bioihbjkbjnl/mcl2 huggingface dataset:
Improving Adherence in Patients With Hypertension - A Novel Use of Communication Technology
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Treating hypertension is known to decrease morbidity and mortality. Despite this 70% of
      patients do not have adequately controlled blood pressure. The main reason for this is
      non-adherence to recommended drug therapy. Although strategies have been developed to improve
      adherence many are time consuming and expensive. We propose to use communications technology
      to develop a novel means of improving adherence to antihypertensive therapy. We will conduct
      a randomised, single-blinded, controlled study to assess the impact of a real-time, automated
      reminder system on adherence rates. This will involve adapting two pieces of currently
      available technology - the electronic pill bottle and the Ambient Globe. The Globe will
      change colour in response to information received, via a wireless link, from the patient's
      electronic pill bottle. We hypothesise that this will provide patients with an up to date,
      but unobtrusive, reminder of their adherence status and thus effect positive behavioural
      change. We will measure the impact of this intervention on adherence rates as well as
      assessing patient views and the impact on provider workload. This trial will elucidate the
      role of communications technology in improving adherence behaviour and allow us to develop
      further strategies to tackle this major health issue.
    


Intervention name(s): Automated feedback regarding drug adherence
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Keywords: Adherence; Hypertension; Telemedicine
Long-Term Study On Home Spirometry After Lung Transplantation
Condition: Lung Transplantation; Rejection; Death; Bronchiolitis Obliterans
MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome
Study type: Observational

Summary: 
      Prospective cohort, mono-center study included electronic data of home spirometry (HS, lung
      function) of lung transplant recipients
    

Detailed description: 
      Study period between 1/2/2000 and 31/12/2003 Follow-up until 31/12/2007

      Patient will be stratified according to adherence to HS during the first 2 postoperative
      years Good adherent patient: patient performed ≥ 80% of predicted HS within 24 months
      Moderate adherent patient: patient performed ≥ 50% of predicted HS within 24 months
      Non-adherent patient: patient performed < 50% of predicted HS within 24 months.

      Primary outcome measure graft loss at end of follow-up

      Secondary outcome measure number of acute rejections during follow-up number of
      hospitalisation during follow-up Incidence of bronchiolitis obliterans syndrome during
      follow-up
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        lung transplant recipients surviving to outpatient follow-up >6 months in Hannover Medical
        School
      
Keywords: Lung transplantation; Home spirometry; non-adherence; outcomes; bronchiolitis obliterans
DORA: A Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV
Condition: HIV-1-infection
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a pilot study investigating the safety of Doravirine (DOR) in combination with
      Lamivudine (3TC) and Tenofovir Disoproxil Fumarate (TDF) administered over 48 weeks in women
      of reproductive potential living with HIV-1 switched from Efavirenz or Dolutegravir-based
      antiretroviral therapy on metabolic and neuropsychiatric outcomes.
    

Detailed description: 
      This is a pilot, open label, single-arm, single centre, phase 3, switch study exploring the
      safety of of Doravirine (DOR) in combination with Lamivudine (3TC) and Tenofovir Disoproxil
      Fumarate (TDF) administered over 48 weeks in women of reproductive potential living with
      HIV-1 switched from Efavirenz or Dolutegravir-based antiretroviral therapy. The metabolic and
      neuropsychiatric outcomes among women (and their infants) in a representative African female
      population of reproductive potential will be investigated.

      Approximately 100 women aged between 18 and 49 years old will be administered a once-daily,
      fixed-dose combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil
      fumarate 300 mg (DOR/3TC/TDF). The study includes screening and baseline visits, 4 study
      visits from Week 4 to Week 36, and an end of study visit at Week 48.
    

Intervention name(s): Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Intervention type(s): Drug
Intervention description(s): DOR/3TC/TDF 100/300/300 mg once daily fixed-dose combination switched from either EFV/TDF/FTC or DTG/TDF/3TC
Other intervention name(s): Delstrigo
Intervention MeSH terms: Tenofovir; Lamivudine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Doravirine; Delstrigo; DOR/3TC/TDF; Women of reproductive potential
Search for Genetic Basis of Vulvodynia
Condition: Vulvodynia
MeSH terms: Vulvodynia
Study type: Observational

Summary: 
      The purpose of this study is to investigate the possibility of an association between
      Localized Provoked Vulvodynia (LPV) that is both severe and primary and polymorphic
      markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding heparanase
      (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).
    

