bioihbjkbjnl/mcl2 huggingface dataset:
Motor Learning and Multi-session tDCS in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The present study seeks to examine the efficacy of multi-session transcranial direct current
      stimulation applied over the primary motor cortex in people with Parkinson's disease on
      sequential motor learning performance.
    

Detailed description: 
      Parkinson's disease is characterised by deficits of motor control triggered by impaired basal
      ganglia function, such as bradykinesia and tremor. Beyond the visibly recognisable motor
      symptoms of Parkinson's disease, the ability to learn a sequence of movements is also
      compromised and poses a significant barrier to effective rehabilitation. In healthy
      individuals, transcranial direct current stimulation applied over the primary motor cortex
      during motor task practice has been shown to significantly improve motor learning compared to
      placebo conditions.

      The present study seeks to examine the effect of multi-session transcranial direct current
      stimulation applied over the primary motor cortex in people with Parkinson's disease on
      sequential motor learning performance. Participants will be required to attend eight
      laboratory sessions, comprising five intervention and three assessment sessions and will be
      tested on their ability to learn a 16-digit finger tapping sequence with their right hand.
      Sessions one to five will form the intervention and will be performed at the same time on
      consecutive days (i.e. mon-fri). In addition, session one will double as a baseline
      assessment and intervention session. Assessments sessions will be performed once before the
      intervention (session one), and three times following the intervention on day three, one
      week, and four weeks post intervention.
    

Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad.
Stimulation is phased in with a 30-second ramp up of the electrical current to the specified stimulation parameters. Following the specified stimulation period, the current is phased-out with a ramp down of the current. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off during the specified stimulation period.
Other intervention name(s): tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Parkinson's disease; Transcranial direct current stimulation; Motor sequence learning
A Study Comparing Two Topicals in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and
      Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris (Study FX2018-23).
    

Detailed description: 
      A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and
      Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris. Eligible subjects
      will be randomized (1:1) to treatment with Test Article A to one side of the face versus Test
      Article B on the contralateral side.
    

Intervention name(s): FMX101 vehicle; Hydro-alcohol solution
Intervention type(s): Drug; Other
Intervention description(s): FMX101 vehicle - hydrophobic oil based vehicle (Test Article A); Hydro-alcohol solution based vehicle (Test Article B)
Other intervention name(s): Test Article A; Test Article B
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible subjects will be randomized (1:1) to treatment with Test Article A to one side of the face versus Test Article B on the contralateral side.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety Study of ABT-263 in Combination With Gemzar (Gemcitabine) in Subjects With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 open-label study evaluating the safety of navitoclax (ABT-263) when
      combined with a standard regimen of gemcitabine in approximately 50 subjects with solid
      tumors and measurable disease.
    


Intervention name(s): ABT-263; gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): 150mg of ABT-263 is taken orally once daily on Days 1-3 and Days 8-10 out of each 21 day cycle.
325 mg of ABT-263 is taken orally once daily on days 1-3, 8-10, 15-17 out of each 28 day cycle.
This is a dose escalation study, therefore the dose of ABT-263 will change throughout the study.; Gemcitabine 1000 mg/m2 will be given by intravenous infusion on Day 1 and Day 8 of each 21 day cycle. Gemcitabine 1000 mg/m2 will be given by intravenous infusion on days 1, 8 and 15 of each 28 day cycle.
Other intervention name(s): navitoclax; gemzar, gemcitabine
Intervention MeSH terms: Gemcitabine; Navitoclax
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of the Beeswax-containing Barrier on the Prevention of Nipple Crack
Condition: Breastfeeding; Cracked Nipple in Puerperium
Study type: Interventional

Summary: 
      In the planned study, it was aimed to evaluate the effectiveness of the beeswax-containing
      barrier and breast milk used in the first ten days of breastfeeding to prevent the formation
      of nipple cracks. It's a prospective, randomized study based on 90 primipara lactating women.
      Participants were assigned randomly 3 groups (beeswax-containing barrier, breast milk, and no
      treatment-control).
    

