cyrilzakka/clinical-trials huggingface dataset:
Microbial Growth in the Suture Thread, After Application of Different Antiseptic Gels in Mandibular Third Molars Extraction

This is a randomized clinical trial in which investigators will compare the antimicrobial effect and inducer of cicatrization as well as the degree of postoperative pain in patients who are extracted the lower third molars.

After the surgery, different bioadhesive gels will be applied in the area of the surgical wound and we will evaluate the aforementioned parameters.

Introduction: Surgical removal of the third molars is one of the most frequent procedures in oral surgery. Healing of the wound is initially sought by approximating the edges using a suturing technique. Adherence and microbiological accumulation of the suture during the period that it remains in the mouth, which can serve as a focus for odontogenic infections. The use of oral antiseptics before and after the surgery is an efficient method for microbial reduction. The purposes of this project were to evaluate the microbial growth in the suture thread on different culture means after the post-surgical application of the gels under study, while assessing the intensity of post-surgical pain and the degree of healing of the surgical wound.

Material and methods: It is a randomized and blind clinical trial. 21 patients participated (42 wisdom teeth), who consulted the unit for a surgical tooth extraction for at least the two lower wisdom teeth. The evaluated bioadhesive gels were: Chlorhexidine gel at 0.2 % (Bexident Gel Gingival®), Chlorhexidine gel at 0.2% + Chitosan (Bexident Post®) and hyaluronic acid gel (ODDENT®). A neutral water-based gel without any active ingredients was also used HISPAGEL 200® (Acofarma, Madrid, Spain) as the control agent. An assessment of the post-surgical healing, the microbiological analysis of the suture thread and the post-surgical pain was developed.

Eligibility Criteria:
Inclusion Criteria:

* Age: between 18 and 39 years.
* Good general health.
* Availability during the study.
* No current odontological treatments or foreseen during the study period.
* Acceptance and compliance with the prescribed oral hygiene instructions.
* Agreement to not used mouthwashes or toothpastes with antiseptic agents during the study period.

Exclusion Criteria:

* Use of antimicrobial mouthwashes or toothpastes during the period during which the suture remains in the mouth.
* Diabetes.
* Smoking.
* Degenerative diseases.
* Deficient oral health (cavities, periodontal disease, pathologies of the oral mucosa...).
* Wearing prosthetic or orthodontic devices.
* Amoxicillin allergy.
* Pregnant or lactating women.
Low-Cost Tool for Compliance and Treatment-Tracking of Low Back Pain Patients

The purpose of the study is to develop, design and implement an easy-to-use, cloud-enabled software for patients with low back pain and evaluate the effect of the system on compliance and quality of life. The investigators hypothesize that a device which measures compliance to physical therapy regimens in patients with low back pain will increase patient participation.

Innovative Design Labs (IDL) proposes to develop and deploy a low-cost measurement system which tracks exercise compliance and enables remote health coaching for patients with low back pain. The system will consist of a series of small motion sensors built into a custom designed harness which connect wirelessly to the user's tablet or smartphone. A software application will guide the patient through the exercise routine while the sensor system monitors their motion, classifies exercise completion, and tracks their progress through the protocol. The results of the routine will be securely uploaded to caregivers where they can monitor progress, modify the patient's exercise prescription, and offer encouragement and coaching to continue the therapy. This research program aims to enable the long term treatment-tracking of patients with chronic low back pain.

Eligibility Criteria:
Inclusion

* 18 years or older
* Diagnosis of chronic low back pain (\> 3 months duration)
* Have a current prescription for at-home exercises for chronic low back pain

Exclusion

* Patients with a high likelihood of being lost to follow-up or contact
* Patients with an inability to provide good data or follow commands
* Patients with an inability to do mild exercise
* Patients with a history of spine surgery that included instrumentation or hardware
* Patients who are taking opioid medication chronically without reasonable reduction in pain
Efficacy of Mobilization With Movement on Conditioned Pain Modulation in Chronic Low Back Pain Patients

Patients with chronic low back pain may have altered endogenous mechanisms, which can be evaluated with conditioned modulation paradigms. Mobilization with movement has demonstrated improvements in endogenous analgesic mechanisms in conditions such as knee osteoarthritis or lateral epicondylalgia. However, its effects have not yet been studied in patients with chronic low back pain. The objective of this randomized clinical trial is to evaluate the efficacy of mobilization with movement compared to placebo on endogenous mechanisms in patients with chronic low back pain.

Low back pain is the leading cause of disability worldwide, and chronic low back pain (CLBP) has a prevalence of 2-25%, 80% of which are classified as non-specific low back pain because the causal factors have not yet been determined. Although different mechanisms can be attributed to the chronification of pain, a frequent denominator is the amplification of nociceptive transmission or decreased inhibition of nociceptive stimuli in the peripheral and/or central nervous system.

To assess inhibitory pathways, conditioned pain modulation (CPM) paradigms are commonly used in humans. They are based on the idea that a noxious stimulus applied to one part of the body can inhibit pain elsewhere by activating the descending inhibitory system.

When CPM is evaluated in patients with chronic low back pain, contradictory results are found, with studies reporting an alteration of pain modulation mechanisms and others not.

Different studies found that manual therapy can improve CPM compared to sham in patients with chronic musculoskeletal pain, such as lateral epicondylalgia or knee osteoarthritis. However, its effects in patients with chronic low back pain have not yet been studied.

Therefore, the aim of this study was to investigate the effect of mobilization with motion on CPM in patients with chronic musculoskeletal pain.

Eligibility Criteria:
Inclusion Criteria:

* Adults with chronic low back pain (\>3 months of pain duration)
* 2 or more on a scale of 0 to 10.

Exclusion Criteria:

* Radiculopathy
* Neurological signs, symptoms, or deficit
* Rheumatic or autoimmune disease
* Cutaneous disease
* History of fracture or spinal surgery
* Pregnancy
* Neuropathic pain
* Active cancer
* Spondylolysis/Spondylolisthesis
* Mild/Severe cognitive impairment which interferes with outcomes measurement
Clinical Trial to Assess the Influenza Vaccination (FLUVAC 02)

This study assesses the seasonal of influenza vaccine effectiveness in adults hospitalised with laboratory-confirmed influenza through a network of hospitals in France

Influenza vaccination strategies aim at protecting high-risk population from severe outcomes. Estimating the effectiveness of seasonal vaccines against influenza related hospitalisation is important to guide these strategies. The objective is to measure the population effectiveness of influenza vaccine in patients hospitalized with virologically confirmed influenza laboratory during the influenza season 2012/2013 in a French hospitals network. This is a study "case-control" involving a nasopharyngeal sample for all hospitalised patients presenting an influenza-like illness within seven days. Cases will be patients RT-PCR positive for influenza. Controls will be patients negative for any influenza virus.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 year
* Affiliated with social security health insurance
* Written informed consent
* Patients hospitalized for 24 hours and presenting an influenza-like illness in the last 7 days before the hospitalization

Exclusion Criteria:

* Against indication for influenza vaccination(Hypersensitivity to the active substances, to any of the excipients and to trace eg eggs, including ovalbumin, chicken protein)
* Patients institutionalized without regular community interaction
* Patient already hospitalized for respiratory infection during the 2012-2013 influenza season
* Flu already virologically documented in the current influenza season 2012-2013 (RT-PCR, multiple RT-PCR and / or culture.)
Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation

The objective of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

The use of progesterone in the prevention of preterm birth(PTB) in both singleton and multiple pregnancies has been extensively investigated. Arguably, the use of progesterone is biologically plausible given that uterine quiescence is maintained throughout pregnancy by progesterone and progesterone receptor-mediated inhibition of inflammation, which causes suppression of the contractile genes. There is no benefit of universal vaginal progesterone to reduce PTB rates in multiple pregnancies. One meta-analysis showed a benefit in adverse perinatal outcome in a subgroup of women with a short cervix ≤25 mm, suggesting it may be useful in this group, but the numbers in the study were small and further research is needed. There appears to be no long-term harm caused to infants exposed to progesterone in utero. So the aim of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome

Eligibility Criteria:
Inclusion Criteria:

* Women pregnant in dichorionic twins.
* Transvaginal sonographic cervical length is \<25 mm at 18-22 weeks gestational age.
* No symptoms, signs or other risk factors for preterm labor.

Exclusion Criteria:

* Known allergy or contraindication (relative or absolute) to progesterone therapy.
* Monochorionic twins.
* Known major fetal structural or chromosomal abnormality.
* Intrauterine death of one fetus or death of both fetuses.
* Fetal reduction in the current pregnancy.
* Cervical cerclage in the current pregnancy.
* Medical conditions that may lead to preterm delivery.
* Rupture of membranes.
* Vaginal bleeding.
Nurse-led Placement of Peripheral Venous Catheters in Overweight Patients Using Standard or Dynamic Ultrasound-guided Technique

Overweight and obesity may be associated with difficult intravenous access leading to longer procedure time and more placement attempts of peripheral venous catheters (PVC). Dynamic ultrasound-guided short-axis needle tip navigation (DUST) may facilitate the procedure.

This was a prospective, randomized, non-blinded study to compare time and placement attempts for nurse-led standard (ST) and ultrasound guided PVC placement in 90 emergency patients with a BMI ≥25kg/m2.

Consenting patients were randomized at a 1:1 ratio to receive PVC by either ST or DUST.

