bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Chronic ACE and DPP4 Inhibition on Blood Pressure
Condition: Type 2 Diabetes Mellitus; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In this study the investigators will test the hypothesis that dipeptidyl peptidase IV (DPP4)
      inhibition attenuates the antihypertensive effect of angiotensin-converting enzyme (ACE)
      inhibition but not angiotensin receptor blockade or calcium channel blockade. The
      investigators further hypothesize that this effect is mediated by substance P.
    

Detailed description: 
      The use of dipeptidyl peptidase IV (DPP4) inhibitors for the treatment of type 2 diabetes
      (T2DM) is growing rapidly. The majority of patients with T2DM are also taking ACE inhibitors
      or angiotensin receptor blockers (ARBs) in order to reduce cardiovascular and renal morbidity
      and mortality. DPP4 and ACE inhibitors share the common vasoactive substrate substance P.
      Substance P acts as a vasodilator but also activates the sympathetic nervous system.
      Understanding the interactive effects of DPP4 and ACE inhibitors on blood pressure and
      neurohumoral activation has important implications for the millions of patients with T2DM who
      take these drugs concurrently.
    

Intervention name(s): Placebo; Sitagliptin; Aprepitant; Mixed Meal Test (MMT)
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Subjects will receive two capsules of placebo to preserve the blinding of the study.
In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin.; Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.; Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.; The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.
Other intervention name(s): Microcrystalline cellulose; Januvia; Emend
Intervention MeSH terms: Sitagliptin Phosphate; Aprepitant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Hypertension; Angiotensin Converting Enzyme Inhibitors; Dipeptidyl Peptidase IV Inhibitors; Sitagliptin; Aprepitant; Ramipril
FLEX - Long-term Extension of FIT (Fracture Intervention Trial)(0217-051)
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was conducted among women who had previously received alendronate for 3 to 6 years
      during the Fracture Intervention Trial (FIT). Participants in the FLEX study were randomly
      assigned to receive alendronate (either 5 or 10 mg/day) or matching placebo during the next 5
      years, in order to evaluate the effects of continuing or discontinuing alendronate treatment
      on bone mineral density and biochemical markers of bone turnover.
    


Intervention name(s): MK0217, alendronate sodium / Duration of Treatment : 5 Years; Comparator : placebo (unspecified) /Duration of Treatment : 5 Years
Intervention type(s): Drug; Drug
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Show Me to Help Me
Condition: Autism
Study type: Observational

Summary: 
      This cohort observation, randomized controlled trial is intended to provide data that icons
      and non-verbal communication improve communication and cooperation with children with
      Autism/communication delay and aid in the transition to an unfamiliar environment. It would
      lay the foundation for future studies and practices of using icons and pictures for the whole
      office visit to enhance communication between the patient and physician/nurse/medical staff
      and cooperation of the patient.

        1. Use icons during triage/check in process to decrease time and increase patient
           compliance. Compare typical children to those with Autism/communication delay.

        2. Use icons during blood draw to improve communication with patients, to help with patient
           understanding, and increase patient cooperation and decrease noise and length of
           procedure.
    


Intervention name(s): Icons
Intervention type(s): Other
Intervention description(s): Clinic- patients first shown picture icons of the steps of taking vital signs Lab - patients first shown picture icons of the steps of a blood draw procedure
Other intervention name(s): Picture Exchange communication system (PECS)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children who are established patients, 4-18 years old, and present to the
        NeuroDevelopmental Science Center for a follow-up office visit during the study period,
        since a diagnosis will be available at the time of the study (patients in the lab study may
        be new patients if they have a diagnosis at the time their lab work is prescribed). The
        NeuroDevelopmental Science Center at Akron Children's Hospital provides nearly 25,000
        visits annually to children and youth affected by neurological, developmental, and
        behavioral disorders. This includes children with autism, intellectual disabilities,
        physical disabilities, learning disabilities, epilepsy and other neurological conditions.
      
