bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Pharmacokinetics and Pharmacodynamics of MK1809 (1809-001)(COMPLETED)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to identify at least one safe and well tolerated dose of MK1809
      that has similar pharmacokinetic qualities as 100 mg losartan.
    


Intervention name(s): MK1809; Comparator: Losartan; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single oral doses of MK1809; single oral doses of 100 mg Losartan; Placebo to MK1809
Other intervention name(s): Losartan
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension
Hypothermia Risk With Continuous Renal Replacement Therapy
Condition: Acute Kidney Injury; Hypothermia
MeSH terms: Acute Kidney Injury; Hypothermia
Study type: Interventional

Summary: 
      The present study aims at testing if the TherMax blood warmer is more accurate and reliable
      in reaching and maintaining chosen target temperature during continuous renal replacement
      therapy as compared to the Prismaflo IIS blood warmer used for the PrismaFlex system.
    

Detailed description: 
      Blood warming devices during continuous renal replacement therapy (CRRT) have not been
      adequately tested.

      The novel TherMax blood warmer for the newly introduced PrisMax System heats blood and
      replacement solutions via a dry heat plate system. In contrast, the PRISMAFLO IIS Blood
      Warmer for PRISMAFLEX System uses an electric heating sleeve on a standard CRRT filter set.

      Data on adverse events (AE) during continuous renal replacement therapy (CRRT) has been
      studied and one of the most common AE was hypothermia, reported in 44% of all cases.

      The present study aims at testing if the TherMax blood warmer is more accurate and reliable
      in reaching and maintaining chosen target temperature during CRRT as compared to the blood
      warmer used for the PrismaFlex system.
    

Intervention name(s): Thermax Blood Warmer
Intervention type(s): Device
Intervention description(s): Patients will be their own controls: Prior to-, during-, and after Thermax blood warming.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The investigators will assess body temperature before-, during- and after Thermax blood warming treatment. Patients are essentially their own controls.
Moreover, we will use historic data on the previous blood warmer for the Prismaflex device to assess temperature changes.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: continuous renal replacement therapy
Medicinal Dependence and Chronic Pain: Addictive Evaluation in CETD
Condition: Opiate Dependence; Chronic Pain
MeSH terms: Chronic Pain; Opioid-Related Disorders
Study type: Observational

Summary: 
      prescription opioid misuse in chronic pain is a growing public health concern. few studies
      got interested in prevalence of misuse and of opiate use disorder in a population of patients
      with a non cancer chronic pain.

      the investigators analyzed during 3 months opiate misuse and opiate ude disorder in a
      population of patients consulting a center specialized in pain management.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        analysis of SUD criteria in a population with a chronic pain (non cancer) , consulting a
        center specialized in pain mangement
A Cost Effectiveness Analysis of Robotic Versus Laparoscopic Distal Pancreatectomy
Condition: Surgery
Study type: Observational

Summary: 
      This is a clinical and cost-effectiveness analysis within a retrospective comparative study
      of RDP and LDP conducted at Sanchinarro University Hospital from 2011 to 2017. Outcome
      parameters included surgical and post-operative costs, quality adjusted life years (QALY),
      and incremental cost per QALY gained or the incremental cost effectiveness ratio (ICER). A
      sensitivity analysis was carried out in order to propagate the uncertainty of the estimations
      to the results of the model. The investigators use a multivariate and stochastic sensitivity
      analysis performed by 5000 Monte Carlo simulations. The cost-effectiveness plane was used to
      represent all pairs of solutions of the model.
    


Intervention name(s): Da Vinci
Intervention type(s): Device
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study was carried out at the General Surgery Department of Sanchinarro University
        Hospital of Madrid.

        Details of the procedure have been described in a previous report and standardized in both
        groups. RDP was performed using a da Vinci Robotic Surgical System model Si and Xi
        (Intuitive Surgical, Sunnyvale, CA, USA) (8). All consecutive cases were conducted by the
        same group of 6 surgeons all with considerable experience in both laparoscopic and robotic
        approaches.

        Patients (aged over 18 years) with benign or malignant mass without evidence of major
        vessel involvement were included and assigned either to RDP or LDP, depending on the
        availability of the robot. The indication for resection was given in the context of a
        multidisciplinary institutional committee.
      
Keywords: Cost-effectiveness; Pancreatectomy; Willingness to pay; Robotic
Safety and Efficacy of Two Types of Botulinum Toxin Type A For the Treatment of Glabellar Lines
Condition: Glabellar Lines
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the safety and efficacy of two different types of botulinum toxin
      type A for the treatment of glabellar frown lines.
    


Intervention name(s): botulinum toxin type A; botulinum toxin type A
Intervention type(s): Biological; Biological
Intervention description(s): 20 units (total dose) botulinum toxin type A injected into glabellar region on Day 0; 30 units (total dose) botulinum toxin type A injected into glabellar region on Day 0
Other intervention name(s): Vistabel®; BOTOX® Cosmetic; Bocouture®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Closed-loop Control of Vasopressor Administration in Cardiac Surgery
Condition: Hemodynamic MAP Stability
Study type: Interventional

Summary: 
      Intraoperative hypotension and blood pressure variability are associated with postoperative
      complications in surgical patients.

      The investigators have developed a closed-loop vasopressor (CLV) controller that titrates
      norepinephrine to correct hypotension.

      After having tested the system in a small cohort series of patients undergoing major
      surgeries, the investigators aimed to test the feasibility of the CLV controller in three
      high risk patients undergoing cardiac surgery
    

Detailed description: 
      The investigators have recently developed an automated closed-loop vasopressor (CLV)
      controller to better titrate vasopressor (e.g:norepinephrine) to maintain MAP within a narrow
      range (±5mmHg of the chosen target).

      The investigators published engineering, animal studies and recently described the
      feasibility of titration of norepinephrine in 20 patients undergoing major noncardiac
      procedures. This initial cohort human study showed the controller was able to keep patients
      within ± 5 mmHg of a target pressure for more than 90% of management time. Cardiac surgery
      represents unique challenges in MAP management as the manipulation of the heart itself, the
      use of cardiopulmonary bypass (CPB) and cardioplegia, and the pre-existing cardiac disease
      all increase the difficulty in maintaining a steady MAP throughout the surgical period.

      In this case series the investigators describe three cardiac surgical procedures managed with
      the CLV system (one coronary artery bypass graft (CABG) procedure done under CPB; one robotic
      minimally invasive direct coronary artery bypass (MIDCAB) procedure (through a
      mini-thoracotomy), and one off-pump CABG) in order to assess its feasibility, efficiency and
      behavior in three high-risk patients before starting a randomized controlled trial.
    

Intervention name(s): closed-loop system for vasopressor administration
Intervention type(s): Device
Intervention description(s): closed-loop system for vasopressor administration
Intervention MeSH terms: Vasoconstrictor Agents
Intervention model: Single Group Assignment
Intervention model description: Closed-loop system to titrate vasopressor
Masking: None (Open Label)
Primary purpose: Other
A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers
Condition: Gastritis; Gastric Ulcer
MeSH terms: Gastritis; Stomach Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      The Purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation
      clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food
      effect of PMK-S005 after oral administration in healthy male volunteers.
    


Intervention name(s): PMK-S005
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Omega-3 Fatty Acid on Cortical Function in ADHD
Condition: Attention Deficit Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The study hypothesis is that DHA is more effective than placebo in increasing brain
      activation and reducing symptoms in psychostimulant-free children with ADHD.
    

Detailed description: 
      This study aims to determine the effects of 10-week dietary supplementation with the
      long-chain omega-3 fatty acid docosahexaenoic acid (DHA) or placebo on prefrontal cortical
      structural and functional connectivity using several neuroimaging techniques: DTI (Diffusion
      Tensor Imaging), 1H MRS(Proton Magnetic Resonance Spectroscopy), and fMRI (Functional
      Magnetic Resonance Imaging) in psychostimulant-free children with attention deficit
      hyperactivity disorder (ADHD). It is postulated that DHA supplements will increase brain
      activation and reduce ADHD symptomatology.
    

Intervention name(s): DHA Omega-3; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 10 weeks; corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)
Other intervention name(s): Docosahexaenoic acid; Omega 3 Fatty Acids; Inactive drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD
The Efficacy and Safety of CC-10004 in Chronic Cutaneous Sarcoidosis
Condition: Sarcoidosis; Cutaneous Sarcoidosis
MeSH terms: Sarcoidosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To determine whether CC-10004, a phosphodiesterase inhibitor, is useful in treating chronic
      cutaneous sarcoidosis.
    

Detailed description: 
      This will be an open label, phase II trial of CC-10004 for chronic cutaneous sarcoidosis. It
      will include two centers (University of Cincinnati and Medical University of South Carolina).
      The study will evaluate patients with chronic disease who are on a stable treatment regimen
      and have no significant change in their Sarcoidosis Skin Activity and Severity Index score
      (SASI) at two visits at least one month apart.
    

Intervention name(s): CC-100004
Intervention type(s): Drug
Intervention description(s): After the screening period, subjects will receive CC-10004 20mg by mouth BID for 84 days. The 84-day duration of treatment is expected to provide adequate time to assess the short-term efficacy and safety of CC-10004 in a population of subjects with chronic cutaneous sarcoidosis.
Other intervention name(s): Aprelimast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sarcodiosis; tumor necrosis factor
Endostar and/or Cisplatin for Treatment of Malignant Pleural Effusion or Ascites
Condition: Malignant Pleural Effusion; Malignant Ascites
MeSH terms: Pleural Effusion, Malignant; Pleural Effusion; Ascites
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to compare the efficacy of Endostar/cisplatin with cisplatin
      alone or Endostar alone in patients with malignant pleural effusion or ascites.
    


Intervention name(s): Endostar; Cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): intrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles; cisplatin 40 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles
Intervention MeSH terms: Cisplatin; Endostar protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Patients With Hepatic Impairment and Healthy Subjects
Condition: Solid Tumors
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244,
      ARRY-142886) in patients with hepatic impairment and healthy subjects.
    

Detailed description: 
      An open label study to assess the pharmcokinetics, safety and tolerability of a single dose
      of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy
      subjects.
    

Intervention name(s): Selumetinib 50mg; Selumetinib 25mg
Intervention type(s): Drug; Drug
Intervention description(s): HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1; Severe (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I, healthy, pharmacokinetic, hepatic impairment
Large Scale ICU Data Sharing for 1000 Critically Ill Patients With Severe Acute Respiratory Distress Syndrome Coronavirus (SARS.COV19) in Three Distinct Isolation Centers
Condition: Median Nerve Entrapement
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Observational [Patient Registry]

Summary: 
      Cohort study of patients with severe respiratory distress syndrome coronavirus2 in three
      different isolation hospitals recording data about outcome.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COVID positive patients
      
Keywords: neuropathy
Fluzoparib in Patients With Metastatic Non-clear Cell Renal Cell Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial aims to prospectively assess the safety and efficiency of Fluzoparib in metastatic
      non-clear cell renal cell carcinoma
    


Intervention name(s): Fluzoparib
Intervention type(s): Drug
Intervention description(s): Fluzoparib
Intervention MeSH terms: Fluzoparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys
Condition: Growth Problem; Low Weight; Short Stature
MeSH terms: Dwarfism
Study type: Interventional

Summary: 
      Study design:

      Double blind, randomized, placebo controlled study. Participants will be randomly assigned
      either to the intervention group or the placebo control group. Randomization for the two
      study groups will be made in a ratio of 1:1.

      The primary objective of the study is to assess the effect of 6-12 months treatment with
      nutritional supplementation standardized formula, in short and lean boys adolescents on
      weight Standard Deviation Score (SDS) and height SDS The Secondary Objectives of the study
      are to assess the effect of 6-12 months treatment with nutritional supplementation
      standardized formula, in short and lean boys adolescents on BMI SDS, growth velocity, time to
      puberty, quality of life and self-esteem The study will continue for 6 months of intervention
      versus active placebo, with additional optional 6 months (an extension period), in which
      participants at both groups, the intervention and the placebo, will be offered to continue
      their participation in the study with the study supplement. All analyses of the effect's on
      primary and secondary outcome measurements will take into account the consumption rate of the
      study formula/placebo
    


Intervention name(s): Nutritional supplementation standardized formula; Placebo comparator
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Powder added to water, containing about 25% of recommended DRI for Calories, high protein (25% of calories) and multi vitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake ); Low caloric formula (Powder added to water), without added vitamins and minerals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Community-based Physical Fitness Exercise on the Older Adults' Functional Fitness and Adherence to Physical Activity
Condition: Older Adult
Study type: Interventional

Summary: 
      Maintaining adequate physical activity (PA) and regularly exercising are very important to
      promote the good physical and mental health of the elderly. According to the transtheoretical
      model (TTM) framework, previous research studies have formulated many strategies to promote
      exercise behaviors, such as incentive strategies, combines municipal resources and links up
      with the referral of primary care institutions, or including patients in the decision-making
      process about exercise choices to enable patients to have greater autonomy. In addition, in
      terms of the strategic aspects of achieving goals, competitive incentives are also an
      effective strategy. Therefore, this study aims to find out the effects of the community-based
      physical fitness exercise course, which is given according to TTM, on improving functional
      fitness and exercise persistence of the older adults.
    


Intervention name(s): Structural exercise course; Autonomous group class
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12-week structured exercise class, team competition, social support, and incentive strategy; 12-week autonomous group class, team competition, social support, and incentive strategy
Intervention model: Single Group Assignment
Intervention model description: This is a single group trial, according to the pre-test result of the exercise stage of the change questionnaire, they were divided into the maintenance phase group (MP, N=15) and under the maintenance phase group (MPb, N=15). All subjects joined the community-based physical fitness exercise course for 24 weeks. To quantify the effect of this intervention method on functional fitness and exercise persistence of the elderly, this study analyzed the related exercise behavior changes of MPb and MP elderly.
Masking: None (Open Label)
Primary purpose: Basic Science
Factor Analysis of Unintended Initial Dissection of the Posterior Plane
Condition: Myopia; Small-incision Lenticule Extraction (SMILE) Surgery
MeSH terms: Surgical Wound
Study type: Observational

Summary: 
      To explore the potential factors for unintended initial dissection of the posterior plane in
      a large sample retrospective analysis and surgeons of different levels.
    

Detailed description: 
      Myopia is the most common eye disease in the world. Femtosecond laser small incision lens
      extraction (SMILE) has increasingly become the first choice in refractive surgery due to its
      greater biomechanical stability, less impact on the tear film and other advantages. However,
      because SMILE surgery is more challenging than flap-based corneal ablative surgery, young
      surgeons sometimes dissect the lenticule posterior plane first in clinical practice, which
      will make it more difficult to extract the lenticule or even cause the retained lenticule.
      The purpose of this study aims to explore the potential risk factors for unintended initial
      dissection of the posterior plane in large samples and surgeons of different surgical volumes
      and different surgical habits (different angles of peripheral corneal incision) in multiple
      scenarios.
    

Intervention name(s): Small incision lenticule extraction
Intervention type(s): Procedure
Intervention description(s): Small incision lenticule extraction surgeries performed by two Refractive surgery experts (Refractive surgery expert 1: YYF, Associate Professor with 10 years of experience as a refractive surgeon; Refractive surgery expert 2: GF, Associate Professor with 5 years of experience as a refractive surgeon) and a Attending ophthalmologist (WNY, Attending ophthalmologist with 1 year of experience as a refractive surgeon).
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients from clinics in ophthalmic center of the second Affiliated Hospital of Nanchang
        University
      
Keywords: femtosecond laser; small-incision lenticule extraction (SMILE); unintended initial dissection of the posterior plane
Cognitive Behavioral Intervention in Diabetes Self-Management
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The proposed study is a two arm randomized controlled trial with longitudinal follow-up that
      compares cognitive behavioral interventions (ENHANCE) to a control group with attention. The
      experiment will consist of a repeated measure 2 X 3 design; Condition (Experiment vs.
      Control) by Time (Pre, Post, Follow Up).
    


Intervention name(s): Cognitive behavioral training
Intervention type(s): Behavioral
Intervention description(s): The behavioral training group will be involved six group sessions focusing on cognitive behavioral training for stress and mood management, cognitive restructuring, empowerment, values clarification, problem solving and decision making via a manualized program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Type 2 Diabetes; Asian Pacific Islanders; Cognitive behavioral intervention