Detailed description: 
      The short-term goal proposed for the current study was to investigate the possibility of an
      association between Localized Provoked Vulvodynia (LPV) that is both severe and primary and
      polymorphic markers/single nucleotide polymorphisms (SNPs) in and around the genes encoding
      heparanase (HSPE-1), Vanilloid Receptor VR1 (TRPV1), and Nerve Growth Factor (NGF).

      Eight polymorphic SNPs in the three different genes suspected to be involved in LPV has been
      examined as follow:

        1. HSPE gene: Four polymorphic SNPs: rs4693608, rs11099592, rs6856901 and rs4364254 that
           were found to be informative in the Ashkenazi Jewish population

        2. TRPV1 gene: Two polymorphic SNPs: rs222747 and rs8065080.

        3. NGF gene: A novel T to C SNP in the promoter region at position -198 (rs11102930) and
           rs6330 which was found to be associated with anxiety-related personality traits and has
           been suggested to may affect intracellular processing and secretion of NGF.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with Vulvodynia, Normal healthy controls
A Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941
Condition: Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) and safety following oral
      administration of ASP1941 in subjects with moderate hepatic impairment and in subjects with
      normal hepatic function based on the Child-Pugh Classification (CPC).
    

Detailed description: 
      Study drug will be orally administered on Day 1. Subjects will be admitted to the clinic
      until completion of clinic discharge procedures on Day 7 with an outpatient follow-up visit
      6-9 days after clinic discharge.
    

Intervention name(s): ASP1941
Intervention type(s): Drug
Intervention description(s): oral
Intervention MeSH terms: Ipragliflozin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Liver disease; ASP1941
Causes of Disqualification of Egyptian Potential Living Liver Donors
Condition: Donors Safety
Study type: Observational [Patient Registry]

Summary: 
      Due to absence of Deceased-donors in Egypt, Living-donor liver transplantation (LDLT) has
      emerged as an option to the traditional deceased-donor transplantation procedure. But there
      is an essential risk related to liver resection for healthy donors.
    

Detailed description: 
      The aim of this work is to identify and analyze the causes of disqualification of potential
      Egyptian living liver-donors in a University based liver transplant program
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        potential living liver donors
      
Keywords: Living donor liver transplantation; Donar safety
Buzzy System Compared to Topical Anaesthesia During Infiltration Injection in Children.
Condition: Local Anaesthesia
Study type: Interventional

Summary: 
      Aim of the study is to test the effect of Buzzy System (vibrating device) compared to topical
      anaesthesia on pain reduction during injection of infiltration anaesthesia in children.
    


Intervention name(s): Buzzy System; Topical anesthetic; Mepecaine - L 1.8 ml carpule
Intervention type(s): Device; Drug; Drug
Intervention description(s): Vibrating Device; 20% benzocaine gel (Opahl Topical Gel); Local dental anesthetic agent
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an single dose,two-way, crossover, oral bioequivalence study.
    

Detailed description: 
      The study was an single dose, two-way, crossover, oral bioequivalence study of Lamotrigine
      tablets 200 mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL®
      tablets 200 mg of GlaxoSmithKline Inc, in healthy, adult, human subjects under fed condition.
      20 subjects (14 male and 6 womens) are enrolled and completed the study. The washout period
      is 14 days between the two periods of the study.
    

Intervention name(s): Lamotrigine; Lamictal®
Intervention type(s): Drug; Drug
Intervention description(s): Lamotrigine Tablets 200 mg; Lamictal® 200 mg Tablets
Other intervention name(s): Lamictal® 200 mg
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Lamotrigine; crossover
Effect of Lithium Therapy on Long COVID Symptoms
Condition: Long COVID
MeSH terms: Post-Acute COVID-19 Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess low-dose lithium's effects on several different symptoms experienced
      by long COVID patients.
    

Detailed description: 
      In this double-blind, placebo-controlled study, 50 patients with long COVID will be randomly
      assigned to either low-dose oral lithium or placebo therapy for three weeks. After the
      double-blind study phase, all patients will be provided with lithium therapy for two
      additional weeks. Study visits will occur at baseline and after the three-week double-blind
      study phase.
    

