cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Periodontal Treatment in Patients With Bronchiectasis

Background: Association between periodontal disease (PD) and chronic obstructive pulmonary disease (COPD) has been widely studied and the aspiration of periodontal pathogens is one of the most accepted causal mechanisms for pulmonary exacerbation. Bronchiectasis is clinically quite similar with COPD, including chronic administration of antibiotics, increased systemic inflammation and relatively similar clinical symptoms, but for the time being; there are no studies that have correlated this condition to PD. This study will evaluate if the scaling and root planning (SRP) associated with photodynamic therapy improves periodontal clinical parameters, halitosis, and the quantity of microorganisms associated with exacerbation of bronchiectasis in saliva, subgingival periodontal microenvironment, sputum and nasal lavage at baseline, after 3 months and one year of SRP. Methods/Design: Ninety patients with chronic periodontal disease and bronchiectasis will be enrolled in the study and they will be treated as follow:G1 control (n = 30) - supragingival scaling (SS) and dental hygiene orientation (DHO); G2 experimental (n = 30) - SRP + DHO; G3- experimental (n = 30) - SRP + PDT + DHO. The quantification of bacterial groups commonly associated with exacerbation of bronchiectasis (P aeruginosa, S. aureus) and periodontal diseases (P. gingivalis), will be evaluated in periodontal pockets, saliva, nasal lavage and sputum by quantitative PCR at baseline 3 months and one year after the SRP. G1 patients will receive SRP upon completion of the investigation. If the mean depth of probing of this group worsen (\> 1mm) at 3 months they will be excluded from the study, treated (SRP) and the data will be described. Discussion: The results of this protocol will determine the efficacy of periodontal treatment in decreasing the total amount microorganisms in saliva periodontal pocket, sputum and nasal lavage, the most probable niches of bronchiectasis exacerbation, and reducing local inflammation and halitosis after 3 months and one year. It is expected an higher improvement in all parameters measured over 3 months and 1 year for G3


Eligibility Criteria:
Inclusion Criteria:

* Patients must have \> 35 years, both genders, \> 10 teeth with chronic moderate generalized periodontal disease , i.e. more than 30% of teeth examined with ≥ 4 mm probing depth.

Exclusion Criteria:

* Exclusion criteria include smokers or former smokers for less than five years, pregnant, people with cystic fibrosis and asthma, phenytoin or cyclosporine users (because they affect periodontal status), decompensated systemic diseases requiring prophylactic antibiotic therapy for periodontal treatment, who used oral antiseptics or anti-inflammatory in the last 3 months, or periodontal treatment performed in the last 6 months.
Evaluation of a Home Visiting Program for First Time Parents

The purpose of this research is to evaluate the Healthy Families Durham (HFD) program by comparing the traditional 3-year program to 18-months of Healthy Families Durham to Yearly Visits with case management referrals to community services as usual, and to determine whether participation in the program reduces the number of reports for child maltreatment within the first seven years of the child's life.


Eligibility Criteria:
Inclusion Criteria:

* mother is a first-time parent (has been a primary caregiver of a child for less than 3 months total
* resident of Durham, North Carolina
* mother is being referred during pregnancy
* has at least one of the following risk factors: 16 years old or younger; lack of social support; history of substance abuse in the past 12 months; ever received treatment for alcohol or drug problems; history of domestic violence; history of being abused or neglected as a child; history of mental health problems in past 12 months; past child protective services involvement as a parent

Exclusion Criteria:

* actively suicidal or homicidal
* acutely psychotic
* moderately to severely mentally retarded
Placenta Accreta Spectrum Topographic Classification

The present study is a prospective multicenter study consisting of a cohort of patients with prenatal or intraoperative diagnosis of PAS, evaluating the clinical outcomes of the group of patients found in each category of the topographic classification. In addition, an approach to evaluate the acceptability of this classification among the obstetrician-gynecologists of the participating medical centers will be included.

