bioihbjkbjnl/mcl2 huggingface dataset:
Study of tDCS for Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The primary objective of this study is to investigate whether the transcranial direct current
      stimulation (tDCS) improves the cognitive function in patients with Mild Cognitive Impairment
      (MCI)
    

Detailed description: 
      Twenty-four patients were recruited and randomized to receive either real- or sham-tDCS over
      the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Their legally
      responsible caregivers were provided with mobile tDCS device, and were instructed to use it
      on the patients at the hospital. 30-minute session of the stimulation were applied 3 times a
      week for 12 weeks. The patients were evaluated at baseline and at Week 12.
    

Intervention name(s): YBand (YDT-201N); sham-YBand (YDT-201N)
Intervention type(s): Device; Device
Intervention description(s): transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 20 sec of ramp-up and -down; left(anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC); transcranial Direct Current Stimulation (tDCS) 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: transcranial direct current stimulation; tDCS; Mild Cognitive Impairment; MCI
The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer
Condition: Cornea Ulcer
MeSH terms: Corneal Ulcer; Ulcer
Study type: Interventional

Summary: 
      The opioid growth factor-receptor antagonist-naltrexone hydrochloride (NTX)- has gained much
      reach interest for applications in ophthalmology, because of its novel mechanism of action
      for speeding up corneal wound healing in both diabetics and non-diabetics, effective both
      locally and systemically and its availability as a low molecular weight synthetic drug.
    

Detailed description: 
      Corneal epithelial defects generally heal within 2 days without complications, in some
      patients with decreased corneal sensitivity, such as patients with severe dry eye, corneal
      neuropathy, or autoimmune diseases, the corneal epithelium shows a reduced tendency for
      spontaneous healing Resistant corneal ulcers may appear as epithelial defects associated to
      Bowman's layer disruption with associated damage and partial variable loss of superficial
      corneal stroma larger than 2 mm in diameter that persist more than 2 weeks even treated with
      conventional treatment . Noninfectious corneal ulcers have a similar clinical presentation
      like that of infectious ulcers but with no known infectious cause . Resistant corneal ulcer
      can lead to serious complications such as infection, inflammation, corneal scarring,
      opacification, corneal thinning, and perforation . In our study NTX accelerated healing of
      resistant corneal ulcers that was refractory to conventional treatment with lubricant eye
      drops and was safe with no complications reported in all treated eyes.
    

Intervention name(s): Naltrexone Hydrochloride; Carboxy methyl cellulose
Intervention type(s): Drug; Drug
Intervention description(s): naltrexone film; Carboxy methyl cellulose drops
Other intervention name(s): NTX; Carboxy methyl cellulose sodium 0.5%
Intervention MeSH terms: Naltrexone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Investigational Protocol for 2 RBC Single Unit Recovery on MCS®+ 8150 Using LN832 Disposable Sets (US)
Condition: Red Blood Cell Donation
Study type: Observational

Summary: 
      The purpose of this study is to validate that single units of RBCs collected by the
      Haemonetics MCS®+ 8150 system using LN832 disposable sets during an interrupted double red
      cell collection protocol meet all in vitro FDA requirements for non-leukoreduced red blood
      cells, and to provide data to support the 510(k) clearance of the MCS®+ 8150 system using
      LN832 disposable sets for this intended use.
    

Detailed description: 
      This study will take place at two sites (Blood Center of Wisconsin (BCW) Milwaukee, WI and
      American Red Cross-Norfolk, VA).

        -  A standard double red cell collection protocol will be initiated using the Haemonetics
           MCS®+ 8150 system using LN832 disposable sets. The collection procedure will be
           terminated after collection of one RBC unit. The maximum target red cell volume will be
           selected based on the donor predonation weight as specified in the nomogram included in
           the MCS®+ 8150 operation manual.

        -  The RBC units will be stored for 42 days at 1° to 6°C.

        -  Upon collection and at 42 days after collection, the RBC units will be weighed and
           tested for hematology parameters (white blood cell count, red blood cell count, residual
           white blood cell count, hemoglobin, hematocrit, platelet count, mean corpuscular volume,
           mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cell
           distribution width, and supernatant hemoglobin) and chemistry parameters (pH, potassium,
           glucose, lactate, and ATP).

        -  Acceptance criteria for this study are as follows:

             1. Hemolysis of less than or equal to 1% at 42 days of storage

             2. Maximum absolute red cell volume is less than or equal to the programmed absolute
                RBC target volume + 15%

             3. Minimum absolute red cell volume is greater than or equal to the programmed
                absolute RBC target volume - 15%

        -  After collection of sixty (60) evaluable RBC units, the study will be considered
           supportive of the intended use noted above if zero (0) units fail the acceptance
           criteria.

        -  If one (1) unit fails acceptance criteria after collection of sixty (60) evaluable RBC
           units, an additional seventy one (71) units will be collected.

        -  The study will be considered supportive of the intended use noted above if not more than
           one (1) total unit out of 131 evaluable units fails the acceptance criteria.

        -  If a total of two (2) units fail acceptance criteria, the study will not be considered
           supportive of the intended use noted above.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy blood donors
      
Keywords: Red Cells; Blood donors
Acupuncture as a Supplemental Treatment for Bipolar Depression
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness of acupuncture in the treatment of
      Bipolar Depression.
    

Detailed description: 
      Patients receive 8 weeks (12 sessions) of acupuncture treatment plus stable medication.
      Patients are randomly assigned to receive either acupuncture designed to relieve symptoms of
      depression or acupuncture designed to relieve some other legitimate physical condition. A
      comparison group of patients who take medication but do not receive acupuncture is assessed
      to evaluate the effectiveness of medication alone. Patients participate in clinical
      assessment each week, which includes visiting with a psychiatrist and completing symptom
      rating scales.
    

Intervention name(s): Acupuncture
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Mood Disorder; Acupuncture
IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery
Condition: Lower Limb Injury
MeSH terms: Leg Injuries
Study type: Interventional
Phase: Early Phase 1

Summary: 
      IV and included steroids have produced the same length of block prolongation in adults as if
      the steroid was given with the nerve block. Clinically, this has not be noticed in children.
      The objective of this study is to examine this in young patients. The investigator will
      blindly give the steroid either in the IV or in the block solution (perineural). This is a
      prospective double blind study.
    

Detailed description: 
      The subject has a 50/50 chance of receiving either cohort. After the subject is randomized to
      receive either steroid given IV or with the nerve block, the subject is anesthetized and the
      subject will receive either an IV injection of 5 cc steroids or placebo, and 20 cc local
      anesthetic plus placebo or steroid in the nerve block, the block will be placed under
      ultrasound to insure proper placement of block, the dose of steroid is based on weight, 0.1 -
      0.15 mg/kg. The investigator will record the time of block and IV injection. The subjects
      will be called by the study PI after 24 hours to determine the time of duration and again at
      48 hours if needed. This is a randomized, double blind study, neither the subject or the
      anesthesiologist giving the injection will know what is being given. The medications will be
      prepared and dispensed by the Research pharmacist, a randomization chart will be obtained by
      the research pharmacist.
    

Intervention name(s): Placebos; Dexamethasone Sodium Phosphate
Intervention type(s): Drug; Drug
Intervention description(s): This will be a saline solution of given IV or perineural.; This will be the active drug solution given IV or perineural.
Other intervention name(s): Non-active; Active treatment
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Dexamethasone 21-phosphate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Novel Therapies for Metabolic Complications of Lipodystrophies
Condition: Insulin Resistance; Hypertriglyceridemia; Diabetes; Hepatic Steatosis
MeSH terms: Fatty Liver; Lipodystrophy; Insulin Resistance; Hypertriglyceridemia
Study type: Interventional

Summary: 
      Lipodystrophies represent a therapeutic challenge with regards to the management of the
      diabetes, insulin resistance, hypertriglyceridemia and fatty liver which frequently present
      in conjunction with significant adipose tissue loss. The purpose of the study and it's four
      subprojects is to examine the safety and efficacy of various novel interventions designed to
      improve or resolve the fatty liver, hypertriglyceridemia, and insulin resistance or diabetes
      that is seen in these patients.
    

Detailed description: 
      We propose novel therapeutic approaches for the management of metabolic complications in
      patients with lipodystrophies. The four interventions to be tested are:

      Hypothesis 1: An extremely low fat diet.
    

Intervention name(s): low-fat diet ( Still recruiting ); Diet
Intervention type(s): Other; Other
Intervention description(s): This study will compare 10% fat versus 35% fat diets in terms if effect on liver fat, triglycerides adn other metabolic parameters.; 10 % versus 35 % fat in diet
Other intervention name(s): Low fat versus extremely low fat Diet
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: lipodystrophy
Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers
Condition: Meningococcal Infections
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy
      toddlers
    


Intervention name(s): MenACWY-CRM + MMRV; MMRV; MenACWY-CRM
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One injection of MenACWY-CRM vaccine at 7-9 months of age; the second injection of MenACWY-CRM vaccine concomitantly administered with MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age.; one injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age; Two injections of MenACWY-CRM at 7-9 months and 12 months of age; one injection of MMRV (Measles, Mumps, Rubella and Varicella) at 13.5 months of age
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; toddlers; healthy; meningitis; meningococcal; measles; mumps; rubella; varicella; Prevention of Meningococcal disease types ACWY
Vitamin D Deficiency and Placental Calcification in Low-risk Obstetric Population - Are They Related?
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency; Calcinosis
Study type: Observational

Summary: 
      Maternal vitamin D deficiency has been suggested to influence fetal and neonatal health. The
      role of placenta in vitamin D regulation is known but alteration of Vitamin D levels at
      placental pathologies is unknown. Placental calcification is usually thought to be a
      physiological aging process. Nevertheless, it can be a pathological change resulting from the
      effects of environmental factors on the placenta. The aim of the investigators study was to
      evaluate the relationship between placental calcification and maternal and cord blood
      25-hydroxyvitamin-D3 [25(OH)D] and calcium concentrations in low-risk obstetric population at
      term and their consequences.
    

Detailed description: 
      Vitamin D deficiency is a public health problem prevalent throughout the World. Low blood
      25-hydroxyvitamin D3 ( 25OHD ) level was found to be associated with preeclampsia,
      gestational diabetes, infectious diseases, decrease in fetal bone mineralization, and
      increase in fetal respiratory infections and infant wheezing [1].

      Requirement of vitamin D is primarily met by the exposure of skin to sun and secondarily by
      intake of food. The provision of vitamin D from the skin depends upon melanin pigment, the
      use of sun screens, age, dressing style and seasonal changes [1]. Placenta plays an important
      role in Vitamin D metabolism during pregnancy and some independent risk factors increasing
      the risk of placental dysfunction at fetomaternal interface also influence vitamin D
      metabolism [2,3]. Nevertheless, there can be a pathological change resulting from the effects
      of environmental factors on the placenta .
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who admitted our clinic without foreknown systemic diseases or multiple pregnancy.
      
Biospecimen description: 
      Maternal venous and umbilical cordon blood
    
Keywords: Calcium; Vitamin D; Placental calcification.
A Study of Effects of Selpercatinib in Hepatically Impaired Participants and Healthy Participants
Condition: Healthy; Hepatic Impairment
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess how selpercatinib gets into the blood stream and
      how long it takes the body to remove it when administered to participants with impaired
      hepatic function compared to healthy participants. Information about safety and tolerability
      will be collected. The study will last up to about 7 weeks, inclusive of screening period.
    


Intervention name(s): Selpercatinib
Intervention type(s): Drug
Intervention description(s): Administered orally.
Other intervention name(s): LY3527723; LOXO-292
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Desensitization of Renal Transplant Candidates
Condition: End Stage Renal Disease; Kidney Transplantation
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      Trial of the use of Myfortic to reduce anti-HLA alloantibody in patients waiting for renal
      transplantation.
    

Detailed description: 
      Pre-formed HLA antibodies prevent renal transplantation because of the risk of hyperacute
      rejection. We propose a prospective study evaluating the efficacy of Enteric Coated
      Mycophenolate Sodium (Myfortic) in decreasing the titers of anti-HLA alloantibodies in
      patients awaiting kidney transplantation. Myfortic is an immunosuppressant that inhibits the
      proliferation of B and T cells by blocking the enzyme inosine monophosphate dehydrogenase. We
      will attempt to determine whether a 6-week course of Myfortic adequately decreases the
      antibody reactivity to a level compatible with transplantation.
    

