bioihbjkbjnl/mcl2 huggingface dataset:
Doravirine, Rifapentine and Isoniazid Interaction
Condition: Latent Tuberculosis; Human Immunodeficiency Virus; Rifamycins Causing Adverse Effects in Therapeutic Use; Drug Interaction Potentiation
MeSH terms: Tuberculosis; Acquired Immunodeficiency Syndrome; HIV Infections; Latent Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Drug therapy for persons living with human immunodeficiency virus (HIV) or acquired
      immunodeficiency syndrome (AIDS) co-infected with latent tuberculosis infection (LTBI) is
      complex. Anti-tuberculosis drugs used to treat LTBI often induce drug metabolizing enzymes
      that share the same metabolic pathway as antiretroviral drugs used for those living with
      HIV/AIDS. This study evaluates the drug-drug interaction (DDI) potential of an antiretroviral
      drug when co-administered with a common anti-tuberculosis regimen of drugs.
    

Detailed description: 
      Rifapentine (RPT) and isoniazid (INH) given once weekly for 12 weeks is commonly used for
      treating LTBI in adults. For people living with HIV-1, the risks of LTBI is increased.
      Individuals living with HIV-1 are often on chronic antiretroviral drugs that prevent
      immunodeficiency and complications associated with infection. Unfortunately, antiretroviral
      drugs are subject to many DDIs especially with RPT which induces drug clearing enzymes.

      Doravirine (DOR) is a newly approved non-nucleoside reverse transcriptase inhibitor indicated
      for the treatment of HIV-1 infection. Because RPT induces the metabolic pathway in which DOR
      is removed, there is concern that taking both concomitantly will result in an unwanted DDI
      leading to reduced DOR concentrations in the blood. Reduced levels will result in loss of
      efficacy for the drug and therefore not provide adequate viral suppression in those living
      with HIV. This study investigates the DDI potential of the once weekly regimen RPT and INH
      together with DOR in healthy volunteers.
    

Intervention name(s): Doravirine (DOR); Rifapentine (RPT); Isoniazid (INH)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Non-nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV-1 infection in adults in combination with other antiretroviral agents.; Rifamycin anti-tuberculosis agent indicated for the treatment of latent and active tuberculosis infection.; Anti-tuberculosis agent indicated for the treatment of latent and active tuberculosis infection.
Other intervention name(s): Pifeltro; Priftin; Generic (various)
Intervention MeSH terms: Isoniazid; Rifapentine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug-drug interaction; Pharmacokinetics; Non-nucleoside reverse transcriptase inhibitor; NNRTI; LTBI; Antimycobacterial
Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery
Condition: Blepharitis; Dry Eye Syndrome
MeSH terms: Cataract; Dry Eye Syndromes; Meibomian Gland Dysfunction; Blepharitis
Study type: Interventional

Summary: 
      The purpose of this pilot feasibility study is to assess whether treating meibomian gland
      dysfunction (MGD) prior to cataract surgery helps promote meibomian gland function, visual
      quality and ocular comfort after cataract surgery.
    

Detailed description: 
      This is a post-market, prospective, non-significant risk, open-label, randomized multi-center
      clinical trial evaluating treatment with the LipiFlow System in patients with meibomian gland
      dysfunction prior to planned bilateral cataract surgery. All subjects undergo examination to
      determine study eligibility and to capture the Baseline status prior to surgery. Subjects are
      randomized to receive LipiFlow treatment (Pre-treatment group) one month before cataract
      surgery or no LipiFlow treatment (Untreated Control group). Cataract surgery is performed on
      both eyes of each subject with the second eye surgery completed within two months of the
      first eye. All subjects are evaluated at one month and three months after cataract surgery on
      the second eye with comparison of the study endpoints between the Pre-treatment and Untreated
      groups. To facilitate subject recruitment, the Untreated Control group receives crossover
      LipiFlow treatment for MGD (Post-treatment group) three months after cataract surgery on the
      second eye.
    

Intervention name(s): LipiFlow Pre-Treatment; LipiFlow Post-treatment
Intervention type(s): Device; Device
Intervention description(s): The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.; The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.
Other intervention name(s): LipiFlow Thermal Pulsation System; LipiFlow Thermal Pulsation System
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Respiratory Syncytial Virus Infection in Neonatal Intensive Care Units Throughout Turkey: Prospective Multicenter Study (TurkNICU-RSV Trial)
Condition: Respiratory Syncytial Virus Infections; Infections, Epidemics
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Respiratory Syncytial Virus Infections
Study type: Observational

Summary: 
      The principle purpose of this multicenter trial is to determine the definition, timing and
      the percentage of nosocomial RSV epidemics throughout Turkey. In addition, secondary purpose
      of the trial is to determine the prevention strategies of further spread of Respiratory
      Syncytial Virus (RSV) in the neonatal intensive care unit (NICU).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hospitalized RSV infected newborn infants in the NICU.
      
Keywords: Respiratory Syncytial Virus Infections; Epidemics; Neonatal Intensive Care Unit; Newborn infants
NACER II: Reducing Prenatal Exposures to Household Air Pollution in Rural Guatemala Through a Gas Stove/Behavior Intervention to Improve Neonatal Health
Condition: Premature Birth; Fetal Growth Retardation; Infections, Respiratory; Exposure to Environmental Pollution, Non-occupational; Infant, Small for Gestational Age
MeSH terms: Respiratory Tract Infections; Premature Birth; Fetal Growth Retardation
Study type: Interventional

Summary: 
      Greater efforts are needed to bring affordable, clean stoves and adaptive behavioral
      strategies to the millions of households worldwide that continue to burn solid cooking fuels
      using inefficient stoves. Two of the leading causes of infant mortality, preterm birth and
      pneumonia, are associated with high exposures to household air pollution during pregnancy and
      early infancy. The proposed study will assess the feasibility and acceptability of an
      introduced liquid petroleum gas stove, complemented by two alternative approaches to
      delivering tailored behavioral change interventions, among pregnant women and their neonates.
    


Intervention name(s): Low-cost gas stove; Peer education classes; Resource-intensive behavioral intervention approach
Intervention type(s): Other; Behavioral; Behavioral
Intervention description(s): Women will be provided with a 3-burner liquid propane gas stove and one year's supply of gas; Women will participate in four classes on how to safely use gas stoves and methods to reduce exposure to air pollution; Women will participate in four classes on how to safely use gas stoves and methods to reduce exposure to air pollution. Additionally, peer educators will visit each home after group classes to help the woman, and key decision-makers in her family, identify top priority strategies to reduce air pollution. Using a checklist, peer educators will observe whether household members are adhering to tailored strategies at subsequent home visits, and provide ongoing support to women and their families.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine in Children Previously Vaccinated in Trial V118_05 (NCT01964989)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared
      to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously vaccinated in Trial
      V118_05. Subjects will receive either the Same or Alternate Type of Vaccine.
    


Intervention name(s): Adjuvanted QIV (aQIV); Non-adjuvanted QIV
Intervention type(s): Biological; Biological
Intervention description(s): Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV); Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza Vaccine; MF59 adjuvant
Effectiveness of Resin Sealants: Retrospective Cohort Study
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      This retrospective cohort study assessed sealant clinical success applied to pit and fissure
      by dental undergraduate students at Piracicaba Dental School - Brazil.
    

Detailed description: 
      A population presenting 1st/2nd permanent molars with sealed occlusal surfaces were
      considered. Dental records were reviewed for: patient's caries risk (High/Low); operator
      experience (scores 1 to 4, beginners to seniors); number of follow-up visits; isolation
      procedure; sealant/tooth type; and age at placement. Posteriorly, the patients were called to
      dental evaluation and the sealed teeth were classified regarding the sealant presence,
      partial presence or absence, with or without caries, or sealant replacement to a restorative
      material in Satisfactory or Unsatisfactory, considering the caries presence/absence.
      Successful outcome was considered in the caries absence.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated at Piracicaba Dental School - Brazil
      
Keywords: Pit and fissure sealants; Dental Caries; Prevention; Dental undergraduate students; patient's caries risk
Tadalafil Plus Tamsulosin for Male LUTS and ED
Condition: Prostatic Hyperplasia, Benign; Lower Urinary Tract Symptoms; Erectile Dysfunction; Metabolic Syndrome
MeSH terms: Erectile Dysfunction; Prostatic Hyperplasia; Metabolic Syndrome; Hyperplasia; Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      Metabolic Syndrome (MetS) is a complex epidemic disorder with an impact on both lower urinary
      tract symptoms (LUTS) and erectile dysfunction (ED). Combination therapy of daily tadalafil
      and tamsulosin may provide relief to both diseases.

      Aim of the present study is to assess the impact of combination therapy of Tadalafil 5mg plus
      Tamsulosin 0.4mg on LUTS and ED, according to presence vs. absence of Mets.
    

Detailed description: 
      75 Consecutive men presenting with ED and LUTS suggestive of bladder prostatic obstruction
      were enrolled. Patients were divided into two groups according to MetS presence or absence.
      All subjects were then treated with tadalafil 5 mg/die plus tamsulosin 0.4 mg/die for 12
      weeks. Patients were re-evaluated after 12 weeks of treatment with Uroflowmetry and PVR,
      IPSS, IPSS QoL, OAB-q and IIEF-5 and comparison were made in and between groups.
    

Intervention name(s): Tadalafil 5mg
Intervention type(s): Drug
Intervention description(s): Combination therapy of daily tadalafil plus tamsulosin
Other intervention name(s): Tamsulosin 0.4mg
Intervention MeSH terms: Tadalafil; Tamsulosin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        75 Consecutive men presenting with ED and LUTS suggestive of bladder prostatic obstruction
        (BPO) were screened for the trial. Inclusion criteria were age >40 to 80 years, mild to
        severe ED (International Index of Erectile Function-Erectile Function-5 <22), moderate to
        severe LUTS (International Prostate Symptom Score >7), while exclusion criteria were
        hypersensitivity to tadalaﬁl or tamsulosin, prostatic cancer or suspected with
        prostate-speciﬁc antigen (PSA) >4 ng/mL, bladder lithiasis, previous prostatic surgery,
        urinary tract infection, neurogenic bladder, ﬁnasteride or dutasteride use within 3 or 6
        months, respectively, clinical history of urethral and/or proven bladder neck obstruction.
      
Keywords: Tadalafil; Tamsulosin; BPH; LUTS; ED; PDE5-I; Alpha-Blockers; METS
The Effects of Pre-operative Anxiety on Anesthetic Recovery and Post-operative Pain in Donor Nephrectomy
Condition: Kidney Transplantation; Anxiety; Pain, Acute; Anesthesia Recovery Period
MeSH terms: Pain, Postoperative; Acute Pain; Anxiety Disorders
Study type: Interventional

Summary: 
      Kidney transplant is the most effective choice of treatment for patients with end-stage
      kidney failure in terms of quality of life and longevity. Today, 20-25% of kidney
      transplantations are implemented with living donors.

      Donor nephrectomy is an operations which has the end goal of a living donor donating one of
      his kidneys to a patient with end-stage kidney failure (1).

      Pre-operative anxiety is a condition which is characterized by a random illness, being
      hospitalised, anesthesia, surgery, or uneasiness or anxiety stemming from not knowing what is
      to be experienced. Educating and informing in the pre-operative period is the first step in
      mentally preparing the patient for the operation. In some studies, it has been pointed out
      that patients who were thoroughly informed in the pre-operative period have lower anxiety
      levels both in the pre-operative and post-operative periods with also less levels of pain and
      increased recovery rates in the latter (2).

      Anesthetic recovery starts at the end of the surgical process and ends with the anesthetized
      patient completely regaining a wide-awake, responsive state, defensive reflex, and muscle
      strength.

      Post-operative pain is acute pain which starts with surgical trauma and ends with tissue
      healing (3). Providing optimal post-operative analgesia plays an important role in the
      prevention of post-operative complications (1,4,5).

      There are studies which examine the link between pre-operative anxiety and post-operative
      pain (59,74,74,77,78). Patients who will undergo a donor nephrectomy constitute a specific
      group of patients both because they are not operated due to a health problem that they have
      and because the operation results with them losing an organ. There are no prospective studies
      about the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in
      individuals who have undergone donor nephrectomy in literature. Because of this, we have
      aimed to research prospectively the effects of pre-operative anxiety on anesthetic recovery
      and post-operative pain in patients that were to undergo donor nephrectomy surgery.
    


Intervention name(s): Donor Nephrectomy
Intervention type(s): Procedure
Intervention description(s): 48 Donor Nephrectomy Patients
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficacy and Safety of "BST104" (Lonicera Flos Extract) in Mild to Moderate Functional Dyspepsia Subjects
Condition: Functional Dyspepsia; Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was conducted to prove the efficacy of BST-104 in patients with mild to moderate
      FD.
    

Detailed description: 
      In this single center, double-blind, randomized clinical trial, patients diagnosed with FD
      using Rome III criteria were allocated to either test group (300 mg of BST-104, containing
      175 mg of Flos Lonicera extracts, twice daily) or placebo group (300 mg placebo, twice
      daily). Male and female patients > 19 years of age who had mild to moderate FD were eligible.
      They had baseline endoscopic screening, and patients without active lesions (peptic ulcer
      disease or gastric erosions) were enrolled. Written informed consent was obtained from all
      participants.
    

