cyrilzakka/clinical-trials huggingface dataset:
Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy

The purpose of this phase 3 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections for treating post-operative pain following bunionectomy.


Eligibility Criteria:
Inclusion Criteria:

* Men and women must be at least 18 years of age. Female subjects must meet additional criteria in relation to childbearing potential.
* Subjects must be undergoing a planned first metatarsal bunionectomy with osteotomy and internal fixation (Austin bunionectomy) without collateral procedures.
* Subjects must have the ability to provide written informed consent.
* Subjects must have the ability to understand study procedures and communicate clearly with the Investigator and staff.

Key Exclusion Criteria:

* Subjects undergoing emergency or unplanned surgery.
* Subjects who had any previous bunionectomy procedure on either foot.
* Subjects with pre-existing conditions (other than bunion) causing preoperative pain at the site of surgery.
* Female subjects who are pregnant or breastfeeding.
* Diagnosis of chronic pain and ongoing or frequent use of pain medications.
A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements (CDEs) Into the Electronic Health Record (EHR) in Large Primary Care Settings ("CDE-EHR-PC" Study), Phase 3

This is a 4-phase study to implement the NIDA CDEs in primary care settings. Collecting and utilizing the CDEs in clinical practice requires a strategy for implementing screening to collect substance use information that populates the CDEs, and assisting primary care medical staff to offer appropriate interventions by providing clinical decision support (CDS) and a mechanism for making referrals to addiction treatment. Investigators aim to maximize the efficient adoption of screening, CDS, and treatment referrals by integrating all of these activities into the electronic health record (EHR).

The study will be conducted at three sites, representing three large health systems. Each phase will include deliverables essential to move to the next phase, and an independent Advisory Committee will review progress and make recommendations at each transition about how best to progress to each subsequent phase. Based on progress during earlier phases, the Advisory Committee may recommend expansion to additional clinics or health systems during the second part of Phase 4.

SPECIFIC AIMS

1. To program the NIDA CTN CDEs, the NIDA/ASAM electronic Clinical Quality Measure (eCQM), and a lean decision support module into Epic.
2. To study the process of implementation of screening and referral using Epic-driven CDEs and CDS in three primary care clinics / practices, including defining potential barriers and facilitators to their adoption.
3. To evaluate the impact of implementation on:

   * Patient level outcomes (diagnosis, treatment referral);
   * Medical staff level outcomes (screening and assessment, clinical interventions including counseling and treatment referral); and
   * Systems level outcomes (logistics and costs of introducing the CDEs, feasibility).

Eligibility Criteria:
Inclusion Criteria:

* English speaking adult individuals age 18 years or older, and current employee or patient at a Wave 1 clinic with direct patient contact.

Exclusion Criteria:

* Inability to provide informed consent.
Improving Nutrition in Children Under Two Through Increased Egg Consumption in Burkina Faso

This project targets vulnerable populations of smallholders, women and children and should lead to increased poultry production, increased egg consumption of children, improved nutrition, and increased household level resilience. This innovative intervention will be the gifting of chickens by religious leaders to children ages 6 to 12 months coupled with integrated nutrition and agricultural trainings.

This study involves innovative behavioral change theoretical methodology to empower caregivers as smallholder poultry producers by improving their access to livestock production resources and agricultural extension services, providing tools for improved decision making, and enhancing nutrition based knowledge. Smallholder production is important in eliminating food insecurities and building resilience to improve nutrition in children under 5. Based on the results of the Ethiopian egg project, through messaging and education, this study will foster favorable attitudes and consequent behavioral changes, including increased egg consumption.

Eligibility Criteria:
The study population will be selected with the assistance of the OCADES Caritas Kaya and the CHWs who are actively involved and trusted within the targeted village communities.

Inclusion Criteria:

* Living within the identified areas of the study population

Exclusion Criteria:

* history of egg allergies
* severe malnutrition
Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma

This research study is a Phase II clinical trial to test the efficacy of Olaparib in adult participants with recurrent/metastatic Ewing's Sarcoma following failure of prior chemotherapy.

Primary Objectives Evaluate the objective response rate of olaparib in adult patients with recurrent and/or metastatic Ewing's sarcoma following failure of conventional chemotherapy.

Secondary Objectives To evaluate the progression-free survival, overall survival, and safety of olaparib in this patient population (ie Number of Participants With Adverse Events). As an exploratory objective, the investigators will evaluate (in subjects who agree to an optional biopsy) differences in pre- and post-treatment tumor DNA alterations and differences in levels of protein and RNA expression related to PARP inhibition.

Study Design Potential subjects who discuss and sign the informed consent form will undergo screening studies. Eligible patients will administer olaparib and obtain restaging imaging studies after 6 and 12 weeks on study, and then every 8 weeks thereafter. Participants will remain on study drug until disease progression, onset of unacceptable toxicities, or subject withdraws consent.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Ewing's sarcoma
* Normal organ and bone marrow function
* Life expectancy of at least 16 weeks
* Not pregnant or breastfeeding
* Willing and able to comply with the protocol for the duration of the study
* Presence of measurable disease

Exclusion Criteria:

* Involvement in the planning and/or conduct of ths study
* Previous enrollment in the present study
* Participation in another clinical study with an investigational product during the 21 days prior to first dose of study drug
* Previous exposure to any PARP inhibitor
* Receiving systemic chemotherapy or radiotherapy within 2 weeks of beginning study treatment
* Receiving prohibited classes of inhibitors of CYP3A4
* Persistent clinically significant toxicities caused by previous cancer therapy
* Known myelodysplastic syndrome or acute myeloid leukemia
* Symptomatic, uncontrolled brain metastases
* Major surgery within 14 days of starting study treatment
* Considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disorder or active, uncontrolled infection
* Unable to swallow orally administered medication or with gastrointestinal disorders likely to interfere with absorption of the study medication
* Known to be serologically positive for HIV and receiving antiretroviral therapy
* Known active Hepatitis B or C
* Known hypersensitivity to olaparib or any of the excipients of the product
* Uncontrolled seizures
Methylphenidate for Attention Problems After Pediatric TBI

Traumatic Brain Injury (TBI) - methylphenidate treatment

The objectives of the study are to (1) determine the efficacy and dose-response of methylphenidate treatment of attention problems after pediatric traumatic brain injury (TBI) and (2) provide a better understanding of the relationship of a prior history of attention deficit hyperactivity disorder (ADHD), ADHD subtypes after TBI, executive function, and attentional control to treatment efficacy. The proposed clinical trial will enroll 50 children, age 6-17 years, with attention problems \>6 months after moderate to severe TBI into a randomized, double-blind, placebo-controlled, cross-over design trial with 3 dose conditions (low, medium, and high).

Eligibility Criteria:
Inclusion Criteria:

* Between ages of 6-17
* Sustained Moderate to Severe TBI
* TBI occurred at least 6 months prior to beginning the study
* TBI occurred no earlier than 5 years of age
* Positive endorsement of 6 out of 9 items on the Vanderbilt ADHD inattention or hyperactivity scale

Exclusion Criteria:

* History of developmental disability or mental retardation
* Current active participation in ADHD-related behavioral intervention
* History of psychiatric condition requiring an inpatient admission in past 12 months
* Actively taking medications with a contraindication to Concerta that cannot be discontinued
* Current use of stimulant medication or ADHD specific medications that cannot be discontinued
* Non-blunt head injury
* Family history of arrhythmia
* Pregnancy
A Pilot Study of CyberKnife Radiosurgery Delivered to the Partial Breast

This pilot study will evaluate the technical feasibility and acute toxicity of Partial Breast Irradiation (PBI) with the CyberKnife in anticipation of a larger multi-institutional Phase II study. It will evaluate quality of life (QOL) issues as they relate to treatment related side effects, cosmetic result, and patient convenience.

Radiosurgery is defined as the stereotactic delivery of ionizing radiation in 5 stages or less to a designated target with sub-millimeter accuracy. Radiosurgery in the context of this protocol will be given to the region of the tumor bed within 7 weeks of lumpectomy and sentinel/axillary node sampling over a period of five to ten days using the CyberKnife (CK). Subjects will receive CK before chemotherapy, if applicable.


