bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Between Transcranial Stimulation Protocols With Continuous Current in the Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      This study aims to compare the effects of transcranial direct current stimulation on the
      clinical and cognitive function in patients with chronic migraine.
    

Detailed description: 
      The patients will be randomized into 1 of 3 groups: active tDCS for 15 minutes, active tDCS
      for 15 minutes, with an interval of 20 minutes and more 15 minutes os stimulation, sham tDCS
      for 15 minutes. The tDCS will be applied for 10 days over 2 weeks.
    

Intervention name(s): tDCS
Intervention type(s): Other
Intervention description(s): Transcranial Current Stimulation equipment consists of an ammeter (measured with current intensity), a potentiometer (voltage controller between the electrodes), a generator (two 9-volt batteries) and two electrodes (anode and cathode). The direct low-amplitude currents released by the electrodes reach the cortex and modify the neuronal potentials.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be randomized into 1 of 3 groups:
group A: active tDCS for 15 minutes, group B: active tDCS for 15 minutes, with an interval of 20 minutes and group C: more 15 minutes os stimulation, sham tDCS for 15 minutes.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcranial Direct Current Stimulation; Migraine Disorders; Cognitive Symptoms
Drug Delivery Via Pressurized Metered-dose Inhaler and Valved Holding Chamber in Asthmatic Children: Determination of Delivered Dose Following Coordinated and Uncoordinated Use
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The primary objective of this study is to determine ex vivo the amount of fluticasone
      deposited onto a filter (delivered dose) interposed between the OptiChamber Diamond Valved
      Holding Chamber (VHC) mouthpiece and the subject's mouth during coordinated and uncoordinated
      actuation/inhalation maneuver.
    


Intervention name(s): Pressurized Metered-Dose Inhaler
Intervention type(s): Device
Intervention description(s): Pressurized Metered-Dose Inhaler
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        40 subjects aged 5-8 diagnosed with asthma
      
Keywords: pediatric; asthma; metered dose inhaler; valved holding chamber; pMDI; VHC
Robotic Versus Conventional Training on Hemiplegic Gait.
Condition: Stroke
MeSH terms: Stroke; Gait Disorders, Neurologic
Study type: Interventional
Phase: Phase 3

Summary: 
      The incidence of stroke in the industrial world is still high. Most of the patients are
      suffering from paresis of the affected side, speech and cognition problems. Modern concepts
      of motor learning after stroke favouring a task-specific repetitive high-intensity therapy
      approach to promote motor outcome. In the last couple of years robot-assisted therapy became
      an important part of modern rehabilitation after stroke. But so far there is no clear
      evidence that robot assisted therapy in combination with conventional therapy is more
      effective than conventional therapy alone to promote motor functions after stroke.
    


Intervention name(s): conventional therapy; conventional plus robotic gait assisted therapy
Intervention type(s): Behavioral; Device
Intervention description(s): conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks; individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy
Other intervention name(s): Gait trainer GT1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; rehabilitation; gait training; robot-assisted therapy
MRI of Glymphatic Clearance During Anesthetic Sedation
Condition: Glymphatic Flow
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is to assess the effect of dexmedetomidine anesthesia on glymphatic flow in 5
      healthy human subjects as visualized by diffusion tensor MRI. The study is designed to
      measure clinically established, safe imaging of DTI and cerebral blood flow at baseline,
      during a continuous intravenous infusion of dexmedetomidine at doses designed to produce
      anesthesia-induced unconsciousness to simulate natural sleep, and again on return to
      wakefulness.
    

Detailed description: 
      Objective:

      The purpose of this study is to assess the effect of dexmedetomidine anesthesia on glymphatic
      flow in human subjects as visualized by diffusion tensor MRI.

      Study Design:

      This study will take place at the University of Pennsylvania. Investigators plan to enroll
      approximately 30 healthy volunteers to generate pilot data for a larger grant submission.

      Characteristics of the Study Population:

      Subjects will be healthy males or females aged 20 to 40 years of age who will be recruited to
      participate in an MRI scan designed to measure clinically established, safe imaging of
      diffusion tensor imaging and cerebral blood flow at baseline, during a continuous intravenous
      infusion of dexmedetomidine at doses designed to produce anesthesia-induced unconsciousness
      to simulate natural sleep, and again on return to wakefulness. They must be able to pass the
      standard MRI safety assessment (e.g., no metallic metal clips or implants or any other
      contraindications to undergoing an MRI).

      Design:

      Upon successful completion of screening questionnaire, urine drug, and urine pregnancy
      subjects will be scheduled for an MRI. On the day of the study subjects will receive an
      intravenous catheter (IV) for study drug and fluids. Set one of MRI scans will be done with
      no dexmedetomidine. Set two of scans will be done when subject is anesthetized with
      dexmedetomidine with the goal depth of sedation will be moderate sedation. Set three of scans
      will be done when dexmedetomidine is stopped and wakefulness is achieved.
    

Intervention name(s): Brain connectivity and physiology; Dexmedetomidine
Intervention type(s): Other; Drug
Intervention description(s): MRI to measure glymphactic flow during simulated natural sleep and again on return to wakefulness.; Administering of 0.5-1.0 mcg/kg/hr of dexmedetomidine to ensure subject's loss of consciousness.
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Human Brain; Magnetic Resonance Imaging (MRI); Dexmedetomidine; Cerebral blood flow
Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Acute Viral Conjunctivitis
Condition: Conjunctivitis, Viral
MeSH terms: Conjunctivitis, Viral; Conjunctivitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the evolution of the symptoms of acute viral
      conjunctivitis using preservative free ketorolac trometamol 0.45% associated with
      carboxymethylcellulose compared with isolated use of preservative-free artificial tears.
    

Detailed description: 
      The purpose of this study is to evaluate the evolution of the symptoms of acute viral
      conjunctivitis using preservative free ketorolac trometamol 0.45% associated with
      carboxymethylcellulose compared with isolated use of preservative-free artificial tears. A
      randomized double-masked study will include 60 patients divided into two groups: Group 1:
      using a formulation of ketorolac tromethamine 0.45% associated with carboxymethylcellulose
      (Acular CMC®, Allergan, Irvine, USA) and Group 0: using artificial tears (Optive UD®,
      Allergan, Irvine, USA), both drugs without preservatives.
    

Intervention name(s): Ketorolac trometamol 0.45% with carboxymethylcellulose; Preservative free artificial tear
Intervention type(s): Drug; Drug
Other intervention name(s): Acular CMC®, Allergan, Irvine, USA; Optive UD®, Allergan, Irvine, USA
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Carboxymethylcellulose Sodium; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Conjunctivitis, Viral; Ketorolac; Artificial tears
Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open-label, fixed sequence, drug-drug interaction (DDI) study in
      healthy subjects.
    

Detailed description: 
      Following a 28-day Screening period, eligible subjects will enter the clinical research unit
      (CRU) and will be enrolled into either Cohort A or B. Subjects in both cohorts will receive a
      single dose of ecopipam on Day 1. On Day 7, subjects will begin taking a UGT inhibitor
      according to their assigned cohort. Subjects in Cohort A will receive mefenamic acid 250 mg
      every 6 hours for 7 days, while subjects in Cohort B will receive divalproex sodium ER 1250
      mg once a day for 10 days. A single oral dose of ecopipam will also be administered to Cohort
      A on Day 7, 1 hour after the first dose of mefenamic acid, and to Cohort B on Day 10, 1 hour
      after administration of divalproex sodium ER. Subjects in Cohort A will continue taking
      mefenamic acid through the evening of Day 13 and will remain in the CRU until discharged on
      Day 14/ET. Subjects in Cohort B will continue taking divalproex sodium ER through Day 16 and
      will remain in the CRU until discharge on Day 17/ET.
    

Intervention name(s): ecopipam HCL; Mefenamic acid; Divalproex Sodium ER
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral tablets; oral capsules; oral tablets
Intervention MeSH terms: Mefenamic Acid; Valproic Acid; Ecopipam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Single Dose Study With 4SC-203 in Healthy Volunteers
Condition: Acute Myeloid Leukemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single
      dose administration in healthy volunteers.
    


Intervention name(s): 4SC-203; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): i.v. administration; i.v. administration
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: 4SC-203; Phase I; single dose; healthy volunteers
Study of Doxorubicin in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer
Condition: Breast Cancer and Ovarian Cancer
MeSH terms: Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a randomized, multi centre, open label, two treatment, two period, two sequence,
      single dose, crossover study, with at least 28 days washout between doses, conducted under
      fed (normal breakfast) conditions.
    


Intervention name(s): SPARC-08-038; Ref-08-038
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg/ml intravenous infusion; 2 mg/ml intravenous infusion
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Efficacy of Pioglitazone/Metformin Combination Therapy in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia.
Condition: Diabetes Mellitus; Dyslipidemias
MeSH terms: Diabetes Mellitus; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare pioglitazone and metformin combination therapy, twice
      daily (BID), to glimepiride and metformin combination therapy for treating diabetic subjects
      with dyslipidemia.
    

Detailed description: 
      Insulin resistance is a major endocrinopathy preceding the development of hyperglycemia,
      diabetic dyslipidemia and cardiovascular disease in type 2 diabetes. The most common pattern
      of dyslipidemia in patients with type 2 diabetes are elevated triglyceride levels, decreased
      hih-density lipoprotein cholesterol and a predominance of small dense low-density lipoprotein
      particles. Each of these dyslipidemia features is associated with an increased risk of
      cardiovascular events.

      Pioglitazone and Metformin are established drugs which can be used for the treatment of type
      2 diabetes. This study will investigate the effects of treatment with fixed
      Pioglitazone/Metformin combination therapy of Metformin and Glimepiride in
      Metformin-pretreated type 2 diabetic patients with dyslipidemia.

      Total participation time in this study is anticipated to be approximately 24 weeks.
    

Intervention name(s): Pioglitazone and Metformin; Glimepiride and Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Pioglitazone 15 mg/metformin 850 mg combination tablets, orally, twice daily and glimepiride placebo-matching tablets, orally, once daily and metformin placebo-matching tablets, orally, twice daily for up to 24 weeks.; Pioglitazone/metformin placebo-matching combination tablets, orally, twice daily and glimepiride 2 mg, tablets, orally, once daily and metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.
Other intervention name(s): ACTOS®; AD-4833; OPIMET; Amaryl; Glista
Intervention MeSH terms: Metformin; Pioglitazone; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Hyperlipidemias; Drug Therapy
Effect of Transcutaneous Vagal Stimulation (TVS) on Endothelial Function and Arterial Stiffness in HFrEF
Condition: Heart Failure With Reduced Ejection Fraction; Endothelial Dysfunction
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Heart failure (HF) is the leading cause of hospitalization in the US. Endothelial
      dysfunction, characterized by the decreased vasodilatory capacity of the vascular
      endothelium, is rampant in atherosclerotic diseases such as coronary artery disease and also
      in HF. Endothelial dysfunction also correlates with HF severity, progression, and mortality.
      It is postulated that endothelial dysfunction may in part be due to enhanced sympathetic
      drive, diminished parasympathetic drive, chronic inflammatory state thereby leading to
      reduced nitric oxide synthase activity in the vascular endothelium. Low-level vagus nerve
      stimulation (LLVNS) is an invasive way to modulate autonomic tone. Recent experimental and
      clinical data suggest that low-level transcutaneous vagal stimulation (TVS) (by stimulating
      the auricular branch of the vagus nerve located at the tragus of the external ear) may
      produce the same desired neuromodulator effect compared to LLVNS. The objective of this study
      is to determine the impact of TVS on endothelial dysfunction and arterial stiffness. The
      study population will include patients with chronic HFrEF. After performing baseline
      flow-mediated dilation (FMD), laser speckle contrast imaging(LSCI) and pulse wave analysis
      (PWA) testing, patients will be randomized to TVS or sham stimulation with a crossover design
      at different time points. The patient randomized to TVS arm will undergo stimulation for 1
      hour followed by immediate measurement of FMD,LSCI and PWA. There will be a washout period of
      at least 24 hours with patient crossing over to the other arms thus serving as their
      self-control.
    


Intervention name(s): TVS; Sham TVS
Intervention type(s): Device; Device
Intervention description(s): Active TVS will be performed by use of a Tragus stimulator device with electrodes attached to the tragus of the ear. Stimulator will be applied continuously for 1 hour; Device will be applied but not to the Tragus of the ear but will be attached to the ear lobule.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Pharmacokinetic Study of Trabectedin in Patients With Advanced Malignancies and Hepatic Dysfunction
Condition: Neoplasm Metastases; Hepatic Insufficiency
MeSH terms: Neoplasm Metastasis; Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the pharmacokinetics (blood levels) of
      trabectedin after administration to patients with advanced malignancies and hepatic (liver)
      dysfunction.
    

Detailed description: 
      This is an open-label (patients will know the names of study drugs they receive),
      single-dose, study that will examine the pharmacokinetics (blood levels) and assess survival
      and safety of trabectedin in patients with advanced malignancies who either have hepatic
      (liver) dysfunction or do not have hepatic dysfunction (patients enrolled without hepatic
      dysfunction will be referred to as the control group). Trabectedin is a drug being developed
      to treat patients with cancer that will be administered intravenously (i.v.) through a
      catheter (tube) into a central vein. In addition, dexamethasone, a drug used to prevent
      nausea and vomiting in chemotherapy patients that may have protective effects on the liver,
      will be administered to patients before the administration of trabectedin. Patients who
      complete the treatment phase of the study who in the opinion of the investigator would derive
      an overall clinical benefit from further treatment with trabectedin will have the opportunity
      to continue treatment with trabectedin in the optional extension phase. The dose and schedule
      of trabectedin may be modified by the treating physician in the optional extension phase to
      be more appropriate for the type of malignancy being treated. A single dose of trabectedin
      (1.3 mg/m2 in patients in the control group and 0.58 mg/m2 in patients with hepatic
      dysfunction) will be administered by i.v.infusion over a 3-hour period. The dose of
      trabectedin may be adjusted if necessary for patients with hepatic dysfunction subsequently
      enrolled in the study. All patients will be administered dexamethasone 20 mg i.v. (or
      equivalent) approximately 30 minutes before the administration of trabectedin.
    

Intervention name(s): Trabectedin; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Trabectedin 0.58 or 1.3 mg/m^2 (or adjusted dose) i.v. will be administered on Day 1.; Dexamethasone will be administered as 20 mg/m^2, 30 minutes prior to trabectedin.
Intervention MeSH terms: Dexamethasone; Trabectedin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Trabectedin, YONDELIS; Antineoplastic Agents; Solid tumors; Locally advanced or metastatic disease; Chemotherapy; Pharmacokinetics; Hepatic Dysfunction
Evaluate the Efficacy and Safety of Brightening Micro-needle Patch on Facial Solar Lentigines
Condition: Solar Lentigines
MeSH terms: Lentigo
Study type: Interventional

Summary: 
      This is a single center, randomized, double-blind and placebo controlled clinical study to
      evaluate the efficacy and safety of brightening microneedle patch on facial solar lentigines.
      Subjects who are 30 to 65-year-old with solar lentigines on their faces will receive
      brightening microneedle patches on facial solar lentigines once a day for 4 weeks.
      Afterwards, facial images and skin detectors will be used to analysis their skin, according
      to various skin tone indexes and skin response score sheets.
    

Detailed description: 
      Method: 35 subjects, Fitzpatrick Skin Type II to IV. Each subject has at least two brown
      solar lentigines on the face, and the two spots are independent, each with a clear boundary
      and diameter ≥ 0.5 cm.

      This trial includes 1 screening visit (Day -1), wash-out period (2 weeks before the trial),
      trial period (4 weeks in total), and 3 return visits for detecting (baseline detecting at the
      end of the wash-out period, the 2nd week and the 4th week of the trial period).
    

Intervention name(s): AIVÍA, Ultra-Brightening Spot Micro-needle Patch; Placebo Micro-needle Patch
Intervention type(s): Other; Other
Intervention description(s): a dissolving micro-needle patch, contains active ingredients; matching placebo will be provided as a dissolving micro-needle patch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Solar Lentigines; Micro-needle patch
ACT34-CMI -- Adult Autologous CD34+ Stem Cells (Follow-Up Study)
Condition: Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Observational

Summary: 
      The purpose of this 12-month, observational, follow-up study is to collect additional data
      (by telephone contact) with which to assess the efficacy, safety, and effects of
      intramyocardial injections of adult autologous CD34+ cells on quality of life (QoL) in
      subjects with chronic refractory myocardial ischemia. No treatments will be administered
      during this study. However, the investigators and other study site personnel and the subjects
      will remain blinded to the treatment assignments from the core therapeutic study (# 24779) so
      as to provide a total of 24 months of blinded data.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects who have received treatment with Auto-CD34+ cells (1 x 10^5 (+/-10%) CD34+
        cells/kg or 5 x 10^5 (+/-10%) CD34+ cells/kg)or with placebo (saline plus 5% autologous
        plasma) and who have completed the final study visit (Month 12) of the core therapeutic
        study 24779
Safety Study of UC-781 Vaginal Microbicide
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will help determine whether UC-781 gel is safe when applied to the vagina twice
      daily for 14 days, and will assess whether women and men find the gel acceptable to use.
    


Intervention name(s): Placebo gel; UC 781
Intervention type(s): Drug; Drug
Intervention description(s): HEC (hydroxyethyl cellulose) Control Gel applied vaginally twice daily for two weeks; UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks
Intervention MeSH terms: UC-781
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Microbicides; HIV seronegativity