bioihbjkbjnl/mcl2 huggingface dataset:
Differential Effects of Zolpidem Versus Ramelteon in Burned Children
Condition: Sleep; Burns
Study type: Interventional
Phase: Phase 2

Summary: 
      To examine sleep changes following therapeutic drug interventions designed to promote sleep.
    


Intervention name(s): zolipidem; ramelteon
Intervention type(s): Drug; Drug
Intervention description(s): zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization; ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
Other intervention name(s): Ambien; rozerem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CPX-351 in Higher Risk Myelodysplastic Syndromes
Condition: Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Study of the efficacy of CPX-351 treatment in patients with higher risk myelodysplastic
      syndromes : as first line treatment or after hypomethylating agents failure
    

Detailed description: 
      A phase I/II study of the efficacy of CPX-351 treatment in patients with higher risk
      myelodysplastic syndromes : as first line treatment or after hypomethylating agents failure.

      CPX-351 is an advanced liposomal formulation of daunorubicin and cytarabine encapsulated at a
      1:5 ratio.

      Patients will receive induction treatment with CPX-351. Patients in response (complete
      response (CR), complete response with incomplete hematologic improvement (CRi), partial
      response (PR)) after induction will receive monthly courses of consolidation therapy with
      CPX-351.
    

Intervention name(s): CPX-351 in cohort A; CPX-351 in cohort B
Intervention type(s): Drug; Drug
Intervention description(s): Treatment by CPX-351 via intravenous infusion over 90 minutes.
Induction treatment with CPX-351 100 Units/m²/D on days 1, 3 and 5.
If response after this induction treatment, 4 courses of consolidation therapy with CPX-351 100 Units/m²/D on day 1.
If no response after this induction treatment, a second induction course of CPX-351 100 Units/m²/D on days 1 and 3. If response is achieved after this salvage course, 3 courses of consolidation therapy with CPX-351 100 Units/m²/D on day1.; Treatment by CPX-351 via intravenous infusion over 90 minutes.
This will be a dose-finding study : CPX-351 100 Units/m²/D on days 1, 3 and 5 or CPX-351 100 Units/m²/D on days 1 and 3 or CPX-351 60 Units/m²/D on days 1 and 3.
In response after induction treatment, 4 monthly courses of consolidation therapy with CPX-351 at the same dose on day 1.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Cohort A: first line treatment Cohort B: after hypomethylating-agents failure
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MDS high risk
The Effect of Dexmedetomidine on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery
Condition: Acute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)
MeSH terms: Acute Kidney Injury
Study type: Interventional

Summary: 
      Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery.
      Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and
      postoperative mortality. Aortic surgery is the most risky surgery that causes the
      postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.

      The α1- and α2-adrenergic receptors in the kidney modulate vasoconstrictor and vasodilatory
      effects, respectively. Agents that attenuate renal vasoconstriction may have potential as
      renoprotective drugs because vasoconstriction most likely contributes to the pathophysiology
      of AKI. Clonidine, an α2-agonist, has been shown experimentally to inhibit renin release and
      cause a diuresis, and it has been evaluated in an experimental AKI model, confirming its
      potential as a renoprotective agent. Furthermore, it has been already reported that
      dexmedetomidine, α2-agonist, reduce the impairment of renal function after cardiac operation.

      The aim of this study is to examine the association between preoperative dexmedetomidine
      infusion and the incidence of postoperative acute kidney injury(AKI) in patients undergoing
      aortic surgery.
    


Intervention name(s): dexmedetomidine; saline
Intervention type(s): Drug; Drug
Intervention description(s): Immediately after the induction of anesthesia, patients in the dexmedetomidine group received dexmedetomidine continuous intravenous (IV) infusion of 0.4 mcg/kg/h until 24 hours after surgery.; same infusion rate (received equal volume of normal saline), IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy and Safety of CD5024 1% in Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using
      intra-individual comparison involving subjects with acne vulgaris on face to evaluate the
      efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.
    

Detailed description: 
      Study drugs application will be performed once daily, 5 days a week during 6 weeks
    

Intervention name(s): CD5024 1% cream; CD5024 cream placebo; CD0271/CD1579 gel; CD0271/CD1579 gel placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 500 µL on half-face, five days a week during 6 weeks; 500 µL on half-face, five days a week during 6 weeks; 500 µL on half-face, five days a week during 6 weeks; 500 µL on half-face, five days a week during 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Modulating the Locus Coeruleus Function
Condition: Healthy Aging
Study type: Observational

Summary: 
      The purpose of this study is to investigate the impact of transcutaneous vagus nerve
      stimulation (tVNS) on specific brain regions involved in memory and attention processes.

      tVNS is a non-invasive and non-pharmacological technique known for targeting the locus
      coeruleus, a small subcortical nucleus in the brain thought to be involved in the earliest
      stages of Alzheimer's disease. This nucleus also plays a role in numerous cognitive
      functions, comprising memory and attention.
    

Detailed description: 
      This study is an observational MRI study with a pseudo-randomized single blind cross-over
      design. The population consists of 30 healthy human volunteers from 60 to 80 years old. These
      healthy older individuals will be recruited from the community.

      After being informed about the study protocol and the potential risks, subjects will be given
      1 week to consider their participation.

      All participants giving written informed consent will be included in the study. The first
      session will consist in neuropsychological assessments and a task practice session in the
      dummy scanner in order to get familiar with the environment. Participants meeting the
      eligibility criteria will be included for the next sessions.

      The second and third sessions are MRI scanning sessions including transcutaneous vagus nerve
      stimulation. Both the placebo and experimental stimulation conditions will be randomized in a
      single-blind manner across scanning sessions.

      About 7 to 10 weeks after each scanning session and at least 4 days previous to the next MRI
      session, participant will be asked to fill in an online memory test for assessing potential
      outlasting effects of the stimulation technique.
    

Intervention name(s): Transcutaneous vagus verne stimulation
Intervention type(s): Device
Intervention description(s): Non-invasive and short electrical stimulation by placing the stimulating electrode at the cymba conchae of the left ear. The reference electrode is placed near the left cymba conchae. It provides a light tingling, massaging feeling in the ear.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy older individuals participating in the study will be recruited from the community.
      
Keywords: Healthy aging; Transcutaneous vagus nerve stimulation; Magnetic resonance imaging; Locus coeruleus; Memory and attention
Prospective Randomized Trial Comparing Two Techniques of Sleeve Gastrectomy
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      This study compares if there is any difference doing antrectomy while performing a sleeve
      gastrectomy for treating morbid obesity. The investigators compare the differences between
      leaving or not leaving the antrum in terms of food tolerance, weight lost and quality of
      life.
    


Intervention name(s): Sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): Perform a gastrectomy guided by a 38F catheter and parallel to the small curvature of the stomach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Morbid obesity; High risk
Validity of the Kinematic Classification of Gait in Diplegic Children With Cerebral Palsy (CP)
Condition: Cerebral Palsy; Diplegia, Spastic
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      In recent years Ferrari et al. proposed a new classification of gait in diplegic children
      with spastic diplegia that describes four different patterns of gait by analyzing the
      strategies that each children adopts to need his/her needs to walk. The investigators believe
      that this classification provides the clinician with clinically meaningful information in
      terms of coping strategies adopted to maximize the ability to walk.

      The aim of this study is to determine the criterion validity of the new classification of the
      pattern of gait in children with spastic diplegia by correlating pattern of diplegic gait
      with the score of the Functional performance measure.
    


Intervention name(s): classification of gait in diplegic children with CP
Intervention type(s): Other
Intervention description(s): To determine the criterion validity of the classification of the pattern of diplegic gait proposed by Ferrari et al. we correlated gait patterns with the score of the FMS.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We retrospectively studied children with diplegia and CP who are followed by the Unit for
        Severe Disability in the Developmental Age at the Hospital of Reggio Emilia (Italy);
      
Keywords: Cerebral palsy; diplegia; gait; classification
Intravesicular Onabotulinumtoxin A in Interstitial Cystitis
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to identify the optimal usage of Onabotulinumtoxin A in
      interstitial cystitis. Onabotulinumtoxin A, more commonly known by the trade name Botox®, is
      a medication that comes from the bacteria Clostridium botulinum. It works by blocking the
      release of the neurotransmitter acetylcholine(a chemical messenger that carries signals
      between nerve cells and other cells in the body). Blocking that neurotransmitter results in
      decreased muscle activity.
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy of intravesicular Onabotulinumtoxin A
      injections for the treatment of interstitial cystitis (IC). Specifically, we hypothesize that
      trigonal Onabotulinumtoxin A injections is an effective treatment for IC and will result in
      more subjective and objective symptom relief than posterior wall Onabotulinumtoxin A
      injections.
    

Intervention name(s): Onabotulinumtoxin A; injections upper aspect of trigone of urinary bladder; injections on posterior bladder wall excluding the trigone
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): 100 units of botox spread out among 10 separate injections; We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.; We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
Other intervention name(s): Botox
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: women; interstitial cystitis; bladder pain syndrome; botox; onabotulinum toxin A
Evaluation of the Role of Propionibacterium Acnes in the Inflammatory Lesions Associated With Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Observational

Summary: 
      The purpose of this study is to determine the response of acne patients and healthy control
      patients to the P. acnes bacteria. Half a tube of blood will be drawn from all participants
      to determine whether or not they have antibodies to the P. acnes bacterium. Anywhere from 1
      to 4 skin biopsies of acne pimples or normal control skin will be taken from all subjects for
      further analysis in the lab to determine whether the inflammation in these pimples can be
      reduced using anti-P.acnes antibodies.
    


Intervention name(s): Skin biopsy; Blood draw
Intervention type(s): Procedure; Procedure
Intervention description(s): 4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls); Approximately half a tube of blood will be drawn from all participants in the study
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        community sample
Effect of Intravenous Infusion of Lidocaine on Patients Undergoing Radical Resection of Colorectal Tumors
Condition: Colorectal Tumors; Lidocaine
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Colorectal cancer (CRC) is one of the most common malignant tumors in the world. Surgical
      resection is the main treatment option for colorectal cancer patients. Surgery may enhance or
      accelerate tumor recurrence and metastasis. Multiple factors in the tumor microenvironment
      play important roles in tumor recurrence and metastasis, and modulating the tumor
      microenvironment can inhibit disease progression. Lidocaine has been found to inhibit tumor
      growth in animal experiments.
    

Detailed description: 
      Lidocaine was applied in the operation of colorectal tumor patients, and the effect on the
      postoperative microenvironment and micrometastasis of the patients was observed by detecting
      the stress, immunity, vascular tumor regeneration, inflammation, etc. of the patients.
    

Intervention name(s): Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operation
Intervention type(s): Drug
Intervention description(s): Administer 1.5 mg/kg lidocaine
Other intervention name(s): same volume of saline
Intervention MeSH terms: Anesthetics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Radical resection of colorectal tumor; lidocaine; stress; immunity; vascular tumor regeneration; inflammation; micrometastasis
7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects
      with Chronic Obstructive Pulmonary Disease (COPD).
    


Intervention name(s): TD-4208; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): revefenacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Long acting muscarinic antagonist; Chronic Bronchitis; Emphysema; Chronic Obstructive Pulmonary Disease; COPD
GSK1349572 Exposure in Blood, Seminal Fluid, and Rectal Fluid and Tissue in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to describe drug concentrations in blood plasma, rectal fluid,
      rectal tissue, and seminal fluid in HIV negative men following single and multiple doses of
      an investigational HIV medication known as GSK1349572 (dolutegravir).
    

Detailed description: 
      The purpose of this study is to determine first dose and steady-state concentrations of
      GSK1349572 in seminal fluid, rectal mucosal fluid, and rectal tissue compared to blood plasma
      (BP) in HIV-1 negative males. GSK1349572 is an investigational next generation integrase
      inhibitor currently in Phase III trials. Understanding the concentrations of GSK1349572 in
      multiple male biological compartments will inform its role in preventing HIV infection by
      making an HIV-infected person less likely to transmit the virus, and protecting uninfected
      persons from acquiring the virus.
    

Intervention name(s): dolutegravir
Intervention type(s): Drug
Intervention description(s): Subjects will take a GSK1349572 (dolutegravir) 50mg tablet by mouth once daily for 8 days. GSK1349572 concentrations will be measured in blood plasma, seminal fluid, rectal fluid, and rectal tissue over 24 hours after a single dose and over two 24 hour periods once steady state is reached. Blood plasma will be collected pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24 hours after dosing. Each subject will also provide a total of 9 seminal and rectal fluid samples and have 2 rectal tissue biopsies performed pre-dose or at 1, 3, 6, 12, 18, or 24 hours after receiving single or multiple doses.
Other intervention name(s): GSK1349572; DTG
Intervention MeSH terms: Dolutegravir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Male; GSK1349572; Dolutegravir; DTG; Integrase; HIV
Biomarkers of the Response to Osteopathic Manipulation
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to identify non-invasive biomarkers of the physiologic response
      to Osteopathic Manipulative Treatment (OMT).
    


Intervention name(s): Osteopathic Manipulation; Placebo
Intervention type(s): Other; Other
Intervention description(s): Standardized rib raising protocol; Light touch control procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: OMT; biomarker; Manipulation, osteopathic
The Vascularity Changes of Scars With Laser Therapy
Condition: Hypertrophic Scar
MeSH terms: Hypertrophy; Cicatrix, Hypertrophic
Study type: Interventional

Summary: 
      The purpose of this study is to explore the effects of pulsed dye laser on managing scar
      vascularity and thickness.
    

Detailed description: 
      The pulsed dye laser is increasingly used in clinical settings to manage scars and shows
      promising outcomes.The pulsed dye laser targets at micro-vascular structures in scar tissues.
      This study aims to explore the vascularity changes in scars with pulsed dye laser during the
      scar formation process.
    

Intervention name(s): pulsed dye laser; standardized care
Intervention type(s): Device; Other
Intervention description(s): The scar will receive PDL 585 nm using a 7 mm spot size. First treatment will be within 1 year post injury.; the scar will receive standardized care such as scar massage.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypertrophic scar; pulsed dye laser
Safety and Tolerability of AQW051 in Elderly Healthy Volunteers.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety and tolerability of AQW051 administered in
      single and multiple doses to elderly healthy volunteers. In addition, pharmacokinetic effects
      will be assessed and the possible effects on cognition.
    


Intervention name(s): AQW051
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Single-rising dose , multiple rising dose, elderly, cognitive, , pharmacokinetic, impairment.; Healthy elderly male and female subjects
A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants
Condition: Healthy Participants
Study type: Observational

Summary: 
      The purpose of this study is to develop taste profiles of iberdomide and mezigdomide drug
      substances and oral formulation prototypes in order to develop a pediatric oral form of
      iberdomide and mezigdomide.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of healthy volunteers who are qualified based on training
        and experience in performing taste evaluations.
Phase II HDM-SPIRE Safety and Efficacy Study
Condition: Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the treatment effect of three treatment regimens of
      HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue
      medication usage, Quality of Life and Sleep Quality
    


Intervention name(s): HDM-SPIRE; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 dose every 4 weeks; 1 dose every 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cat allergy; Rhinoconjunctivitis