bioihbjkbjnl/mcl2 huggingface dataset:
Study on the Effect of Kaletra + Nevirapine as Maintenance Bitherapy Compared to a Triple Therapy Including Kaletra + Analogues in HIV Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to evaluate the changes in mitochondrial DNA (mDNA) by means of the
      mDNA/nuclearDNA (nDNA) ratio as a marker of mitochondrial toxicity following the interruption
      of nucleoside analogues.
    

Detailed description: 
      At the moment it is known that mitochondrial toxicity is the main pathogenic mechanism of
      toxicity associated with nucleoside analogues, including lipoatrophy, which at facial level
      is a stigmatising factor for patients with HIV infection.

      The primary outcome measure of the design of an "NTRI-sparing" bitherapy is to retard the
      onset of mitochondrial toxicity or reverse it, mainly with regard to the loss of subcutaneous
      fat or lipoatrophy.

      Lopinavir/ritonavir and nevirapine are two antiretrovirals with different mutation patterns
      and with high antiviral potency. Their combination therefore guarantees antiviral success.
      The NEKA study endorses efficacy immunologically and virologically (Negredo E. et al,
      NRTI-sparing regimen. XIV International AIDS Conference. Barcelona 2002. LB PeB9021).

      Similarly, the protective effect of nevirapine on lipid metabolism would counteract the
      negative impact attributed to lopinavir/ritonavir, reducing cardiovascular risk in these
      patients.
    

Intervention name(s): Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h; Nevirapine (Viramune): 1 comp (200mg)/12h
Intervention type(s): Drug; Drug
Intervention description(s): Lopinavir-rtv (Kaletra): 3 capsules (600 mg)/12 h; Nevirapine (Viramune): 1 comp (200mg)/12h
Intervention MeSH terms: Lopinavir; Nevirapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mitochondrial toxicity; Lopinavir-rtv; Nevirapine; DNA mitochondrial/DNA nuclear
The Effect of Mandala Painting on Anxiety in Coronary Heart Patients
Condition: Coronary Artery Disease; Anxiety
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Anxiety Disorders
Study type: Interventional

Summary: 
      This study was planned as a randomized controlled trial to determine the effect of mandala
      painting on the anxiety of coronary heart patients.
    

Detailed description: 
      Patients in the control group will receive routine care.Patiens in the experimental group
      will receive routine care and mandala painting. Experimental group will paint mandala for 30
      minutes/day in the evenings for six consecutive days. In order not to interrupt the duties of
      the nurse and doctor in the clinic, it was planned for the experimental group to paint
      mandalas in the evening. Six pre-selected mandalas were planned to be printed separately on
      A4 paper. Each patient will be given a new mandala each day. At the beginning of the study,
      six colors will be given to the experimental group (yellow, blue, green, red, purple, brown).
      It was planned to do it for 6 days, as it was found that painting mandala for more than a
      week in the studies could reduce the patient's attention. In addition, based on the average
      hospitalization days of the patients, reaching patients for more than a week will be a
      problem.
    

Intervention name(s): Mandala
Intervention type(s): Device
Intervention description(s): Experimental group will paint mandala for 30 minutes/day in the evenings for six consecutive days. Six pre-selected mandalas were planned to be printed separately on A4 paper. Each patient will be given a new mandala each day. Additionally, At the beginning of the study, the experimental group will be given six colors (yellow, blue, green, red, purple, brown).
Other intervention name(s): Mandala Painting
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: control group (usual care) and experimental group (mandala painting)
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Coronary Artery Disease; Anxiety; mandala
The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia
Condition: Heart Failure
MeSH terms: Pneumonia; Heart Failure
Study type: Observational

Summary: 
      Study to assess the risk of incident heart failure associated with the use of pramipexole
      compared with other dopamine agonists and additionally, to assess the risk of incident heart
      failure associated with the use of dopamine agonists in comparison with no use of dopamine
      agonist therapy
    


Intervention name(s): Mirapexin® (Sifrol®)
Intervention type(s): Drug
Intervention MeSH terms: Pramipexole
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Users of anti-parkinsonian drugs registered with an up-to-standard practice from the United
        Kingdom's General Practice Research Database (GPRD)
Stress Analysis of Hip Dysplasia
Condition: Hip Dysplasia
MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
Study type: Observational

Summary: 
      The main objective of this study is to predict cartilage contact pressures in the hip after
      periacetabular osteotomy (PAO).
    

