bioihbjkbjnl/mcl2 huggingface dataset:
Periconception PrEP for HIV-exposed Ugandan Women
Condition: HIV Prevention
Study type: Interventional

Summary: 
      In this mixed-methods research study, the study team will offer comprehensive safer
      conception services to 150 HIV-uninfected women reporting an HIV-infected or high-risk
      partner and personal or partner plans for pregnancy in rural Uganda to evaluate prevalence
      and determinants of uptake and adherence (tenofovir plasma concentration >40ng/mL, opening
      pill device to take >80% of dispensed pills) to PrEP and other safer conceptions strategies
      among Ugandan women exposed to HIV.
    

Detailed description: 
      The study plans to enroll 150 HIV-uninfected women with an HIV-positive or HIV-serostatus
      unknown partner and personal or partner pregnancy plans. Eligible women will participate in
      comprehensive safer conception counseling including offering daily, oral TDF/FTC as PrEP. The
      primary outcomes are to evaluate uptake of and adherence to periconception PrEP among
      HIV-exposed women in rural Uganda.

      To accomplish this, women will participate in quarterly study visits, HIV and pregnancy
      testing, questionnaires and safer conception/adherence group counseling sessions.
      Participants will be eligible to initiate PrEP at any time during the first 6 months of the
      9-month study follow-up period. Participants who initiate PrEP will use an electronic pill
      cap to measure daily adherence and will be asked to give blood samples to measure plasma TFV
      at quarterly study visits.

      For women who become pregnant in the first 9 months, investigators will follow them up
      through completion of pregnancy to evaluate PrEP use, pregnancy and infant outcomes.

      Study duration will be a maximum 19 month follow-up period (through pregnancy outcome) .

      Investigators will offer objective sexually transmitted infection (STI) testing to all
      participants in order to measure the prevalence, incidence, and factors associated with STIs.
      Investigators will compare incidence among women who choose and who do not choose PrEP.
      Investigators will also measure the number of episodes of condomless sex each month as a
      mediator variable for STI development.
    

Intervention name(s): Safer conception counseling inclusive of periconception PrEP
Intervention type(s): Behavioral
Intervention description(s): Observational evaluation of factors associated with uptake of and adherence to daily, oral TDF/FTC PrEP and other safer conception methods (including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive during follow-up) over 9 month. Maximum 19 month follow-up period (through pregnancy outcome).
Intervention model: Single Group Assignment
Intervention model description: Safer conception counseling
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PrEP; conception; prevention
Using Telemedicine to Optimize Teamwork and Infection Control of Critical and Highly-infectious Patients in an Emergency Department
Condition: Critical Illness; Infections, Respiratory; Emergency Service, Hospital; Telemedicine
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Emergencies; Critical Illness
Study type: Observational

Summary: 
      Since 2000, various emerging infectious diseases have repeatedly caused serious impact on the
      health of the global population and the healthcare systems. With the growing international
      transportation and improving accessibility of the healthcare systems, hospitals have been
      inevitably the first sentinels dealing with emerging infectious diseases. The biological
      disasters, such as the Severe Acute Respiratory Syndrome (SARS) in 2003, the Middle East
      Respiratory Syndrome (MERS) outbreak in South Korean in 2015, and the Coronavirus disease
      2019 (COVID-19) outbreak this year, challenged our vulnerable healthcare systems and caused
      great loss of lives.

      Regarding the ongoing global epidemics and possible community outbreaks of the COVID-19, the
      management of biological disasters for an overcrowded emergency department should be planned.
      In the early 2020, the emergency department used a double-triage and telemedicine method to
      treat non-critical patient with suspected COVID-19. This application reduced the exposure
      time of the first responders and reserve adequate interview quality. However, for the
      critical patients treated in the isolated resuscitation rooms, the unique environment limited
      the teamwork and communication for the resuscitation team. These factors might led to poorer
      quality of critical care.

