cyrilzakka/clinical-trials huggingface dataset:
Preservation vs. Dissection of Inferior Pulmonary Ligament for Thoracoscopic Upper Lobectomy

Many thoracic surgeons tend to dissect the inferior pulmonary ligament (IPL) during upper lobectomy, which in theory reduces the free space in the upper thoracic cavity by increasing the mobility of the residual lung. However, the dissection of IPL may lead to bronchial deformation, stenosis, obstruction or lobe torsion, and distortion. Some studies have found that stenosis might be associated with chronic dry cough and shortness of breath, and could result in a significant decline in lung function. Moreover, the dissection of IPL may lead to greater surgical trauma and increase the incidence of complications. Therefore, this study tries to identify whether we should dissect or preserve the inferior pulmonary ligament during the thoracoscopic upper lobectomy.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old \< age \< 70 years old;
2. Meet the indications for thoracoscopic left/right upper lobectomy;
3. Gave informed consent and were willing to undergo thoracoscopic left/right upper lobectomy;
4. Preoperative pulmonary function test: FEV1\>1L and FEV1\>60% of the predicted value;
5. Preoperative ECOG score of 0-1;
6. Preoperative ASA score I-II.

Exclusion Criteria:

1. Inferior mediastinal lymphadenopathy was found in preoperative screening;
2. Found that other lobe operations were required at the same time due to multiple lesions in the preoperative discussion;
3. Pregnant or lactating women;
4. Suffering from severe mental illness;
5. History of thoracic surgery (including intrathoracic surgery only, excluding surface surgery such as mastectomy);
6. History of unstable angina or myocardial infarction within the past six months;
7. History of cerebral infarction or cerebral hemorrhage within the past six months;
8. History of continuous systemic corticosteroid therapy within the past month;
9. Abnormal coagulation function, bleeding tendency, or receiving antithrombotic or antiplatelet therapy recently;
10. Suffering from severe liver, kidney, and other systemic diseases;
11. Other situations that are not suitable for surgery.
Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis

To compare the safety and efficacy of Padagis' product to an FDA approved product for the treatment of plaque psoriasis


Eligibility Criteria:
Inclusion Criteria:

1. Signed IRB approved written informed consent/assent
2. 12 to 75 years of age, inclusive.
3. Subjects must have a clinical diagnosis of stable symptomatic plaque psoriasis.
4. Baseline Investigator's Global Assessment Score of 3 (moderate).
5. Subjects must have a Body Surface Area (BSA) between 2% to 20%
6. Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.

Exclusion Criteria:

1. Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.
2. Current diagnosis of unstable forms of psoriasis in the treatment area.
3. History of unresponsiveness to topical treatment for psoriasis
4. Presence of any other skin condition that, in the Investigator's opinion, might interfere with psoriasis diagnosis and/or evaluations
5. Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments
6. Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study
7. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
8. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study
Pilot Study: Lactoferrin for Prevention of Neonatal Sepsis

We will test the hypothesis that bovine lactoferrin supplementation prevents serious infections in preterm infants. We will conduct a randomized placebo-controlled double blind study in 190 premature infants \<2500 gm in 5 Neonatal Intermediate and Intensive Care Units in Lima, Peru to determine whether bovine lactoferrin prevents the first episode of late-onset sepsis.

Lactoferrin is an iron chelating protein with multiple physiological functions (anti-microbial, anti-inflammatory and immunomodulatory) and is one of the most important proteins present in mammalian milk. We hypothesize that lactoferrin as an oral supplement given daily to low birth weight will improve their health by mimicking their protective role in milk. There is extensive literature showing in vitro and in animal models the benefits of lactoferrin. However, there are few clinical trials designed to translate this knowledge into patient care.

We will conduct a pilot randomized, double-blinded placebo-controlled trial comparing daily supplementation with bovine lactoferrin versus placebo in neonates to reduce the incidence of sepsis in the first month of life. We will enroll 190 neonates with a birth weight less than 2,500 g, younger than 3 days of age in the neonatal intensive care unit of 5 pediatric hospitals in Lima, after informed consent of both parents. Infants will be followed in the hospital until death or discharge and then at home up to 1 month of age. Bovine lactoferrin will be used in this trial (200 mg/Kg per day). Although bovine and human lactoferrin are not identical, their bioactivity is quite comparable. Maltodextrin (an inert sugar) will be used for controls. The primary study outcome will be the number of first late-onset sepsis episodes (occurring \>72h after birth with isolation of any pathogen in blood or cerebrospinal fluid).

Eligibility Criteria:
Inclusion Criteria:

1. Neonates with a birth weight between 500g and 2500g
2. Neonates born in, or referred to the Neonatal Intermediate and Intensive Care Units of one of the participating hospitals in the first 72 hours of life.