Detailed description: 
      Current evidence-based guidelines report that the incidence of nipple cracks ranges between
      34-96%. Nipple cracks generally occur in the first week after the birth and may continue in
      the following periods of breastfeeding. Nipple crack is the second most common reason to stop
      breastfeeding early, after perceived insufficient milk release. Nipple crack pain in studies
      has been expressed as extremely painful and terrible. It is known that breast milk, olive
      oil, quince seed jelly, mint juice, lanolin, jujube fruit lotion, guaiazulen pomade, aloe
      vera gel, menthol essence, vitamin A-E, curcumin extract, hydrogel dressings are recommended
      to mothers to prevent nipple cracks during breastfeeding. The prevention of nipple cracks,
      will successfully allow to continue breastfeeding. In this way, breastfeeding will not be
      interrupted and the rate of breastfeeding-only feeding will increase in the first 6 months.
      Using non-pharmacological, effective and therapeutic methods will also have a positive effect
      to increase the rate of breastfeeding.

      Studies in the literature cover the evaluation of the effectiveness of beeswax or
      beeswax-containing mixtures on wound, burn and crack healing. Due to its natural composition
      with antioxidant, antimicrobial, and antiulcerative properties, beeswax is thought to be an
      effective and sufficient material in preventing and healing nipple cracks.

      In this study, it is planned to include 90 lactating women (30 women in each group) to meet
      the parametric test assumptions in the experimental and control groups (beeswax-containing
      barrier, breast milk, and no treatment-control). Breastfeeding mothers to be included in the
      experimental and control groups will be randomized.
    

Intervention name(s): Beeswax containing barrier; Breast milk
Intervention type(s): Device; Biological
Intervention description(s): Use beeswax containing barrier on each nipple after each breastfeeding.; Apply breast milk on each nipple and areola after each breastfeeding.
Intervention MeSH terms: Propolis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: None (Open Label)
Primary purpose: Prevention
A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type
Condition: Agitation Associated With Alzheimer's Dementia; Alzheimer Dementia
MeSH terms: Dementia; Alzheimer Disease; Psychomotor Agitation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study compares the efficacy of 2 doses of brexpiprazole with placebo in participants
      with agitation associated with dementia of the Alzheimer's type.
    

Detailed description: 
      This is a phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled,
      fixed-dose trial designed to assess the efficacy, safety, and tolerability of brexpiprazole
      compared with placebo. The trial consists of a 12-week double-blind treatment period with a
      30 day follow-up. The trial population will include male and female participants between 55
      and 90 years of age (inclusive) with a diagnosis of probable Alzheimer's disease, who are
      residing either in an institutionalized setting or in a non-institutionalized setting where
      the participant is not living alone. This trial will analyze data gathered from approximately
      330 participants at multiple countries. Participants may also be eligible to enter an active
      treatment extension trial.
    

Intervention name(s): Brexpiprazole; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral tablets; Oral tablets
Other intervention name(s): OPC-34712
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Agitation
IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis
Condition: Acute Pyelonephritis
MeSH terms: Pyelonephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the safety and efficacy of intravenous (iv) or
      iv/per oral (po) omadacycline as compared to iv or iv/po levofloxacin in the treatment of
      female adults with acute pyelonephritis.
    

Detailed description: 
      This was a randomized (1:1:1:1:1), double-blind, double-dummy, adaptive designed, Phase 2
      study. Based on review of the efficacy and microbiology data, the DMC modified the
      randomization algorithm, and no further participants were enrolled in the following treatment
      arms after May 2019: the omadacycline 200 iv/100 iv, omadacycline 200 iv/300 po or 100 iv,
      and omadacycline 200 iv/450 po or 100 iv arms. After this change, participants were
      randomized in a 1:1 ratio to either the omadacycline 200 iv/200 iv or levofloxacin arms.
    

Intervention name(s): Omadacycline; Levofloxacin; Omadacycline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): po tablets; iv solution/po tablets; iv solution
Other intervention name(s): Nuzyra; Levaquin; Nuzyra
Intervention MeSH terms: Levofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
BSE on Blood Glucose
Condition: Blood Glucose, High
Study type: Interventional

Summary: 
      Here we will investigate the effect of sulforaphane, provided as a broccoli sprout extract
      (BSE) on blood glucose in pre-diabetic individuals without metformin treatment. This will
      address whether BSE could be used to improve glucose control in drug-naïve pre-diabetic
      individuals. The participants will receive BSE or placebo in a randomized double-blind
      parallel arm study. The participants will take their study compound once daily over 12 weeks.
      The primary study variable is fasting glucose.
    