Detailed description: 
      PAO was designed as a joint preserving surgical procedure to compensate for a shallow
      acetabulum by re-orienting the acetabulum into a position that provides better coverage of
      the femoral head. Although the overall theory that increasing load bearing area (improving
      coverage of the femoral head) results in reduced joint stress is intuitive, the complex bony
      surface may not behave in this manner. It is possible that joint stress may increase when the
      acetabulum is reoriented into a position that increases load bearing area if post-operative
      joint congruency is worse than pre-operative.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        18-40 years old
Social and Clinical Aspects of Pelvic Pain in Turkey
Condition: Chronic Pelvic Pain Syndrome
MeSH terms: Pelvic Pain
Study type: Observational

Summary: 
      Chronic Pelvic Pain (CPP) is a common medical condition with a complex treatment due to
      different variables that influence its clinical course.There is a growing literature which
      discussing the effect of ethnicity and culture on pain. It was aimed to invesitigate whether
      there is a considerable difference in the presentation and experience of pelvic pain in women
      from a different societies and cultures.
    

Detailed description: 
      Chronic Pelvic Pain (CPP) is a common medical condition with a complex treatment due to
      different variables that influence its clinical course.There is a growing literature which
      discussing the effect of ethnicity and culture on pain. It was aimed to invesitigate whether
      there is a considerable difference in the presentation and experience of pelvic pain in women
      from a different societies and cultures.

      The study includes randomly selected 45 females who completed a comprehensive set of
      questions derived from International Pelvic Pain Society (IPPS), pelvic pain assesment form.
      Character and intensity of pain, sexual abuse and harresment, coping with pain, physical
      activites (exercising) and comorbidities were evaluated. The McGill pain questionnaire short
      form was used to evaluate pain. Sexual Abuse Items in the Questionnaire (modified) to assess
      patients' sexual abuse status.
    

Intervention name(s): Diagnosis
Intervention type(s): Diagnostic Test
Intervention description(s): Baseline data were presented with descriptive statistics. Sociodemographic information, pregnancy status, surgical history, exercise habits, gynecologic, obstetric, urologic and gastrointestinal history of the patients were evaluated with the "Patient Information Form".Pain intensity was evaluated with the McGill pain questionnaire short form. At the same time, the patients drew the areas where they felt the most pain with the pain maps scale. Pain intensity during sexual intercourse was evaluated with the Visual Analog Scale (VAS).Sexual Abuse Items on the Questionnaire (Modified from Badgley).
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study included 45 women with pelvic pain. Women aged 18-65 years with pelvic pain ≥6
        months were eligible. The study was conducted at Yeditepe University Hospital on female
        patients diagnosed with chronic pelvic pain syndrome due to pelvic floor muscle problems by
        a gynecologist.
Investigating the Mechanisms of Mindfulness-based Cognitive Therapy (MBCT)
Condition: Major Depression (in Remission)
MeSH terms: Depressive Disorder, Major
Study type: Interventional

Summary: 
      This research will investigate the neuropsychological mechanisms underlying the eight-week
      Mindfulness-based Cognitive Therapy (MBCT) programme.

      Participants in remission from depression will be seen pre- and post-MBCT to assess the
      underlying neuropsychological mechanisms. All will be followed-up over 12 months to assess
      the relationship of these neuropsychological changes with relapse risk.

      The research will focus primarily on changes in self-compassion, rumination, attention and
      structural brain changes, with secondary focus on other mechanisms of emotional processing
      and memory.
    

Detailed description: 
      There will be three groups in total.

        -  The first group will take 36 participants in remission from major depression (rMDD)
           through the 8 week MBCT program.

        -  A control group of 36 rMDD participants will not receive the intervention.

        -  A group of never depressed healthy control participants will also be recruited.

      Research visits for participants not undergoing MBCT will be separated by an 8 week gap.

      All participants will be seen before and after the 8 weeks for completion of
      neuropsychological assessments and questionnaires.

      rMDD participants will be followed up over the following 12 months to identify any predictors
      of relapse.
    

Intervention name(s): Mindfulness-based Cognitive Therapy
Intervention type(s): Behavioral
Intervention description(s): MBCT: Mindfulness-based Cognitive Therapy is an 8 week group-based programme consisting of approximately 12 participants per group. There is also a full one day of practice around week 6. MBCT was initially designed for individuals in remission from depression and at risk of relapsing. The intervention is a mix of mindfulness meditation, cognitive behavioural therapy exercises and psychoeducation. MBCT has been shown to be effective in reducing relapse risk over 12 months.
Other intervention name(s): MBCT
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Bioavailability Study of Oral OZ439 Prototype Granule Formulations Administered With Piperaquine Phosphate (PQP) Tablets
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, 2-part, randomised, single-dose parallel group study in healthy male
      subjects and female subjects of non-childbearing potential.
    