The aim of this study is to describe the demographic and clinical characteristics of patients with a diagnosis of placenta accreta spectrum, and to determine the correlation between the topographic classification and the clinical outcomes found in the study. Finally, to evaluated whether the proposed classification is accepted by the obstetrician-gynecologists of the participating centers that manage placenta accreta spectrum patients.

It is an observational, multicentric study of a prospective cohort, in which data will be obtained from the medical records and other documents in each participating center, which are considered to be of routine use in day-to-day clinical practice. The study of the outcomes proposed in this protocol will be limited to those recorded in the clinical records and will be taken into account until the participant is discharged from the hospital, during which a surgical intervention was performed due to the suspicion or diagnosis of PAS.

It is projected that the period of patient enrollment will last 2 years, counting on from the first participant included. The study population is pregnant patients with a diagnosis of placenta accreta spectrum who visits any of the participating medical centers, and also obstetrician-gynecologists working in participating medical centers.

The centers invited to participate are hospitals or clinics that already have knowledge in how to apply the surgical staging of PAS, and the topographic classification and have experience using it.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman over 18 years old.
* Prenatal diagnosis by ultrasound or MRI of Placenta Accreta Spectrum (PAS), regardless of the suspected degree of severity of the disease.
* Case requiring surgical management, either as scheduled or emergent procedure.
* Application of the topographic classification of placenta accreta spectrum during laparotomy.

Exclusion Criteria:

* None.
Clinical Evaluation of the miraDry System in Subjects With Hyperhidrosis

The purpose of this study is to determine whether treatment by the miraDry System can safely reduce the severity of axillary hyperhidrosis (excessive underarm sweating).


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older at the time of consent.
* Subject reports a quality-of-life rating of 3 or 4 on the Hyperhidrosis Disease Severity Scale.
* Subject has a baseline gravimetric measurement of spontaneous resting sweat production of at least 50mg/5min at room temperature in each axilla.
* Subject has primary focal axillary hyperhidrosis evidenced by at least two of the following:

  * Bilateral and relatively symmetric
  * Impairs daily activities
  * Frequency of at least one episode per week
  * Age of onset less than 25 years old
  * Positive family history
  * Cessation of focal sweating during sleep.
* In the opinion of the physician, treatment with the miraDry System is technically feasible and clinically indicated.
* Subject has provided written informed consent using a form that has been approved by the reviewing IRB/ethics committee.
* Subject is willing and able to comply with protocol requirements and all study visits.
* Female subjects of child-bearing potential must not be pregnant or lactating and must agree to not become pregnant during the course of the study.

Exclusion Criteria:

* Subject has secondary hyperhidrosis due to medications, infections, malignancy or endocrinopathy.
* Subject has hyperhidrosis on the trunk or chest.
* Subject has evidence of active infection.
* Prior endoscopic thoracic sympathectomy, liposuction or other surgery for axillary hyperhidrosis.
* Axillary injection of botulinum toxin within one year preceding the miraDry treatment.
* Oral anticholinergic medication use (e.g., Robinul) or cholomimetic medication use within the last 4 weeks or planned use during the study's follow up phase.
* Subject is a prisoner or under incarceration.
* Currently participating in or recently participated in another clinical trial (within the last 30 days).
* History of or current neurologic deficit in the treatment limb.
* Known resistance to or history of difficulty with local anesthesia (lidocaine with epinephrine).
* History of cancer with the exception of (1) successfully treated basal cell or squamous cell carcinoma of the skin or (2) subjects with a history of successfully treated cancer that have been disease-free for five years.
* Injury in the treatment area, shoulder or limb, which, in the opinion of the physician would render this subject an unacceptable candidate for DTS treatment (e.g., prior surgical repair, injury of the shoulder requiring physical therapy).
* Subject has a pacemaker, defibrillator or other electronic implant
* Subject requires supplemental oxygen.
Randomized Study on Effects of Uniportal VATS Versus Triportal VATS

For the treatment of stage I-II NSCLC, two mini-invasive techniques are mostly utilized: uni-portal and three-portal VATS. In the uniportal approach, the injury on a single intercostal space could determine a lower level of pain than the three-portal approach, allowing a better postoperative course. Few studies in Literature compare these techniques, and most of them are retrospective.

The main purpose of this randomized study is to compare uni-portal VATS with three-portal VATS, in terms of postoperative pain.

Secondary objectives of the study are valutations of:

* respiratory and functional capacity between the two groups
* operative time
* number of resected lymphnodes
* intra and postoperative complications, such as conversions to open surgery, amount of bleeding, prolonged air leaks, surgical site infections, pulmonary complications.

Randomized cohort clinical trial, prospectic, monocentric. Procedure of randomization: the day before the operation, with the "Random Allocation Rule" technique

Arm 1: pulmonary lobectomy and lymphoadenectomy with uni-portal VATS approach

Arm 2: pulmonary lobectomy and lymphoadenectomy with three-portal VATS approach

Misurations Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation.

The choice of cumulative analgesic consumption as parameter of primary outcome is because pain valuation with VAS is significantly affected by individual variability.

Secondary outcomes: measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery. A pain score will be assigned to each patient after the total amount of NRS.

Respiratory function will be valuated with spirometry after 7 and 30 days from surgery, and compared with pre-operative tests.

All intraoperative parameters will be compared between the two groups: operative time (skin to skin), proportion of conversions to open surgery, number of resected lymphnodes, amount of bleeding.

Postoperative complications will be analyzed: rate of prolonged air leaks, surgical site infections, cardiac rythhm disfunctions, pulmonary complications, post-thoracotomy syndrome, as well as lenght of stay at the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cT1-2N0-1M0 NSCLC, maximum diameter 5cm
* ASA (American Society of Anestesiology) score 1-2-3

Exclusion Criteria:

* N2-N3 disease
* Induction chemotherapy
* Thoracic wall infiltration
* Previous thoracic surgery
* Important pleural adhesions
* Severe COPD, asthma, interstitial lung disease - Liver, kidney or cardiac failure
* Clotting disorders
* Analgesic allergy
* Sublobar resection, sleeve lobectomy, pneumonectomy
* Chronic analgesic, oppioids or cortisonic use
* Absence of informed consent
The Effect of Health Literacy Based Practices

It is important to adopt healthy lifestyle behaviors such as nutrition and physical activity in adolescence. Health literacy, which is the competence of adolescents to participate in their own health decisions and takes responsibility for health, needs to be developed. Developing healthy nutrition and physical activity behaviors with a focus on health literacy is important in terms of maintaining the desired behavior in adulthood. This study aims to examine the effects of health literacy-based motivational interviewing and health education on nutrition and exercise behaviors of adolescents. The research will be conducted with a single-blind randomized controlled experimental design. The population of the research consists of ninth-grade students. It is planned to include 72 people in the research sample according to the power analysis calculation. The research will be carried out with two intervention groups as motivational interview and health education and a control group.


Eligibility Criteria:
Inclusion Criteria:

* Continuing education in 9th grade
* Volunteering to participate in the research
* Permission by their families to participate in the research
* Being at a low or moderate level of health literacy according to the Health Literacy Scale for School-Age Children

Exclusion Criteria:

* Have a chronic illness
* Dieting within a program
* Doing regular physical activity
* Having a high level of health literacy according to the Health Literacy Scale for School-Age Children
Effects OF Acute Aerobic Exercise On Higher Cerebral Functions

We are comparing higher cerebral functions including cognitive flexibility, inhibitory control and working memory in healthy young adults between a group of acute aerobic exercise and a control group.

The objective of this study is to compare cognitive flexibility, inhibitory control, and working memory in healthy young adults between two groups: a group undergoing acute aerobic exercise and a control group.

Methodology:

Study Design: A Randomized Controlled Trial Study Setting: The Physiology Laboratory at Khyber Medical College, Peshawar Study Duration: The study will last for three months. Sample Size: The study will include 19 participants in each group - the Exercising group (E-Group) and the Control group (C-Group).

Healthy young people between 18-25 years who are non-smokers will be included. Sampling: The enrollment in the Randomised Control Trial will be conveniently based, wherein all those who meet the inclusion and exclusion criteria will be enrolled as per study numbers. A lottery method will be adopted for randomization.

Procedure:

The first step is to take ethical approval from the Institutional Research \& Ethical Review Board. Following which, after taking informed consent from the participants, the enrolled participants will be randomly allocated to 2 groups. A demographic questionnaire will be filled. This will be followed by a general physical examination.

Both groups will be familiarized with the executive function tasks, while the E-group will have an additional session regarding the exercise protocol.

Both groups will have an initial assessment of executive functions using online psytoolkit followed by intervention. The E-group will undergo 30 minutes of treadmill walking at 60-65% of HRmax with continuous recording of heart rate and ECG via the Biopac system, while the control group session will consist of sitting idly and quietly in the laboratory doing nothing with continuous recording of heart rate and ECG via the Biopac student lab system.

In the end, executive function tests will be assessed before and after exercise using online psytoolkit.org. The data will be extracted via a properly designed proforma and on Microsoft Excel sheet.

Statistical Analysis:

Statistical Package for Social Sciences (SPSS)25.0 will be used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy young adults

Exclusion Criteria:

* smokers
* cardiorespiratory disorders
* psychiatric disorders
Advanced HIV: Outcomes for Rapid ART

AHORA is designed as a single-arm, open label, non-comparative, real-world prospective, observational study evaluating the outcomes for viral control and CD4 recovery/immune reconstitution in predominantly Hispanic/Latinx patients of the Rio Grande Valley (RGV) with advanced HIV who are rapidly initiated on bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) at Valley AIDS Council (VAC) dba Westbrook Clinic (WBC). This research will help to fill data gaps still present for Biktarvy in a rapid start setting among an Hispanic/Latinx population, including those with advanced HIV.

VAC is the primary provider of HIV prevention, education and testing services and the only Ryan White funded agency providing medical care and supportive services for people with HIV in the RGV. VAC provides services to over 1700 patients with HIV, 52% of patients at VAC are diagnosed with advanced HIV disease. Generally speaking, HIV clinical trials have often lacked representation and enrollment of patients of Hispanic/Latinx ethnicity, and those with advanced HIV and this study has the potential to fill in those data gaps.

For AHORA, data from ART-naive, newly diagnosed HIV-1+ adults (18 years of age and older) with late presentation (CD4\<200 or diagnosed Opportunistic infection/AIDS-defining illness) initiated on Biktarvy within 7 days from diagnosis will be collected and analyzed. Patients will be enrolled through VAC's linkage to care and RAPIDO (Rapid Start) programs. Patients appropriate for Rapid ART initiation with Biktarvy will be recruited, with a goal of 50 enrollees. Patients who agree to participate will have data collected at weeks 1,4,12, 24, 36, and 48 weeks for evaluation of time to viral suppression and efficacy, as well as evaluation of CD4 cell recovery.

Eligibility Criteria:
Inclusion Criteria:

* ART-naive adults,18 years of age and older
* diagnosed with HIV within 7 days of study entry
* diagnosis of Advanced HIV: clinical (diagnosed Opportunistic Infection/AIDS-defining illness) or laboratory (CD4\<200) diagnosis of advanced HIV.

Exclusion Criteria:

* Known severe renal impairment (CrCl \<30 mL/min/1.73 m2);
* Known or suspected severe hepatic impairment or unstable liver disease (Child Pugh Class C);
* Use of rifamycins for treatment of OIs
* use of concomitant medications that would be contraindicated for coadministration with Biktarvy;
* OI diagnosis requiring initiation of OI treatment for \>7 days prior to initiation of ART.
* pregnant at time of diagnosis
Goal-directed Labor Epidural Analgesia Maintenance

The GLEAM trial is a multicenter, pragmatic, cluster-randomized trial to assess the effects of programmed intermittent epidural bolus versus continuous epidural infusion on the rate of spontaneous vaginal delivery and several other clinically-relevant outcomes.

BACKGROUND: The goal of Labor Epidural Analgesia (LEA) to provide optimal analgesia while limiting any impact on the course of labor. Until recently, the most common technique for epidural analgesia was a combination of continuous epidural infusion (CEI) and patient controlled epidural analgesia (PCEA). CEI delivers an infusion of local anesthetic into the epidural space at a constant rate. Programmed intermittent epidural bolus (PIEB)-a more recently-developed alternative to CEI-delivers intermittent boluses of local anesthetic into the epidural space at scheduled time intervals.

A series of randomized control trials (RCT) have compared PIEB and CEI with overall results favoring PIEB for superior analgesia. However, CEI has been shown to be associated with an increased amount of local anesthetic consumption, which may increase the degree of motor blockade, placing parturients at higher risk for instrumental and cesarean deliveries. Studies to date have offered conflicting conclusions on whether CEI is associated with a reduced rates of normal spontaneous vaginal delivery (NSVD).

AIM: The GLEAM trial aims to investigate the hypothesis that PIEB will have higher rates of NSVD than CEI. The effects of CEI vs. PIEB on cesarean delivery rate, instrumental vaginal delivery rate, length of second stage of labor, failed epidural rate.

TRIAL DESIGN: Multi-center, pragmatic, cluster-randomized trial

* Centers will be assigned to use either PIEB or CEI for the first-line labor epidural analgesia maintenance infusion for clusters of minimum one month duration
* Participating institutions will be recruited via the Society for Obstetric Anesthesia and Perinatology (SOAP) Research Network
* Centers must use an epidural solution with a low concentration of local anesthesia with an opioid.
* Both PIEB and CEI must include PCEA - rates and volumes are determined by the institution
* Neuraxial anesthesia can be initiated with Dural Puncture Epidural (DPE), Combined Spinal Epidural (CSE) or epidural bolus
* Our sample will consist of all women, at least 18 years of age, who were admitted to the labour \& delivery ward for planned vaginal delivery and had neuraxial analgesia
* Data will be collected in routine clinical care and automatically extracted from the electronic health record (EHR)

PARTICIPATING SITE CRITERIA:

* Routinely provided LEA with Ropivacaine ≤ 0.125% or Bupivacaine ≤ 0.1% epidural solutions with fentanyl (1-3 mcg/ml)
* Can provide LEA with PIEB or CEI
* Must include PCEA as part of all LEA regardless of PIEB or CEI

Eligibility Criteria:
Inclusion Criteria:

* Requests labor epidural analgesia requiring epidural maintenance with local anesthesia and opioid for planned vaginal delivery

Exclusion Criteria:

* Planned cesarean delivery
* Planned operative vaginal delivery
* Epidural time (placement to delivery) \< 1 hour
The Effects of Epidural Anesthesia on the Bioavailability of Nitric Oxide and Renal Function in Patients Undergoing Laparoscopic Surgery

This study was designed to investigate the effects of epidural anesthesia combined with general anesthesia during laparoscopic surgery. The investigators hypothesized that epidural anesthesia will effectively block the activation of the sympathetic nervous system during surgery, thus activating nitric oxide and reducing splanchnic ischemia and decrease in postoperative renal function.


Eligibility Criteria:
Inclusion Criteria:

* ASA class 1 or 2 adult patients scheduled for endoscopic prostatectomy

Exclusion Criteria:

* Patient refusal
* Patients on diuretics
* Patients with renal failure (eGFR \< 60 ml/min/1.73 m2)