Exclusion Criteria:

1. Neonates with underlying gastrointestinal problems that prevent oral intake.
2. Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities)
3. Neonates with a family background of cow milk allergy
4. Neonates that, according to the investigator criteria, will not have the chance to complete the subsequent study visits (patients that before one month old would not be living in Lima).
5. Neonates whose parents decline to participate.
Cohort Study on the Age-related Macular Degeneration: Incidence and Research for Predisposing Factors

Age-related Macular Degeneration (AMD) is the most cause of blindness in the industrialised countries. There are few epidemiological studies on the incidence of this disease. Studying the incidence of AMD in an elderly French population and identifying the predisposing factors is very important to allow a major advance in the epidemiological knowledge of AMD. This study will contribute to the identification of the clinical, genetic and modifiable parameters associated at the risk of developing AMD. This could result in means prevention as well as in the identification of subjects as high risk of AMD

Age-related Macular Degeneration is the most cause of blindness in the industrialised countries. There are few French epidemiological data on this disease. Worldwide, studies have included a small number of very old subjects. Thus, it is important to estimate the AMD incidence in an elderly French population, in order to evaluate more precisely the number of cases in the French population. Besides, some clinical, genetic and modifiable parameters predisposing to the AMD are under study. The aim of the ECLAIR project is to study the 8-year incidence of AMD in an elderly French population and to identify the predisposing factors. It is based on an existing cohort study (ALIENOR) in which some clinical, genetic and modifiable data were collected at baseline, 2 and 4 years. It is the only cohort study performed in France in this field since fifteen years in parallel with another one performed in Dijon according to the same methodology. It is important to extend the study to 8 years in order to have a sufficient statistical power for the identification of predisposing factors. In the ECLAIR study, there is no treatment. The subjects will be followed during 2 years (6 and 8 years after baseline of the Alienor study). The visit 1 (A0) will be the inclusion visit where the subjects will sign the inform consent and will perform ophthalmological examinations. The subjects will come back 2 years later for the visit 2 (A2). In this second visit, the ophthalmological examinations will be the same that is: measure of clinical parameters, measurement of visual acuity exams, retinophotography,spectral domain optical coherence tomography (SD-OCT), intraocular pressure, retinal imaging (OPTOMAP), axial length (IOL master)

Eligibility Criteria:
Inclusion Criteria:

* Subject participating in the study ALIENOR
* Affiliated to a social security
* Consent signed by the patient and the investigator

Exclusion Criteria:

- Health incompatible with one hour and a half ophthalmic examination
A Study Using L5 as a Risk Factor of Cardiovascular (CV) Disease in Chronic Renal and Dialytic Patients

The purpose of this study is to determine whether L5, one of the Low Density Lipoproteins, is an effective predicting factor for cardiovascular disease in chronic renal and hemodialytic patients.

Cardiovascular disease (CVD) is the most important cause of death of chronic kidney disease (CKD) and hemodialysis (HD) patients. Low Density Lipoprotein (LDL) is an essential indicator of CVD.The higher the plasma LDL level, the higher the risk of CVD. LDL is a heterogenous substance composed of different mass and size. Oxidized LDL (oxLDL) is the oxidation product of LDL and is the most important component of LDL associated with CVD. The oxLDL is mostly trapped within tissue and not easily to be detected from blood. L5 iw a kind of electronegative LDL and is associated with CVD in smokers and diabetic patients, even if these patients have normal plasma LDL. Uremia patients have lipid profile different from that of general people,while HD Patients have lower LDL and CKD patients have LDL higher than that of general population. Thus LDL plasma level cannot fully explain the high risk of CVD in CKD and HD patients. As patients with normal LDL but high L5 are prone to have CVD, we suspect there might be association of L5 with CVD in both CKD and HD patients.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of CKD
* clinical diagnosis of HD

Exclusion Criteria:

* N/A
Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation

This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in Veterans with chronic obstructive pulmonary disease (COPD) and insomnia receiving an Internet-based behavioral treatment for insomnia versus online insomnia patient education. Participants will undergo a sleep and health assessment that will be performed at baseline, post-treatment, and 3-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia or online insomnia patient education.

Veterans with chronic obstructive pulmonary disease (COPD) are a vulnerable group for developing insomnia. Insomnia has been found to be associated with limitations in activities of daily living (ADL), lower physical activity levels, poor quality of life, greater COPD symptom severity, and reduced exercise performance. Cognitive-behavioral therapy for insomnia (CBT-I) is an efficacious and durable non-pharmacological treatment for insomnia that provides guidance on changing unhealthy sleep-related beliefs and behaviors across a variety of illnesses. CBT-I not only improves sleep-specific symptoms of insomnia but also improves quality of life and daytime function, reduces ADL limitations, and improves condition-specific symptoms.

This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in Veterans with chronic obstructive pulmonary disease (COPD) and insomnia receiving an Internet-based behavioral treatment for insomnia versus online insomnia patient education. Veterans 40 years and older, who received care from the VA Pittsburgh Healthcare System, and who have COPD and insomnia will be recruited for this study. Participants will undergo a sleep and health assessment that will be performed at baseline, post-treatment, and 3-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia or online insomnia patient education. Both the insomnia treatment and patient education will be provided remotely.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 years and older
* Primary diagnosis of COPD defined by GOLD
* Meets criteria for Insomnia Disorder
* At least moderate insomnia severity based on Insomnia Severity Index score \>7
* Stable psychiatric and medical conditions
* Must have telephone, email, and reliable Internet access via computer, smartphone, or tablet

Exclusion Criteria:

* Untreated current major depression
* Serious suicidal risk
* Substance abuse disorder within past 3 months
* History of bipolar or psychosis
* Untreated restless legs syndrome, delayed sleep phase syndrome, irregular sleep schedules
* Very severe untreated obstructive sleep apnea
* Severe excessive daytime sleepiness based on Epworth Sleepiness Scale score \> 16
* Restrictive lung disease (FEV1/FVC 70 and FEV1 \< 80% predicted) or asthma
* Plans to move during the following 6 months
* Non-English speaking or sensory deficits
Methocarbamol in Ventral and Inguinal HR

The purpose of this study is to gather information on methocarbamol as a pain management treatment for ventral or inguinal hernia repair.

Methocarbamol has been part of the pain management treatment for both inpatient and outpatient procedures at Prisma Health. This study will compare the outcomes of patients who receive methocarbamol, those who receive the standard opioid pain management treatment, and those who receive methocarbamol plus the standard opioid pain management treatment.

Participants will be randomized into one of the study groups listed below.

Primary ventral hernia repair or inguinal hernia repair:

Group 1: standard opioid after surgery Group 2: methocarbamol after surgery

Open or robotic ventral hernia repair outpatient:

Group 1: standard opioid after surgery Group 2: standard opioid plus methocarbamol after surgery

Open or robotic ventral hernia repair inpatient:

Group 1: standard opioid at discharge Group 2: standard opioid plus methocarbamol at discharge

A total of 200 participants will be included in the study.

Participation will last for about 30 days after surgery.


Eligibility Criteria:
Inclusion Criteria:

* \>18 y/o
* Patients undergoing open primary ventral hernia repair (group 1)
* Patients undergoing inguinal hernia repair (open, laparoscopic, or robotic; group 2)
* Patients undergoing open incisional hernia repair (group 3)
* Robotic repair ventral or incisional hernias (group 4)
* Given consent for randomization

Exclusion Criteria:

* \<18 y/o
* Pregnancy
* Chronic opioid users
Early Sodium Intake in Preterm Newborns

Hyponatremia is a common complication among preterm infants, renal losses of sodium contribute to the development of hyponatremia in preterm newborns. Sodium imbalances impact in newborns outcome. There is controversy about the time of initiation and the requirements of sodium in premature infants. Hypothesis: early (24 hours of life) sodium supplementation (5mEq/kg/day) prevents the develop of hyponatremia in preterm infants.

This study is a randomized controlled trial in infants less than 35 weeks gestation admitted to the Newborn Intensive Care Unit at Children Hospital in Saltillo Coahuila Mexico.

Infants receive at 24 hours of life; sodium (5mEq/kg/day) versus less than 1mEq/kg/day. Weight, serum and urine sodium, serum chloride, serum and urine creatinine, serum chloride, bicarbonate and glucose are monitored daily during the first 3 days of life. Patients are assessed for hyponatremia, hypernatremia, weight change, sepsis, necrotizing enterocolitis and intraventricular hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants \<35 Weeks gestation

Exclusion Criteria:

* Urinary malformations
* Congenital abdominal wall defect
* Intestinal atresia / obstruction
* Congenital heart defect
Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing

Investigators have designed a single-center randomized controlled trial to compare chlorhexidine gluconate (CHG)-impregnated dressing and standard dressing with respect to their effects on the infection outcomes. The study was condcuted in the pediatric intensive care unit in the 18 months period.

The single-center randomized controlled trial study aimed to compare chlorhexidine gluconate (CHG)-impregnated dressing and standard dressing with respect to their effects on the frequency of central-line associated bloodstream infection (CLABSI), catheter related bloodstream infection (CRBSI), primary bloodstream infection (BSI) and catheter colonization in critically ill pediatric patients with short-term non-tunneled central venous catheter (CVC) in a pediatric intensive care unit (PICU) of a tertiary referral hospital in Turkey.. Pediatric patients aged 1 month to 18 years admitted to our PICU between May 2018 and December 2019, who had received placement of a short-term non-tunneled CVC which had stayed in place for at least 48 hours were included into the study. The patients were grouped with respect to the type of catheter fixation they had received, either with CHG-impregnated dressing or standard dressing, which were assigned in a randomized fashion. The groups were compared with regard to the frequencies of CLABSI, CRBSI, primary BSI and catheter colonization, as well as microorganism etiology. Any adverse event related to catheter dressing were recorded. Independent risk factors of CLABSI frequency were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* being aged age less than 18 years old,
* providing informed consent to participate in the study
* insertion of a short term non-tunneled, percutaneously inserted CVC (jugular, subclavian, or femoral) that would remain in place for greater than 48 hours during PICU admission.

Exclusion Criteria:

Patients were excluded if they:

* had known allergies to CHG-impregnated or standard dressing,
* would receive insertion of any other type of CVC device (e.g., peripherally inserted CVC, tunneled CVC), were included in the study previously,
* had a current BSI (positive blood culture within 48 hours),
* had received CVC insertion within the 30 days prior to PICU admission.

Additionally, investigators also excluded patients in which

* catheterization had not been performed by the PICU specialist,
* those that were discharged from the PICU with indwelling CVC,
* patients who received extracorporeal membrane oxygenation,

Individuals in which the following events were recorded:

* Accidental catheter removal,
* CVC removal before 48 hours, and
* death within 48 hours after CVC insertion.

In the event that a patient required CVC re-insertion after the initial catheter was removed (due to any reason), only the first application was included in the study -given that any other exclusion criteria did not exclude the patient. Finally, if a patient required catheter reinsertion before the completion of the 48-hour catheter-infection monitoring of the initial application, the first catheterization was excluded from the study.
To Demonstrate the Relative Bioavailability of Fluoxetine Hydrochloride Capsules, 40 mg

To demonstrate the relative bioavailability of fluoxetine hydrochloride capsules, 40 mg.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris);
* Have plaque-type psoriasis covering at least 10% of total body surface area
* Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis

Exclusion Criteria:

* Non-plaque or drug induced forms of psoriasis
* Cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis
* Cannot discontinue phototherapy
* Any uncontrolled significant medical condition
Observational Study of Adult Participants With Diabetic Macular Edema and Suboptimal Response to Anti-Vascular Endothelial Growth Factor Treated With Dexamethasone Intravitreal Implant

The dexamethasone 700 μg intravitreal implant (DEX-I) delivers dexamethasone gradually to the retina over time. It is an approved drug for the treatment of DME. This study will assess adult participants with diabetic macular edema (DME) and suboptimal response to anti-vascular endothelial growth factor therapy that are treated with DEX-I in the routine clinical setting.

Approximately 327 participants who are prescribed DEX-I by their physicians will be enrolled at approximately 40 sites in approximately 10 countries globally.

Participants will be followed for 18 months post-DEX-I implantation according to the routine clinical practice of the prescribing centers. Only one eye per participant will be evaluated in the study.

No additional burden for participants in this trial is expected.


Eligibility Criteria:
Inclusion Criteria:

* Participant diagnosed with DME in the study eye
* Study eye has received at least 3 and no more than 9 anti-VEGF injections in the 12 months prior to DEX-I initiation
* Study eye newly prescribed DEX-I. The prescribing decision lies with the physician and reflects their standard practice
* Participant showing a suboptimal response to anti-VEGF at Baseline in the study eye

Exclusion Criteria:

* Any concomitant ocular or neurologic condition in the study eye that could cause macular edema or affect vision (except cataract)
* History of ocular surgery within 60 days of Baseline in the study eye
* History of Pan-Retinal Photocoagulation (PRP) or sectorial photocoagulation in the study eye in the 3 months prior to Baseline
* Significant media opacities in the study eye limiting Optical Coherence Tomography (OCT) quality
* Uncontrolled Ocular Hypertension (OHT) or advanced glaucoma in the study eye
* Active ocular inflammation in either eye
* Study eyes that are aphakic with Posterior Capsule Rent (PCR), Anterior Chamber Intraocular Lens (ACIOL), iris or scleral-fixed Intraocular Lens (IOL) or history of complicated cataract surgery with PCR
* Prior use of intravitreal corticosteroids in the study eye
* Patients with contraindications to DEX-I