cyrilzakka/clinical-trials huggingface dataset:
Development of Automated Molecular Diagnostic Platform for Tuberculosis Diagnosis (New Assay TB)

It is intended for patients who have been admitted to the outpatient or emergency room or are hospitalized For patients who diagnose pulmonary tuberculosis or extrapulmonary tuberculosis using Xpert TB/RIF, additionally, diagnose pulmonary tuberculosis or extrapulmonary tuberculosis using a new diagnostic method, and check the test results. Check whether the tuberculosis bacteria were actually cultured in the sample in the future, and compare the sensitivity and specificity in each test.

Validation in animal model In an animal model (rat) with chronic obstructive pulmonary disease that shows similar characteristics to tuberculosis destructive lung, It will be investigated whether the HI method can be validated by separating and concentrating microbiome for various pathogens including Mycobacterium tuberculosis using HI method. Confirm.

Usefulness of Pulmonary Tuberculosis Diagnosis A comparison of the new diagnostic method with the Xpert TB/RIF test, which is widely used in clinical practice, that can quickly diagnose pulmonary tuberculosis within 1-2 days. ; Considering the sensitivity of the Xpert TB/RIF test as 70% and the sensitivity of the new diagnostic method as 90%, the number of patients with pulmonary tuberculosis required to confirm that the new diagnostic method is useful is estimated as 90 (study power 90%, alpha error = 0.05). And, if 200 patients with suspected pulmonary tuberculosis are registered, it is possible to verify the clinical usefulness compared to Xpert TB/RIF even in 60 AFB smear negative patients. In addition, for the same reason, if 150 additional patients who underwent bronchoscopy were enrolled, it would be possible to compare the diagnosis rate and utility of sputum and bronchoscopy fluid. Waiting for the tuberculosis bacteria culture test for 6 weeks and using the final culture-positive patient as a gold standard for tuberculosis diagnosis -Usefulness of extrapulmonary tuberculosis diagnosis

Millet tuberculosis is disseminated tuberculosis through blood, and there are numerous millet-like lesions in the lungs, but in fact, the positive rate of AFB smear is low due to paucibacillary TB. It is planned to prove the usefulness of the new test method in 35 people with millet tuberculosis.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary TB
* Extrapulmonary TB

Exclusion Criteria:

* under 19
Reduced Pressure for Less Pressure Ulcers

Pressure ulcers (PU) cause pain and discomfort to affected patients, as well as considerable costs for society. The present study will evaluate the effect of the Continuous Bedside Pressure Mapping (CBPM)- system on PU prevalence and incidence. A RCT including 180 patients will be conducted in a geriatric setting in a Swedish University hospital

Background The first national PU prevalence study in Sweden conducted in 2011 showed a prevalence of 16.6% (n=16 466) in hospital settings. High age and reduced mobility/activity are main risk factors. International evidence-based guidelines for prevention of PU are available. Pressure relief (e.g repositioning, mattresses, chair cushions, heel cushions) is the main stay of preventive measures. Recent research shows that PU prevention is not a high priority. For example, the corner stone of prevention, repositioning, is not conducted for risk patients.

Aim To evaluate the effect of the CBPM-system on the prevalence and incidence of PU in hospital setting

Method Design: A randomised controlled trial will be conducted Sample: All patients admitted to the geriatric unit. Intervention: The CBPM-system will be used from admittance to discharge (not more than 14 days). Standard PU prevention (PU reducing mattress, floating heels, repositioning) Control group: Standard PU prevention (PU reducing mattress, floating heels, repositioning) Randomisation: Sealed envelopes will be used. Procedure: Two study nurses are responsible for inclusion of patients and data collection on day 1,3,7 and discharge. A photo will be taken of any PU. A PU expert will assess the photos after completed data collection (PU category 1-4). She will be blinded to group allocation.

Power calculation: The primary outcome of interest is the PU prevalence. Previous point prevalence studies in this geriatric unit shows a prevalence of 45%. The investigators goal is that the CBPM-system results in 20% decrease in the PU prevalence. In order to have 80% power to detect such a decrease with a two-sided two-sample proportions test at the 5% level, 89 patients per treatment group is needed. Intention-to-treat principals will be used.

Discussion The prevalence of PU, as well as prevention to risk patients are quality indicators in health care. National studies reveal an urgent need for quality improvement, New nursing methods and equipment must be systematically and scientifically evaluated.The results of this study will be valuable for nursing education and in international and national patient safety work to prevent PU. The results will also be valuable for other health professionals (physicians, physical and occupational therapists).

Eligibility Criteria:
Inclusion Criteria:

* Admitted to geriatric unit 30A during Sunday after 4 pm to Friday until 4 pm

Exclusion Criteria:

* Expected to be discharged before data collection in day 3
Hysterectomy Versus Uterine Preservation for Pelvic Organ Prolapse Surgery

Pelvic organ prolapse (POP) is the descent of pelvic organs into the vagina resulting in bulge symptoms and occurs in approximately 50% of women. Almost 20% of women will elect surgical correction of this condition by age 85. Removal of the uterus (hysterectomy) with concomitant vaginal vault suspension is a longstanding practice in POP surgery to address apical (uterine) prolapse. Yet, contemporary evidence on the merits of this approach relative to preservation of the uterus through suspension is needed to better inform surgical decision-making by patients and their healthcare providers. The objective of this trial is to evaluate POP-specific health outcomes and service utilization of women electing uterine suspension compared to those electing hysterectomy and vaginal vault suspension for POP surgery up to 1-year post-surgery.


Eligibility Criteria:
Inclusion Criteria:

* Have diagnosed POP of stage ≥2 using the globally recognized Pelvic Organ Prolapse-Quantification System (POP-Q)
* Elect surgical management of POP
* Demonstrate presence of apical prolapse on clinical exam deemed to require either a hysterectomy and concomitant vaginal vault suspension or uterine suspension to properly address their POP during surgical correction
* Desire no further pregnancy
* Can communicate in English
* Are ≥18 years in age

Exclusion Criteria:

* Prior hysterectomy
Multiple-Dose Pharmacokinetics (PK), and Pharmacodynamic (PD) Effect of NSI-189 Phosphate in Depression Patient Subjects

This is a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Escalation in depressed human subjects study.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has the ability to understand the purpose and risks of the study and to provide signed and dated informed consent, authorizing to use of protected health information in accordance with national and local patient privacy regulations.
2. Males and females 18 to 60 years of age, inclusive, at the time of informed consent.
3. Diagnosis of major depressive disorder, recurrent, as per DSM-IV-TR criteria and confirmed by SCID-CT. Their major depressive episode must be confirmed via SCID mood module interview administered by remote, independent raters.

   Note: Both patients who are being treated with antidepressants and patients who are not on antidepressants but had a history of taking antidepressants are permitted in the study.
4. Montgomery-Asberg Depression Scale (MADRS) score of 15 to 30, inclusive, at Screening and baseline.
5. The following applies to female patients:Non-pregnant, non-lactating females of childbearing potential who agree to use medically acceptable forms of birth control (hormonal contraception, abstinence, diaphragm with spermicide, condom with spermicide, or intrauterine device) from Screening until the end-of-study.
6. The following applies to male subjects:
Performance and Safety Use of the Mono Block Implant "KONTACT MB"

A multicenter prospective observational study aims to illustrate the clinical outcome of dental implants "Kontact MB" and the effects of its Mono Block design on the peri implant bone tissue recession and soft tissue conservation.

All the enrolled patients will be eligible for one or multiple implant-supported fixed restoration(s) according to the routine clinical practice and the manufacturer's instruction for use.


Eligibility Criteria:
Inclusion Criteria:

* Edentulous patient (partially or completely AND formerly, recently or just before implantation) requiring the placement of one (or more) dental implant (s) in maxillary or mandibular
* Age ≥ 18 years
* Good general health (ASA score between \[1-2\])
* Sufficient bone volume and quality (with or without bone graft) to support the implant
* Given a writing consent for the collection of his medical data as part of the study (delivery of a patient's sheet)

Exclusion Criteria:

* Poor oral hygiene
* Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints
* Infections and oral inflammation such as periodontitis, gingivitis
* Patient with metabolic disorders (eg diabetes mellitus) or bone disease that may compromise peri-implant tissue healing
* Heavy smoker (\> 10 cigarettes / day)
* Patient with a pathology or immunosuppressive therapy such as chemotherapy, radiotherapy
* Patient on prolonged steroid therapy
* Titanium / titanium alloy allergy
* Alcohol or drug abuse
* Pregnant woman (or likely to be pregnant); or breastfeeding
* Difficulty of medical follow-up patients with geographical, social or psychological constraints
* Persons deprived of liberty or guardianship
* Involuntary / patient refusal to participate in the study
Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery

The main objective of this study is to analyze the effects of local anesthetic application into the retropharyngeal space and its ability to reduce dysphagia symptoms and/or occurrence rates in patients undergoing anterior cervical discectomy and fusion.

The patients will be randomly assigned into one of the two groups to receive either bupivacaine hydrochloride 0.5% solution if they are randomized to the treatment group or 0.9% NaCl solution if they are randomized to the control group. These solutions will be poured into the retropharyngeal space intraoperatively before wound closure.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 y.o.
* Patients undergoing one- or two-level anterior cervical discectomy and fusion surgery for radiculopathy or myelopathy symptoms
* Patients are wiling and able to sign informed consent and complete questionnaires

Exclusion Criteria:

* More than 2-level ACDF surgeries
* Previous cervical spine surgery
* Surgeries for trauma, infection or tumor
* Known hypersensitivity reactions to bupivacaine hydrochloride or other amino-amide anesthetics (e.g. lidocaine)
* Known history of swallowing issues (e.g. dysphagia, odynophagia)
* Pregnant or breastfeeding
Non-invasive Early Oxygen- Reserve-index (ORI) Determination to Prevent Hypoxaemia During Endotracheal Intubation

The purpose of this study is to determine whether ORI monitoring increases the lowest oxygen saturation level during the interval between the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) and the end of the second minute after successful ETI.

The trial population will be adults (18 years of age or older) who need endotracheal intubation while hospitalized in ICU

Eligibility Criteria:
Inclusion Criteria:

* ICU admission and need for ETI to allow mechanical ventilation
* Need for supplemental oxygen (via any device and at any flow rate) to obtain SpO2\>97%
* Patient or next of kin informed about the study and having consented to participation of the patient in the study (patients with coma are unable to consent). If patient is no competent and no next of kin can be contacted during screening for the study, trial inclusion will be completed as an emergency procedure by the ICU physician, in compliance with French law
* Patients affiliated to a social security system

Exclusion Criteria:

* Patients participating in intubation research with an oxygenation endpoint will not be eligible for inclusion
* Fiberoptic intubation required according to physician in charge
* Contra-indications to laryngoscopy (e.g., unstable spinal lesion)
* Insufficient time to include and randomise the patient (e.g., because of cardiac arrest)
* Age \<18 years
* Currently pregnant or breastfeeding
* Correctional facility inmate
* Under guardianship, curatorship or under protection of justice
DilAtation Versus Endoscopic Laser Resection in Simple Benign trAcheal sTEnosis

Multicenter randomized controlled trial comparing endoscopic laser resection vs dilatation in benign tracheal stenosis.

An observational study suggests the superiority of endoscopic laser resection over dilatation in idiopathic tracheal stenosis but little litterature has been published on the subject. Hence we decided to design a prospective multicenter open label randomized controlled trial to compare the two interventions. Patients refered for endoscopic treatment of a simple benign tracheal stenosis will be randomized to endoscopic laser resection or dilatation. Randomisation will be stratified for center, type of stenosis (idiopathic vs other) and history of previous endoscopic treatment. Patients will be blinded to treatment but not physician. All patients will be treated with proton pump inhibitors.

Eligibility Criteria:
Inclusion Criteria:

* Benign simple tracheal stenosis (length of stenosis \<1cm without underlying cartilage damage) with planned endoscopic treatment (first treatment or recurrence)

Exclusion Criteria:

* Less than 18 years old
* Pregnant
* Incapacity to give informed consent
* Underlying inflammatory suspected to be the cause of stenosis (ex : granulomatosis with polyangitis)
Transdiagnostic REBT Prevention Program for Adolescents

Anxiety and depressive disorders are common in adolescents, however they are often unrecognized. Rational emotive behavioral therapy (REBT), a form of cognitive behavioral therapy (CBT) is efficient for children and adolescents. School settings are appropriate environments to deliver such interventions for vulnerable youths. Given youth's access and predilection to use technology, a video-based prevention program was developed. The present study aims to investigate the efficacy of a transdiagnostic REBT prevention program for internalizing symptoms in adolescents, implemented in a school setting.

Classes from different Romanian public schools will be randomized in either intervention or wait list group.

The prevention program will be group-based, delivered in 6 sessions, over 3 weeks.

Each of the six modules aimed a different component: Psychoeducation, Relaxation, Relationship between cognitive distortions/irrational beliefs and emotions, Cognitive restructuring, Exposure/ behavioral activation and problem solving, Maintenance of gainings. Despite specific activities, for each session a video cartoon on that subject will be viewed and discussed. Homework would be given at every session.

REBT prevention programs delivered in school settings represent ecological modalities to target vulnerable groups. Technology components added to traditional programs may lead to greater motivation and satisfaction with treatment.

Adolescents will complete assessments at four time-points: T1 (baseline), T2 (post-intervention), T3 (3 months follow-up) and T4 (12 months follow-up).

Eligibility Criteria:
Inclusion Criteria:

1. Preadolescents and adolescents will have ages between 12 and 17 years old;
2. Are attending middle school or high-school;
3. Adolescents have sufficient understanding of the Romanian language in order to complete assessments at all time points and to participate in the prevention program;
4. Their parents have sufficient understanding of the Romanian language in order to sign the informed consent;
5. Parents will sign the informed consent and adolescents will provide informed assent.

Exclusion Criteria:

1. Age below 14 or above 17 years;
2. No signed informed consent from parents;
3. Adolescents will score high on suicidal ideation according to (1 item on the Depression subscale from Beck Youth Inventories);
4. Not Romanian-speaking in order to understand the content of the prevention program and to complete the assessments.
Serial Hybrid Atrial Fibrillation Ablation

Treatment of (long-standing) persistent atrial fibrillation (AF) remains cumbersome and the surgical (epicardial) approach seems to be the most effective. Still, however a significant amount of failures exist which is mostly due to incompleteness of the surgical ablation lines. Checking, and if necessary additional ablation, of these lines afterwards endocardially by the cardiologist (the so-called serial hybrid approach) could overcome this problem.


Eligibility Criteria:
Inclusion Criteria:

* patients are screened and accepted for pulmonary vein isolation according to the current guidelines
* long standing persistent or persistent AF as defined in the guidelines
* left atrial size needs to be more than \>46 mm on long axis or \>35 cc/m2
* CHADSVASC score should be more than 0 as an indicator of a substantial substrate for atrial fibrillation.

Exclusion Criteria:

* Significant coronary artery disease has to be excluded as a trigger for AF by means of cardiac CT, if necessary a coronary angiogram will be performed.
* Previous PVI ablation (epicardial or endocardial) or cardiac surgery.
* Significant valvular disease present on echo.
* Concomitant cardiac surgery needed.
HORIZONS HIV Intervention

The Horizons Program will test the efficacy of a multi-session HIV prevention program for African American female teens attending reproductive health clinics in Atlanta, GA.

African-American adolescent females are a population at high risk for HIV infection. Recent findings suggest that culturally and gender appropriate HIV interventions can significantly reduce HIV-associated sexual risk behaviors among this vulnerable population. The Horizons HIV intervention was developed for African-American female adolescents attending reproductive health clinics in Atlanta, GA. The specific objectives were:

1. To evaluate the efficacy of the HORIZONS HIV intervention plus standard of care counseling versus the standard of care counseling alone in reducing self-reported HIV sexual risk behaviors and incident STDs over a 12 month follow-up period.
2. To evaluate the cost-effectiveness of the HORIZONS HIV intervention plus standard of care counseling to the standard of care counseling alone with respect to reducing risky sexual behavior and averting incident STDs.

715 participants, ages 15-21, were recruited and enrolled at a large urban county health department, a teen clinic in a public hospital and a reproductive health clinic in the Atlanta area. After a computer interview assessing adolescents' sexual risk and preventive behaviors, and STD testing (Chlamydia and gonorrhea), participants were randomized to one of 2 conditions: the HORIZONS Intervention or the Standard-of-care counseling group. Two trained female health educators lead the 2-session HORIZONS intervention which addressed gender and ethnic pride issues, STD/HIV knowledge, assertive partner communication and refusal skills, and role-play practice. Social Cognitive Theory (SCT) and the Theory of Gender and Power were complementary theoretical frameworks guiding the design and implementation of the HIV intervention. To supplement this group intervention, four phone contacts delivered by the original health educator were conducted during the follow-up period. The supplemental contacts reinforced workshop materials with an individually tailored plan for each participant. The control group received tracking calls only. Follow-up assessments identical to the baseline were conducted at 6 and 12-months post-randomization.

Eligibility Criteria:
Inclusion Criteria:

* Female
* African American
* Ages 15-21
* Receiving care at participating clinic
* Vaginal sex in the past 60 days
* Ability to give written informed consent

Exclusion Criteria:

* Married
* Pregnant
* In a detention center
Thin-Flap Laser in Situ Keratomileusis Associated Dry Eye

Laser in situ keratomileusis (LASIK) eye surgery continues to be the most common refractive procedure used to correct different forms of ametropia. Although the introduction of femtosecond technology has markedly reduced the incidence of intraoperative flap complications and allowed a better control on flap parameters, dry eye remains one of the most challenging postoperative complications.

The pathophysiology of post LASIK dry eye is not clear; however, many mechanisms have been suggested including inflammation, loss of conjunctival goblet cells during suction, exacerbation of a preexisting dry eye, abnormal interaction between the lid margins and the ocular surface. Intact corneal sensation is crucial for proper tear production and distribution on the ocular surface as well as maintaining the normal dynamics of eyelid blinking. Disruption of corneal nerves in LASIK decreases the release of neurotrophic factors necessary for the normal function of the corneal epithelium as well as the integrity of the lacrimal functional unit, a condition referred to as LASIK induced neurotrophic epitheliopathy (LINE) that largely contributes to the development of post- LASIK dry eye .

Many studies evaluated the incidence of post-refractive dry eye after LASIK compared to flapless laser vision correction (LVC) procedures such as PRK and small incision lenticule extraction (SMILE). The aim of this study is to assess and compare different dry eye parameters following LASIK with planned thin flaps created by femtosecond laser (FS) and mechanical microkeratome (MK).

Eligibility Criteria:
Inclusion Criteria:

1. Candidates for Laser Vision Correction (LVC).
2. Eyes with spherical equivalent (SE) up to - 10 diopters (D),
3. Corneal thickness at thinnest location of ≥ 500 um and estimated postoperative residual stromal bed of at least 300 um

Exclusion Criteria:

1. Patients with symptoms or signs of dry eye (TBUT \<10 sec, Schirmer I test \<10mm and Ocular Surface Disease Index OSDI score \>13),
2. Posterior blepharitis, contact lens wearers ,
3. Ocular surface disease ,
4. Systemic diseases contraindicating LASIK and previous ocular surgery.
Efficacy and Safety of First-line ART With BIC/FTC/TAF Introduced at the First Clinical Visit

Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is a recommended first-line antiretroviral regimen. Croatia has a centralized care for people living with HIV (PLWH) and all persons are seen and treated in a single center, preferably in a same-day initiation model whenever suitable. This retrospective cohort study evaluated antiretroviral therapy (ART) naïve PLWH who initiated BIC/FTC/TAF, in a same-day model. The goal of the study is to assess safety and efficacy of this model by collecting information from the electronic database of the Croatian HIV Reference Centre.


Eligibility Criteria:
Inclusion Criteria:

* HIV seropositivity confirmed by a fourth generation test
* the subject had not previously taken ART
* ART was started within 24 hours of the first examination

Exclusion Criteria:

* persons under 18 years of age
* people who are pregnant, breastfeeding or planning to become pregnant
* unacceptable interaction with a drug that the subject is already taking