cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Imaging of Thoracic Malignancies With Indocyanine Green

Our specific aim is to determine if Indocyanine Green (ICG) administered intraoperatively and imaged using our camera will aid in the identification of a suspected lung nodule.

According to the World Health Organization, lung cancer is the most common cause of cancer-related death in men and women, and is responsible for 1.3 million deaths worldwide annually as of 2004. Surgery remains the best option for patients presenting with operable Stage I or II cancers, however the five year survival rate for these candidates remains at a dismal 53% for Stage I and 32% for Stage II1. The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through near-infrared imagery with a safe non-toxic contrast agent it would be possible for the investigators to improve the rates of recurrence free patients and thus overall survival. This study is a small pilot/feasibility study to determine if the investigators camera system can be effective at identifying malignancies in lung cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients over 18 years of age
2. Patients presenting with a lung nodule or mass presumed to be resectable stage I, II, or IIIa non-small call lung cancer on pre-operative assessment
3. Good operative candidate as determined by a thoracic oncology multidisciplinary team
4. Subject capable of giving informed consent and participating in the process of consent

Exclusion Criteria:

1. Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
2. Subjects with a history of iodide allergies
3. At-risk patient populations

   * Homeless patients
   * Patients with drug or alcohol dependence
   * Children and neonates
   * Patients unable to participate in the consent process
Early Versus Late Stoma Closure After Traumatic Colorectal Injuries

The aim is to study feasibility,advantages and disadvantages of early closure of stoma versus late closure of stoma

Most traumatic colon injuries can be repaired primarily, but a stoma may still be required for severe colonic or rectal injury. The current trend is to reverse the stoma early, rather than to wait the traditional 3 months before closure)1-3) Trauma patients, however, are usually young and otherwise healthy individuals, with an excellent potential for optimal healing once they have overcome the initial insult. It is these patients who could benefit from early closure of the stoma(4-6). Once the temporary stoma has been constructed, various reasons have been cited for the development of colon-related complications after closure. The timing of the operation, the age of the patient, the type of colostomy, and the use of primary or delayed skin closure have all been implicated(7-8). Of all these, the timing of the operation is the most controversial. The early closure of a temporary stoma has many attractions. It can reduce hospitalization time and cost, eliminates the need for stoma care by the patient, and abolishes the psychologic, social, and financial burdens of a stoma in an otherwise healthy person(9-11)

Eligibility Criteria:
Inclusion Criteria:

* age between (10-50)

Exclusion Criteria:

* pathological causes
* deep, open perineal tear
* Severe co-morbid conditions (uncontrolled diabetes, Hypertension)
Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction

The arthroscopic anterior cruciate (ACL) ligament reconstruction surgery is widespread. The creation of the tibial tunnel, retrograde or antegrade, is not consensual. A cadaveric study demonstrated tibial subchondral microfractures in the group "antegrade tibial tunnel" unlike group "retrograde tibial tunnel." To our knowledge, no clinical evaluation was performed. The investigators hypothesize that retrograde drilling will cause less local bone injury than antegrade drilling in creation of the tibial tunnel for ACL reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* arthroscopic reconstruction surgery of an Anterior Cruciate Ligament tear

Exclusion Criteria:

* previous reconstruction of ACL
* associated lesions (meniscal tear, other ligament...)
* Refusal consent
Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children: a Multi-country Evaluation

The WHO has recommended TB preventive therapy (TPT) for children living with HIV (CLHIV) and household contacts of people living with TB, however, the scale-up and implementation of TPT has been sub-optimal globally particularly in children. A safe and effective short-course TPT regimen, 3HP (rifapentine and isoniazid given once weekly for three months), is available but there is a lack of child-friendly formulations resulting in increased pill burden and there is a need to improve acceptability and adherence among children. The introduction of a dispersible rifapentine formulation has potential to improve uptake, treatment adherence and completion.

Overall goal is to generate critical knowledge to improve delivery of TPT and, more specifically, of dispersible 3HP, in children in routine programs.

This evaluation will create an important understanding of TPT uptake and completion among children and assess the impact of the introduction of a dispersible 3HP formulation. These results will provide actionable information for improving service delivery and the scale-up of TPT in the respective countries.


Eligibility Criteria:
Clinic record review

Inclusion Criteria:

* Medical records of children \<12 years who are either CLHIV or who are household contacts of people with pulmonary TB and who are initiated on TPT

Exclusion Criteria:

* Records will be excluded for children who are contacts of a drug-resistant, have presumptive TB disease or are currently on TB treatment

Qualitative study

Inclusion Criteria:

* Adult caregiver (\>18 years) of a child \<12 years of age who is eligible for TPT
* Healthcare worker from one of the clinics in which the study will be conducted who sees outpatient pediatric consultations including TB-exposed children
* Policy maker or program manager who manages or is involved in PMTCT, TB and/or pediatric programming

Exclusion Criteria:

* Any adult caregivers, healthcare workers, policy makers or program managers who are unable or unwilling to provide informed consent for both the interview and audio-recording.
Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants

OBJECTIVES: I. Compare the incidence of late onset sepsis and/or necrotizing enterocolitis and duration of hospitalization in low birth weight infants fed with fortified mother's milk supplemented with either fortified pasteurized donor human milk or preterm formula, and with fortified mother's milk versus preterm formula.

II. Determine the relationship between functional antibody titers in serial milk samples and the incidence of pathogen specific late onset sepsis (e.g., Staphylococcus epidermidis, Staphylococcus aureus) in these patients.

III. Determine the long term sequelae (growth, body composition, health, and neurodevelopment) of human milk versus formula feeding in these patients.

IV. Determine the relationship between stress and milk production in the mothers of these patients.

PROTOCOL OUTLINE: This is a randomized, double blind study in arms I and II. Patients are randomized to receive either fortified pasteurized donor human milk (arm I) or preterm formula (arm II) as a supplement to mother's milk, if needed. Patients are stratified according to gestational age (less than 26 weeks vs 27-29 weeks) and prior antenatal steroids (yes vs no). Patients are also assigned to groups receiving fortified mother's milk (arm III) and preterm formula only (arm IV).

Milk samples are obtained from the patient's mother for analyses of functional antibody against Staphylococcus epidermidis and Staphylococcus aureus; bacterial culture and sensitivity; bacterial colony count; and immunoglobulin and nutrient composition (i.e., energy, protein). Maternal blood samples to measure functional antibody are obtained every 2 weeks throughout hospitalization as long as infant is receiving own mother's milk. Cord blood is obtained at delivery.

Patients are studied at 40 week postmenstrual age, and then every 6 months for 3 years. Records of health (e.g., number of doctor, clinic, and emergency room visits; hospitalizations; and illnesses), dietary intake, and growth are collected. Urine is collected every 2 weeks to monitor infection. Neurodevelopment is assessed at 3 years using the McCarthy Scales of Infant Development.

Mothers who plan to nurse their infants after hospital discharge complete the STAI "trait" form at beginning of study. Mothers are assessed weekly for 6 weeks postpartum, and every other week thereafter as long as they are expressing milk by mechanical means only. Following a session of skin to skin contact, the number of milk expressions, the duration of each pumping, and a 24 hour milk collection is obtained. Mothers also complete the Spielberger State Trait Anxiety Inventory, STAI, Beck Depression Inventory, Norbeck Social Support questionnaire, Parental Stressor Scale, and the Neonatal Perception Inventory during each 24 hour milk collection.

Eligibility Criteria:
* Infants of less than 30 weeks gestational age
* Less than 96 hours after birth
* No HIV positive mothers who plan to nurse
* No major congenital malformations
Efficacy of Gamified Cognitive Control Training Using de:)Press on Depression Severity add-on to Treatment as Usual

Depression is one of the most frequent and devastating psychiatric diseases with a substantial bur-den for patients and society. It is specifically associated with dysfunctional activity in brain networks subserving cognitive control of emotional information processing. Normalization of this activity is a hallmark of various treatment approaches. Computerized training of cognitive control has shown antidepressant effects in experimental lab settings and small clinical pilot trials. However, motiva-tion, treatment adherence, and access for patients are major challenges that limit its broader use. To address these challenges, we developed a software application (de:)press®) that integrates gamification elements in a standard cognitive control task to support motivation, usage time, usabil-ity, and therefore symptom reduction. In a previous pilot trial, we were able to document that de:)press® is superior to a non-gamified standard cognitive control training in reducing depression symptomatology. Based on these data, we now designed a full-size confirmatory trial for the pur-pose of testing the hypothesis that de:)press® provides a positive healthcare effect by means of reduction in depression severity compared to treatment as usual (TAU). In this randomized, con-trolled, clinical trial 112 patients will be randomized to the intervention group (IG) with de:)press® additional to TAU, or the control group (CG) receiving only TAU. For a period of 6 weeks, the IG is provided with de:)press®. To prove a stable efficacy of de:)press®, the primary endpoint is the dif-ference in the Montgomery-Åsberg Depression Scale (MADRS) change 4 weeks after the end of training between IG and CG.


