cyrilzakka/clinical-trials huggingface dataset:
Myofunctional Therapy in Patients With Mild-moderate Sleep Apnea

The main objective of this study is to compare the change in the apnea-hypopnea index (AHI) in patients with mild to moderate sleep apnea without daytime sleepiness after 12 months of myofunctional therapy exercises with respect to the placebo group (the placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway)

Background: Alternative treatment therapies to positive upper airway pressure (CPAP) for obstructive sleep apnea syndrome (OSAS) have been developed in recent years. Myofunctional orofacial therapy (MFT) is one of these alternatives and consists of exercises that improve mobility and increase muscle strength of the orofacial structures that contribute to the etiopathogenesis of OSAS. To date, any study to treat sleep apnea patients under this therapy has been conducted in Spain. Moreover, its long-term effect has not been evaluated worldwide.

Main objective: to compare the reduction in the apnea-hypopnea index (AHI) in patients with mild to moderate sleep apnea without daytime sleepiness after 12 months of myofunctional therapy exercises with respect to the placebo group (the placebo group will be instructed in simulation exercises that do not alter the function or morphology of the upper airway) Methodology: A 12-month, randomized, parallel-group, clinical trial will be conducted. Patients with an AHI ≥ 5 events per hour assessed by a respiratory polygraphy (RP) will be randomized to a MFT treatment branch or to another placebo exercises branch. A speech therapist will instruct patients to perform the exercises in both groups for three months. At the end of this period, a RP will be performed on both groups and the same treatment that they were doing will be maintained at home. One year later, a new RP will be performed and changes in AHI, oximetry parameters and snoring will be compared in both groups, as well as sleepiness, quality of life and the degree of adherence to the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 and under 80 years old.
* Patients with apnea-hypopnea index from 5 to 29 assessed by a respiratory polygraphy.
* Absence of daytime sleepiness (Epworth sleepiness scale \<12).

Exclusion Criteria:

* Refractory high blood pressure (blood pressure that is not controlled with three antihypertensive drugs, including a diuretic).
* Ictus, transient ischemic attack, neuromuscular diseases, acute coronary syndrome or hospitalization for worsening heart failure, in the previous 30 days.
* Professional drivers, profession of risk or respiratory failure.
* Previous surgical intervention for the treatment of sleep apnea (those patients who have refused treatment with CPAP or mandibular advancement devices after 1 month of not using them,could be included).
DNA Clearance of Uncomplicated Trichomonas Vaginalis Infections in HIV Negative Women

The objective of this study is to screen treated Trichomonas vaginalis (TV) positive women weekly using culture and Polymerase Chain Reaction (PCR) to determine how long TV DNA is detectable post treatment and to examine potential confounders to clearance such as bacterial vaginosis.

Trichomonas vaginalis (TV), the most common sexually transmitted infection in the world, is associated with inflammation of the vagina, cervix, and urethra; low birth weight; preterm delivery; pelvic inflammatory disease; and may increase the risk of acquiring and transmitting genital herpes and HIV. Repeat infections are common, ranging from 5% - 31%, and have similar health outcomes as primary infections. Given the high prevalence of TV, the absence of a national screening program, the deleterious reproductive outcomes associated with TV and the potential for a TV infection to increase HIV transmission, reducing repeat TV infections is an important targeted public health approach. However, rescreening for TV should not happen until there is sufficient time for the parasites and DNA to clear from the vaginal cavity after treatment. HIV negative women who attend Delgado Personal Health Center will be asked to enroll in the screening component in order to test them for TV using InPouch culture along with the standard TV screening of wet preparation. The objective of this study is to screen treated TV positive women weekly using culture and Polymerase Chain Reaction to determine how long TV DNA is detectable post treatment and to examine potential confounders to clearance such as bacterial vaginosis. The outcome of interest will be a negative PCR result indicating that TV DNA has cleared.

Eligibility Criteria:
Inclusion Criteria:

* English speaking females
* \>18 years old
* HIV-negative
* a patient at the Delgado Personal Health Center

Exclusion Criteria:

* HIV+ women
An Innovation During the Surgical Wait; Evaluation of the Opportunity for Intervention

The investigators will compare the differences in the scores between the baseline questionnaire (at diagnosis) and the second questionnaire (at treatment) in the RADS II patients that enrolled in pre-treatment trials versus those that don't.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Diagnosis of BI-RADS 4 and 5 (highly suspicious for carcinoma) on an initial imaging
* \>2cm area of disease
* Provide informed consent

Exclusion Criteria:

* Previous neo-adjuvant therapy
* Patients with recurrent disease
Improving the Reproductive Health of Families

This research will assess the effectiveness of a parent- and an adolescent- intervention in lowering risk of STIs, HIV, and unintended pregnancies among Batswana youth.

Youth in Botswana face extraordinary challenges as they transition through adolescence. High rates of teen pregnancy force girls to drop out of school after which few resume their education. Sexually transmitted infections (STIs) are prevalent and the country has the 3rd highest Human Immunodeficiency Virus (HIV) prevalence in the world, with incidence increasing rapidly among adolescents 15-19, peaking at 40.2% HIV seroprevalence at ages 30-34. Traditional methods for sex education through village initiation schools are no longer available and parents are not comfortable with discussions addressing reproductive health within the family. As a result, adolescents have no conduit to educate them about healthy sexual development. This study will recruit 456 families, ½ with a male and ½ with a female adolescent. Families will be randomized to one of three intervention arms. Parents will participate in Families Matter 2! (FM2) and adolescents in Living as a Safer Teen (LAST), both evidence-based interventions that were adapted and pilot tested in Botswana during an earlier R34 award. In Arm 1, the parent will participate in FM2 immediately and the youth will participate in LAST six months later. In Arm 2, both the parent and youth will participant in their respective interventions simultaneously. In Arm 3, the comparison condition, participants will be offered the interventions immediately after the final assessment. Each adolescent and parent will complete assessments in English or Setswana at baseline, post-intervention, and 6- and 12-month follow-ups. Results from a pilot trial of the adapted interventions suggest that these interventions may result in improved family communications, child management skills, knowledge of sexual development, more favorable attitudes toward contraception, less tolerance for intergenerational transactional sex, greater rejection of gender violence, and lower rates of sexual risk behavior by both parents and adolescents. It is further anticipated that youths who are abstinent upon entering the intervention will delay sexual debut to a greater extent than youth in the comparison arm. This proposed study addresses the highest priority in Botswana's current national strategic plan: preventing early pregnancy, STIs and HIV in adolescents. If the proposed randomized controlled trial (RCT) provides strong evidence of effectiveness, the investigators will work with the Ministries of Education, Health, Youth \& Culture and the Office of the President to disseminate the intervention throughout Botswana.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent 13-18 in or near Gaborone Botswana and parent/guardian

Exclusion Criteria:

* None
Effectiveness of Handheld Ultrasound for Diagnosing Patients with TMD

The aim of this research is to add to the limited body of knowledge comparing the effectiveness of ultrasound (US) to MRI diagnoses in patients with TMJ disorders. More specifically, we will review the efficacy of handheld US devices, which has not yet been done to the author's knowledge.

Currently, patients complaining of temporomandibular joint (TMJ) pain are evaluated clinically, which includes measurements of their maximal incisal opening (MIO) lateral and protrusive excursions, recording their current pain duration and frequency, and any clicking/popping/grinding of the joints. Based on these findings, the patient is sent for an MRI if temporomandibular joint disorder is suspected.

MRI is currently the gold standard of care for imaging of the joint, as it provides valuable information on the position, morphology and signal intensity of the joints and its surrounding structures. Magnetic resonance imaging (MRI) is currently the gold standard of imaging for diagnosis of internal derangement due to its ability to provide valuable information on the position, morphology and signal intensity of the joints and its surrounding structures. However, using MRI is not without its challenges, as patients with severe TMJ pain find it difficult to complete a full TMJ series and access to MRI is often restricted due to limited locations and associated waits, further prolonging time between initial consultation and diagnosis. In addition, MRI is contraindicated in patients with metallic implants, coronary and peripheral artery stents, cardiac pacemakers, prosthetic heart valves, intrauterine contraceptive devices, and claustrophobia. For these reasons, the author believes that attempting to find an alternative reliable screening tool for internal derangement is a worthwhile endeavor. For this study, handheld ultrasound would be used at the time of clinical examination to come up with a preliminary diagnosis, and this diagnosis would be compared to the MRI findings.

Eligibility Criteria:
Inclusion Criteria:

* The patient population will be those patients who meet the criteria for temporomandibular joint disorders based on clinical examination and patient history, including anterior disc displacement with or without reduction, joint effusion, or degenerative joint disease.

Exclusion Criteria:

* Patients under the age of 18.
* Patients unable to consent for themselves.
Evaluation of Left Ventricular Function by Speckle Tracking Echocardiography in Patient Hospitalised in Intensive Care Unit for Vaso-occlusive Crisis

Vaso-occlusive crisis in Sickle cell disease might alter myocardial function through micro vascular obstruction. Evaluation of strain alteration using speckle tracking echocardiography is a non invasive technique that may allow us to observe such myocardial dysfunction. No such study has yet been conducted in patient hospitalised in intensive care unit. Our hypothesis is that strain alteration during vaso-occlusive crisis, if they do exist, can be correlated with other markers of myocardial injury such as troponin level or thoracic pain.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalisation in an intensive care unit for vaso-occlusive crisis

Exclusion Criteria:

* Pregnancy
* Individuals under guardianship
* Unsufficient echogenicity
* Thoracic pain prohibiting echocardiography assessment
Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD)

To determine whether individuals who suffer from depression and obesity are able to lose weight and show improvements in mood and cardiovascular disease risk factors following 20 weeks of a combined treatment of cognitive-behavior therapy for depression and behavior modification for weight loss. Participants will be assigned to one of three treatments: 1) cognitive-behavior therapy for the treatment of depression combined with an alternative approach to weight loss, 2) a weight loss intervention combined with a depression support and education , or 3) cognitive-behavioral therapy for depression combined with a weight loss intervention.


Eligibility Criteria:
Inclusion Criteria

* Female and male participants, with a BMI of 27 kg/m2 to 45 kg/m2
* Age 18 - 70 years old
* Presence of current major depressive disorder or dysthymic disorder
* At least 2 CVD risk factors, as characterized by the metabolic syndrome, including:

  * Elevated waist circumference (males 40 inches or 102 cm; females 35 inches of 88 cm)
  * Fasting blood glucose 100 mg/dL
  * Blood pressure 130/85 mm Hg
  * Triglycerides 150 mg/dL
  * Reduced HDL cholesterol (males 40 mg/dL; females 50 mg/dL)
  * OR medications for these conditions
* Able to comply will all study procedures and schedule
* Able to speak and read English

Exclusion Criteria

* Cardiovascular event (e.g., myocardial infarction, stroke) within the past 12 months
* Use of tricyclic anti-depressants, monoamine oxidase inhibitors or paroxetine, mood stabilizers, or antipsychotic medications. (Note: participants who take SSRI/SNRI may be acceptable, provided they have been on a stable dose of these medications 3 months.)
* Use of weight-loss medications or any medications known to significantly affect weight (e.g., oral steroids) in past 3 months
* Weight loss of 5% or more in past 6 months
* Enrollment in weight reduction program in prior 3 months
* Treatment in individual psychotherapy for any psychiatric disorder in prior 3 months (Note: participants in couples or family counseling will be allowed.)
* Severe depression or severe impairment of functioning as judged by the assessor or PI
* Presence of active suicidal ideation
* Diabetes
* Alcohol/drug abuse/dependence
* Renal/hepatic disease
* Change in thyroid medications in last 3 months
* Pregnant/lactating, within 6-months post-partum
* Current diagnoses, or history within the last 5 years, of anorexia or bulimia
* Psychotic symptoms or hospitalization for a psychiatric disorder in previous 12 months
* Mood disorder NOS, substance-induced mood disorders, mood disorders due to a general medical condition
* History of bipolar disorder
* History of head trauma
* Any changes in smoking behavior in prior 3 months (or plans to change in the next 3 months)
* Plans for bariatric surgery
* Any other uncontrolled major medical problems
* Women who are pregnant
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)

The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).

People with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by PA. Treatment with antibiotics is used to reduce the presence of the bacteria. The antibiotics may be given orally, intravenously, or inhaled as a mist. The purpose of this study was to evaluate whether AZLI, an investigational formulation of the antibiotic aztreonam, is safe in repeated courses in patients with CF and PA.

A course of AZLI treatment in this study comprised 28 days, followed by a 28-day period off treatment. Participants could receive up to 9 courses of AZLI, with a total time on study of up to 18 months. Safety and efficacy results for the 18-month, 9-course period are reported, with efficacy results presented on a by-treatment course basis.

Eligibility Criteria:
Inclusion Criteria:

* Compliance with Studies CP-AI-005 (NCT00104520) or CP-AI-007 (NCT00112359) by taking at least 50% of expected study medication.
* Completion of CP-AI-005 or CP-AI-007 or was withdrawn due to need for antipseudomonal antibiotics or for an AE unrelated to study medication tolerance.
* Ability to provide written informed consent/assent prior to initiation of study-related procedures.
* Ability to perform reproducible pulmonary function tests.

Exclusion Criteria:

* Use of any investigational medication or device between the last visit of CP-AI-005 or CP-AI-007 and Visit 1 of this study.
* Concurrent participation in a study of another investigational drug or device.
* Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone/day or 20 mg prednisone every other day.
* History of sputum or throat swab culture yielding Burkholderia cepacia in the previous 2 years.
* History of daily continuous oxygen supplementation or requirement for more than 2 liters/minute at night.
* Inability to tolerate study medication in CP-AI-005 or CP-AI-007.
* Known local or systemic hypersensitivity to aztreonam.
* Inability to tolerate inhalation of a short acting beta-2 agonist.
* Abnormal renal or hepatic function based on results of most recent test.
* Female of child-bearing potential who was pregnant, lactating, or not (in the opinion of the investigator) practicing an acceptable method of birth control.
* Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would have interfered with participant treatment, assessment, or compliance with the protocol.
Duloxetine on Bone Metabolism

The aim of the study was to determine the effect of duloxetine as monotherapy on biochemical markers and bone mineral density.

51 patients diagnosed with chronic pain or fibromyalgia syndrome who were using duloxetine for at least 3 months and age and sex matched 51 healthy individuals were recruited for this cross-sectional study. Bone mineral density of both groups were measured by dual energy x ray absorbsiometry(DXA), bone biochemical markers, serum calcium, and vitamin D levels were investigated.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years or \<50 years
* patients using duloxetine for at least 3 months due to chronic pain or fibromyalgia

Exclusion Criteria:

* postmenopausal women
* clinical conditions which cause secondary osteoporosis
* patients using medication that cause secondary osteoporosis
* pregnancy and malignity
Scoring System for Inhalation Injury

The goal of this multicenter study is to develop a standardized scoring system for inhalation injury that can be used both to quantify and predict injury severity inhalation injury in adults over 18 years of age. A model will be developed based on clinical, radiographic, bronchoscopic, and biochemical parameters that will predict the severity of inhalation injury with greater than 80% predictive accuracy

The goal of this multicenter study is to develop a standardized scoring system for inhalation injury that can be used both to quantify and predict injury severity inhalation injury in adults over 18 years of age. A model will be developed based on clinical, radiographic, bronchoscopic, and biochemical parameters that will predict the severity of inhalation injury with greater than 80% predictive accuracy

Eligibility Criteria:
Inclusion Criteria:

* Injury consistent with inhalation of smoke or products of combustion
* Requires intubation within 24 hours of injury
* Meets one of the following 4 criteria

  1. history of closed space injury
  2. carbonaceous sputum
  3. elevated carboxyhemoglobin
  4. dx of inhalation injury is considered likely by investigator

Exclusion Criteria:

* ≤ 17 years of age
* Prisoner
Early Anti-Retroviral Treatment in HIV- Infected Children

EARTH study is conducted as part of the EPIICAL project. It is a prospective cohort study which aims to monitor clinical, virological and immunological features of HIV-positive, early treated children (≤90 days after diagnosis), in order to identify participants with excellent viral and immunological control, and also other without excellent control, in order to stratify potential participants in proof-of-concept trials directed to HIV cure.

The duration of the study is 4 years from the start of enrollment with at least 4 years of follow-up for each participant. The study is conducted in South Africa, Mali, and Mozambique with an expected enrollment target of 200 participants (as a minimum). In this study, newly diagnosed HIV-infected children will start ART as early as possible, following local standards of care, and will be followed up to 4 years of age. Clinical and blood data for viral load, immunology, and serology will be collected at the 11 visits. HIV reservoir size and HIV-specific immune responses will be analyzed at visit 1 and at 1, 2, 3, and 4 years after enrollment. We will identify children with HIV infection eligible to participate in proof-of-concept treatment/remission studies.

A predictive model developed from European participant data will help identify children with low reservoir. These predictions will then be compared with available data from participants already enrolled with an excellent control to refine the model.

Eligibility Criteria:
Inclusion Criteria:

1. Perinatally infected infants who start ART at ≤90 days after diagnosis (HIV infection diagnosed and confirmed by molecular methods in 2 different samples, i.e., positive qualitative HIV DNA/RNA test).
2. Breastfed-infected children found to be infected ≤ 90 days of age and who started ART at \< 90 days after diagnosis. This group will be younger than six months of age at ART initiation.
3. Caregivers (mother, if alive and available) able to provide informed consent.
4. Able to take ART.

Exclusion Criteria:

1. Second and successive RNA PCR negative
2. Malignancy
3. Current concomitant immunosuppressive therapy (including\>15 days and \>2 mg/kg/day of prednisone-equivalent).
4. Caregivers withdraw consent
5. Age \>180 days.