Intervention name(s): Myfortic
Intervention type(s): Drug
Intervention description(s): Myfortic 360mg PO BID for six weeks
Intervention MeSH terms: Mycophenolic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal; Transplant; PRA
Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
Condition: Non-invasive Ventilatory Support; Infant Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Observational

Summary: 
      The purpose of this observational study is to collect data on vital signs, oxygen
      requirements and other data related to ventilator care in preterm neonates under standard of
      care treatment.
    

Detailed description: 
      The objective of this study is to collect data on vital signs, oxygen requirements and other
      data in preterm infants who are breathing stably on non-invasive ventilatory support. The
      data obtained during this study will be used to compare data obtained in a future study that
      will add a new medicinal product in combination with non-invasive ventilatory support to
      accelerate lung development in preterm infants.

      The study will enroll approximately 40 patients. Participants will not be receiving any
      investigational medicinal product or device in this study.

      All participants will have vital signs, oxygen requirements and other data collected
      continuously throughout the study.

      This multi-centre trial will be conducted in Germany. The overall time to participate in this
      study is up to 10 weeks. Participants will be observed until they reach 36 weeks of
      gestational age or until they are discharged from the hospital.
    

Intervention name(s): Preterm Neonates
Intervention type(s): Other
Intervention description(s): Preterm Neonates
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm neonates on non-invasive ventilatory support in a hospital setting.
      
Keywords: Drug therapy
LYT-300 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Part 1 is a single ascending dose (SAD) trial in healthy volunteers (HV) to assess the
      safety, tolerability, and pharmacokinetic (PK) profile of orally administered LYT-300.

      Part 2 is a crossover assessment in HV of the effects of food on the safety, tolerability,
      and PK profile of orally administered LYT-300.

      Part 3 is a multiple ascending dose (MAD) trial in HV to assess the safety, tolerability, and
      PK profile of multiple doses (up to 7 days) of orally administered LYT-300.

      Part 4 is an assessment of the effects of LYT-300 vs. placebo on pharmacodynamic and patient
      reported outcome response to a validated clinical model of anxiety.
    

Detailed description: 
      Part 1: This is a randomized, double-blind, placebo-controlled, SAD design to assess the
      safety, tolerability, and PK profile of orally administered LYT-300 in HV, in a 3-period,
      3-sequence, crossover, dose escalation design.

      Part 2: This is a randomized, open label, 3-period, 3-sequence, crossover assessment of the
      effects of food on the PK, safety, and tolerability of orally administered LYT-300 in HV. A
      single dose of LYT-300 will be administered on 3 occasions, separated by a minimum 7-day
      washout period. Part 2 is planned as a single dosing cohort.

      Part 3: This is a randomized, double-blind, placebo-controlled, sequential, MAD trial in HV
      to assess the safety, tolerability, and PK profile of multiple doses (up to 7 days) of orally
      administered LYT-300. This part will include ascending doses given either once daily in the
      morning (QAM), once daily in the evening (QHS), or twice daily (BID).

      Part 4: This is a double-blind, randomized assessment of the effects in HV of a single dose
      of LYT-300 vs. placebo on pharmacodynamic and patient reported outcome response to a
      validated clinical model of anxiety.
    

Intervention name(s): LYT-300; Placebo
Intervention type(s): Drug; Other
Intervention description(s): A prodrug of allopregnanolone, a small molecule drug; Placebo for LYT-300
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1 consists of 1 Arm with crossover of active treatment and placebo; Part 2 consists of 1 Arm with active treatment; Part 3 consists of 4 Arms with active treatment or placebo; Part 4 consists of 2 arms with active or placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparative Study of Two Multifocal Intraocular Lens With Different Add Power
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      This study will compare cataract patients with implantation of diffractive multifocal IOL
      with an additional power of +2.75 diopters (Group 1) and with +3.25 diopters (Group 2).
      Evaluations will be performed 1 and 3 months following cataract surgery, including
      measurement of uncorrected distance visual acuity (UDVA), refractive error (manifest
      refraction [MR]), and uncorrected near visual acuity (UNVA) at 33, 40, and 50 cm. At 3
      months, internal aberrations and contrast sensitivity will be evaluated and subjects will
      complete a questionnaire on outcomes satisfaction, visual symptoms, and spectacle use.
    


Intervention name(s): +2.75 diopters multifocal intraocular lens; +3.25 diopters multifocal intraocular lens
Intervention type(s): Device; Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment