cyrilzakka/clinical-trials huggingface dataset:
Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia

The purpose of this study is to determine if late doses of Infasurf surfactant given when patients are receiving inhaled nitric oxide will interact to improve surfactant function and increase survival without BPD in treated infants.

This is a multi-center, blinded, randomized controlled clinical trial to evaluate the effects of booster doses of exogenous surfactant (Infasurf®, calfactant) in addition to inhaled nitric oxide (iNO) on the outcome of survival without bronchopulmonary dysplasia (BPD, or chronic lung disease of prematurity, characterized by chronic lung dysfunction) at 36 weeks' post-menstrual age (PMA) in extremely low gestational age (ELGAN) infants that are at high risk of the development of BPD. This multi-center trial, with a planned enrollment of 524 infants, will also enable us to evaluate for any adverse effects of late surfactant treatment on short- and long-term outcomes, as we will be collecting data on effects of dosing of late surfactant, co-morbidities of prematurity and neurodevelopmental and pulmonary outcome at 1 year and 24 months corrected age. In addition, we will collect biological specimens for evaluation of the effects of late surfactant replacement therapy (administered as described in this trial) on surfactant function and inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* \<=28 0/7 weeks gestational age
* Day of life 7-14
* Intubated and mechanically ventilated
* Plan to treat with inhaled nitric oxide

Exclusion Criteria:

* Serious congenital malformations or chromosomal abnormalities
* Life expectancy \<7 days from enrollment
* Clinically unstable
* Less tha 48 hours since last dose surfactant
* Ability to obtain 36 week primary outcome information is unlikely
Nevirapine Clearance After Short-term Highly Active Antiretroviral Therapy (HAART) for Prevention of Mother to Child Transmission of HIV (PMTCT)

Three-drug combination of antiretroviral regimens has been used increasingly in HIV-infected pregnant women worldwide, both for the prevention of mother to child transmission of HIV (PMTCT) and for women's own health. Use of these drugs in pregnant women solely for PMTCT means that these drugs will need to be discontinued in the majority of women after delivery.

Certain antiretroviral regimens contain drugs with long half-life (drugs that stay in the body for a longer period of time after discontinuation than other drugs in the same regimen), such as nevirapine (NVP). HIV can easily develop resistance to NVP when NVP is the only drug left in the body (similar to monotherapy). Given two other drugs for up to 1 week after discontinue NVP (to mimic three-drug regimen while waiting for NVP elimination) can help reduce, but not eliminate, the development of resistant virus.

Unfortunately, NVP-containing regimens are the most widely used regimens for pregnant women in developing countries due to its low cost and its availability in fixed-dose combinations. These study will explore how fast NVP is eliminated from women after delivery and to see if given zidovudine/lamivudine (AZT/3TC) for 1 or 2 weeks after NVP discontinuation can help reduce the development of NVP resistant virus.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide 2 separated written informed consents to take part in the Thai Red Cross PMTCT program and in the study
2. Female and aged between 18-45 years
3. Documented HIV-1 infection
4. Pregnant for a maximum of 36 weeks at the first dose of study medication
5. Baseline CD4 cell count \>250 cells/mm3
6. Intend to discontinue ART after delivery

Exclusion Criteria:

1. History of significant reaction or allergy to the drugs that may be used in the study
2. Antiretroviral (ARV)-experienced including previous ARV use for the prevention of mother-to-child transmission of HIV
3. Documented NVP- or 3TC-resistant HIV-1 strains
4. Concomitant use of medications that interfere with NVP plasma level
5. Serum aspartate transaminase (AST) or alanine transaminase (ALT) \>1.25 times the upper limit of normal
6. Inability to understand the nature and extent of the trial procedures required
7. Pregnant woman, in the opinion of the investigator, should not participate in the study
Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP

This study aims to assess the role of intraprostatic injection of tranexamic acid in decreasing the blood loss during Transurethral resection of the prostate.

Benign prostatic hyperplasia (BPH) is a process in which the pathology results in increased number of both stromal and epithelial cells in the area of the prostate around the urethra, which is pathologically known as hyperplasia, and not hypertrophy.

The accurate cause is not well known; however, "reactivation" of embryonic processes is one of the hypotheses that may cause benign prostatic hyperplasia (BPH). Benign prostatic hyperplasia (BPH) is a common condition that affects elderly men. Recently, many noninvasive and mini-invasive modalities have become popular for the management of men with voiding symptoms.

Transurethral resection of the prostate (TURP) is one of the most common and well-developed techniques used to treat benign prostatic hyperplasia (BPH), recognized as the 'gold standard' of the surgical treatments of enlarged prostates. The most relevant complications are the inability to void (5.8%), surgical revision (5.6%), urinary tract infection (UTI) (3.6%), bleeding requiring transfusions (2.9%), and Transurethral resection syndrome (1.4%). As the prostate has a rich blood supply, bleeding is one of the most common complications of Transurethral resection of the prostate.

Eligibility Criteria:
Inclusion Criteria:

* Patient with an age between 50 and 85 years old
* who had benign prostatic hyperplasia (aged 50-85 years) with a prostate weight of 50-80 g.
* undergoing Transurethral resection of the prostate

Exclusion Criteria:

* Patient refusal.
* Patients hypersensitive to Tranexamic Acid, or on antiplatelet and anticoagulant drugs.
* Patients with a history of thrombotic events, bleeding disorders, chronic kidney disease.
* Patients with abnormal liver function test.
* Patients with cardiovascular disease and receiving with a drug-eluting stent, bladder stone, urethral stricture, or with previous prostate surgery, prostate cancer, with a UTI or who receiving 5α-reductase inhibitors.
Correlation of Early Postoperative Scar Appearance With Long-term Scar Outcomes

A retrospective cohort study of early and late period postoperative scars using previously validated survey measures and clinical photographs. The target population consists of participants treated with Mohs micrographic surgery (MMS) for a facial skin cancer by the division of dermatologic surgery. This study aims to determine if patient assessment of scar appearance correlates with physician ratings and/or third-person observer ratings. Secondary goals are to assess for correlations between early post-operative scar appearance and long-term scar appearance as well as identification of predictive factors for scar healing.

Scarring is an inevitable outcome of surgical manipulation of the skin. Previous studies have shown that postoperative scarring, especially in cosmetically sensitive areas, may negatively affect patient quality of life and social interactions. The impact of surgical scarring is magnified in Mohs micrographic surgery, for which the large proportion of treated lesions are in highly visible areas, such as the head, face, and neck. Clinicians often underestimate the significance of scarring in patients' daily activities. Patients desire quick healing surgical scars in order to reintegrate into their normal social routines. Anecdotal evidence suggests that scars that heal well early in the post-operative period will achieve better results in the late postoperative period. Determining a model of early and late surgical scar evolution, as rated by patients, physicians, and third-party observers may; 1. Identify gaps between physician and patient evaluations; 2. Assist clinicians in effectively evaluating and counseling patients regarding their post-operative scar appearance.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants diagnosed with a biopsy-proven facial skin cancer (melanoma and non-melanoma skin cancers) and treated with Mohs micrographic surgery (MMS) from August 2015 to February 2016.

Exclusion Criteria:

* Participants with post-excisional reconstruction requiring multiple techniques, incomplete or missing patient photographs from postsurgical visits, or if the patient received any postoperative scar interventions (pulse-dye laser, scar revision, etc.).
Effects of an Osteopathic Treatment Protocol on Sleep Quality

SIngle-centre interventional single-blinded randomized controlled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio) and to be carried out with volunteers that present alterations in the quality of sleep. Eligible and accepting subjects participating in the study will be assigned to receive an osteopathic treatment protocol or a placebo technique

Intervention protocol in the intervention group:

The intervention protocol consists of 4 techniques that will be performed according to the following order:

1. Inhibition of the suboccipital muscles.
2. Parietal Lift.
3. Sutherland Technique of Sphenobasilar Synchondrosis.
4. Compression technique of the fourth ventricle (CV4).

Intervention protocol in the control group:

Placebo technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.

Eligibility Criteria:
Inclusion Criteria:

* Adults ranging from 18 to 80 years old and with a score greater than 5 on the Pittsburgh Sleep Quality Index

Exclusion Criteria:

1. Recent head injuries or fractures.
2. Having suffered a stroke or intracranial hemorrhage.
3. Tumors.
4. Epilepsy.
5. Bradycardia.
6. Hypotension.
7. Heart disease
8. Neurological problems
9. Psychiatric problems
X-Ray Study Investigating The Safety And Efficacy Of SD-6010 In Subjects With Osteoarthritis Of The Knee

The objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS). The efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.


Eligibility Criteria:
Inclusion Criteria:

Subjects aged \>= 40 years Diagnosed with knee OA (ACR definition of OA) Radiographic evidence of OA in the study knee

Exclusion Criteria:

A diagnosis of any other rheumatic disease Current conditions in the study knee that would confound efficacy Selected, traditional clinical safety and laboratory parameters
Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.

In the current study the investigators wish to evaluate the effect the doctors and midwives in the delivery room have on the timing and modality of analgesia chosen by the participants. The participants will be randomly divided into 2 groups. Both groups will be advised of the different modalities of analgesia available during labor. One group will be managed in the delivery room the same as if not part of the study, meaning the doctors and midwives will treat the participants the way they usually do regarding analgesia. The second group of participants will not be asked by the doctors and midwives about analgesia at all but will be able to receive analgesia by a modality of choice at the timing of choice.

After explaining to the participants the study and having signed a confirmed consent, participants will receive an extensive explanation regarding the different modalities of analgesia available during labor. After the explanations the participants will be randomly divided into 2 groups:

1. Routine management-doctors and midwives will treat the participants the way they usually do regarding analgesia including frequent inquiries about wishes for analgesia.
2. Interventional management-participants will not be asked by the doctors and midwives about analgesia at all during labor but will be able to receive analgesia by a modality of choice at the timing of choice after being advised by the medical team.

After delivery, participants will fill a questionnaire regarding the experience of labor in general and the relevance of analgesia during labor including the effect the medical team may have had on decision making during labor.

Medical information regarding visual analogue scale (VAS), analgesia modality, cervical conditions, parity etc. will be extracted from patients' electronic files.

Eligibility Criteria:
Inclusion Criteria:

* Women planned for vaginal delivery.

Exclusion Criteria:

* Women planned for cesarean section.
* Women with comorbidities related to pain that may exacerbate during labor.
Stromal Vascular Fraction for Treatment of Xerostomia

Prospective, single center, double armed, randomized treatment with observation only (standard of care) control group. Subjects receiving study treatment will have 6 months of study follow-up. Stromal vascular fraction (SVF), an adipose-derived tissue preparation, will be injected into salivary glands to determine safety and efficacy to restore saliva production in head and neck cancer patients with chronic xerostomia resulting from radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female subjects are both eligible
* Subjects must be 21 years of age or older
* History of treated Head and Neck Cancer, no evidence of active cancer at the time of the study
* Original tumor not located adjacent to the parotid or sub-mandibular glands
* Diagnosis of radiation-induced xerostomia
* study is fully explained
* Females of child bearing potential agree to use acceptable methods of contraception through 6 month study follow-up.
* No current malignancy or history of previous malignancy within the last five years, other than the head and neck cancer, with the exception of adequately treated non-abdominal, non-melanoma cutaneous carcinoma (basal cell or squamous cell carcinoma of the skin)
* Willing to undergo a minor surgical procedure (small-volume liposuction, totaling approximately 60-120cc) and a single treatment of an injection of approximately 30ml of autologous Stromal Vascular Fraction taking approximately 10 minutes
* Abdominal area amenable to liposuction of at least 60-120cc of adipose tissue based on Investigator(s) examination
* Willing to be available for all baseline, treatment and follow-up examinations required by protocol
* Willing to forego participation in any other study throughout the duration of this study unless receiving prior approval by Investigator

Exclusion Criteria:

* Patients taking immunosuppressive therapy in the prior 3 months
* Autoimmune disorders
* Patients who are pregnant or currently breast-feeding children
* Patients participating in a study of an experimental drug or medical device within 60 days of study entry
* Uncontrolled hypertension
* Reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening
* Hemoglobin A1c \> 8% within 8 weeks prior to study treatment
* Current use of steroids or immunosuppressant therapies
* Any other condition, which, in the opinion of the Investigator, would contraindicate treatment, affect compliance, interfere with study evaluations, limit study participation, or confound the interpretation of study results
* History of Sjogren's Syndrome or related autoimmune disease.
* Taking medication for which xerostomia is a known major side effect
Myopia Progression After Ceasing Myopia Control Contact Lens Wear

This is a continuation study for subjects who were previously fit with test or control lenses; all will stop wearing their study lenses assigned in the previous study and will start to wear an FDA-approved marketed spherical soft contact lens.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must be enrolled in the parent protocol for at least one year.
2. The subject's parent or legal guardian must read and sign the STATEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form.
3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

1. Ocular or systemic allergies that may interfere with contact lens wear.
2. Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with contact lens wear.
3. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Any infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV)
8. Diabetes
9. Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study.
10. Strabismus.
11. Pupil or lid abnormality or infection in either eye
12. Central corneal scar in either eye
13. Aphakia in either eye
14. Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear.
15. History of participation in prior clinical trials aimed to control myopia progression, except for the parent trial
16. Surgically altered eyes, ocular infection of any type, ocular inflammation.
17. Anterior chamber angle grade 2 or narrower by Van Herrick method.
Solutions for Atrial Fibrillation Edvocacy (SAFE)

The aim of this demonstration project is to create an additional access point in the community at local pharmacies for atrial fibrillation screening, detection, and referral to physicians for follow-up and initiation of evidence-based therapy when appropriate.

The APhA Foundation will implement the Solutions for Atrial Fibrillation Edvocacy (SAFE) demonstration project integrating atrial fibrillation (Afib) screening, detection, and referral services as a routine component of care in community-based pharmacies. The SAFE solution is designed to improve awareness about Afib, increase access to screening and education opportunities related to Afib, and offer a team-based approach to care that will ultimately improve public health outcomes.

This multi-site study will utilize community pharmacies to identify patients at-risk for Afib through point-of-care patient encounters, proactive patient profile reviews, risk assessment tools, and AliveCor's FDA-cleared EKG technology.

As part of their usual and customary care, pharmacists can identify patients potentially at-risk for Afib through routine patient encounters, proactive patient profile reviews, and subsequent discussions with the patient. Identified patients will then be asked to complete a stroke risk assessment which will help determine the patient's risk level. The pharmacist will utilize the results from the stroke risk assessment to educate the patient on why these factors could add risk, why it's important to monitor these factors, and how the patient can work to reduce or improve upon certain modifiable risk factors. All patients will be educated about the risks of Afib and the importance of future monitoring based on their risk level.

Patients will then be offered the opportunity to utilize the AliveCor EKG technology to capture an EKG reading at the point-of-care. This FDA-cleared device is easy for patients to use and a pharmacy team member will be available to guide the patient to ensure proper use. Patients who are identified as having an abnormal heart rhythm, based on their EKG reading, will be referred to their physician for evaluation and follow-up. Pharmacists will follow-up with the patients that were referred to the physician to facilitate the transition of care and inquire about confirmation of Afib and initiation of treatment. Coordination and communication among patients, pharmacists, and physicians is the foundation of this patient-centered team-based care approach.

Eligibility Criteria:
Inclusion Criteria:

* Any person at least 18 years of age
* Person who is able to present to a pharmacist for usual and customary care

Exclusion Criteria:

* Persons who are pregnant
* Persons who are lacking in capacity
* Persons who have a pacemaker or implantable cardioverter defibrillator (ICD) or other implanted electronic devices
Providing Mental Health Services to Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans

The purpose of this study is to gather information from VISN 19 Denver VA mental health professionals regarding their perspectives of necessary resources to provide best practice mental health service to Operation Iraqi Freedom (OIF)/ Operation Enduring Freedom (OEF) Veterans. Specifically, this study aims to describe provider perspectives regarding the following: a) clinical needs of OIF/OEF Veterans; b) collaboration and referral processes; c) barriers to providing optimal treatment to this cohort d) provider needs and resources that may improve service delivery to this cohort; e) provider perspectives regarding psychiatric outcomes in this cohort; and f) professional satisfaction. Support for this study is provided by previous research evaluating Veteran's Administration (VA) needs to provide service to OIF/OEF Veterans (Sayer, et al. 2009; Friedmann-Sanchez, et al. 2008).

The above information will be obtained using semi-structured interview. Hypotheses are not provided as this is an exploratory qualitative study.

No hypotheses are associated with this study as this is a qualitative study wherein subjects will participate in a semi-structured interview developed specifically for this study, which serves as the outcome measure. Up to 30 providers will be interviewed.

Data Analysis Interviews will be transcribed in their entirety and de-identified. Dr. Signoracci and 4 additional MRIECC researchers will independently code each interview for themes. Finally, group meetings with Dr. Signoracci and MIRECC researchers will be held in order to achieve larger consensus regarding such unique and universal themes (Rubin \& Rubin, 1995).

Any reporting of information regarding: a) length of time employed at Denver VA; b) length of time employed within VA system; c) provider professional title; d) provider degree; f) professional licenses held; g) clinic/service in which provide services will be done in the aggregate, across clinics. No individual data will be reported with respect to these items. Also, any selected quotes that are reported will remain de-identified.

Power analyses will not be conducted because no hypothesis quantitative testing is being done, and therefore there are no parameters to estimate. With qualitative designs one conducts interviews until reaching the saturation point. In other words, subsequent interviews do not yield any new information (Rubin \& Rubin, 1995). Previous experience (Brenner et al., 2008) suggests that 25 completed interviews should provide a wide enough range of responses for important themes to emerge.

Eligibility Criteria:
Inclusion Criteria

* Denver VA Mental Health Providers that provide mental health treatment to OIF/OEF Veterans
* Age 18-70

Exclusion Criteria Denver VA providers that do not provide mental health to OIF/OEF Veterans