nap) by class. Measurements include
      parent-report questionnaires, children's self-report questionnaires, and cognitive tasks.
    

Intervention name(s): Nap
Intervention type(s): Behavioral
Intervention description(s): Participants will be given 20-min nap opportunity in the classroom on a daily basis during school-days.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental group (with daytime classroom nap) versus control group (without nap)
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: primary school children; nap; sleep deprivation
Effect of Probiotics on Periodontitis Stage III Grade C Molar-incisor Pattern
Condition: Periodontal Diseases
MeSH terms: Periodontitis; Periodontal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      the research highlight the effectiveness of probiotics as adjuncts to SRP in the treatment of
      periodontitis stage III grade C molar-incisor pattern
    

Detailed description: 
      Background data : Periodontitis is a common disease that represents a public health problem.
      Aggregatibacter actinomycetemcomitans (A. a ) especially the JP2 genotype plays a major role
      in the pathogenesis of periodontitis. The aim of this study is to evaluate the effect of
      topically applied probiotics on the management of periodontitis stage III grade C
      molar-incisor pattern.

      Methods: Sixty-five patients having periodontitis stage III grade C molar-incisor pattern.
      Screening for A. actinomycetemcomians (A.a) and the JP2 genotype was done using conventional
      polymerase chain reaction (PCR). Patients positive for (A. a) were randomly divided into two
      groups. Group I: received conventional periodontal treatment combined with topically applied
      probiotic, while Group II: received conventional periodontal treatment only. Both groups were
      evaluated microbiologically and clinically. Quantitative assessment of A. a levels was done
      by real time PCR (qPCR) at baseline as well as one week, 4 weeks, and 12 weeks after
      treatment. Clinical parameters were assessed before treatment as well as 3,6 and 9 months
      after treatment.
    

Intervention name(s): Probiotic Formula; placebo formula
Intervention type(s): Drug; Drug
Intervention description(s): intra-pocket formula (local delivery drug); intra-pocket formula (local delivery drug)
Other intervention name(s): A mixture of Lactobacillus brevis and Lactobacillus plantarum; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sixty-five patients having periodontitis stage III grade C molar-incisor pattern. Screening for A. actinomycetemcomians (A.a) and the JP2 genotype was done using conventional polymerase chain reaction (PCR). Patients positive for (A. a) were randomly divided into two groups. Group I: received conventional periodontal treatment combined with topically applied probiotic, while Group II: received conventional periodontal treatment only. Both groups were evaluated microbiologically and clinically.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Periodontitis; Agg. actinomycetemcomitans; JP2 genotype; PCR; local delivery drug; probiotics
A Phase 1 Dose Escalation and Expanded Cohort Study of EPZ-5676 in the Treatment of Pediatric Patients With Relapsed/Refractory Leukemias Bearing a Rearrangement of the MLL Gene
Condition: Leukemia; Acute Myeloid Leukemia; Acute Lymphocytic Leukemia; Acute Leukemias
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      A subset of patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL)
      harbor rearrangements of the MLL gene, which are detected either by cytogenetic or
      fluorescent in situ hybridization evaluation at the time of diagnosis. A protein called DOT1L
      plays an important role in the malignant process in these leukemias. EPZ-5676 is a molecule
      that blocks the activity of DOT1L, and is therefore being evaluated in the treatment of
      patients with MLL-rearranged leukemias.
    

Detailed description: 
      This is a Phase 1b study of EPZ-5676 in pediatric patients. The study will have two phases.
      The first phase will assess escalating doses of EPZ-5676 in order to determine the maximally
      tolerated dose (MTD) or recommended phase 2 dose (RP2D) of EPZ-5676 as a 28-day continuous IV
      infusion. Once the MTD and/or RP2D is established, a second phase of the study will further
      evaluate the safety of EPZ-5676 and assess the anti-leukemia activity.
    

Intervention name(s): EPZ-5676
Intervention type(s): Drug
Intervention description(s): 28-day continuous IV infusion of each 28-day cycle, given until disease progression or unacceptable toxicity develops.
Other intervention name(s): EPZ5676; DOT1L
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leukemia; Advanced hematologic malignancies; Epizyme; Phase 1b; MLL gene; 11q23; Ambiguous lineage; ALL; AML; Acute leukemias; MLL-r