Keywords: icons in clinic or office for patients with Autism
Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery
Condition: Uterine Atony; Uterine Atony With Hemorrhage; Postpartum Hemorrhage; Cesarean Section Complications
MeSH terms: Postpartum Hemorrhage; Uterine Inertia; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality
      worldwide. Up to 80% of PPH is caused by uterine atony, the failure of the uterine smooth
      muscle to contract and compress the uterine vasculature after delivery. Laboratory and
      epidemiological studies show that low extracellular and serum calcium levels, respectively,
      decrease uterine contractility. A pilot study performed by the investigators supports the
      hypothesis that intravenous calcium chloride is well tolerated and may have utility in
      preventing uterine atony. The proposed research will establish the relationship between
      uterine tone and calcium through a clinical trial with an incorporated pharmacokinetic and
      pharmacodynamic (PK/PD) study. In a randomized, placebo-controlled, double-blind trial,
      investigators will establish the effect of 1 gram of intravenous calcium chloride upon
      quantitative blood loss and uterine tone during cesarean delivery in parturients with high
      risk of uterine atony. Investigators will concurrently collect serial venous blood samples to
      measure calcium for PK/PD modeling in this pregnant study cohort. High-quality clinical
      research and development of novel therapeutics to manage uterine atony are critical to reduce
      the high maternal morbidity and mortality from PPH.
    


Intervention name(s): Calcium chloride; Saline placebo
Intervention type(s): Drug; Drug
Intervention description(s): See arm description above; see arm description above
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind, placebo controlled randomized clinical trial with 1:1 allocation
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: calcium chloride; uterine atony; postpartum hemorrhage; cesarean delivery; intrapartum cesarean
Varenicline Effects In Schizophrenic Smokers
Condition: Schizophrenia; Tobacco Use Disorder; Nicotine Dependance
MeSH terms: Tobacco Use Disorder; Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open label pre-post study of the effects of clinical treatment with varenicline on
      1) decreasing smoking in schizophrenic patients, 2) improving selected cognitive measures in
      schizophrenic patients, and 3) psychopathology in schizophrenic patients. Patients are
      assessed on subjective and objective measures of smoking, selected cognitive measures, and
      special chemical measures, during baseline testing and during 8 weeks of treatment with
      varenicline (1-2 mg/day).
    


Intervention name(s): Varenicline
Intervention type(s): Drug
Intervention description(s): Varenicline 1-2 mg/day
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; varenicline; cognition; cigarette smoking
Transition From Adolescents to Adulthood for Patients With Congenital Heart Diseases
Condition: Congenital Heart Diseases
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      The Investigators aim to measure the impact of a transition program in congenital cardiology
      in terms of health-related quality of life.
    

Detailed description: 
      The number of adults with congenital heart diseases (CHD) is increasing. However, many young
      adults are lost to follow-up even in experienced tertiary care centers. American and European
      guidelines recommend to improve the management of young adults with CHD. Structured
      therapeutic education programs are therefore needed to optimize the transfer to adult
      healthcare. Our tertiary care CHD center recently implemented a transition program and
      simultaneously investigators decided to measure its impact. Indeed investigators need data
      from randomized trials in this filed. After previous controlled quality of life studies among
      children and adults with CHD, investigators chose to use the health-related quality of life
      (HR-QoL) as primary endpoint in this randomized study to focus on patient related outcomes.

      The investigators assume that patients who participate in this program will improve their
      quality of life compared to controls. If investigators demonstrate the benefit of this
      program, it will have important consequences for patients with CHD and eventually for
      patients with other chronic medical conditions.
    

Intervention name(s): Therapeutic education; Standard follow-up
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Perioperative Risk Factors for Postoperative Delirium in Children
Condition: Delirium, Postoperative
MeSH terms: Delirium; Emergence Delirium
Study type: Observational

Summary: 
      Despite recent advances in postoperative delirium research, the proportion of children with
      postoperative delirium is still high. Although postoperative delirium is a frequent
      complication and is associated with the need for more inpatient hospital care and longer
      length of hospital stay, little is known about risk factors for recovery room delirium (RRD)
      occurred in postanaesthesia care unit. The aim of the study was to determine pre- and
      intraoperative risk factors for the development of RRD among children undergoing non
      cardiovascular surgery.
    

Detailed description: 
      Recovery room delirium (RRD) defined as delirium occurred in PACU was diagnosed according to
      RASS-PAEDS criteria. Pre-, intra-, and postoperative data of patients undergoing elective non
      cardiovascular surgery were prospectively collected, univariate and multivariate logistic
      regression were performed to find the risk factors related to postoperative delirium.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients between 3 to 12 years old, who were admitted to the PACU after elective
        non-cardiac surgery under general anaesthesia during regular working hours (9:00Am to
        5:00Pm)
      
Keywords: Delirium; Postoperative; Non-cardiovascular surgery; Post-anaesthesia care unit; patients between 3 to 12 years old; undergoing selective non-cardiac surgery; under general anesthesia; surgery; general anesthesia
Long-Term Safety Of PF-00547659 In Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will
      receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of
      the drug.
    


Intervention name(s): 75mg SHP647 (PF-00547659); 225mg SHP647 (PF-00547659)
Intervention type(s): Drug; Drug
Intervention description(s): 75 mg sterile liquid injected subcutaneously every 4 weeks.; 225 mg sterile liquid injected subcutaneously every 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anti-TNF Refractory; Active Ulcerative Colitis; Immunosuppressant Refractory
Sanitary Napkins for Urinary Assessment of Micronutrients
Condition: Focus: Nutritional Deficiency
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      This study aims to find an easy urinary collection method for the assessment of urinary
      markers of micronutrient status.
    

Detailed description: 
      Urinary collection in newborns and infants can be difficult. Our study aims to find an easy
      and cheap alternative to urinary collection bags and specialized pads that can be used to
      measure biomarkers of iodine and vitamin B12 status in urine and can be employed in large
      scale trials. Using correlation analyses, the association of urinary iodine and methylmalonic
      acid from healthy volunteers will be assessed between untreated sample and a sample expressed
      from a sanitary napkin. Participants will be recruited based on their dietary pattern
      (omnivorous, vegetarian and vegans) to have a broad spectrum of analyte concentration.
      Participants weight, height, age, nutritional supplement use and diet will be assessed.
    

Intervention name(s): Urine collection and assessment of dietary intake by food frequency questionaire
Intervention type(s): Diagnostic Test
Intervention description(s): urinary iodine, creatinine and methylmalonic acid, iodine and vitamin B12 dietary intake from foods and supplements
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants are primarily recruited at the University of Hohenheim
Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Observational

Summary: 
      This is a prospective, observational study to collect stool and blood from acute myeloid
      leukemia patients undergoing intensive chemotherapy.
    


Intervention name(s): Sample Collection Blood; Stool Sample
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Collected from each patient twice weekly.; Collected from each patient twice weekly.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with acute myeloid leukemia (new diagnosis, refractory, or relapsed)
        undergoing any intensive chemotherapy with expected inpatient stay of ~4 weeks.
      
Keywords: AML
"It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure
Condition: Premature Ovarian Failure
MeSH terms: Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this work is to evaluate the therapeutic potential of Autologous Mesenchymal
      sc (MSC) therapy in women suffering from POF.
    

Detailed description: 
      Stem cells (sc) are the foundation cells for every organ, tissue and cell in the body. They
      are self sustaining and can replicate themselves for long periods of time. They have the
      remarkable potential to develop in many different cell types in the body. Premature ovarian
      failure (POF) is the loss of ovarian function in women less than 40 years. It is associated
      with sex steroid deficiency, amenorrhea, infertility, and elevated serum gonadotropins. This
      work aimed to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC)
      transplantation in women suffering from POF. Out of 112 high risk patients for POF, 10 cases
      were diagnosed as POF. The ten POF patients were scheduled for MSC transplantation at Al-
      Azhar University Hospitals. MSC preparation from the bone marrow of the iliac crest was
      laparoscopically injected in the ovaries. Endometrial fractional biopsy is
      histopathologically (HP) and Immunohistochemically (IH) stained and evaluated according to
      Edessy stem cells score (ESS) (1).
    