Detailed description: 
      Here we will investigate the effect of sulforaphane, provided as a broccoli sprout extract
      (BSE) on blood glucose in pre-diabetic individuals without metformin treatment. This will
      address whether BSE could be used to improve glucose control in drug-naïve pre-diabetic
      individuals. The participants will receive BSE or placebo in a randomized double-blind
      parallel arm study. The participants will take their study compound once daily over 12 weeks.
      The primary study variable is fasting glucose.
    

Intervention name(s): BSE; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): BSE powder will be provided as dry mixtures in sealed, non-transparent portion size bags. Each BSE bag contains 150 μmole, equal to 0.26 g, sulforaphane at a minimum. The mixtures are suspended with appr. 1 dl water and are ingested once daily in the morning. BSE should be stored at room temperature in dry conditions.
The doses of sulforaphane contained in the BSE is not possible to get by eating fresh broccoli, thus it has to be given as an extract.; Placebo powder will be provided as dry mixtures in sealed, non-transparent portion size bags. The mixtures are suspended with appr. 1 dl water and are ingested once daily in the morning.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel arm study with placebo and intervention substance
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Urinary Sensor for Cystourethrography
Condition: Radiation Dose During VCUG
Study type: Interventional

Summary: 
      Evaluation of urinary sensor that will be activated by the urine during voiding
      cystourethrography in pediatric patients
    

Detailed description: 
      It is of immense importance to perform fluoroscopy during voiding phase of VCUG (Voiding
      Cystourethrogram) procedures in order to rule out vesicourethral reflux. It is difficult to
      know exactly when a child will start voiding, so the child is intermittently imaged by
      fluoroscopy. Fluoroscopy involves radiation, and this we try to diminish as much as possible.
      We suggest application of small urinary sensor in the perineum of the patient, that will
      signal the beginning of urination, and only then fluoroscopy will begin. This urinary sensor
      should cut down substantially radiation dose to the patient.
    

Intervention name(s): placebo; Urinary sensor
Intervention type(s): Other; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: radiation dose; VCUG; pediatric patients
Phase Ib of Recombinant Human Albumin Injection
Condition: Ascites
MeSH terms: Ascites
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Multicenter,Open-label, positive-controlled, Multi-dose Phase 1 Study to
      Evaluate the Safety, Tolerance,Efficacy, Pharmacokinetics and Immunogenicity of recombinant
      human albumin injection in Patients With Hepatic Cirrhosis
    

Detailed description: 
      This study was to evaluate the safety, tolerability,efficacy, pharmacokinetics and
      immunogenicity of recombinant human albumin injection in Patients With Hepatic Cirrhosis. The
      study design consists of two phases: Screening and treatment phase(dose increasing
      stage).Following the Screening phase, all eligible subjects will be randomized to receive
      recombinant human albumin injection or HumanAlbumin, study medication in a 3:1 ratio.Dose
      increasing stage (including 3 dose groups with increasing dose, and each group was set with
      HumanAlbumin control).The initial dose was 10g. The highest dose group was set at 30g.
    

Intervention name(s): Recombinant Human Albumin Injection; HumanAlbumin
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive Recombinant Human Albumin Injection of intravenous infusion; Participants will receive HumanAlbumin of intravenous infusion
Other intervention name(s): Intravenous infusion of human albumin injection; Intravenous infusion of recombinant human albumin injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack
Condition: Heart Failure; Myocardial Infarction
MeSH terms: Heart Failure; Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      When a patient has a heart attack, a blockage occurs in a coronary artery that delivers
      oxygen to the heart muscle. The heart muscle may weaken, causing heart failure. The body
      naturally makes a protein called insulin-like growth factor-1 (IGF-1) that may protect the
      heart muscle cells from dying and may prevent heart failure or lessen the damage that occurs.
      IGF-1 is also available as a drug called mecasermin. In this study, heart attack patients
      will be given either a dose of mecasermin or a placebo (inactive treatment) after their
      coronary artery has been opened by a stent. The purpose of the study will be to evaluate the
      safety of the therapy and to test if the therapy will prevent or lessen heart failure by
      evaluating a cardiac magnetic resonance imaging (MRI) taken one day and eight weeks after the
      heart attack.
    


Intervention name(s): mecasermin; mecasermin; 0.9% sodium chloride injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intracoronary bolus; Intracoronary bolus; Intracoronary bolus
Other intervention name(s): rhIGF-1; IGF-1; rhIGF-1; IGF-1; normal saline
Intervention MeSH terms: Mecasermin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Heart Failure; Myocardial Infarction
Citicoline for Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if citicoline, as an add-on therapy, will help
      reduce alcohol use in outpatients with alcohol dependence.
    

Detailed description: 
      A total of 62 outpatients with alcohol dependence will be enrolled in a 12-week, randomized,
      placebo-controlled trial. Participants will be randomized to receive either placebo or
      citicoline.

      Throughout the study, participants will be asked about their alcohol use and any withdrawal
      or craving symptoms. Depressive symptoms will be measured as well. Cognition and memory will
      be measured as well with a neurocognitive battery. Blood will be drawn at study start and
      week 12 to measure liver enzyme levels.

      Appointments will be weekly for the entire study. Participants will have a physician
      follow-up at every study appointment.
    

Intervention name(s): Placebo; Citicoline
Intervention type(s): Drug; Drug
Intervention description(s): Inactive ingredient matching the active comparator in appearance; Citicoline is an over-the-counter nutritional supplement that is used for neuroprotective effects. It is a naturally occurring neurochemical in the human body.
Other intervention name(s): Sugar pill; CDP-choline; cytidine diphosphate-choline
Intervention MeSH terms: Choline; Cytidine Diphosphate Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcohol dependence; alcohol abuse
Fluoxetine vs. Brief Psychotherapy for Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      In this study we compare two treatments for major depression - fluoxetine and brief
      psychodynamic psychotherapy. In addition to more traditional outcome measures, we also
      measure the densities of 5HT-1A and D-2 receptors before and after the treatment. The main
      hypothesis is that brief psychotherapy is as effective as fluoxetine.
    

Detailed description: 
      This study is a randomized comparison of two treatments for major depression - fluoxetine and
      brief psychodynamic psychotherapy. The patients are recruited from occupational health
      services and suffer from mild to moderate major depressive disorder. The treatments last for
      16 weeks. The main outcome measures include HAM-D, BDI, SOFAS, Rand-36. In addition to more
      traditional outcome measures, we also measure the densities of 5HT-1A and D-2 receptors
      before and after the treatment using Positron Emission Tomography (PET) . The main hypothesis
      is that brief psychotherapy is as effective as fluoxetine, but differences between the
      treatments are seen in PET scanning.
    

Intervention name(s): Fluoxetine; Short-term psychodynamic psychotherapy
Intervention type(s): Drug; Behavioral
Intervention description(s): 20-40 mg / day orally; 1 session / week for 16 weeks
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major depressive Disorder; fluoxetine; short-term psychodynamic psychotherapy; PET
Corchorus Olitorius Buccal Films for the Treatment of Recurrent Minor Aphthous Ulcerations
Condition: Aphthous Ulcer Recurrent
MeSH terms: Stomatitis, Aphthous; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      A methanol extract of Corchorus olitorius edible plant was perpared for extration of
      glycosideal compounds. the extract was tested for its efficacy as antiinflammatory and
      analgesic activity invitro and approved by the biomarkers. a fast dissolvinf mucoadhesive
      film was prepared by a certain amounts of highly safe polymers for a pilote study on human
      for treament of Aphthous Ulcerations. two groups of study, placebo and intrvention will be
      recurited and followed for pain, erthymia and size of ulcers for 6 days.
    


Intervention name(s): Corchorus Olitorius Buccal fast dissolving Films; plain mucoadhesive fast dissolving film
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Corchorus Olitorius Buccal fast dissolving Films; plain mucoadhesive fast dissolving film
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment