bioihbjkbjnl/mcl2 huggingface dataset:
A 2-part Study to Assess Local Tolerability, Safety and Pharmacokinetics of Ceftaroline in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of
      Ceftaroline 600 mg when administered by varying infusion volumes.
    

Detailed description: 
      A Phase I, Single-center, 2-part, Randomized, 2-way Crossover Study to Assess the Local
      Tolerability and Safety (Multiple-dose) and to Assess the Pharmacokinetics, Safety, and
      Tolerability (Single-dose) of Ceftaroline in Healthy Subjects when Ceftaroline Fosamil is
      Diluted in Various Infusion Volume
    

Intervention name(s): 600 mg ceftaroline fosamil in 50 ml infusion volume; Placebo in 50 ml infusion volume; 600 ceftaroline fosamil in 250 ml infusion volume; Placebo in 250 ml infusion volume; 600 mg ceftaroline in 100 ml infusion volume; Placebo in 100 ml infusion volume
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): IV infusion; IV infusion; IV infusion; IV infusion; IV infusion; IV infusion
Intervention MeSH terms: Ceftaroline fosamil; Cephalosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; healthy volunteers; cross-over study; ceftaroline fosamil; various infusion volumes; local tolerability; Cmax; tmax; AUC
The Pharmacokinetics and Pharmacodynamics Between HR011408 and NovoRapid® in Healthy Subject
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to compare the pharmacokinetics and pharmacodynamics between
      HR011408 and NovoRapid® in healthy subject.
    


Intervention name(s): HR011408 injection; NovoRapid®; NovoRapid®；HR011408 injection; HR011408 injection; NovoRapid®; NovoRapid®；HR011408 injection; HR011408 injection; NovoRapid®; HR011408 injection; NovoRapid®
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): HR011408 injection, administered subcutaneously in dose 1. NovoRapid®, administered subcutaneously in dose 1.; NovoRapid®, administered subcutaneously in dose 1. HR011408 injection, administered subcutaneously in dose 1.; HR011408 injection, administered subcutaneously in dose 2. NovoRapid®, administered subcutaneously in dose 2.; NovoRapid®, administered subcutaneously in dose 2. HR011408 injection, administered subcutaneously in dose 2.; HR011408 injection, administered subcutaneously in dose 3. NovoRapid®, administered subcutaneously in dose 3.; NovoRapid®, administered subcutaneously in dose 3. HR011408 injection, administered subcutaneously in dose 3.
Intervention MeSH terms: Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assigned to HR011408 or NovoRapid®
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Reproductive Outcomes After a Previous Episode of Tubal Ectopic Pregnancy in Patients Managed Expectantly and Surgically
Condition: Ectopic Pregnancy
MeSH terms: Pregnancy, Ectopic; Pregnancy, Tubal; Cardiac Complexes, Premature
Study type: Observational

Summary: 
      Although ectopic pregnancy was considered a leading cause of first-trimester maternal
      mortalities, current technological improvements allowed early diagnosis and opened a door for
      applying less invasive approaches. A tubal pregnancy could be managed either expectantly,
      medically, or surgically. The expectant management of ectopic pregnancy relies on the fact
      that a considerable proportion of ectopic gestations terminate by spontaneous tubal abortion.
      This approach is usually kept for stable cases with a small gestational sac and low
      beta-human chorionic gonadotropin (beta-HCG) serum levels. For hemodynamically unstable
      patients, higher levels of beta-HCG, and larger gestational sacs, surgery is often considered
      as the treatment of choice (16).

      Considering this background, the study aims to analyze the subsequent natural reproductive
      outcomes of patients that had a previous tubal ectopic pregnancy and were managed either
      expectantly or surgically. Moreover, it amis to determine the factors that could influence
      the fertility potential of these patients in each treatment group.
    