      The investigators designed a telemedicine-teamwork model, which connected the isolation room,
      prepare room and nursing station by an video-conferencing system in the emergency department.
      This model try to break the barriers of space between the rooms and facilitate the teamwork
      communications between each unit. Besides, by providing a more efficient workflow, this model
      could lower the total exposure time for all workers in the contaminated area. This study was
      conducted to evaluate the benefits of the telemedicine-teamwork model and provide a
      practical, safe and effective alternative to critical care of the patients with suspected
      highly infectious diseases.
    


Intervention name(s): telemedicine; traditional communication tools
Intervention type(s): Other; Other
Intervention description(s): Using telemedicine system to communicate; Use telephone or direct verbal communication
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients triaged as highly-infectious patients, needed to be treated in isolation rooms in
        the emergency department.
      
Keywords: telemedicine; isolation; critical care; emergency medicine; COVID-19
Preterm Delivery After Septum Resection
Condition: Septum; Uterus; Infertility, Female; Preterm Birth
MeSH terms: Premature Birth; Infertility; Infertility, Female
Study type: Observational

Summary: 
      Uterine septum is the most common congenital uterine malformation. It accounts for
      approximately 35% of all uterine malformations, while the frequency of uterine malformations
      in the general fertile population is estimated to be between 1% and 4%.

      The presence of a uterine septum is associated with subfertility and a high incidence of
      obstetric complications, such as spontaneous abortion, 3-fold increase in preterm premature
      rupture of the membranes (PROM), 6-fold increase in preterm delivery, malpresentation at
      delivery, caesarean section, and increased perinatal morbidity and mortality.

      Some studies have found that surgical resection of the uterine septum improves pregnancy
      outcomes and significantly reduces the risk of preterm delivery. Therefore, the risk for a
      short-term adverse outcome and long-term sequelae due to preterm delivery such as
      intraventricular hemorrhage, necrotizing enterocolitis, sepsis, patent ductus arteriosus,
      retinopathy, deafness, chronic lung disease, cerebral palsy, perinatal death, and impaired
      mental development in women with uterine septum could be lowered by performing a relatively
      simple and safe hysteroscopic septum resection (HSR).

      However, there are two major concerns regarding HSR: cervical incompetence due to excessive
      dilatation during hysteroscopy and the rare yet serious complication of uterine rupture in
      subsequent pregnancy or delivery.

      Considering these elements, the aim of this study will be to evaluate the rate of preterm
      delivery in singleton pregnancy comparing primary infertile women who underwent HSR and who
      did not undergo the same procedure, with our without in vitro fertilization.
    


Intervention name(s): Hysteroscopic septum resection; In vitro fertilization
Intervention type(s): Procedure; Procedure
Intervention description(s): Hysteroscopic septum resection, using a 26 French continuous-flow resectoscope with monopolar energy and electrolyte-free distension medium.; Fertilization of oocytes with the spermatozoa of the partner, after induction of ovulation and capacitation of the sperm, using fertilization in vitro and embryo transfer (FIVET) or intracytoplasmic sperm injection (ICSI).
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women affected by primary infertility who obtained the first ongoing pregnancy with (cases)
        or without (controls) previous hysteroscopic septum resection, with or without in vitro
        fertilization.
      
Keywords: Hysteroscopy; Metroplasty; Primary infertility; Preterm delivery
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Children
Condition: Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a study to investigate the pharmacokinetics, safety and tolerability of several doses
      of voriconazole, intravenous and oral suspension formulations, in children
    


Intervention name(s): Voriconazole
Intervention type(s): Drug
Intervention MeSH terms: Voriconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study
Condition: Chemo Brain; Chemotherapy-related Cognitive Impairment; Chemo Fog; Breast Cancer; Chemobrain
MeSH terms: Chemotherapy-Related Cognitive Impairment; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the use of a nicotine patch as a treatment for
      problems with attention, learning and memory in breast cancer patients who are 1-5 years post
      chemotherapy.
    

Detailed description: 
      Studies have suggested that chemotherapy treatment for breast cancer may change the way the
      brain functions. As a result, patients who receive chemotherapy for breast cancer may
      experience problems with their attention, learning, and memory that they did not have before
      receiving chemotherapy. The investigators have found that nicotine treatment can help other
      types of patients with similar difficulties with attention, learning, and memory. Nicotine is
      a naturally occurring substance found in tobacco and is known to interact with nerve cells in
      the brain that are important for functions like learning and memory, and has been studied in
      a number of disorders. This study is designed to test whether nicotine treatment is helpful
      for learning and memory problems after chemotherapy for breast cancer.

      This study will be a randomized, placebo-controlled pilot study to evaluate the effect of
      transdermal nicotine to 1) reduce subjective complaints and 2) enhance cognitive performance
      on laboratory measures of cognitive performance in breast cancer patients with persistent
      chemotherapy-related cognitive impairment (CRCI), a condition also known as "chemo brain."
      Participants will be randomized to either placebo or active compound (50/50) for the 6-week
      treatment portion of the study. Participants will be assessed before, during, and at the end
      of treatment. At the end of the 8-week study, participants will have the option to take part
      in the open-label portion of the study for an additional 6 weeks.
    

Intervention name(s): Transdermal nicotine; Placebo Transdermal Patch
Intervention type(s): Drug; Other
Intervention description(s): Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence.; Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chemo brain; Chemotherapy-related cognitive impairment; CRCI; Breast cancer; Chemo fog; Nicotine; Transdermal nicotine
Distance for Interscalene Block
Condition: Regional Anesthesia; Inter Scalene Block; Post Operative Analgesia
Study type: Observational

Summary: 
      Patients experience significant postoperative pain following shoulder surgery, Single shot
      interscalene block is used in ambulatory shoulder surgery for its advantages that include
      significant reduction in acute pain and analgesic requirements, prolonged time to first
      analgesic request, decreased incidence of nausea, as well as earlier hospital discharge.The
      process of nerve block requires several needle passes, with each of them being at risk of
      causing nerve injury either by direct trauma or intraneural injection even with the use of
      the ultrasound. These facts raised concerns and several authors stated that maybe the
      anesthesiologists should be more careful, keep a safe distance from the nerve, and inject the
      local anesthetics into fascial planes containing the nerve and not attempt to place the
      needle in close proximity to the nerve. This study is designed to determine the maximal
      effective distance away from the nerve for the injection to be effective.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing shoulder surgery (shoulder arthroscopy or open shoulder surgery)
      
Keywords: Inter-scalene Block; Regional Anesthesia; shoulder surgeries
Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in Healthy Korean Subjects
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this trial is to investigate the PK (Pharmacokinetic) of repeated-dose
      applications of the Rotigotine transdermal patch in healthy young male and female Korean
      subjects to be submitted to MFDS for new drug application approval.
    


Intervention name(s): Rotigotine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Day 1-3: 2 mg patch once daily
Day 4-6: 4 mg patch once daily; Placebo patches matching with Rotigotine 2 mg patches and 4 mg patches.
Frequency:
Day 1-3: 2 mg patch once daily
Day 4-6: 4 mg patch once daily
Other intervention name(s): Neupro
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Parkinson's Disease; Rotigotine; Pharmacokinetics; Healthy subjects
Omega 3 Supplementation in Cystic Fibrosis Patients
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Essential fatty acids (EFA) deficiency has been often reported in patients with cystic
      fibrosis (CF), particularly in those homozygous for the DF508 mutation. Clinical symptoms of
      CF may be influenced by correcting EFA deficiency. Nevertheless, the value of EFA
      supplementation in CF remains controversial. Within this multicentric and international
      randomized placebo-controlled trial it will be evaluated, according to recommendations of
      Cochrane analysis, beneficial effects of an oral supplementation with polyunsaturated fatty
      acids on selected biochemical and functional outcome parameters such as inflammatory
      biomarkers, incorporation into cell membrane phospholipids, lung function, exercise
      tolerance, clinical and nutritional status and properties of transepithelial ion transport.
      The study will be undertaken in a cohort of CF patients aged over 6 years old (60 patients),
      homozygous for the DF508 mutation and treated by Azithromycine. Supplementation will be
      performed with a triglyceride source at a daily dose of 60 mg/kg of omega-3 polyunsaturated
      fatty acids (Omega 3 Premiumâ, Laboratoires Ponroy, France). Before enrolled into the trial
      and during the study, patients will undergo nutritional assessment by evaluation of total and
      fat dietary intake and overall calorie intake using a 3-days diet records and a food
      frequency questionnaire. Plasma and erythrocyte membrane EFA profiles and inflammatory
      markers will be monitored in baseline conditions, at 3, at 6 and 12 months after starting the
      treatment. Lung function will be performed at each patient visit and an exercise test will be
      done before and at the end of the treatment. Properties of ion transport will be searched by
      sweat testing before and at the end of the treatment.
    


Intervention name(s): omega-3 triglycerides; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): capsules containing 300mg of omega-3 triglycerides with 100mg DHA and 150mg EPA, 60mg/kg/day 3 times a day during 12 months.; capsules containing middle chain triglycerides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Omega 3; Cystic Fibrosis; Inflammatory markers
A Study to Assess Co-Administered AZD9056 (Steady State) and Simvastatin (Single Dose) in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the pharmacokinetics of both AZD9056 (steady state) and
      simvastatin (single dose) when co-administered in healthy volunteers
    


Intervention name(s): simvastatin; AZD9056 + simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): One single dose of 40mg; AZD9056: 400 mg od, 8 days simvastatin: one single dose of 40 mg on day 7
Other intervention name(s): Zocor; Zocor
Intervention MeSH terms: Simvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: simvastatin; AZD5672
Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.
Condition: Infection, Fungal
MeSH terms: Mycoses; Candidiasis, Vulvovaginal; Vulvovaginitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Fungal infections have increased over the last two decades, largely because of the increasing
      size of the population at risk, including patients who are immunocompromised, broad-spectrum
      antibiotics and intravascular catheter users. Essential oils and other extracts of plants
      have evoked interest as sources of natural products. They have been shown to possess
      antibacterial, antifungal, antiviral, insecticidal and antioxidant properties. To the best of
      our knowledge, no study has examined the efficacy of cumin seed extract on relieving
      vulvovaginal candidiasis in vivo.
    


Intervention name(s): Cumin seed extract; clotrimazole
Intervention type(s): Drug; Drug
Intervention description(s): patients will receive the drug in suppository form; patients will receive the drug in suppository form
Intervention MeSH terms: Clotrimazole; Miconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Attitudes & College Experiences
Condition: Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      High volume drinking by young adults has proven resistant to long term change, so new
      approaches are needed. Given strong associations between alcohol-related attitudes and
      drinking behavior, the investigators adapt a theory-based attitude change strategy for use in
      alcohol prevention. This research tests the impact of a brief counter attitudinal advocacy
      activity on subsequent drinking and negative consequences.
    

Detailed description: 
      The persistence of risky drinking among young adults in college calls for continued efforts
      to prevent harms related to alcohol. Current prevention interventions have achieved some
      success, but rely on a single mechanism of change: correcting exaggerated drinking norms. The
      investigators propose to test a novel prevention strategy targeting another mechanism of
      change: creating attitude-behavior dissonance. To date, changing alcohol-related attitudes
      and the resulting attitude-behavior discrepancy has been underutilized as a behavior change
      strategy for alcohol abuse prevention. Informed by an extensive literature showing strong and
      consistent associations between alcohol attitudes and drinking behavior, the investigators
      adapted a brief counter-attitudinal advocacy (CAA) manipulation to the alcohol prevention
      context.
    

Intervention name(s): CAA; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will write about the use of PBS and alcohol use.; Participants will write about eating and exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Alcohol Intervention; College Students
Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency
Condition: Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to: test the safety, tolerability, and pharmacokinetics
      (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a
      drug) of a single dose of the investigational study drug NBI-98854 in subjects with normal
      hepatic function or mild, moderate, or severe hepatic impairment.
    


Intervention name(s): NBI-98854 50 mg capsule
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science