Detailed description: 
      Parts 1 and 2 will be randomised with 8 subjects receiving each regimen:

      Part 1:

        -  Regimen A: Reference: 800 mg OZ439 + α-Tocopherol polyethylene glycol 1000 succinate
           (TPGS) granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 ×
           320 mg) PQP tablets

        -  Regimen B: Prototype 1: 800 mg OZ439 granules (oral suspension 60 mL volume and 50 mL
           rinse volume) and 960 mg (3 × 320 mg) PQP tablets

        -  Regimen C: Prototype 3: 800 mg OZ439 granules (oral suspension 60 mL volume and 50 mL
           rinse volume) and 960 mg (3 × 320 mg) PQP tablets

      There will be an interim decision after Part 1 to determine the formulation prototypes and
      the oral suspension volume to be administered in Part 2.

      Part 2

        -  Regimen D: Reference: 800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and
           100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets

        -  Regimen E: Prototype 1 or 3: 800 mg OZ439 granules (oral suspension and rinse volume to
           be determined) and 960 mg (3 × 320 mg) PQP tablets

        -  Regimen F: Prototype 1 or 3: 800 mg OZ439 granules (oral suspension and rinse volume to
           be determined) and 960 mg (3 × 320 mg) PQP tablets
    

Intervention name(s): OZ439 + TPGS; OZ439 Prototype 1; OZ439 Prototype 3; PQP
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): 800 mg OZ439 + TPGS Reference Treatment; OZ439 Granules Prototype 1 Granules Formulation; OZ439 Granules Prototype 3 Granules Formulation; PQP 960 mg tablets
Intervention MeSH terms: Artefenomel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria; Bioavailability; Formulation
Topical Nitrates for Myofascial Trigger Points
Condition: Myofascial Trigger Points
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a topical nitroglycerine patch applied
      daily over a trapezius trigger point can improve patients' symptoms.

      If there is improvement, this open label study will help determine the degree of improvement
      and contribute to the design of a larger double blind placebo controlled trial.

      We would consider moving forward to a large randomized trial if:

        -  The intervention is acceptable to patients (>= 70%) and

        -  Compliance is satisfactory (>=80%) and

        -  We find preliminary evidence of efficacy, i.e. average reduction in pain of 20mm on the
           VAS.
    


Intervention name(s): Nitroglycerin patch
Intervention type(s): Drug
Intervention description(s): Nitroglycerin 0.1 mg/hr patch
Other intervention name(s): Nitro-Dur 0.1
Intervention MeSH terms: Nitroglycerin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myofascial pain; Trigger point; Nitroglycerin
3-part Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EXS21546
Condition: Oncology
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      A 3-part Study to Assess Safety, Tolerability, PK and PD of Single (Part 1) and Multiple
      (Part 2) Ascending Doses of EXS21546, and to Evaluate the Relative Bioavailability of a Solid
      Dose Formulation Compared to a Powder for Oral Suspension (Part 3), in Healthy Male Subjects.
    

Detailed description: 
      Part 1 is a randomised, double-blind, placebo-controlled, SAD study with a food effect
      assessment.

      Part 2 is a randomised, double-blind, placebo controlled, MAD study over 14 days. In order to
      explore the potential CYP3A4 inducer effect, midazolam will also be administered in one
      cohort.

      Part 3 is a 3-period, open label, randomised, sequential study. Each subject will receive
      solid dose formulation and powder for oral suspension in a randomised manner.
    

Intervention name(s): EXS21546 Powder for Oral Suspension; EXS21546 Granule in Capsule; Midazolam; Food Effect; Placebo Powder for Oral Suspension
Intervention type(s): Drug; Drug; Other; Other; Other
Intervention description(s): EXS21546 Powder for Oral Suspension; EXS21546 Granule in Capsule; Interaction; Fed/Fasted; Placebo Powder for Oral Suspension
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Impact of Increased Water Intake in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The investigators have designed a randomized controlled trial to test whether increased water
      intake slows renal decline in patients with Stage-III Chronic Kidney Disease. Participants
      randomized to the hydration-intervention group will be asked to drink 1.0 to 1.5 L of water
      per day (depending on sex and weight), in addition to usual fluid intake, for one year. The
      investigators will calculate the change in kidney function (estimated glomerular filtration
      rate, measured every three months for 12 months), and compare renal decline between the
      intervention and control groups. The investigators hypothesize that increased water intake
      will slow renal decline.
    


Intervention name(s): Hydration
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Kidney Disease; estimated glomerular filtration rate; water intake; fluid intake; renal decline
Pilot Study of Effect of Intravenous Lidocaine on Propofol Requirement in Facial Plastic Surgery
Condition: Anesthesia, Intravenous; Surgery, Plastic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this randomized pilot study is to evaluate the effect of intravenous lidocaine
      on propofol requirement during BIS (Bispectral index) guided MAC (monitored anesthesia care)
      in facial plastic surgery.
    

Detailed description: 
      Several studies reported the usefulness of intravenous lidocaine as a coadjuvant agent during
      general anesthesia. We thought that there would be an interaction between intravenous
      lidocaine and hypnotic agent requirement. However, there is no data regarding the effect of
      systemic lidocaine during MAC. We, thus, would like to perform a randomized, double-blinded
      pilot study to evaluate the effect of intravenous lidocaine on propofol requirement during
      BIS guided MAC in facial plastic surgery.
    

Intervention name(s): lidocaine; normal saline; propofol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients in lidocaine group will be received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous infusion of 2 mg/kg/hr lidocaine.; Patients in control group will be received an intravenous bolus injection of 1.5 mg/kg normal saline followed by a continuous infusion of 2 mg/kg/hr normal saline.; Propofol will be administered using target controlled infusion during monitored anesthesia care to adjust 60 to 80 of bispectral index.
Other intervention name(s): 0.9% saline; Presofol MCT
Intervention MeSH terms: Lidocaine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Bioavailability Study of Valacyclovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to

        1. Compare and evaluate the single-dose bioavailability study of 1000mg Valacyclovir HCl
           tablets of Dr. Reddy's and Valtrex (R)(Valacyclovir Hydrochloride)CAPLETS 1 gram of
           GlaxoSmithkline, in healthy, adult human subjects under fasting conditions.

        2. monitor the adverse events and ensure the safety of subjects.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-sequence two-period, single-dose,
      crossover comparative bioavailability study of 1000 mg Valacyclovir Hydrochloride Tablets of
      Dr. Reddy's Laboratories Ltd., India and valtrex (R) (Valacyclovir Hydrochloride) CAPLETS 1
      gram of GlaxoSmithkline in healthy, adult human subjects under fasting conditions
    

Intervention name(s): Valacyclovir Hydrochloride
Intervention type(s): Drug
Intervention description(s): Valacyclovir Hydrochloride Tablets, 1000 mg of Dr. Reddy's Laboratories Limited
Other intervention name(s): Valtrex (R)(Valacyclovir Hydrochloride) CAPLETS 1 gm
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Valacyclovir Hydrochloride
Early Intervention For Families Experiencing Homelessness: A Randomized Trial Comparing Two Parenting Programs
Condition: Behavior Problem; Parenting
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      This study aims to compare the efficacy in delivering two evidence-based parenting programs
      to families and young children experiencing homelessness. Outcomes evaluated include
      feasibility, treatment completion, treatment satisfaction of delivery of interventions as
      well as child outcomes (e.g., behavior problems, trauma symptoms) and parenting outcomes
      (parenting stress and parenting skills).
    

Detailed description: 
      The number of homeless families in the U.S. has increased since the 1980s to over half a
      million as of 2018. Most troubling, in 2013 (the most recent year for which census data is
      available) one in every 30 children in the U.S., or 2.5 million, experienced homelessness. In
      addition to having disproportionally higher rates of unmet health needs (e.g., acute health
      problems, trauma-related injuries), children experiencing homelessness have staggering mental
      health needs such that 78% suffer from at least one mental health issue (e.g., depression,
      behavior problems) along with academic/developmental delays. Given that over half of all
      homeless children in the US are under the age of 6, it is particularly important to
      investigate the effectiveness of evidence-based parenting programs within a homeless
      population. This study aims to compare the efficacy in delivering two evidence-based
      parenting programs to families and young children experiencing homelessness.
    

Intervention name(s): Parent Child Interaction Therapy; Child Parent Psychotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parent-child Interaction therapy (PCIT; Eyberg and Robinson, 1982) s a manualized evidence-based behavioral parent training program that integrates social learning and attachment theories. Parents proceed through two distinct phases: Child-Directed Interaction (CDI) resembles traditional play therapy, and Parent-Directed Interaction (PDI) resembles clinical behavior therapy. During all sessions, the therapist coaches each parent in vivo in their use of the CDI and PDI skills with their child.; Child-parent psychotherapy (CPP; Lieberman et al., 2005) is a relationship-based treatment that integrates attachment, cognitive-behavioral, social-learning, and psychodynamic theories. CPP focuses on the child-parent relationship as a way to improve the child's adaptive functioning. Various treatment strategies are employed including a focus on safety, affect regulation, the joint construction of a trauma narrative, and engagement in developmentally appropriate activities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: early intervention; parenting; homelessness; parent child interaction therapy; child parent psychotherapy; behavior problems; trauma symptoms