Application time was defined as the time from applying stasis to visible blood in the PVC flash-chamber.

No difference in time was found (medians: ST 42 s; DUST 53.5 s, P = 0.535). There were on average 17 % less placement attempts in the DUST-group (median 1 attempt; Q1 = 1 Q3 = 1) compared to the ST-group (median 1 attempt; Q1 = 1 Q3 = 1.5), (p = 0.031). Patients reported no differences in perceived pain (p = 0.955) or perceived satisfaction (p = 0.342). Pain and subcutaneous infiltrations were the only side-effects reported (ST-group 6, DUST-group 5).

DUST does not decrease time to functional PVC but reduces the number of PVC placement attempts in patients with BMI ≥25 kg/m2.


Eligibility Criteria:
Inclusion Criteria:

* REETS prioritization level of "Orange", "Yellow", "Green" or "Blue"
* 18 years old
* BMI ≥25 Kg/m2
* Need of PVC according to Emergency department guidelines
* Able to give written informed consent

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Life threatening patient status (REETS prioritization level of "Red")
* Immunosuppression
* Pregnant or lactating women
* Blood infections
* Puncture zone skin damaged (burns, eczema, infection)
A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers

The primary objective of this study is to assess the corrected QT interval (QTc) effect of volanesorsen (ISIS 304801) administered as a 300 mg subcutaneous (SC) therapeutic and a 300 mg intravenous (IV; 2-hour infusion) supra-therapeutic dose relative to placebo in healthy adult male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Must have given written informed consent and be able to comply with all study requirements
* Males and females aged 18-55 at the time of informed consent
* Females must be non-pregnant and non-lactating surgically sterile, post-menopausal or if engaged in sexual relations of childbearing potential, using an acceptable contraceptive method
* Males must be surgically sterile, abstinent or using an acceptable contraceptive method
* The subject has a BMI of 19 to 32 kg/m\^2 inclusive
* Consumption of nicotine or nicotine-containing products for at least 6 months before Screening

Exclusion Criteria:

* History of risk factors for Torsades de Pointes, unexplained syncope, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinical significant abnormal laboratory assessments including hypokalemia, hypocalcemia, hypercalcemia, or hypomagnesemia
* Abnormal screening ECG
* Use of concomitant medications unless authorized by the Sponsor Medical Monitor
* Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
* Treatment with another Study Drug, biological agent, or device within one-month of Screening
* Tests positive for drugs of abuse or cotinine
* Considered unsuitable for inclusion by the Principal Investigator
Myoelectric SoftHand Pro to Improve Prosthetic Function for People With Below-elbow Amputations: A Feasibility Study

A study to investigate the hypothesis that a Pisa/IIT Robotic SoftHand Pro converted to a prosthetic terminal device will enhance the performance of people with limb loss in a wider range of daily living tasks than allowed by today's commercially available prosthetic hands, and will exceed established benchmarks for activities of daily living (ADL).

Preliminary data suggest that the SoftHand Pro (SHpro) is extremely versatile and can be used to grasp and manipulate common objects. We will perform extensive testing of the myoelectric SHpro by asking subjects to perform a wide variety of ADL tasks in a structured environment onsite at Mayo Clinic Rochester. These data will be used by the Mayo Clinic, ASU, and the IIT research teams to modify the SHpro design to adapt it for use by people with amputations while focusing on the SHpro socket design, surface electromyography (EMG)-based control (typically used in commercially available prostheses today).

We will quantify the ability of patients with below-elbow amputation to perform the above tasks using the prosthetic terminal device version of the SHpro. We hypothesize that people with amputations will learn to use the SHpro and perform grasp and manipulation tasks to a greater level than that allowed by their current terminal devices.

The long-term objectives of this exploratory study are to design and build a low-cost, high-performance prosthetic hand terminal device that will be accepted by patients with below-elbow amputation and allow them to perform a wider range of ADL tasks than allowed by today's commercially available prostheses. The data collected through the proposed studies will provide an important foundation for optimizing the design of the SHpro for future testing on a large number of people with limb loss. Future studies will also assess the extent to which the SHpro's functionality and acceptance might benefit from embedding additional synergistic hand motion patterns in the SHpro.

Eligibility Criteria:
Inclusion Criteria:

1) Subjects \> 18 years of age.

Exclusion Criteria:

1. Patients with an amputation for less than 6 months.
2. Patients who have been fit and trained to use a prothesis but chose not to do so.
3. Clinical history of brachial plexopathy, cervical radiculopathy or polyneuropathy and persistent weakness.

5) Visual problems that would interfere with our grasp task.

6) Co-existing central nervous system disease (e.g., multiple sclerosis, motor neuron disease, myasthenia gravis, Parkinson's disease, dystonia) that would interfere with our grasp task

7) Significant spasticity/rigidity as assessed through range of motion testing that would interfere with our grasp task.