Intervention name(s): BST-104 (Lonicera Flos Extract); Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): 175 mg of Lonicera Flos extract in 1 tablet (300 mg); 0 mg of Lonicera Flos extract in 1 tablet (300 mg)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a single center, random assignment, double blind placebo human application study. If a subject agrees in writing to participate in the human aptitude test, the medical examination required in accordance with the human aptitude test plan were conducted and randomly assigned only to those who are suitable for the selection criteria. The randomly assigned target was given a Lonicera Flos extract (BST104) 250 mg/day or placebo for eight weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Functional dyspepsia; Irritable Bowel Syndrome; Lonicera Flos; GSRS; Antioxidant
Surgical Outcomes for Proliferative Diabetic Retinopathy by Preoperative Glycemic Control and Renal Function
Condition: Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Observational

Summary: 
      The surgical outcomes of 25-gauge vitrectomy for proliferative diabetic retinopathy has been
      evaluated by preoperative glycemic control and renal function
    

Detailed description: 
      The purpose of this study is to evaluate the surgical outcomes of 25-gauge vitrectomy for
      proliferative diabetic retinopathy by preoperative glycemic control and renal function.
    

Intervention name(s): Vitrectomy
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The eyes with proliferative diabetic retinopathy
A Psychoeducational Intervention for Brain Awareness, Metacognition, Self-efficacy and Treatment Motivation
Condition: Substance Use Disorders; Alcohol Use Disorder
MeSH terms: Substance-Related Disorders; Alcoholism
Study type: Interventional

Summary: 
      The aim of this study is to examine the effect of brain awareness intervention on
      metacognition, self-efficacy and treatment motivation in patients with alcohol and substance
      use disorders. It is an experimentally designed study with a randomized control group and
      repeated measurements (pre-test, mid-test, post-test).
    

Detailed description: 
      The aim of this study is to examine the effect of brain awareness intervention on
      metacognition, self-efficacy and treatment motivation in patients with alcohol and substance
      use disorders. It is an experimentally designed study with a randomized control group and
      repeated measurements (pre-test, mid-test, post-test). 77 inpatients at the Alcohol and Drug
      Addiction Treatment and Research Center included between April and October 2021. In addition
      to standard treatment, psychoeducation and counseling provided as part of the Brain Awareness
      Intervention for the experimental group of 39 patients. The control group of 38 patients will
      receive education about Being Healthy in addition to standard treatment and standard
      follow-up. Patients' pathological metacognitive activities, self-efficacy perceptions and
      treatment motivation will assessed with the Metacognition Scale-30, Self-Efficacy Scale and
      Treatment Motivation Questionnaire using one-way and two-way repeated measures analysis.
    

Intervention name(s): Brain Awareness Intervention; Being Healthy Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): effect of brain awareness intervention on metacognition, self-efficacy and treatment motivation in patients with alcohol and substance use disorders; This training included trainings on Healthy Nutrition, Sexually Transmitted Diseases, Importance of Physical Activity and Personal Hygiene prepared by the researcher in the form of presentations for the patients in the control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is an experimentally designed study with a randomized control group and repeated measurements (pre-test, mid-test, post-test).
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Brain Awareness; Psychoeducation; Metacognition; Self-efficacy; Treatment Motivation
The Effect of Testosterone Replacement on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Hypogonadotrophic Hypogonadism
Condition: Hypogonadotrophic Hypogonadism
MeSH terms: Insulin Resistance; Hypogonadism; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The study searched for answers to two questions

        1. What is the effect of testosterone replacement therapy on endothelial dysfunction,
           inflammation and insulin resistance?

        2. Regarding the above parameters, is there any difference between daily transdermal
           testosterone implementation and intramuscular injection performed in three weeks.
    


Intervention name(s): Testogel 50 mg transdermal gel; Testosterone 250mg injection
Intervention type(s): Drug; Drug
Intervention description(s): 50mg testosterone gel implementation on every night; The testosterone 250mg ester IM injections performed in three weeks.
Other intervention name(s): Testogel 50mg transdermal gel; Sustanon 250 mg amp.
Intervention MeSH terms: Testosterone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypogonadism; Endothelial dysfunction; Inflammation; Insulin resistance; Testosterone replacement therapy