Intervention name(s): Expectant management; Salpingectomy; Salpingostomy
Intervention type(s): Other; Procedure; Procedure
Intervention description(s): Follow-up with beta-HCG dosages and transvaginal ultrasound scans; Removal of the affected Fallopian tube by laparoscopy; Removal of the ectopic pregnancy from the Fallopian tube, without removing the whole Fallopian tube, by laparoscopy
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women with either surgically-confirmed tubal ectopic pregnancy or a diagnosis of tubal
        ectopic pregnancy based on a positive beta-HCG serum measurement with the visualization of
        an adnexal mass resembling a tubal gestational sac and an empty uterine cavity upon
        transvaginal ultrasonographic scan.
      
Keywords: Ectopic pregnancy; Expectant management; Pregnancy outcome; Salpingectomy; Salpingostomy
The Efficacy and Safety Study of Tung's Acupuncture for Polycystic Ovarian Syndrome
Condition: Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the efficacy and safety in improving ovarian function of polycystic
      ovarian syndrome in adults. Half of patients will receive Tung's acupuncture therapy, while
      the other half will receive Diane-35(CPA/EE) as the control group.
    

Detailed description: 
      Both Tung's acupuncture therapy and Diane-35(CPA/EE) could improve the symptom of patients
      with polycystic ovarian syndrome, but until now there is no definite evidence to indicate
      acupuncture could play the same role in improving ovarian function. So we design this study
      to observe the change of follicular development, ovary size and sex hormone( testosterone,
      follitropin, luteinizing hormone) before and after the treatment, and evaluate the efficacy
      and safty of acupuncture.
    

Intervention name(s): Tung's acupuncture; Cyproterone acetate/ethinylestradiol (CPA/EE)
Intervention type(s): Other; Drug
Intervention description(s): The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).; Cyproterone acetate/ethinylestradiol (CPA/EE) contains 2mg cyproterone acetate (an anti-androgenic progestin) and 0.035mg ethinylestradiol (CPA/EE). The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).
Other intervention name(s): Diane-35
Intervention MeSH terms: Cyproterone Acetate; Ethinyl Estradiol; Cyproterone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was a randomized, drug-controlled, and parallel group trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acupuncture; LH/FSH; total testosterone (TT); polycystic ovarian syndrome(PCOS)
Increasing Physical Activity Among Overweight Women With Mobility Disabilities.
Condition: Obesity
MeSH terms: Overweight; Mobility Limitation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to increase physical activity among overweight African-American women with
      mobility limitations.
    

Detailed description: 
      Regular, sustainable physical activity can have a dramatic effect on reducing obesity and
      other secondary conditions and increasing quality of life. People with mobility limitations
      have a higher level of physical inactivity resulting from numerous personal and environmental
      barriers to physical activity participation. This project will evaluate the feasibility of
      increasing physical activity among overweight individuals with mobility limitations through
      physician-referrals to a personalized exercise programme at the Chicago-based National Center
      on Physical Activity and Disability (NCPAD).
    

Intervention name(s): Personalized exercise programme (PEP)
Intervention type(s): Behavioral
Intervention description(s): Physician referred overweight and obese clients to 24 month personalized exercise programme at the U. of Illinois, Chicago
Other intervention name(s): PEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity, mobility limitations, women, physical activity
A Study to Assess the Ingestion of Dentifrice by Children
Condition: Healthy Individuals
Study type: Interventional

Summary: 
      The objective of this study was to examine the amount of dentifrice ingested and used by
      various age groups of children.
    


Intervention name(s): Marketed Dentifrice; Marketed Flavored Dentifrice; Marketed Flavored Dentifrice
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Marketed Dentifrice; Hawaiian Punch Flavored; Bubble Gum Flavored
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia
Condition: Vascular Dementia
MeSH terms: Dementia; Dementia, Vascular
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical trial was performed to assess the clinical efficacy and safety of two 4 week
      treatment courses of daily intravenous administration of Cerebrolysin (20mL [milliliter] IV
      [intravenous] per day). The study was performed as prospective, randomised, double-blind,
      placebo-controlled, parallel group, multicentre study with 2 study groups.