8) Active psychiatric illness.

9) Cognitive impairments which would interfere with following study instructions and filling out surveys (at the investigator's discretion).

10) Use of medications that might affect sensory and/or motor functions.
Serum Zn Status of Patients With Cystic Fibrosis at Diagnosis and One Year Later, Compared to a Healthy Control Group

Serum Zn status of patients with cystic fibrosis at diagnosis and one year later, compared to a healthy control group

Serum Zn status of patients with cystic fibrosis at diagnosis and one year later, compared to a healthy control group

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis

Exclusion Criteria:

-
UCSF BP Activate Letter Study

The BP Activate Study aims to assess the effectiveness of the BP Report letter with personalized BP medication recommendations, compared with Control letters and no intervention, at shortening time to appointment, time to visit, time to medication change, and time to achievement of BP goal.

The BP Activate Study is a randomized quality improvement trial. We will deliver one of two versions of a letter to established English-speaking primary care patients at Mt Zion with uncontrolled hypertension, defined by SBP\>140 or DBP\>90 in the past two years (identified via EHR). The letter will prompt patients to schedule a visit with their provider or team nurse practitioner to discuss their BP recommendations with their clinician. We will test 2 versions of the letter and a usual care control:

1. The "BP Activate Report Letter" group will get a letter that presents recommendations for medication changes from a computerized algorithm using the patient's medical records and recommends discussing these specific recommendations with their clinician; or
2. The "Control Letter" group will get a letter that suggests they talk to their clinician about their BP without providing any specific medication recommendations.
3. The "Usual Care" group will not receive any intervention.

This primary goal of the study is to assess the effectiveness of the BP Activate Report Letter compared with the Control Letter, and see if it shortens time to appointment, time to visit, time to medication change (primary outcome), and time to achievement of BP goal. Clinicians, with patient input, will still have full control of how BP is clinically managed. A small number of patients will be contacted by a research coordinator to hear what they thought when they received the letter, and why they did or did not act upon the information.

Eligibility Criteria:
Inclusion Criteria:

* Patient is a primary care patient of a clinician in a general internal medicine clinic who has agreed to have their patients participate in the study
* Lowest SBP\>140 or lowest DBP\>90 at last visit in general internal medicine clinic
* Last visit in general internal medicine clinic was \< 2 years ago
* EngageRx algorithm determines that a medication intensification step is indicated

Exclusion Criteria:

* Primary language is not English
* Patient's provider indicates (through an active opt-out process) that they do not want the patient to receive a BP Activate letter
Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)

The purpose of this study was to generate effectiveness data of Angiotensin receptor neprilysin inhibitor (ARNI), in the Chinese Heart failure with reduced ejection fraction (HFrEF) patients with implantable cardioverted defibrillator (ICD) or Cardiac resynchronization therapy-defibrillator (CRT-D).

The rationale of this study was to compare the effect of angiotensin-converting enzyme inhibitor (ACEI) / Angiotensin receptor blockers (ARB) with the effect of ARNI on ventricular arrhythmia (VA) events for HFrEF patients with ICD or CRT-D, thus a multicenter, interventional, open-label, and prospective single-arm study was considered.

ACEI/ARB was given to the patient for 6 months. After 6 months, patients using ACEI needed to undergo a 36-hr washout period (36-hr washout period was not needed for patients using ARB at month 6). Patients then received ARNI (sponsored by Novartis only for this study).

Eligibility Criteria:
Key Inclusion criteria:

1. Male or female patients ≥18 and ≤80 years of age
2. Implanted with an ICD or CRT-D within 2 weeks
3. NYHA functional class II - IV
4. LVEF ≤40% (measured by echocardiography)
5. Signed informed consent must be obtained prior to participation in the study.

Key Exclusion criteria

1. History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes.
2. Patient received target dose (≥200 mg/d) of ARNI for 2 weeks continuously within the 6-week period prior to study enrollment.
3. Participation in other clinical studies 3 months prior to participating study.
4. Advanced cancer or other significant comorbidities with life expectancy of \<1 year.
5. Previous history of angioedema associated with ACEI/ARB treatment, hereditary or idiopathic angioedema.
6. Patients with renal artery stenosis history.
7. Current stage D HF patients requiring vasoactive drugs.
8. Symptomatic hypotension \< 100/60 mmHg at visit 1 (screening) or Symptomatic hypotension \< 90/60 mmHg in anti-hypertension drug treatment at visit 1 (screening).
9. Serum potassium \>5.4 mmol/L at visit 1 (screening).
10. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2 as measured at visit 1 (screening).
11. Pregnant or nursing (lactating) women.
12. Other exclusion depend on investigator's discretion.