Intervention name(s): Stem cell
Intervention type(s): Biological
Intervention description(s): Out of 112 high risk patients for POF diagnosis was established in 10 cases. Endometrial fractional biopsy was taken, stained with H&E stain and by Immunohistochemical (IH) staining by stem cell marker OCT4. IH expression of stem cell was evaluated before and after transplantation according to Edessy Stem Cell Scoring (ESS). After laparoscopic injection of stem cell sample in the ovaries, participants were followed up monthly for a period of one year by hormonal (FSH, LH and E2), clinical (resuming menstruation and pregnancy), US (folliculometry), histopathological (HP), and IH expression of stem cell (stem cell positivity and scoring according to ESS).
Other intervention name(s): - Edessy Stem cell Score.; - Laparoscopic stem cell transplantation.; - Hormonal Analysis; - Ultrasonic evaluation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: POF; ESS; stem cell therapy
Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The hypothesis to be investigated is that no difference will be found upon comparing resin
      composite strip crowns and NuSmile zirconia crowns (NuSmile ZR) esthetic primary anterior in
      restoring anterior primary teeth.
    

Detailed description: 
      The aim of this study is to clinically evaluate the performance of a new NuSmile ZR esthetic
      primary anterior crowns, compared with anterior resin composite strip crowns in the
      restoration of 120 teeth (primary incisors and lateral anterior teeth in the deciduous
      dentition of child patients).
    

Intervention name(s): NuSmile Zirconia crowns by NuSmile company; Composite resin strip crowns by 3M company
Intervention type(s): Device; Device
Intervention description(s): anterior carious teeth restored with Zirconia crowns; anterior carious teeth restored with Strip crowns
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: one group assigned to be treated with Zirconia crowns, the other group assigned to be treated with resin composite strip crowns
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: caries; full coverage; strip crown; Zirconia crown; primary anterior teeth; crown
Metformin Glycinate on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to compare the efficacy and safety of Metformin Glycinate versus
      Metformin Hydrochloride in metabolic control and inflammatory mediators in Mexican type 2
      diabetes patients, in a 12 months follow up.
    

Detailed description: 
      Metformin glycinate salt is a new drug , which has better pharmacokinetic characteristics
      (better bioavailability and absorption) making a proper antihyperglycemic power without
      increasing the frequency of adverse effects. The drug has been tested in preclinical test
      with animals, in healthy subjects and in patients with type 2 diabetes; which showed that it
      has adequate antihyperglycemic effect. Now, its important to compare metformin glycinate and
      metformin hydrochloride for evaluate the relative antihyperglicemic power. In addition, a
      study with a larger number of patients improve the statistical power of the test to
      investigate the effects of these drugs on possible weight loss and lipid profile improve.
      Additionally, it will also explore the relative power of the two medications tested to modify
      inflammatory response mediators and oxidative stress have been associated with the incidence
      of cardiovascular disease in diabetes. This project was designed with the intent to answer
      the next question: What are the efficacy and safety of metformin glycinate dose of 2101.2
      mg/day (equivalent to 1700 mg/day metformin hydrochloride), compared with metformin
      hydrochloride in doses of 1700 mg/day for 12 months of treatment in patients with Type 2
      diabetes.
    

Intervention name(s): Metformin glycinate; Metformin hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Metformin glycinate 12 months: 1 month,one tablet 1050.6 mg once daily + 11 months, one tablet 1050.6 mg twice daily; 12 months: 1 month, once daily dose of 850 mg (before dinner) and 11 months, twice daily dose 850 mg (before breakfast) + 850 mg (before dinner).
Other intervention name(s): Predial
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; metformin glycinate; metabolic control
Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment
Condition: Restless Legs Syndrome (RLS)
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the safety, efficacy and pharmacokinetics of gabapentin enacarbil in moderate to
      severe primary RLS patients with moderate renal impairment and to confirm dosage and
      administration in such population.
    

Detailed description: 
      This study is a multicenter, non-blinded, non-comparative study. Patients who meet the
      eligible criteria will undergo one week observation period followed by four week treatment
      period. In treatment period, patients will receive gabapentin enacarbil orally one daily
      after dinner. After the four-week treatment period with gabapentin enacarbil, a one-week
      post-observation period will be undertaken.
    

Intervention name(s): Gabapentin enacarbil
Intervention type(s): Drug
Intervention description(s): Oral
Intervention MeSH terms: Gabapentin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gabapentin; Restless legs syndrome (RLS)