      Group 1: 20 mL Cerebrolysin and 100 mg (milligram) acetylsalicylic acid Group 2: Placebo
      (0.9% NaCl [sodium chloride]) and 100 mg acetylsalicylic acid The study drug was given once
      daily by intravenous infusion (20ml in 250ml saline solution) for 4 weeks on five consecutive
      days per week. This treatment regimen was repeated after a two-month treatment-free interval.
      Acetylsalicylic acid was given orally, once daily throughout the study duration of 24 weeks.

      Altogether five clinical evaluation visits at Baseline (day 0) and at week 4, 12, 16, and 24
      were necessary.
    


Intervention name(s): Cerebrolysin; 0.9% Saline Solution
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cerebrolysin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants
Condition: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis
MeSH terms: Hepatitis B; Tetanus; Diphtheria; Poliomyelitis; Whooping Cough; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to generate immunogenicity and safety data of an investigational
      hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when
      given along with Prevenar™ and Rotarix™ vaccines.

      Primary Objectives:

        -  To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T
           vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with
           Prevenar™ and Rotarix™, in terms of immunoresponses.

        -  To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the
           licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™.

      Secondary Objectives:

        -  To describe in each group the immunogenicity parameters for all antigens for each
           vaccine

        -  To assess the safety profile in terms of solicited and unsolicited adverse events and
           serious adverse events in each group for each vaccine.
    

Detailed description: 
      Each participant will receive 3 doses of 1 of 3 lots of the investigational hexavalent
      vaccine or the control vaccine, Infanrix hexa™, administered with Prevenar™ at 2, 4, and 6
      months of age and Rotarix™ at 2 and 4 months of age.

      All participants will be monitored for safety for 6 months after the last injection of the
      primary vaccination series.
    

Intervention name(s): DTaP-IPV-Hep B-PRP-T Vaccine; DTaP-IPV-Hep B-PRP-T Vaccine; DTaP-IPV-Hep B-PRP-T Vaccine; DTaP-Hep B-IPV vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Infanrix hexa™
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Whooping cough; Hepatitis B; Poliomyelitis; Diphtheria-Tetanus-acellular Pertussis Vaccines
Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response
Condition: Primary Biliary Cirrhosis
MeSH terms: Liver Cirrhosis, Biliary
Study type: Observational [Patient Registry]

Summary: 
      To compare intestinal flora diversity in different PBC patients with UDCA responses, and
      further study the differences of bile acid metabolism and short chain fatty acid metabolism
      in feces and serum of two groups of PBC patients.
    

Detailed description: 
      The PBC patients have been enrolled in the study for UDCA treatment more than 1 year, who is
      divided into the UDCA total response Group and the other poor response group according to
      Paris-I/II standard .The feces of two groups of patients were collected and the differences
      of microbial polymorphism of fecal microorganism in two groups were observed. The metabolic
      differences of bile acids and short chain fatty acids in serum and feces of two groups of PBC
      patients were studied by means of metabolic proteomics.
    

Intervention name(s): total response Group
Intervention type(s): Other
Intervention description(s): biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard
Other intervention name(s): poor response group
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Primary biliary cholangitis patients
Folate-Depleted Diet Compared With Folate-Supplemented Diet in Preventing Colorectal Cancer in Patients at High Risk for Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain agents to try to prevent the
      development of cancer. The use of folic acid may be effective in preventing colorectal
      cancer. Eating a diet rich in folic acid may prevent the development of colorectal cancer.

      PURPOSE: This randomized phase I trial is studying how well a folate-depleted diet works
      compared to a folate-supplemented diet in preventing colorectal cancer in patients who are at
      high risk for developing colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Analyze the effects of a folate-depleted vs a folate-supplemented diet on folate-related
           DNA endpoints (e.g., genomic and gene-specific DNA methylation and DNA strand breaks) in
           rectal epithelial cells in patients at high risk for colorectal neoplasia.

        -  Analyze the effects of these dietary interventions on folate-related DNA endpoints
           (e.g., genomic and gene-specific DNA methylation, DNA strand breaks, and uracil
           incorporation into DNA) in blood mononuclear cells in these patients.

      Secondary

        -  Analyze the effects of these dietary interventions on the patterns of differential gene
           expression in rectal epithelial cells and blood mononuclear cells in these patients.

      OUTLINE: This is a randomized, single-blind study.

        -  Run-in period: Patients are placed on an average folate-containing diet for 56 days.

        -  Randomization: After completion of the run-in period, patients are randomized to 1 of 2
           arms.

             -  Arm I (folate depleted diet): Patients are placed on a low-folate diet for 84 days.
                Patients receive oral folic acid supplementation once daily on days 57-84.

             -  Arm II (folate supplemented diet): Patients continue on an average
                folate-containing diet for an additional 56 days. Patients receive oral folic acid
                supplementation once daily on days 1-56.

      Patients are followed at 4 weeks.

      PROJECTED ACCRUAL: A total of 20 patients (10 per arm) will be accrued for this study within
      2.5 years.
    

Intervention name(s): dietary intervention; folic acid
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): oral folic acid supplementation once daily on days 57-84; oral folic acid supplementation once daily on days 1-56.
Intervention MeSH terms: Folic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: colon cancer; rectal cancer
Pseudoxanthoma Elasticum (PXE) Natural History Biomarkers in PXE Individuals and Their Biological Non-PXE Siblings
Condition: Pseudoxanthoma Elasticum
MeSH terms: Pseudoxanthoma Elasticum
Study type: Observational

Summary: 
      This PXE biomarker study aims to characterize the levels of inorganic pyrophosphate (PPi),
      pyridoxal 5´-phosphate (PLP), and other biomarkers relevant to PXE and ectopic calcification
      in both PXE patients and their biological siblings who are PXE carriers or normal non-PXE
      individuals.
    

Detailed description: 
      This non-interventional PXE study is designed to assess differences in circulation levels of
      selective biomarkers related to PXE and tissue-nonspecific alkaline phosphatase (TNAP)
      inhibition, between PXE patients, PXE carriers, and non-PXE normal individuals.
    

Intervention name(s): Non Interventional
Intervention type(s): Other
Intervention description(s): This is an observational study.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        PXE probands with identified ABCC6 mutations and non-PXE biological siblings will be
        invited for study participation.
      
Keywords: Pseudoxanthoma Elasticum; Bone turnover biomarkers; Tissue mineralization biomarkers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Dose-Response Relationship of Multiple Doses of GSK2269557 Administered as a Dry Powder to Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomised, double-blind, placebo controlled, parallel group study to evaluate the
      safety, tolerability, pharmacokinetics and dose response of multiple doses of GSK2269557
      administered as a dry powder in COPD subjects. Pharmacodynamic effects on biomarkers will
      also be assessed. This study will have two parts. In Part A, subjects will be randomized to
      active or placebo treatment in a 3:1 ratio and in Part B, to placebo or one of the six doses
      of active treatment in an equal ratio. A sufficient number of COPD subjects (male and female
      of non-child bearing potential) will be screened to ensure that approximately 30 subjects are
      enrolled and at least 20 evaluable subjects are obtained for Part A and approximately 35
      subjects will be enrolled for Part B. In both the parts, subjects will receive study
      treatment once daily for 14 consecutive days. Placebo control will be included for a valid
      evaluation of adverse events attributable to treatment versus those independent of treatment.
    


Intervention name(s): GSK2269557 100 MCG; GSK2269557 500 MCG; PLACEBO
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mcg of GSK2269557 blended with lactose per blister administered using a dry powder inhaler device; 500 mcg of GSK2269557 blended with lactose per blister administered using a dry powder inhaler device; Lactose administered using a matching dry powder inhaler device
Intervention MeSH terms: Nemiralisib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PI3Kd; Pharmacodynamics; dry powder inhaler; GSK2269557; safety; COPD subjects