bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of T-817MA in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD
Condition: Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective is to evaluate the neuroprotective effect of T-817MA on Tau protein
      phosphorylated at threonine 181 (p-tau 181) in cerebrospinal fluid (CSF) compared with
      placebo in patients with a diagnosis of MCI due to AD or mild AD.

      Secondary objectives are:

        1. To evaluate in patients on T-817MA and placebo:

             -  cognitive function measured by the Clinical Dementia Rating Scale Sum of Boxes
                (CDR-sb) and working memory and attention domain as measured by the Cognitive
                Functional Composite (CFC).

             -  AD-related biomarkers in CSF and plasma

             -  imaging analysis using volumetric magnetic resonance imaging (vMRI)

             -  alpha/theta ratio of the electroencephalogram (EEG)

        2. To evaluate the safety of T-817MA by clinical laboratory tests and adverse events (AEs).

        3. To evaluate the pharmacokinetics of T-817MA
    


Intervention name(s): T-817MA; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 224mg T-817MA orally once daily for first 4 weeks, and then 448mg T-817MA orally once daily for the following weeks.; Placebo once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intervention Study Investigating the Effect of a Phospholipid Drink on Cognitive Performance in 6-8 Year Old School Children
Condition: Healthy
Study type: Interventional

Summary: 
      Six week RCT intervention on the effects of phospholipid containing milk drink vs. placebo
      milk drink on cognitive performance in 6-8 year old school children.
    

Detailed description: 
      A randomised, double blind, placebo controlled study with parallel groups investigating a 6
      week intervention in 6-8 year old school children of phospholipid containing milk drink vs.
      placebo milk drink. Participants were familiarised with the test battery and IQ (Wechsler
      abbreviated scale of intelligence) and colour blindness (Ishihara test) measurements were
      taken prior to the intervention. Milk drink taste testing and milk preference selection was
      also carried out prior to the intervention. The test battery was administered at baseline
      (week 0), midpoint (week 3) and endpoint (week 6), and the milk intervention was given Monday
      - Friday at school shortly before their mid-morning break over a 6 week period. This study
      design, including both the test days and morning milk supplementation, was intended to
      emulate the children's normal routine as far as possible. The milk drink was a supplement to
      the children's usual diet.
    

Intervention name(s): Lacprodan PL20; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Milk protein concentrate that is high in phospholipid content (min 16%).; Placebo milk drink.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Milk; Lacprodan PL20; Glycerophospholipids; Cognition
A Dose-finding Study to Evaluate the Effect of a Contraceptive Vaginal Ring, Releasing Nestorone® and Estradiol, on Cycle Control, Ovulation Inhibition, and Pharmacokinetics in Normal Cycling Women
Condition: Suppression of Ovulation
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial is an experimental research study using a potential new form of birth
      control. Clinical trials include people who volunteer to take part in a study. Take your time
      to decide if you want to be part of this experimental research study. If you want to know
      more about this study first, ask the study doctor or study site staff. The investigators can
      also give you the study information written for doctors and clinic staff.
    


Intervention name(s): 10 µg/day E2 with NES 200® µg/day; 20 µg/day E2 with NES 200® µg/day; 40 µg/day E2 with NES 200® µg/day
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days); 20 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days); 40 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaginal ring
An Open Label Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment Facial Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is looking at a new oral drug to treat acne. All patients in the study will get
      active drug, there is no placebo arm.
    


Intervention name(s): Talarozole
Intervention type(s): Drug
Intervention description(s): Oral Dose 1.0 mg once daily
Other intervention name(s): Rambazole; R115866
Intervention MeSH terms: R 115866
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Home Air in Agriculture: Pediatric Intervention Trial
Condition: Asthma in Children
Study type: Interventional

Summary: 
      This study seeks to reduce exposure to asthmagens in the homes of a community of Latino
      children residing in an area of intense agricultural production in Eastern Washington by
      testing the effectiveness of an intervention (high efficiency particulate air filter- HEPA
      portable room air cleaners) plus asthma education to reduce indoor measures of particulate
      matter, ammonia, improve clinically relevant measures of asthma health, and reduce biomarkers
      of inflammation.
    

Detailed description: 
      Over the course of five years, this project's specific aims are as follows:

        1. Build on a well-established community based participatory research program to engage
           community partners in the design, implementation and evaluation of this asthma
           intervention study.

        2. Conduct a year-long intervention study with longitudinal measurement of key asthmagen
           exposures and health outcome indicators with minimal participant burden.

        3. Develop and characterize evaluation metrics for the process, impact and outcomes of this
           project in achievement of the aims.

        4. Promote sustainable public health action via positive and transparent communications
           about the project to participants, local stakeholders, and state level policy makers
           through broad-based community outreach.
    

Intervention name(s): HEPA air cleaner
Intervention type(s): Device
Intervention description(s): Participants in the intervention group received two HEPA air cleaners per household. They were informed to place the HEPA air cleaners in the child's bedroom and the living room. Field staff provided and discuss how to use the air cleaner which promoted continuous operation of both air cleaners, keeping the child's bedroom door closed, and selected the highest fan speed. Typical use of the HEPA cleaners were questioned during the mid-study and final visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Latinx children; agriculture; HEPA air cleaner; home indoor/outdoor sampling; coarse particulate matter; fine particulate matter; endotoxins; antigens; spirometry; exhaled nitric oxide
Phosphodiesterase Type 5 Inhibition to Improve Endothelial Function and Vascular Remodeling in Chronic Kidney Disease and End Stage Renal Disease Patients Requiring New Arteriovenous Fistula
Condition: Improve Endothelial Function and Decrease Vascular Stenosis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Arteriovenous Fistula; Fistula; Vascular Remodeling
Study type: Interventional

Summary: 
      Patients with stage IV and V chronic kidney disease and end stage renal disease requiring
      hemodialysis at University of Alabama at Birmingham (UAB) Dialysis Clinics will be recruited
      from the UAB Vascular Access Clinic, which has been the site for recruitment of patients
      requiring new vascular access for the last 10 years.
    

Detailed description: 
      The main purpose of this research study is to conduct a research study to determine if
      Sildenafil compared to placebo will improve the vascular health of arteries and veins before
      arteriovenous fistula creation (shunt) and how quickly your veins and arteries dilate and
      increase in blood flow after fistula creation. An arteriovenous fistula (shunt) is a
      connection between the artery and vein in the arm for dialysis use. Another purpose of this
      study is to determine if Sildenafil reduces the blood and tissue levels of oxidants prior to
      fistula creation. Oxidants are harmful substances in the body that damage the cells tissues,
      and organs.
    

Intervention name(s): Sildenafil; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Sildenafil, a phosphodiesterase 5 inhibitor that enhances the effects of nitric oxide (NO), has been shown in experimental and clinical studies in cardiovascular disease to improve endothelial function and decrease vascular stenosis.; Placebo will be over encapsulated to identical to drug comparison
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Arteriovenous Fistulas (AVFS); Hemodialysis Fistula Maturation (HFM); Flow-Mediated Dilation (FMD); Nitroglycerin-Mediated (NMD); Venous Plethysmography (VP)
Sleep in Pediatric Intensive Care Patients
Condition: Sleep
Study type: Observational

Summary: 
      This research will be carried out experimentally in order to investigate the Effect of Sleep
      Band and White Noise Use on the Time to Sleep in Pediatric Intensive Care Patients aged 3-12
      months. The research will be carried out in Adana Province Seyhan State Hospital Pediatric
      Intensive Care Unit. The data obtained by creating experimental and control groups will be
      calculated. "Baby Information Form, Baby Sleep Problems Diagnosis Form, Baby Sleep
      Observation Form and Vital Findings Follow-up Chart" will be used to collect research data.
      In the study, sleep bands and white noise will be used for sleep for the babies in the
      experimental group, while the control group will not be interfered with. Ethics committee,
      institutional permission and informed consent from the parents of the infants will be
      obtained for the conduct of the study. SPSS demo package program will be used in data
      analysis. Examining the Effect Effect of Sleep Band and White Noise Use on Transition Time to
      Sleep in Pediatric Intensive Care Patients aged 3-12 months

      , sleep ecology , sleep diagnostics Patients aged 3-12 months At the end of the research, it
      will be examined whether there is a difference between the sleep time, waking frequency and
      total sleep time of the babies in the experimental group using the sleep band and white
      noise, and the babies in the control group.
    


Intervention name(s): Sleep Band and White Noise
Intervention type(s): Device
Intervention description(s): Not taking any sedative or anesthetic drug in the last 12 hours (Such duration of action) An average of 12 hours of sleepiness at the patient's departure and travel hindrance will.)
Being extubated
A Glasgow coma scale of 15 (to be investigated by the Glasgow coma scale).
Baby dreams of boredom
Besides pain (to the "Wong Baker Face Scale" used in the Pediatric Intensive Care Unit) evaluation).
Other intervention name(s): Sleep Band; White Noise
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        The sample of the study consists of a total of 78 patients, 39 in the experimental and 39
        in the control group. As a result of the power analysis using the G*Power 3.0.10 program; A
        total of at least 78 samples were found to be sufficient with 90% power and 5% margin of
        error (n1: 39, n2: 39).
      
Keywords: White noise; sleep band; pediatric intensive care; baby/child
Hypofractionated Image-Guided Radiotherapy For Prostate Cancer: The HEIGHT Trial
Condition: Prostate Cancer; Prostate Adenocarcinoma
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      1. Delivery of directed hypofractionated targeted (HT) radiotherapy (RT) tumor boost to the
           dominant tumor lesion in the prostate as identified by multiparametric MRI will increase
           tumor eradication from the prostate.

        2. Biomarker expression levels differ in the multiparametric MRI defined regions at high
           risk of harboring tumors that determine outcome.

        3. 10-15% of men undergoing RT have Circulating DNA or tumor cells (CTC) that are related
           to an adverse treatment outcome.

        4. Quality of life will not differ significantly between the treatment arms.

        5. Prostate cancer-related anxiety will be reduced in the HTIMRT arm, because the patients
           will be aware that the dominant tumor will be targeted with higher radiation dose.
    


Intervention name(s): SIMRT; HTIMRT
Intervention type(s): Radiation; Radiation
Intervention description(s): A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).; Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.
Other intervention name(s): Standard Fractionated Intensity Modulated Radiotherapy; Hypofractionated Targeted Intensity Modulated Radiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Special Investigation in Patients With Crohn's Disease (All Patients Investigation)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      This study will be conducted to assess adverse drug reactions, incidence of adverse events,
      and factors that may affect the safety and effectiveness of Humira for the treatment of
      Crohn's disease.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who receive Humira for the treatment of Crohn's Disease
      
Keywords: Crohn's Disease
The Clinical Efficacy of Supraglottic Airway Device, Self-pressurized Air-Q Intubating Laryngeal Airway (ILA -SP) in Adult Patients: Comparison With Classic-laryngeal Airway (c-LMA)
Condition: Surgery
Study type: Interventional

Summary: 
      Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these
      devices ,classic laryngeal airway has been typically widely used. The self-pressurised air-Q
      (air-Q) is newly developed supraglottic airway devices. It is a new single-use device that
      may optimise the airway sealing while reducing the potential for postoperative complications
      such as sore throat. The overall structure of the air-Q SP is identical to the original
      air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to
      compare the clinical performance of the classic LMA and the air-Q SP.
    


Intervention name(s): Insertion of C-LMA; Insertion of air-Q according
Intervention type(s): Device; Device
Intervention description(s): After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.; After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: supraglottic airway devices; the classic laryngeal mask airway; the self-pressurised air-Q intubating laryngeal airway in adult patients; elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway in adult patients
An Open Label Study To Investigate the Pharmacokinetics and Pharmacodynamics of Repeat Escalating Doses of the Oral AKT Inhibitor GSK2141795 by 18F FDG PET Analysis in Subjects With Ovarian Cancer
Condition: Solid Tumours
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to explore the potential dose response relationship between the
      pharmacokinetics of GSK2141795 and [18F] FDG PET pharmacodynamic markers of glucose
      metabolism in tumor tissue. Three to six subjects will be enrolled in each cohort and dosed
      with repeat escalating doses of GSK2141795. [18F] FDG PET imaging and optional tumor biopsies
      will be done prior to initiation of dosing and sequentially at select time points during the
      first five weeks of dosing. The maximal dose of a given schedule evaluated in this study will
      not exceed the maximal tolerated dose established in the first-time-in-human trial PCS112689
      for the same schedule.
    