Eligibility Criteria:
Inclusion Criteria:

* Male, female, diverse,
* age \>= 18,
* informed consent,
* sufficient understanding of German (native speaker or CEFR level B skills or higher),
* unipolar depression diagnosed according to ICD-10 (F32.0, F32.1, F32.2 or F33. 0, F32.1, F32.2).
* consultation with a physician due to depressive symptomatology within the last 6 months

Exclusion Criteria:

* Inability to give consent,
* inability to use de:)press® on a tablet or smartphone,
* acute suicidality,
* schizophrenia (F20),
* brief psychotic disorder (F23),
* schizoaffective disorder (F25),
* mental disorders due to known physiological conditions (F00 - F09),
* major depressive disorder, single episode, severe with psychotic features (F32.3),
* major depressive disorder, recurrent, severe with psychotic features (F33.3),
* Intellectual disability (F70 - F79).
Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins

The aim of this study is to show the hypoallergenicity of a new thickened rice based formula (TRHF) through a double blind placebo controlled food challenge (DBPCFC), as recommended by the American Academy of Pediatrics, in subjects with IgE-mediated CMA and in subjects with non-IgE-mediated CMA.

The study is made of 2 different steps : 1st step is a double blind randomised food challenge where the new formula is compared to a placebo.

The second part of the trial consists in an open phase during which all infants will be fed with the study formula.

Eligibility Criteria:
Inclusion Criteria:

* with suspected CMA or with a CMA diagnosed by a DBPCFC performed in the last 2 months prior to inclusion
* free of clinical allergic symptoms for at least one week (i.e. successfully fed an elimination diet);
* whose parents signed the informed consent

Exclusion Criteria:

* mainly breast fed, drinking less than 250ml of formula/day, presenting any situation, which, according to the investigator, may interfere with the study participation or lead to a particular risk for the subject
Treatment of Severe Hypertension During Pre-Eclampsia: A Preliminary Equivalence Study Between Urapidil and Nicardipine

The aim of this study is to confirm that URAPIDIL is as efficient and as safe as NICARDIPINE to correct severe hypertension in pre-eclamptic patients.

* efficacy endpoint : mean arterial blood pressure corrected to 105-125 mmHg after 120 min of study drug administration.
* safety endpoints : clinical, biological and ultrasound observation for any side effect.All infants will be observed in the neonatology unit (during 48h).


Eligibility Criteria:
Inclusion criteria:

* patients 'written informed consent dated and signed by investigator and patient
* affiliation to a social security system
* single pregnancy
* arterial hypertension (PAS ≥140 and/or PAD≥90) in the context of severe pre-eclampsia

Exclusion criteria:

* patient under 18 year old or unable to give informed consent
* protocol rejected by patient-impossibility to use non invasive blood pressure monitoring
* antihypertensive treatments within 24h before inclusion
* allergy to or contraindication for one of the study drugs-pre
* eclampsia that does not require an antihypertensive treatment
* acute eclampsia-requirement for other drugs with potential dangerous interactions with study drugs
* participation to a therapeutic protocol within 6 months prior to the start of study
Improving Consent and Survey Procedures for Young MSM in Web-based HIV Prevention

A two-part study to test the efficacy of alternative consent procedures and the efficacy of alternative methods to improve survey completion.

Men who have sex with men are the risk population most heavily impacted by HIV in the United States by any measure; in 2009, at least 61% of new HIV infections were estimated to have occurred in MSM. MSM are experiencing an increase in HIV transmission that has been occurring since at least 1990, and accelerated in multiple North American and European countries from 2000-2005. The expansion of the HIV epidemic has been proposed to be attributable, in part, to the extent to which the internet has facilitated sexual connectivity among MSM.

Researchers have attempted to reach MSM for HIV prevention research and intervention on the internet. In the past 10 years, there has been a proliferation of internet surveys and HIV research studies among men who have sex with men that utilize the internet for data collection and, in some cases, the delivery of HIV prevention content. The development of internet-based interventions has been recently identified as especially promising because of its potential for scalability. However, there are also important limitations to internet-based data collections and prevention studies. The most important of these relate to representativeness and opportunities to introduce bias to data collections and differences in access to and use of internet among different subgroups of MSM. Equally important, although less discussed, are the unique ethical and human research protections challenges posed by online sexual health prevention studies.

The investigators will conduct a series of experiments that will result in improved knowledge of how to conduct internet-based HIV prevention research with MSM in ways that improve the protection of human subjects and decrease biases in data collections. The design will consist of preparatory online qualitative research with up to 100 MSM, followed by two cross-sectional randomized controlled trials of MSM recruited online; a total of 2440 MSM will be enrolled in the two randomized quantitative studies (1,440 in Study 1 to determine optimal methods to provide informed consent, online, and 1000 in Study 2 to determine how to best improve retention in online surveys). About 2440 men will be enrolled in the study in total. This summary describes Study 1; a separate submission will be completed for Study 2.

Eligibility Criteria:
Inclusion Criteria:

* ages 18-34
* have had sex with another man in the past 12 months

Exclusion Criteria:

* female, transgender
* younger than 18 years old
* older than 34 years old
* have not had sex with a man in the past 12 months
Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)

The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.


Eligibility Criteria:
Inclusion Criteria:

A patient can be considered for eligibility to participate if he/she:

* Has been consistently treated for chronic, noncancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to screening
* Is diagnosed with OBD
* Is capable of utilizing an electronic diary to report daily spontaneous bowel movements (SBMs)
* Is willing to continue opioid therapy and discontinue the use of laxatives, stool softeners, and other concomitant medications affecting gastrointestinal motility throughout the study

Exclusion Criteria:

A patient cannot be considered for eligibility to participate if he/she:

* Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical bowel obstructions, bowel disorders, and constipation not arising from opioid use, but instead attributable to dietary, neurologic, congenital, or endocrine disorders, scleroderma, and/or for the management of drug addiction
Effects of Latanoprost on Choroidal Blood Flow Regulation in Human Subjects

Latanoprost is a synthetic prodrug of 17-phenyl-substituted prostaglandin F2α analog. Used at a dose of one drop per day, it has been reported to produce a 30 to 35% reduction in intraocular pressure. Its mechanism of activation involves augmentation of the eye's natural uveoscleral outflow capacity .

There is evidence that ocular blood flow plays a role in the clinical course of glaucoma. Glaucoma medication that lowers IOP simultaneously increases ocular blood perfusion pressure, which in turn may increase ocular blood flow.

This could well contribute to the partially contradicting results concerning ocular hemodynamic effects of latanoprost. In vitro studies indicate that latanoprost has no effect on ocular vascular tone in therapeutical doses. By contrast, it has been reported in several studies that latanoprost 0.005% increases pulsatile ocular blood flow in patients with primary open angle glaucoma and normal tension glaucoma. This increase in pulsatile ocular blood flow mainly reflects an increase in the choroidal circulation.

Little is known about the potential effect of latanoprost on choroidal blood flow regulation in humans. The present study therefore tries to elucidate whether treatment with latanoprost may alter choroidal blood flow regulation during artificial changes in ocular perfusion pressure. In addition, the present study aims to clarify whether the change in choroidal blood flow after latanoprost administration are due to direct vasoactive effects or due to the increase in ocular perfusion pressure. The second alternative may have important implications on our understanding of glaucoma treatment, because reduction of IOP may then per se result in normalization of ocular blood flow regulation.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 19 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile (Must et al. 1991)
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 3 dpt.

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
* Ametropia \>= 3 dpt
* Iris bicolor
The Application of Fibrin Glue in Ocular Surface Diseases

This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries, which includes pterygium surgery, corneal melting/perforation, Gunderson's flap, conjunctival laceration, and muscle/clinical/filtering surgery.

This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries. The inclusion criteria are:

1. ocular surface disease which may need amniotic membrane transplantation (corneal pro epithelization, pterygium surgery, etc)
2. infectious or noninfectious corneal ulcer with perforation less than 3 mm
3. conjunctival transplantation/suture
4. corneal surgeries which can be treated by conventional suture technique or application with cyanoacrylic acid tissue glues.

Informed consents will be obtained from the patients before applications. After surgeries, topical steroids and antibiotics will be used, and therapeutic contact lens will be used. The patients will be followed up for at least three months.

Eligibility Criteria:
Inclusion Criteria:

* Ocular surface diseases, which are expected to be treated by tissue fibrin glues

Exclusion Criteria:

* Pregnancy
* Children younger than 3 years old
A Retrospective Study With Prospective Follow-Up of Laparoscopic Ventral Hernia Repair Utilizing the Bard Sepramesh IP Composite

This study will enroll subjects who underwent a laparoscopic ventral hernia repair utilizing Sepramesh at least 12 months before starting in this study.

The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.


Eligibility Criteria:
Inclusion Criteria:

* Have undergone a laparoscopic ventral repair utilizing Sepramesh at least 12 months before starting in this study.
* Have signed an Informed Consent Form (ICF).

Exclusion Criteria:

* Underwent implantation of Sepramesh for any reason other than ventral hernia repair.