Intervention name(s): Lithium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.; Inactive pill
Intervention MeSH terms: Lithium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lithium, long COVID
Mitiglinide in Combination With Metformin vs. Metformin Alone in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to demonstrate whether mitiglinide administered in
      combination with metformin is more effective than metformin alone in patients with Type 2
      diabetes mellitus (T2DM) whose blood sugar is not well controlled taking metformin alone.
      This is a 24 week study which measures improvement in blood sugar after of treatment.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel group study designed to
      evaluate the efficacy and safety of mitiglinide in combination with metformin in patients
      with T2DM who are less than adequately controlled on metformin alone. Patients who are
      receiving metformin alone for T2DM will be randomized equally into one of three treatment
      groups.
    

Intervention name(s): placebo for mitiglinide; mitiglinide; mitiglinide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): three times a day with meals; three times a day with meals; two times a day with meals
Intervention MeSH terms: Mitiglinide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Botulinum Toxin for Neck Rejuvenation
Condition: Botulinum Toxin, Rejuvenation, Neck, Therapy
Study type: Interventional

Summary: 
      The purpose of this study is to describe a safe and consistent technique for neck
      rejuvenation using botulinum toxin. This study will also evaluate the efficiency of the
      intervention and determine the patients that would benefit most.
    

Detailed description: 
      The abobotulinumtoxinA will be used for the Nefertiti lift The abobotulinumtoxinA will be
      prepared by adding 2.5 cc of normal saline to a 500-unit Dysport© (Ipsen Ltd, Berks, UK) vial
      Preinjection frontal, oblique and lateral patient pictures will be taken (at rest and with
      contraction)

      Injection points:

        -  A series of 4 injection points 1-2 cm apart on a horizontal line under the mandible
           posterior to the hypothetical line were the nasolabial fold meets the mandible

        -  If present, injection of each platysmal band every 2 cm with 2 to 4 injection points per
           band (Injection of platysmal band will be done by holding the band between 2 fingers and
           injecting intramuscularly) For all injection points 5 units per point of
           abobotulinumtoxinA will be used

      A maximum of 125 units of abobotulinumtoxinA will be allowed for the global neck treatment

      Follow up will be done at 15 days for retouching or for post op pictures if no retouching is
      needed. if retouching is needed post injection pictures will be taken 10 days post retouching

      Retouching: each residual platysmal band will be reinjected every 2 cm with 2 to 4 injection
      points per band (Injection of platysmal band will be done by holding the band between 2
      fingers and injecting intramuscularly) (5 units per point of abobotulinumtoxinA will be used)

      A total of 30 patients will be recruited
    

Intervention name(s): Nefertiti lift
Intervention type(s): Procedure
Other intervention name(s): neck rejuvenation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dry Needling Treatment in Hemiplegic Shoulder Pain
Condition: Hemiplegia; Shoulder Pain; Myofascial Pain
MeSH terms: Shoulder Pain; Hemiplegia
Study type: Interventional

Summary: 
      To evaluate the efficacy of dry needling therapy on shoulder pain and upper extremity
      functions in hemiplegic patients.
    

Detailed description: 
      The myofascial trigger point is an overlooked issue in hemiplegic shoulder pain. Our aim in
      this study is to evaluate whether dry needling treatment contributes to the conventional
      treatment approach.
    

Intervention name(s): Conventional physical therapy; Conventional physical therapy plus dry needling
Intervention type(s): Other; Other
Intervention description(s): Conventional physical therapy: The patients received physical therapy to the shoulder, transcutaneous electrical nerve stimulation, and stretching and strengthening exercises (5 days per week for three weeks in a total of 15 sessions).; Conventional physical therapy plus dry needling: The patients received physical therapy to the shoulder, including transcutaneous electrical nerve stimulation, stretching, and strengthening exercise (5 days per week for three weeks in a total of 15 sessions). And also, a total of 3 dry needling sessions were applied at 7-day intervals.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomised controlled
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hemiplegic shoulder pain; Conventional treatment; Dry needling
Phase 0 Study of [18F]MNI-968 as a Marker for D1 Receptor in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The overall goal of this protocol is to evaluate [18F]MNI-968 (aka PF-06730110) as a D1
      receptor targeted radiopharmaceutical.
    

Detailed description: 
      The overall goal of this protocol is to evaluate [18F]MNI-968 (aka PF-06730110) as a D1
      receptor targeted radiopharmaceutical.

