bioihbjkbjnl/mcl2 huggingface dataset:
Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate safety,
      tolerability and pharmacokinetics (the exposure of the trial drug in the body) of multiple
      doses of NNC0113-0987 in an oral formulation in healthy subjects.
    


Intervention name(s): NNC0113-0987; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets for once-daily oral administration. Multiple doses with sequential dose increments over 10 weeks. The end-dose levels and the dose levels during the escalation regime may be adapted during trial conduct based on safety evaluations.; Tablets for one-daily oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Circadian Rhythm of Blood Lactate
Condition: Healthy
Study type: Observational

Summary: 
      To elucidate whether blood lactate, lipid transfer proteins and PPARs/CLOCK/Bal1 have a
      circadian rhythm
    

Detailed description: 
      Blood will be drawn fasting and then every hour over a period of 24 hours in 30 healthy
      probands.
    

Intervention name(s): Blood Sampling
Intervention type(s): Other
Intervention description(s): Blood Sampling over 24 hours
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        30 healthy probands
      
Keywords: Blood lactate; Lipid transfer proteins; Lactate; PLTP; CETP; PPARs; CLOCk; Bal1
Masculine Norms and Skin Care Knowledge, Attitudes, and Behaviors
Condition: Social Norms
Study type: Observational

Summary: 
      Examining whether men with greater Avoidance to Femininity subscores using the Male Role
      Norms Inventory - Short Form will demonstrate differences in skin care knowledge, attitudes,
      and behaviors, compared to men with lower subscores.
    

Detailed description: 
      This purpose of this study is to examine whether a man's adherence to traditional masculine
      norms correlates with his skin care attitudes or behaviors. A stronger understanding of these
      associations may enable dermatologists to better understand their patient's perception of
      skin care. The utility of this knowledge lies in creating outreach interventions and
      informing risk stratification. The study also seeks to determine whether skin care knowledge
      varies by adherence to masculine norms. This knowledge can be used to guide patient education
      in a clinical setting.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult men residing in the United States
      
Keywords: Masculine Norms; Skin Care; Gender
Thalamic Deep Brain Stimulation for Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In this single-center trial, we aim to include 8 patients with severe and medically
      refractory Tourette's syndrome. All patients undergo deep brain stimulation surgery with two
      electrodes located in the centromedian-parafascicular complex. Tic severity and secondary
      outcome measurements are assessed six and twelve months after surgery. Additionally, a short
      randomized, double-blinded sham controlled crossover sequence of 24 to 48 hours in either
      active or sham stimulation is implemented after both 6 and 12 months assesments. Subjects and
      clinicians are blinded to treatment allocation.
    


Intervention name(s): Bilateral Deep brain stimulation of the thalamus, Medtronic Device
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A pragmatic trial with brief randomized, double-blinded sham controlled sequences
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ADvance DBS-f in Patients With Mild Probable Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The primary objective of this feasibility study is to evaluate the safety of DBS-f in
      patients with mild Alzheimer's disease by assessing all device and/or therapy related adverse
      events. The secondary objective is to preliminarily estimate the treatment effect size on the
      outcomes of interest at 12 months post-randomization. The objectives do not involve formal
      tests of hypotheses.
    


Intervention name(s): DBS-f on; DBS-f off
Intervention type(s): Device; Device
Intervention description(s): deep brain stimulation of the fornix; deep brain stimulation of the fornix turned off
Other intervention name(s): DBS-f system includes:; *Medtronic Activa PC Model 37601 Implantable Neurostimulator (INS); *Medtronic Model 3387 DBS Lead; *Medtronic Model 37085 DBS Extension Kit; *Medtronic Model 3708660 DBS Extension Kit; DBS-f system includes:; *Medtronic Activa PC Model 37601 Implantable Neurostimulator (INS); *Medtronic Model 3387 DBS Lead; *Medtronic Model 37085 DBS Extension Kit; *Medtronic Model 3708660 DBS Extension Kit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mild probable Alzheimer's Disease
Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery
Condition: Articular Cartilage Defect Grade III or IV of the Knee
MeSH terms: Fractures, Stress
Study type: Interventional

Summary: 
      The purpose of this study is to assess the potential benefit of enhancing knee surgery for
      cartilage injury using some of the patient's own cells, taken from fat tissue, that may be
      able to help cartilage to regenerate.
    

Detailed description: 
      Participation in this study will allow the surgical team to remove a small amount of fat (20
      to 30 ml, or between 1 and 2 tablespoons) from just below the skin in the belly region that
      will be processed to remove regenerative cells, which will then inserted into the knee to the
      damaged cartilage. These cells may encourage healing at the surgical site, although whether
      or how much they encourage healing is unknown. Determining whether such improved healing
      occurs is the purpose of this study.

      Some patients will have the fat removed and cells inserted in their knee, and other patients
      will not have the fat removed or cells inserted. To which group patients are assigned is
      determined by a random process, similar to flipping a coin. The surgery is the same in all
      other ways for all patients.

      Participation will require attending regularly scheduled postoperative visits, having 3 MRI
      tests, and answering a short survey. No additional visits other beyond those normally
      scheduled for postsurgical care are required.
    

Intervention name(s): Autologous Cell; Standard microfracture arthroscopic surgery
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee; cartilage; microfracture; cell therapy
Non-invasive Stimulation of Brain Networks and Cognition in Alzheimer's Disease and Frontotemporal Dementia
Condition: Alzheimer's Disease; Frontotemporal Dementia, Behavioral Variant
MeSH terms: Alzheimer Disease; Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Study type: Interventional

Summary: 
      This pilot study aims to test clinical and connectivity changes following non-invasive
      stimulation of disease-specific networks in Alzheimer's disease (AD) and behavioral variant
      frontotemporal dementia (bvFTD). Brain network stimulation will be carried out with
      transcranial direct current stimulation (tDCS). Target networks will be the default mode
      network (DMN) and salience network (SN). Twenty AD and 20 bvFTD patients will be recruited
      and assessed with a comprehensive clinical, behavioral and cognitive battery, and 3 Tesla MRI
      scan (including resting-state functional MRI, arterial spin labeling, diffusion tensor
      imaging, structural MRI) at three time-points: baseline, after tDCS, and after 6 months.
      Patients will be randomized to 2 arms: anodal stimulation of the disease-specific network
      (DMN in AD, SN in bvFTD) or cathodal stimulation of the anti-correlated network (SN in AD,
      DMN in bvFTD). The intervention will consist of 10 tDCS sessions over two weeks.
      Cerebrospinal fluid (CSF) samples will be collected at baseline for biomarker's assessment;
      blood samples will be collected at each time-point to assess changes in peripheral
      inflammatory markers. Blood and CSF collection will be optional. A sample of 20 elderly
      controls will be included for baseline comparisons.
    


Intervention name(s): transcranial direct current stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): 10 daily 25-minutes tDCS sessions over two weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of PRP, Conditioned Medium UC-MSCs Secretome and Hyaluronic Acid for the Treatment of Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The clinical trial will be carried out at the Dr. Moh. Hoesin Central Hospital, Palembang and
      planned from October 2022 to March 2023.

      This study aims to compare the efficacy of Platelet Rich Plasma, Conditioned Medium From
      Umbilical Cord Mesenchymal Stem Cell (MSC) Culture Secretome and hyaluronic acid for the
      Treatment of Knee Osteoarthritis
    

Detailed description: 
      In this, prospective, Open-label study, patients with mild to moderate symptomatic knee
      osteoarthritis will be randomized to receive either a series of platelet-rich plasma or
      hyaluronic acid or Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell (MSC) Culture
      Secretome injections under ultrasound guidance. Each of the groups were given 5 times
      injection 3 cc platelet-rich plasma or 2 cc hyaluronic acid or 2cc Conditioned Medium From
      Umbilical Cord MSC Secretome at intervals 1 weeks.

      Clinical data in the form of subjective outcome measures will be collected pre-treatment and
      6 months after injection.
    

Intervention name(s): Platelet-rich Plasma; Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome; Low Molecular Weight Hyaluronic Acid
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Research participants own blood will be used to prepare the platelet rich plasma injectate.; Conditioned Medium UC-MSCs Secretome which will be injected into the affected knee using ultrasound guidance.; low molecular weight hyaluronic acid which will be injected into the affected knee using ultrasound guidance.
Other intervention name(s): PRP; Conditioned Medium UC-MSCs Secretome; HA
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Dexmedetomidine to Postoperative Awakening and Extubation-related Changes in Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The postoperative removal of intubation tube induces a noticeable sympathic response and
      increase of blood pressure. The risk of complications is especially elevated with the
      patients having cardiac surgery. Though sedation inhibits the sympathetic responses to
      extubation, according to the current protocol the propofol infusion has to be discontinued
      well before extubation because of its inhibitory effects on breathing centers.

      Dexmedetomidine is relatively new anesthesia drug. Dexmedetomidine is unique in its
      characteristic that it does not have the paralyzing effect on breathing. The aim of our study
      is to work out whether dexmedetomidine-extended propofol sedation over the extubation
      diminishes the aforementioned harmful effects of the extubation procedure.

      Study design is prospective double-blinded randomized study. The investigators compare two
      groups of 25 patients (total 50), who are of 60-90 years of age and are having either aortic
      valve surgery or the mentioned accompanied with cardiopulmonary bypass operation. The first
      group receives dexmedetomidine infusion and the other receives placebo infusion after the end
      of propofol infusion.

      The specific goal of the study is to figure what haemodynamic - mostly blood pressure related
      - changes can be observed when the postoperatively cut propofol infusion is continued with
      dexmedetomidine over the extubation procedure.

      Our hypothesis is that by using dexmedetomidine supplemented sedation the normally notifiable
      peak in blood pressure may be avoided.

      The study will be carried out completely in Cardiac ICU in Tampere University Hospital.
    


Intervention name(s): Dexmedetomidine; Saline (placebo)
Intervention type(s): Drug; Other
Intervention description(s): Dexmedetomidine will be diluted into a saline solution to a recommended concentration of 4 micrograms per millilitre. The saline will then be initially administered at the rate of 0.5 micrograms/kg/h and from that point the amount will be reduced to the point where the patient breathes well and is calm (compare dexmedetomidine recommendation at 0.2-1.4 ug/kg/h). The infusion rate will then be approximately 1-10 ml/h for a patient of 80 kgs weight. The exact dosage cannot be predetermined because it differs in each individual. In the control group the infusion speed is matching.; Saline placebo infusion will be adjusted the same fashion as the active comparator drug.
Other intervention name(s): Dexdor; Saline 0,9%; Normal saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dexmedetomidine; Postoperative Period; Airway extubation; Systolic Pressure
ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the efficacy of treatment with ADDERALL XR and STRATTERA compared to placebo on
      simulated driving safety and performance of young adults with ADHD as measured by Driving
      Safety Scores derived by the Driving Simulator.
    


Intervention name(s): Mixed salts of a single-entity amphetamine; Atomoxetine hydrochloride
Intervention type(s): Drug; Drug
Other intervention name(s): ADDERALL XR; STRATTERA
Intervention MeSH terms: Amphetamine; Adderall; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Efficacy of PRP Combined With Exercise to Treat Knee Osteoarthritisq
Condition: Platelet-rich Plasma; Physical Exercise; Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Objective. In this study, the investigators aimed to investigate the efficacy of combined a
      single platelet-rich plasma (PRP) and physical exercise (leg swing and quadriceps
      strengthening exercise) versus PRP and hyaluronic acid (HA) combination therapy. Methods. One
      hundred and six patients with grade Ⅱ-Ⅲ Knee osteoarthritis (KOA) according to the
      Kellgren-Lawrence classification were randomly divided into intra-articular injection of PRP
      combined with leg swing and quadriceps strengthening exercise (group A) and intra-articular
      combination injections of PRP and HA (group B). Patients in group A received twice
      intra-articular injection of PRP (2 ml, 2 weeks apart) and regular leg swing and quadriceps
      strengthening exercise for 3 months. Patients in group B received twice intra-articular
      combination injections of PRP (2 ml) and HA (2 ml) every 2 weeks. The primary outcome
      measures were Visual Analogue Scale (VAS) and Western Ontario and McMaster Universities
      (WOMAC) score. The second outcomes included single leg stance test (SLS) and functional
      activity by 2 minutes walking test (2MWT) and time up and go test (TUGT). All outcomes were
      evaluated at baseline and after 1,3,6, and 12 months.
    


Intervention name(s): platelet-rich plasma
Intervention type(s): Drug
Intervention description(s): intra-articular combination injections of platelet-rich plasma and hyaluronic acid or intra-articular combination injections of PRP combined with leg swing and quadriceps strengthening exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Feeding Trial to Determine How Combinations of Different Dietary Bioactive Ingredients Influence High Density Lipoprotein (HDL) Metabolism
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      This study involves measuring subject's blood lipid responses after they consume a mixture of
      dietary fats of marine and dairy origin and vitamin supplements mixed into a milkshake, on
      three separate days. The investigators hope to learn more about how different food
      ingredients influence the metabolism HDL in individuals with low blood levels of HDL
      cholesterol.
    

Detailed description: 
      This study a partial randomized crossover study designed to determine how consumption of
      bioactive dietary ingredients in various combinations on three separate test days influences
      postprandial lipoprotein metabolism in participants with low circulating HDL-cholesterol.

      The dietary ingredients include:

      Dairy phospholipids(PC700); krill oil (K); lutein (L); and Niacin

      Eligible participants will arrive to the University of California Davis (UC Davis), Ragle
      Human Nutrition Center on the morning of each test day after a 10-12-hr overnight fast. Upon
      arrival participants will fill out a questionnaire about their dietary and medication intakes
      and physical activity for the past 72 hours to ensure compliance. Compliant participants'
      weight and blood pressure will be measured and a fasting blood draw will be taken before
      participants consume their test meal in the form of a milkshake (control, PC700KL, PC700KL +
      Niacin). On each test day, participants will be given only this meal and provided with ample
      supply of bottled water.

      Participants will only consume this test meal and water freely for the duration of the test
      day. Blood will be drawn serially at 2 and 4 hours postprandially. Participants will also be
      asked to provide 3 urine samples throughout the study: before and 2, and 4 hours after
      consumption of the milkshake. Participants will be tested on two additional separate test
      days after the first day separated by a two-week washout. The first two test days will be
      randomized, however the third test day will always contain niacin in order to require
      participants remain at Ragle for the first two hours of the study to monitor niacin flushing
      reactions. Participants have the option of participating in two out of three of the test days
      if they wish to exclude themselves from the niacin test day.
    

Intervention name(s): Krill Oil; Lutein; Nicotinic acid; Dairy phospholipids; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Neptune Krill Oil Gold; Jarrow Formulas; Natures Way; PC700 manufactured by Fonterra; Control shake without dietary supplements
Intervention MeSH terms: Nicotinic Acids; Niacin; Niacinamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Single and Multiple Dose Study to Assess How the Drug Enters, Moves Through and Exits the Body, Safety and Tolerability of Safinamide in Healthy Adult Chinese Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single center, single and multiple-dose, open-label, randomised,
      parallel-group, pharmacokinetics, safety and tolerability study. The subjects will be
      randomised into two study cohorts to receive single and multiple doses of 50 mg safinamide
      (cohort 1), or single and multiple doses of 100 mg safinamide (cohort 2) as follows:

      Cohort 1: One safinamide 50 mg film-coated tablet will be administered on day 1 followed by 7
      safinamide 50 mg film-coated tablets in total from day 8 to day 14 and hence administered 1
      tablet orally from day 8 to day 14.

      Cohort 2: One safinamide 100 mg film-coated tablet will be administered on day 1 followed by
      7 safinamide 100 mg film-coated tablets in total from day 8 to day 14 and hence administered
      1 tablet orally from day 8 to day 14.

      The investigational products will be administered in the morning, at 8:00±1hour, under
      fasting conditions, with 240 mL (total volume) of still mineral water. A mouth-and-hand check
      will be performed immediately after dosing to ensure treatment compliance.

      The primary endpoint will assess the pharmacokinetic parameters after single and multiple
      dose administration of the study drug. The secondary endpoint will provide the safety and
      tolerability data after single and multiple dose administration of the study drug.
    


Intervention name(s): Safinamide 50 mg; Safinamide 100mg
Intervention type(s): Drug; Drug
Intervention description(s): Safinamide 50mg film-coated tablets will be administered to subjects in Cohort 1. The subjects will receive the tablets orally in the morning, at 8:00±1hour, under fasting conditions, with 240 mL (total volume) of still mineral water. A mouth-and-hand check will be performed immediately after dosing to ensure treatment compliance.; Safinamide 100mg film-coated tablets will be administered to subjects in Cohort 2. The subjects will receive the tablets orally in the morning, at 8:00±1hour, under fasting conditions, with 240 mL (total volume) of still mineral water. A mouth-and-hand check will be performed immediately after dosing to ensure treatment compliance.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be 2 treatment groups. A total of 24 subjects will be randomized to receive 50mg or 100 mg Safinamide in Period 1 (Day 1) and Period 2 (Days 8 to 14) separated by a 7 days washout period.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic; Safety; Tolerability; Healthy Chinese subjects