Intervention name(s): GSK2141795
Intervention type(s): Drug
Intervention description(s): GSK2141795 is an oral, low nanomolar pan-AKT kinase inhibitor that demonstrates activity in hematologic and solid tumor cell lines. It also delays tumor growth in a dose dependent manner in solid tumor xenograft mouse models
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; 18F FDG; PK; PET; Positron Emission Tomography; PD; AKT Inhibitor; GSK2141795
Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients After Hip Operations
Condition: Pain; Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients scheduled for primary total hip replacement needs postoperative pain treatment: i.e.
      morphine. Unfortunately morphine has side-effects: nausea, vomiting, sedation and dizziness,
      which is unpleasant for the patients and sometimes keeps them at bed longer time than needed.
      We investigate in new combinations of analgesics for postoperative pain, hoping to minimize
      the need for morphine and improve the patients pain score after operation.
    

Detailed description: 
      We investigate the effect of paracetamol versus paracetamol + pregabalin versus paracetamol +
      pregabalin + dexamethasone on pain and morphine usage in the first 24 hours postoperatively
      in patients getting a new hip alloplastic.
    

Intervention name(s): Pregabalin; Dexamethasone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexamethasone; Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Total hip replacement; Pregablin; Dexamethasone; Multimodal postoperative analgesia.
Feelings About Exercise
Condition: Physical Activity; Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study seeks to investigate why some individuals exercise more than others by focusing on
      feelings related to exercise. This two part study first examines whether regular exercisers
      (n=30) and non-exercisers (n=30) differ in how a 30-minute moderate-intensity exercise bout
      makes them feel. All participants will walk on a treadmill for 30 minutes on two separate
      occasions and will be asked to report on how they feel before, during, and after exercise,
      how they anticipate that exercise will make them feel, and how they remembered feeling during
      exercise. In addition, after exercise session #2, non-exercisers will be randomized to: 1) a
      brief intervention focused on providing general information about the physical activity
      guidelines, or 2) a brief intervention which provides general information about physical
      activity guidelines, but also focuses on affective responses to physical activity.
      Non-exercisers will complete an identical, third exercise session approximately 1-week
      following this intervention. Further, all participants will receive a 12-week,
      Internet-delivered weight loss program following all exercise visits and physical activity
      will be assessed before and after the weight loss program.
    


Intervention name(s): Affect and physical activity; Physical activity information
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The focus of this intervention is to help the participant to become more aware of their positive feelings and experiences related to exercise. They will learn about typical affective responses to exercise, view their own affective responses to exercise, and they will be taught cognitive strategies for altering affective responses to exercise. Participants will also receive general information about exercise safety, physical activity guidelines, and exercise intensity.; Participants will receive general information about exercise safety, physical activity guidelines, and exercise intensity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; physical activity; obesity; weight loss
A Study to Test How Healthy Women Tolerate Different Doses of BI 1819479
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety, tolerability and
      pharmacokinetics (PK) of BI 1819479 in healthy female subjects of non-childbearing potential.
    


Intervention name(s): BI 1819479; BI matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 1819479; BI matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relationship between plasma drug levels and
      receptor binding in brain using PET; and to evaluate safety and tolerability after a single
      administration of PF-05212365 in healthy volunteers
    


Intervention name(s): PF-05212365
Intervention type(s): Drug
Intervention description(s): Single dose of up to 30 mg PF-05212365, delivered as 1 mg, 3 mg, and/or 5 mg on study day 1.
Other intervention name(s): SAM-531
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers