cyrilzakka/clinical-trials huggingface dataset:
Comparison of HIV Testing Algorithms

The primary objective of the study is to assess whether an improved MSF HIV diagnostic algorithm which includes a simple and easy to perform confirmation test has significantly better positive predictive value than WHO recommended RDT testing algorithms that do not include confirmatory testing.

Rapid Diagnostic Tests (RDT's) are essential tools in antiretroviral treatment (ART) scale up. An important drawback to RDTs is the risk of false positive results. In 2005, MSF-Holland has therefore changed the testing algorithm to introduce a confirmation test. This proposal outlines an evaluation study of the results of the new confirmatory testing algorithm. It aims to compare the confirmatory algorithm employed by MSF-OCA to the MoH serial algorithm which is based on WHO recommendations. A secondary objective of the study is to determine if there is a correlation between kala-azar infection and risk of false positive HIV RDT results as clinicians in the projects suspect such a correlation. Furthermore, the study will look at the positive predictive value of weak test lines, which have been associated with higher risk of false positive results. Finally, the study aims to evaluate the results of a new simplified confirmation test, the dilution testing. Clients for the study will be recruited at two counseling and testing sites in Abdurafi and Humera, aiming to reach a sample size of 200 serial-algorithm positive and 200 negative samples in each site.

Eligibility Criteria:
Inclusion Criteria:

* • Age \>= 59 months (to help ensure success of venepuncture)

  * Informed consent from the individual or guardian to participate in study

Exclusion Criteria:

* • Inability to obtain venous blood sample

  * Withdrawal of consent to test or to participate in the study
Circulating Progenitor Cells Levels in Periodontal Disease Patients

Recently, a key role played in the ethiology of periodontitis has been highlighted by a subtype of stem cells derived from bone marrow, the circulating endothelial progenitor cells (EPCs). EPCs possess the ability to express surface antigens of endothelial and hematopoietic stem cells and to assist in maintaining vascular integrity and the repair mechanism of the endothelium. Among the main markers for the analysis of EPCs levels are CD34+, CD133+ and the kinase insert domain-containing receptor (KDR). CD34+ and CD133+ originate from hematopoietic stem cell antigens whereas KDR is a specific marker of endothelial cells. More specifically, CD34+ and CD133+/ KDR+ allows less mature and mature EPCs to be evaluated.

The aim of the present study was to investigate the association between endothelial progenitor cells (EPCs) levels subtype (CD133+/KDR+), in patients with periodontitis.

Furthermore, the objective was to determine if the periodontal status influenced CD133+/KDR+ levels.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 16 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives

  * Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
  * Status of pregnancy or lactation
  * Previous history of excessive drinking
  * Allergy to local anaesthetic
  * Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
Effectiveness of High Fidelity Simulation for Safety in the Medication Process in Intensive Care

Nursing plays an important role in the medication process in intensive care units. The application of active methodologies guided by the simulation strategy can help in the formation of qualified professionals and in the safer promotion of health care. The objectives to evaluate the effectiveness of the high fidelity simulation applied to nursing students in the process of administering drugs to critical patients in the intensive care setting; evaluate knowledge acquisition, satisfaction and self-confidence after the simulation. This is a prospective, single-blinded, controled clinical trial, with a quantitative approach. The sample will be composed of nursing students who are attending or have completed the discipline of critical care. The students will be randomized electronically to the experimental group, whose intervention will be guided by the high fidelity simulation method and, to the control group, the handling of static dummies / traditional teaching will be adopted as teaching strategy. Both strategies will emphasize the safety process during medication administration to critical patients hospitalized in the intensive care unit and will have an expository class dialogued prior to the intervention. Pre and post-tests will be applied at different times to evaluate the evolution of the level of knowledge and its retention and also, scales of satisfaction and self-confidence in learning. Descriptive and inferential statistics will be performed, as appropriate. It is believed that students submitted to simulation will have the opportunity to better consolidate knowledge during the training process, improve clinical and critical thinking, and decision-making, which will positively influence the safety of critically ill patients of the intensive care unit.

Objective

To evaluate the effectiveness of the high fidelity simulation for learning related to the drug preparation and administration process in the scenario of critical patient care in the cognitive, psychomotor and affective domains for undergraduate students of the nursing course.

Hypothesis of the study

Null hypothesis

There will be no difference between learning through high fidelity simulation and traditional teaching / low fidelity simulation.

Alternative hypothesis

The high fidelity simulation strategy improves the performance of nursing students in drug administration more significantly when compared to traditional teaching / low fidelity simulation.

Eligibility Criteria:
Inclusion Criteria:

* Students enrolled in the undergraduate nursing course of a public university in Brazil; Students coursing or who have completed critical care discipline.

Exclusion Criteria:

* Students with previous training in health.
Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy.

The goal of this observational study is to follow patients being treated with the FDA approved drug AGAMREE® in male patients 2 years of age or older with Duchenne's Muscular Dystrophy for long term safety and quality of life.

This is a multi-center, observational, prospective, longitudinal registry designed to collect data in male patients aged 2 years and older with DMD treated with AGAMREE®.

This registry will be conducted in the US, at approximately 25 sites known to treat and follow patients with DMD. The registry plans to enroll approximately 250 male patients aged 2 years and older with DMD.

Evaluations will include:

* Growth parameters
* Body mass index (BMI)
* Vital Signs
* Physical Exam
* Laboratory (Chemistry and Hematology)
* North Star Ambulatory Assessment (NSAA)
* Performance of Upper Limb (PUL)
* Cardiovascular status
* Fractures
* Bone density
* Puberty
* Quality of life (QoL)
* Adverse events (AEs)

Patients will be followed for approximately 5 years in the registry and will return to the site for Yearly Follow-up Visits (+/- 30 days) for registry assessments. Information on standard of care treatment and procedures for management of DMD will also be collected. Patients and/or their parents/legal guardians will be asked to complete paper QoL questionnaires at enrollment and at each Yearly Follow-up Visit (+/- 30 days).

Eligibility Criteria:
Inclusion Criteria:

1. Patient or parent/guardian willing and able to provide written informed consent after the nature of the registry has been explained and before the start of any registry-related procedures.
2. Patient and/or parent/guardian are willing and able to complete QoL questionnaires.
3. Male patients at least 2 years old.
4. Confirmed diagnosis of DMD (via genetic testing or muscle biopsy with absent dystrophin staining to antidystrophin antibodies 3, 1, or 2, or dystrophin immunohistochemistry or western blot).
5. Currently on treatment with AGAMREE®.

Exclusion Criteria:

1. Any contraindication to AGAMREE® or medical condition, which, in the opinion of the investigator, would affect registry participation, performance, or interpretation of registry assessments.
Investigating Attention Patterns in Young People With Anxiety

Adolescents with elevated anxiety have been found to direct their voluntary and involuntary attention more readily toward threatening stimuli, and spend more time dwelling upon that stimuli. Various computerised tasks have been developed to attempt to retrain these "attention biases" back away from threat.

This study will test a newly developed intervention, that uses (eye-tracking) methods to track the gaze of the individual. This intervention is called Gaze-Contingent Music Reward Training (GC-MRT), and is designed to re-train the individual away from dwelling upon threatening stimuli (emotional faces), using their favourite music to re-infornce this learning.


Eligibility Criteria:
Inclusion Criteria:

* 12-18 years of age upon study commencement
* Diagnosed generalised or social anxiety disorder (assessed by SCID)
* Informed written and witnessed consent

Exclusion Criteria:

* Psychosis
* Autism
* Learning difficulties
* Uncorrected abnormal vision
* Current use of SSRIs
Targeting Right Ventricle in Pulmonary Hypertension Gilead

This study is looking to see if giving ranolazine to subjects on stable pulmonary hypertension therapies but with right ventricular dysfunction (RVEF \<45%) will improve their health by improving right ventricular (RV) function.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic pulmonary hypertension based on one of the following criteria:

  * Idiopathic pulmonary arterial hypertension
  * Familial pulmonary arterial hypertension
  * Pulmonary hypertension associated with connective tissue disease
  * Chronic thromboembolic pulmonary hypertension-nonsurgical/distal vessel disease or patients who are reluctant to go to surgery within a 6-month period and are willing to participate
  * Simple congenital such as repaired atrial septal defect or ventricular septal defect or unrepaired small atrial septal defect or ventricular septal defect with persistent and out of proportion pulmonary arterial hypertension
  * Group 3 patients who have a component of pulmonary arterial hypertension \*Pulmonary hypertension caused by conditions affect the veins and small vessels of the lungs
  * Sickle cell disease
  * Group 5 pulmonary hypertension such as polycythemia vera
  * Essential thrombocythemia
  * Sarcoidosis
  * Vasculitis
  * Metabolic disorder
* World Health Organization functional class II, III, or IV
* Mean pulmonary artery pressure \>25 mmHg at rest
* Pulmonary capillary wedge pressure or left ventricular end diastolic pressure \< 15 mmHg
* Pulmonary vascular resistance \> 3 mmHg/L/min
* Right ventricle ejection fraction \< 45%
* 6-minute walk test distance \> 50 meters

Exclusion Criteria:

* Previous treatment with or prior sensitivity to ranolazine
* Any family history of corrected QT interval prolongation, congenital long QT syndrome, or receiving drugs that prolong the corrected QT interval
* Parenchymal lung disease showing total lung capacity \< 50% of predicted OR forced expiratory volume at one second/forced vital capacity \< 50%
* Portal hypertension associated with chronic liver disease
* Left sided heart disease including any of the following: moderate or greater aortic or mitral valve disease, Any left ventricle cardiomyopathy, Left ventricular systolic dysfunction defined as an ejection fraction \< 50%, Symptomatic coronary artery disease
* Uncontrolled systemic hypertension
* Implantable cardioverter-defibrillator, Pacemaker, hazardous metallic implants or any other contraindication to MRI.
Irofulven in Treating Patients With Metastatic Breast Cancer

Phase II trial to study the effectiveness of irofulven in treating patients who have metastatic breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Evaluate the response rate and time to treatment failure in patients with refractory metastatic adenocarcinoma of the breast treated with irofulven.

II. Assess the qualitative and quantitative toxic effects of this drug in these patients.

III. Determine the population pharmacokinetics and the pharmacokinetics-pharmacodynamic relationships of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive irofulven IV over 30 minutes on days 1 and 15. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic adenocarcinoma of the breast
* Measurable disease outside previously irradiated area or occurred/progressed after completion of radiotherapy
* Must have received 1 or 2 prior chemotherapy regimens for metastatic disease

  * More than 3 prior regimens allowed
* No active brain metastases or meningeal breast cancer involvement

PATIENT CHARACTERISTICS:

Sex:

* Male or female

Performance status:

* SWOG 0-2

Hematopoietic:

* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 3 times ULN (5 times ULN for liver metastases)

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* No history of myocardial infarction or unstable angina within the past 6 months
* No uncontrolled congestive heart failure

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Prior diagnosis of cancer allowed (must be off cancer therapy and have no evidence of disease)
* No history of retinopathy and/or macular degeneration

PRIOR CONCURRENT THERAPY:

Chemotherapy:

* No prior irofulven
Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy Volunteers

The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability three different formulations of PF-04991532 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy

In France, in 2007, 17 000 patients underwent carotid endarterectomy. The risk of having an ipsilateral postoperative stroke after carotid endarterectomy remains at 1-1.5%. There is no consensus concerning the best cerebral monitoring and hemodynamic optimisation during carotid cross-clamping.

The objective of this prospective, multicentric, double-blinded and randomized study is to evaluate the interest of continuous cerebral oximetry monitoring by INVOS™ cerebral oximeter to direct the hemodynamic optimisation during carotid endarterectomy and reduce the new-onset of postoperative radiological (MRI) ischemic lesions. A cost/effectiveness analysis will be conducted to estimate the impact of this monitoring versus standard care on direct and indirect postoperative costs during 120 days.

A substudy will evaluate the effect of this monitoring on neurocognitive outcome and on a serum marker of brain injury, protein S-100B

After consent, patients will be randomized in two groups: one group with continuous per operative cerebral oximetry monitoring associated with hemodynamic optimisation algorithm (excluding norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline; the second group is continuously monitored with cerebral oximeter but this latter is blinded to the medical team, the alarm switch off , and patients are managed with the standard care of the centre.

All patients have a preoperative and a postoperative diffusion cerebral MRI to detect new onset of cerebral ischemic lesion. The amount and the volume of cerebral ischemic lesions will be scored to compare groups.

Quality of life as well as direct (medical and nonmedical) and indirect costs were collected using questionnaires during the 120 postoperative days.

A substudy including 200 patients will be conducted to compare the two groups concerning postoperative protein S-100B level and a composite score of neurocognitive tests (measured pre- and postoperatively) The trial will be conducted according to GCP

Eligibility Criteria:
Inclusion Criteria:

* Patients (male-female) over 18 y.o.
* Presenting an internal carotid stenosis requiring surgery
* Mini Mental State Examination \>24 during preoperative examination
* Informed written consentExclusion Criteria:

Exclusion criteria:

* Severe renal failure or requiring dialysis
* Liver failure or cirrhosis (Child class ≥ B) or prothrombin activity\<50%
* Heart failure (NYHA ≥ III), left ventricular ejection fraction \< 40%, acute coronary syndrome,
* Associated surgery
* Pregnancy
* Contraindication to MRI
* History of allergy to modified gelatine or starch
* History of allergy to adhesive part of electrode
Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia

The purpose of the study is to evaluate the safety and tolerability of fluvastatin 80 mg in a Chinese population. This study is not recruiting patients in the US.


Eligibility Criteria:
Inclusion Criteria:

* Mixed dyslipidemia
* Primary hypercholesterolemia

Exclusion Criteria:

* Pregnant or lactating women
* Age \> 18 years

Other protocol-defined inclusion and exclusion criteria may apply.
Study of Collagen Membrane in Guided Bone Regeneration

The main purpose of this study is to investigate the efficacy of Hypro-Sorb® F, a bilayered bioabsorbable membrane in inducing bone regeneration in different dental procedures requiring GBR.

Guided bone regeneration is a procedure used in dentistry for the reconstruction of osseous defects around teeth, dental implants, and prior to implant placement. The main function of the membrane barrier in GBR is to mechanically prevent the undesirable penetration of epithelial cells and fibroblasts to the bone defect area, creating a secluded space where bone regeneration may occur. Resorbable and non-resorbable membranes have been used in GBR. While non resorbable membranes require another surgical procedure for removing the membrane after the healing period, the resorbable membranes have the advantage of transmitting tissue fluids, excluding undesirable cell penetration and sparing an additional unwanted surgical procedure. The aim of this study is to investigate the efficacy of Hypro-Sorb® F, a bilayered bioabsorbable membrane in inducing bone regeneration in different dental procedures requiring GBR.

Eligibility Criteria:
Inclusion Criteria:

* Cystectomy
* Segmental growing of alveolar tissue
* Lifting of the sinus bottom
* Root amputation
* Apicoectomy
* Filling of the alveolus after resections in prosthetic surgical practice
* Periimplantitis
* Maxillofacial surgery

Exclusion Criteria:

* Inside bone fractures when acrylate adhesives are applied.
Digital Assessment of Mandibular Flexure in Full Arch Fixed Restorations

Nine patients (five males and four females) were included in this study who had long-term (10-15 years) of long-span rigid mandibular fixed prostheses that may have led to radiographic changes around the supporting teeth. The treatment plans included the removal of the long-span fixed rigid prostheses followed by restoring the patients with segmented implant-supported prostheses. In order to digitally measure the mandibular flexure, reference markers were adhered to the prostheses, and intraoral scans were obtained before and after splitting the preexisting prostheses at the minimum and maximum mouth opening. The distances between the markers were measured, and mandibular flexure was calculated by subtracting the distance between the markers during the maximum mouth opening from the minimum mouth opening. An independent sample T-test was used to compare mandibular flexure before and after splitting the long-span fixed prostheses.


Eligibility Criteria:
Inclusion Criteria:

* full-arch mandibular single fixed prostheses that served for many years (average 12 years) opposed by natural dentition.
* Patients were free from any systemic or debilitating diseases such as bone diseases, diabetes melilites, or blood dyscrasias.

Exclusion Criteria:

* patients with healthy fixed full-arch prosthesis
* patients with segmented prosthesis
* patients with systematic debilitating diseases.
* Patients with temporomandibular joint dysfunction, maxillofacial surgeries, or mandibular trauma.
Effect of Normobaric Hypoxia and Hyperoxia in Patients With Pulmonary Hypertension

Pulmonary Hypertension (PH) is a severe disease with a bad prognosis. However, thanks to extensive research in this field, there are more and better treatment options that allow patients to participate in recreational activities at moderate altitude or bring up the question of air-travel.

Still very few is known about the effects hypoxic conditions have on PH patients. The aim of this study is to investigate the effects of hypoxia in comparison to normoxia and hyperoxia on pulmonary hemodynamics in patients with pulmonary hypertension during routine right heart catheterisation. We aim to get insight into the pathophysiology of pulmonary hemodynamics under hypoxic conditions in comparison to normoxia and hyperoxia in patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension compared with control patients, that are scheduled for right heart catheterisation due to dyspnea but have no PH.


Eligibility Criteria:
Inclusion Criteria:

* clinically indicated right heart catheterisation
* diagnosis of pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension or control without pulmonary hypertension

Exclusion Criteria:

* hemodynamically unstable
* partial pressure of Oxygen \< 7.3kPa
* no informed consent
* pulmonary hypertension due to left heart disease, chronic lung disease or miscellaneous (Groups II, III and V) according to Galié ERJ 2015