        -  To measure the dynamic uptake and washout of [18F]MNI-968 in brain using positron
           emission tomography (PET) in healthy volunteers.

        -  To measure blood metabolites of [18F]MNI-968 in the healthy volunteers and to perform
           invasive as well as non-invasive modeling to assess [18F]MNI-968 binding to D1 receptor.

        -  To acquire safety data following injection of [18F]MNI-968

        -  Evaluation of [18F]MNI-968 PET reliability (test/retest) of several outcome measures
    

Intervention name(s): [18F]MNI-968
Intervention type(s): Drug
Intervention description(s): Healthy volunteers recruited for the study will undergo two [18F]MNI-968 injections and PET scans.
Other intervention name(s): PF-06730110
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HV
Treatment Compliance in Children and Adolescents on ADHD Medication
Condition: ADHD
Study type: Observational

Summary: 
      The primary research objective of this observational study is to evaluate treatment
      compliance over one year in children and adolescents who are newly initiated on medication
      approved for the treatment of ADHD in a routine clinical setting. Compliance will be assessed
      using the Pediatric Compliance Self-Rating (PCSR) Instrument. A patient will be considered as
      compliant at a given visit, if the PCSR score is at least 5, corresponding to taking the
      medication at least often.
    


Intervention name(s): Atomoxetine; stimulants (any approved ADHD medication)
Intervention type(s): Drug; Drug
Intervention description(s): in-label use; in-label use
Other intervention name(s): Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents who are newly initiated on medication approved for the treatment
        of ADHD in a routine clinical setting.

        Participating physicians may be office or hospital based psychiatrists and pediatricians
        throughout Germany.
A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery in Healthy Adults
Condition: Hypertrophic Scar
MeSH terms: Hypertrophy; Cicatrix, Hypertrophic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effectiveness of RXI-109 in reducing the
      recurrence of hypertrophic scar formation following elective revision of a pre-existing
      hypertrophic abdominal scar.
    


Intervention name(s): RXI-109; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): surgery.; surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertrophic scar; Cicatrix; Scar prevention; Scar revision
Treatment of Cognitive Impairment in Men With Schizophrenia (MK5757-005)(COMPLETED)
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate the safety and efficacy of the study drug compared to placebo in
      the treatment of cognitive impairment in men with schizophrenia.
    


Intervention name(s): MK5757; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 25 mg capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 MK5757 50 mg capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days; This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 one placebo capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 two MK5757 placebo capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Oral Sulfate Solution on Bowel Preparation for Colonoscopy
Condition: Bowel Preparation for Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate whether oral sulfate solution used for colon cleaning in adults prior to
      colonoscopy was not inferior to 3-liter polyethylene glycol in the proportion of subjects
      with BBPS score (total colon) ≥6 after colonoscopy
    

Detailed description: 
      Polyethylene glycol (PEG) is the most widely used laxative at present, but volume of oral PEG
      liquid is large and the taste of PEG is not good, so some patients could not take enough
      laxative to complete bowel preparation. Oral sulfate solution containing sodium sulfate,
      magnesium sulfate, and potassium sulfate as active ingredients was developed as osmotic
      laxative for bowel cleansing preparation. The OSS works on the principle that sulfate is a
      poorly absorbed anion. Compared to traditional magnesium sulfate solution, OSS not only
      tastes better, but also reduces the occurrence of electrolyte disturbances.
    

Intervention name(s): Oral sulfate solution (OSS); Polyethylene Glycol Electrolyte
Intervention type(s): Drug; Drug
Intervention description(s): OSS contained 17.5 g sodium sulfate, 3.13 g potassium sulfate, 1.6 g magnesium sulfate, and flavoring agents in an aqueous liquid form supplied in a 177 mL bottle. Take 177ml sodium, potassium and magnesium sulfates oral solution (diluted to 480ml) within 30 minutes 14-16 hours before colonoscopy, followed by two doses of 480ml warm water within 1 hour; Repeat the procedure 3-4 hours before colonoscopy.; Take 1000 ml polyethylene glycol electrolyte solution within 1 hour at 8 p.m. the day before colonoscopy; take 2000 ml polyethylene glycol electrolyte solution within 2 hour 4-6 hours before colonoscopy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: colonoscopy; Bowel preparation; Sodium Potassium and Magnesium Sulfate; polyethylene glycol