cyrilzakka/clinical-trials huggingface dataset:
Acute Application of Antibiotic Powder in Open Fracture Wounds

The purpose of this study is to help determine the best treatment for severe injures like open fracture wounds.

Some broken bone injuries can be more likely to get an infection. It is mostly due to the way they were injured. Surgical site infection in the orthopedic surgery population is a big public health issue. Wound infections result in both longer length of hospital stay and total cost of care. This study will be using an antibiotic called Vancomycin or Tobramycin in a powder form.

The investigators aim to investigate the effectiveness of preoperative intrawound antibiotic powder in preventing infection and reducing bacterial burden after open fracture.

The investigators hypothesize that the participants who receive preoperative intrawound antibiotic powder will have fewer superficial and deep surgical site infections compared to participants who do not receive the antibiotic powder. The investigators also anticipate that the application of the antibiotic powder to open fracture wounds preoperatively will decrease the bacterial burden.

Sample swabs will be analyzed using the 16S metagenomics sequencing on the Illumina platform. Both RNA and DNA extracts will be utilized to identify and quantify the bacterial load in the wound bed at the time immediately prior to surgical debridement.

Eligibility Criteria:
Inclusion Criteria:

* Subject or proxy willing and able to provide written informed consent.
* Age between 18 years and 80 years (inclusive), with an upper or lower extremity Gustilo Type II, IIIA, or IIIB open fractures requiring debridement and internal fixation.
* Open extremity fractures
* Time from injury to study intervention 24 hours or less

Exclusion Criteria:

* Individuals under the age of 18 years or over 80 years
* Type I or IIIC open fractures
* Over 24 hours from time of injury
* Subjects who have received acute operative care of the open fracture at an outside facility prior to presenting at the Emergency Department.
* Open fractures distal to the wrist and midfoot
* History of chronic infection in the extremity involved.
* Subjects who are currently pregnant
* Subjects who are Prisoners
* Subjects with a known allergy to vancomycin or tobramycin
* Subjects with a condition or social circumstances that would reduce adherence and follow-up.
* Subjects Participating in other clinical research involving investigational antimicrobial products within 30 days of randomization.
Macular Function During Anti-VEGF Treatment

The purpose of this study is to determine the changes in macular function during anti-VEGF treatment for neovascular age-related macular degeneration.

Macular function will be investigated using visual acuity, contrast sensitivity, mfERG and microperimetry.

Eligibility Criteria:
Inclusion Criteria:

* Neovascular AMD in first or second eyes
* angiographic signs of active subfoveal or juxtafoveal choroidal neovascularization (CNV)
* BCVA ≥35 ETDRS letters

Exclusion Criteria:

* Spherical equivalent ≥ ± 6 D
* Previous treatments for CNV in the studied eye
A Study to Assess 7/8 HLA-matched Hematopoietic Stem Cell Transplantation Participants Treated With or Without Abatacept in Combination With a Calcineurin Inhibitor and Methotrexate

The purpose of this study is to estimate overall survival (OS) for participants treated with abatacept versus those not treated with abatacept prior to hematopoietic stem cell transplantation (HSCT). Participants were included if their donors were unrelated and had 1-allele mismatched human leukocyte antigen (HLA) status.


Eligibility Criteria:
Inclusion Criteria:

* Participants who underwent first allogenic transplant in the US
* Participants with an unrelated donor who are HLA-matched at 7/8 loci (A, B, C, DRB1)
* Participants at least 6 years old with weight at least 20 kilograms
* Participants with a Karnofsky/Lansky Performance Score ≥80%
* Participants whose first allogeneic transplant occurred from January 1, 2011 to December 31, 2018
* Participants with any of the following diseases: AML, ALL, CML, MDS, HL, NHL
* Participants with any of the following graft versus host disease (GVHD) prophylaxis treatments:
* CNI plus MTX (with or without ATG and with or without abatacept); or
* Post-transplant cyclophosphamide (PT-Cy) without antithymocyte globulin (ATG)
* Participants treated with any of the following conditioning regiments: total body irradiation (TBI)/cyclophosphamide (Cy), busulfan (Bu)/Cy, Bu/fludarabine (flu), Flu/Melphalan (MEL)

Exclusion Criteria:

* Participants with missing information on ATG (yes/no)
* Participants receiving alemtuzumab (Campath)
* Participants with cord blood grafts
* Participants with non-MDS myeloproliferative disorders (NOTE: Participants with chronic myelomonocytic leukemia \[CMMoL\] will be included)
* Participants who did not consent to participate in research
* Participants treated at embargoed centers for research
* Participants treated with abatacept and ATG
* Among non-abatacept treated participants, participants transplanted at centers with abatacept trial participants
* Participants with any of the following missing propensity score variables:
* Disease status at transplantation (early, intermediate, advanced HL and NHL-chemosensitive)
* Age
* Gender (male, female)
* HSCT graft source (bone marrow \[BM\], peripheral blood \[PB\])
* Conditioning intensity (myeloablative, non-myeloablative / reduced intensity)
* Karnofsky/Lansky Performance Score (80%, 90-100%)
* CNI type (tacrolimus, CsA)
Access to Pediatric Rheumatology Centers for JIA Patients: Factors Associated With Time to Access Pediatric Rheumatology Centers

JIA patients, their parents, and the health care professionals experience the complexity of the initial care pathway. The aim of the study is to explore the referral pathway to access pediatric rheumatology centers for JIA patients. The exploration will aim to identify the barriers and facilitators of referral, based on the conceptual framework of the health literacy. The investigators will conduct a qualitative study using semi-structured interviews. The perspectives of parents/children/health care professionals will be crossed to enrich the data.


Eligibility Criteria:
Inclusion Criteria:

Children:

* age \> 11 years
* JIA diagnosed between 4 and 24 months prior to the start of the study

Parents:

- parent of a child with JIA diagnosed between 4 and 24 months prior to the start of the study

Health care professional:

* Physician with experience in the initial management of children with JIA (between symptom onset and first visit with a pediatric rheumatologist).

Exclusion Criteria:

For all participants:

* Refusal to participate in interviews
* Presenting a health condition incompatible with an interview
* Participants with inadequate French to take part in semi-structured interviews
Clinical Survey of Oticon Medical Ponto BHX Implant

Investigation of stability of the BHX implant in adult patients indicated and counselled for a bone anchored hearing aid system. Patients are followed according to clinical practice for a total of 12 months in the study. Stability of the implant is evaluated by implant stability quotient.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for treatment with a bone anchored hearing aid
* 18 years or older

Exclusion Criteria:

* Inability to participate in follow-up
* Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients

The goal of this clinical trial is to evaluate which biopsy collection method helps to better diagnose rejection and relevant pathologic findings in lung transplant recipients. The main questions it aims to answer are:

Does the 1.1 mm cryoprobe or the biopsy forceps provide better quality samples of lung tissue for detecting rejection in transplant recipients?

How much tissue is adequate for lung transplant 1.1 mm cryobiopsy samples as compared to biopsy forceps?

Which samples received by the pathologist did they find they were most confident to exclude rejection, based on their satisfaction with the samples?

Which collection method has the least amount of procedural time?

Researchers will compare lung tissue samples obtained using a 1.1mm cryoprobe and a biopsy forceps during the lung transplant.

Participants will:

Be randomly assigned to receive either the cryoprobe or biopsy forceps collection method at the time of biopsy.

Assessed for any adverse events following the biopsy for up to 30 days after transplant.

The purpose of this 1:1 randomized clinical trial is to compare the histological quality and diagnostic yield of tissue samples acquired using a 1.1 mm cryoprobe with those obtained with biopsy forceps in lung transplant recipients for graft surveillance.

Eligibility Criteria:
Inclusion Criteria

* Male and female lung transplant recipients age \&gt;18 at the time of informed consent
* Patients clinically meet indication for post-transplant lung biopsy or planned routine surveillance and have been scheduled for bronchoscopy with transbronchial biopsy.
* Be willing and able to sign the informed consent.

Exclusion Criteria

* Patients with known bleeding diathesis
* Platelet count \&lt;50,000 per μL within 14 days of the biopsy procedure
* Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable)
* Inability or unwillingness to give informed consent or study procedures
* Pregnant or nursing females, or females who intend to become pregnant
* Females of child-bearing potential who decline a pregnancy test prior to enrollment
* If an investigator does not feel that this study is in the subject's best interest or would be a good fit for the study.
* International Normalized Ratio (INR) \&gt;1.5
* Do Not Resuscitate (DNR) status
* Do Not Intubate (DNI) status
* Single lung transplant recipients
Pain and Safety of Restylane Perlane With and Without Lidocaine for Correction of Moderate and Severe Nasolabial Folds

The purpose of this study is to evaluate the pain and safety in associated with injection of Restylane Perlane Lidocaine compared to Restylane Perlane using VAS scale


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent to participate in the study.
* Men or women aged 20 years or older of Chinese origin.
* Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study.
* Intent to undergo correction of both nasolabial folds (NLF) with a wrinkle severity in Wrinkle Severity Rating Scale (WSRS) of either grade 3 on both NLFs or grade 4 on both NLFs.

Exclusion Criteria:

* Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the lower orbital rim.
* Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment.
* Previous tissue revitalization treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion in the midface within 6 months before treatment.
* Scars or deformities, active skin disease, inflammation or related conditions near or in the area to be treated.
* Other condition preventing the subject from entering the study in the Investigator's opinion
Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism

To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms and at the jaw muscle activity during sleep.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated ICF
* 18 years or older
* Fulfill the RDC-criteria for myofascial TMD diagnose (group 1a or 1b)

Exclusion Criteria:

* Contraindication of concommitant diseases for the study judged by investigator
* Patients who are using occlusal splints in the treatment period.
Insulin Resistance and Hypertensive Disorders in Pregnancy

The purpose of this study is to determine whether insulin resistance might affect the pathogenesis of hypertensive disorders in pregnancy since midtrimester. Furthermore, markers of vascular and placental injuries, of oxidative stress and inflammation will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* PCOS, BMI\>/=30
* previous pregnancy affected by hypertension or gestational diabetes
* thrombophilia
* Type I or II diabetes mellitus
* autoimmune diseases
* twin pregnancy
* renal diseases
* previous pre-eclampsia in relatives
High Dose Ascorbic Acid Treatment of CMT1A

This study will look at the impact of ascorbic acid (Vitamin C) on the progression of disease in people with CMT1A as compared to volunteers receiving a placebo. This study will assess whether is it futile to proceed with a larger, longer-term, placebo-controlled study.

Charcot Marie Tooth disease (CMT), or inherited peripheral neuropathies, are among the most frequent heritable disorders, affecting approximately 1 in 2500 people. The most frequent genetic form of CMT is CMT1A. CMT1A is caused by a 1.4 Mb duplication within chromosome 17p11.2 in the region containing the PMP22 gene. Most subjects with CMT1A have a "typical" phenotype characterized by onset in childhood or early adulthood, distal weakness, sensory loss, foot deformities and absent reflexes. How increased expression of PMP22 causes these disabilities is unknown but is currently being investigated in both animal and tissue culture systems. In this study, researchers will evaluate whether ascorbic acid (Vitamin C), administered orally, slows clinical progression of CMT1A and affects the PMP22 mRNA levels of myelinated peripheral nerve fibers obtained from biopsies of glabrous skin.

Eligibility Criteria:
Inclusion Criteria:

* The subject has CMT1A, defined by the duplication on chromosome 17p11.2 performed by either Pulse Field Gel Electrophoresis or Fluorescence In Situ Hybridization (FISH) by a CLIA certified laboratory, OR the subject has a first or second degree relative with a documented duplication performed by the above methods AND the subject has uniform motor conduction slowing of the median or ulnar nerve between 16 and 30 m/s.
* The subject is between 13 and 70 years of age.
* The subject, if 18 years or older, has signed the Informed Consent Form and agrees to follow the stipulations of the protocol.
* If the subject is less than 18, his or her parents or guardians have signed the Informed Consent Form and agree to follow the stipulations of the protocol. The subject has also signed a written assent form.

Exclusion Criteria:

* A known neuropathy from another source (For example, diabetes, drug induced, alcohol, etc.)
* The subject has ever received Vincristine.
* The subject has a known allergy to ascorbic acid.
* The subject has ever had kidney stones.
* The subject has a known history of G6PD deficit.
* The subject has a history of hemochromatosis.
* The subject suffers from a serious illness or medical condition that is not stabilized or that could require hospitalization.
* The subject has a high ascorbic acid level at screening.
* The subject is pregnant or nursing.
* The subject, in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.
* The subject participates to another clinical trial or is still within a washout period of a previous clinical trial.
* The subject is taking neurotoxic medications.
Study of FK463 for the Treatment of Invasive Aspergillosis

The purpose of the study is to evaluate the safety and efficacy of FK463 in patients with proven or probable invasive infections due to Aspergillus species.

This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.

Eligibility Criteria:
Inclusion Criteria

* Has proven or probable systemic infection with Aspergillus species

Exclusion Criteria

* Has abnormal liver test parameters, e.g., AST or ALT \> 10 times upper limit of normal
* Has bronchopulmonary aspergillosis, aspergillomas, sinus aspergillosis or external otitis but does not have histologic evidence of tissue invasion
* Has life-expectancy judged to be less than 5 days
Evaluation of Bone Length Measurement

The purpose of this study is to determine if Lunar iXDA scanning with the use of a computer software program can make accurate measurements of the length of leg bones compared to conventional x-rays.

The investigators would like to see how well the calculation of bone length using Lunar iDxa compares to conventional x-ray since the Lunar iXDA exposed patients to less radiation than conventional x-rays.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 yrs. of age or older
* Have recent x-rays of lower extremity
* Are at least 3 feet 7 inches tall and not taller than 6 feet 7 inches.

Exclusion Criteria:

* Are unwilling to read and sign the consent
* Are pregnant or if subject has not had a negative pregnancy test just prior to the iXDA scan
* Have severe deformities of your legs or back
* Unable to lay on the scanning table for the scan
Infection Related to Short-term Central Venous Catheters

This study aims to evaluate the incidence of infection of short-term central venous catheters by comparing different cannulation techniques (by anatomical references and under ultrasound control) and according to the experience of the operator in patients undergoing elective surgery.

A prospective observational study will be carried out in which all scheduled surgery patients who have a central venous line inserted for 12 months will be included. Those under 18 years of age, patients with catheters lasting more than 14 days and those who do not sign the informed consent will be excluded from this study. A chest X-ray will be performed on all patients in order to diagnose possible complications associated with the technique and, only in case of suspected infection, culture of the catheter tip and blood cultures of blood obtained from the catheter and peripheral blood will be requested.

A prospective observational study will be carried out. The maximum time between the intervention and the final evaluation will be 21 days, since the study evaluates the infection related to short-term catheters and its probable improvement after the removal of the device.

All patients undergoing elective surgery who have a central venous line inserted for 12 months will be included in the study. Those under 18 years of age, patients with catheters lasting more than 14 days and those who do not sign the informed consent will be excluded.

A follow-up of the central venous catheters that are inserted in those patients scheduled for surgery who have an indication for it will be carried out. The criteria for choosing the access route will be carried out according to the usual clinical practice of the responsible anesthesiologist.

The asepsis measures that will be carried out both in the insertion and in the maintenance of the catheter will be those used on a regular basis, which follow the recommendations of the guidelines for the prevention of infections related to intravascular catheters of the American Center for Control and Prevention. of Diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective surgery who have a central venous line inserted during the three months in which the study runs

Exclusion Criteria:

* Patients under 18 years of age
* Patients who need to wear the central venous catheter for more than 14 days
* Patients who do not sign the informed consent.
Pilot Study: Identification of a Multi-omic Predictive Signature for Preterm Birth in Obese African American Women

1. Determine if the stool or vaginal microbiome and urinary metabolite profiles in a pregnant obese population of African American women differ from their pregnant non-obese counterparts
2. Determine if the stool or vaginal microbiome and urinary metabolite profiles vary by class of obesity and magnitude of excess weight gain in this population of pregnant African-American women.
3. Assess the ability of the stool, vaginal microbiome, or metabolites, or the combination of all biomarkers as predictors of preterm birth (PTB) and onset of labor.
4. Determine if any dietary or clinical variables are correlated with changes in the microbiome or urinary metabolites or modify their association with PTB

This is an exploratory pilot study to determine the omic footprint in pregnant AA women and then compare difference between obese and non-obese pregnant AA women and comparisons by class of obesity. Variations in the omic findings (vaginal and gut microbiome and urinary metabolites) will be assessed by dietary findings and by variations in gestational weight gain.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 or older English Speaking Access to internet- The dietary assessment for this study is The Automated Self-Administered 24-hour Recall (ASA24-2014), a web-based instrument developed by researchers at the National Cancer Institute (NCI).

Exclusion Criteria:

- 1. History of preterm birth and taking progesterone. Progesterone may influence the microbiota and metabolites so therefore these women will not be eligible for the study. However, if the women fit other inclusion criteria and have a history of preterm birth but are not on progesterone they will be eligible for enrollment 2. History of antibiotic use in the last month (includes pre-biotics and probiotics). These medications will change the baseline microbiota.

3. History of chronic disease on medications