Eligibility Criteria:
Inclusion Criteria:

* DCIS or infiltrating ductal carcinoma of the breast \<= 3cm
* margins clear by at least 2 mm
* age \>=45 years

Exclusion Criteria:

* invasive lobular carcinoma
* multicentric disease
* nodal metastases
* breast implants
* pregnancy
* connective tissue disease
Protection From Acute Kidney Injury (AKI) With Basis™ Treatment

This study is a single-center, prospective, randomized, double-blinded, placebo-controlled phase II clinical trial to evaluate the efficacy of "NAD+ supplementation" with Basis™ (Nicotinamide Riboside and Pterostilbene) in preventing acute kidney injury (AKI) in patients undergoing complex aortic aneurysm repair and open aortic arch reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* A patient may be included in the study if the following conditions are present:

  1. Male or female;
  2. Age \> 18 years old;
  3. Patients who match the criteria for indication of elective open aortic arch replacement or repair:

     1. Total arch;
     2. Non-total arch;
  4. Patients who match the criteria for indication of elective complex aortic aneurysm repair has to respect the following conditions:

     a. Patients undergoing complex aortic aneurysm open reconstruction with a suprarenal clamp; i. thoracoabdominal aortic aneurysms Crawford extent I to IV ; ii. abdominal aortic aneurysms of juxtarenal, pararenal, or paravisceral type; b. For endovascular approach: i. patients with pararenal or thoracoabdominal aortic aneurysms Crawford extent I to IV and known stage III or IV of chronic kidney disease (CKD); ii. patients with pararenal or thoracoabdominal aortic aneurysms Crawford extent I to IV and solitary or single functioning kidney and known stage III or IV CKD;
  5. Patients will be allowed to participate in concomitant endovascular aortic stent-graft trials and prospective cohort studies as long as these do not involve another investigational study drug.

Exclusion Criteria:

* Patients must be excluded from the study if any of the following conditions are true:

5.2.1 General Exclusion Criteria

1. Unwilling to comply with the follow-up schedule;
2. Inability or refusal to give informed consent by the patient or a legally authorized representative;
3. Pregnant or breastfeeding;
4. Subject who takes multivitamins containing vitamin B3 derivatives in a dose \> 200 mg/day; 5.2.2 Clinical / Laboratory Exclusion Criteria
5. Renal failure defined as eGFR\< 15 mL/min/1.73m2
6. Patients in permanent Renal Replacement Therapy;
7. Patients with chronic liver disease: Child-Pugh score class B and C; 5.2.3 Medication Exclusion Criteria
8. Patients in chemotherapy scheme;
9. Patients taking any immunosuppressant, except for corticosteroids;
10. Patients taking any of these well-known P-glycoprotein substrates: digoxin, fexofenadine, indinavir, sirolimus.
A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%

The purpose of this study was to describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Sign Informed Consent document.
* Diagnosis of open-angle glaucoma or ocular hypertension
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
* Severe central vision loss in either eye.
* Any chronic or recurrent inflammatory eye disease.
* Ocular trauma within the preceding 6 months.
* Ocular infection or ocular inflammation within the preceding 3 months.
* Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
* Any intraocular surgery within the preceding 6 months.
* Any ocular laser surgery within the preceding 3 months.
* History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitable for the study.
* Other protocol-defined exclusion criteria may apply.
Interest of a 30 Minutes' Intermittent Work Exercise Test in Patients With Chronic Obstructive Pulmonary Disease: Cardiac and Pulmonary Functions

The aim of the study is to observe the ventilatory and cardiac function (included the pulmonary arterial pressure) during an intermittent work exercise test with high density work load.


Eligibility Criteria:
Inclusion Criteria:

* COPD patients (male and female) with moderate obstruction (FEV1/CV\<60%)

Exclusion Criteria:

* acute respiratory disease
* any type of cardiac disease
Pilot Study of Perindopril in Childhood Cancer Survivors

The purpose of this study is to evaluate the feasibility of conducting a medical intervention trial in childhood cancer survivors with early echocardiographic evidence of cardiac remodeling.

Anthracycline cardiotoxicity is characterized by ventricular remodeling and progressive cardiac dysfunction. Since ventricular remodeling in other types of heart failure can be treated effectively with an angiotensin-converting enzyme inhibitor (ACEi), these agents would appear a logical therapy in children with anthracycline-induced heart failure. Previous experience with ACEi in childhood cancer survivors has shown mixed results, possibly due to the fact that treatment is initiated too late in the natural history of the disease. Providing treatment in childhood cancer survivors with early signs of cardiac remodeling may be more effective than treating children who have global dysfunction. The benefits of early intervention are unclear, so it is unclear whether CCS and their parents will be willing to receive treatment where the target outcome (prevention of decreased global function or congestive heart failure) may not occur for years after the intervention. Assessing the feasibility of this pre-emptive approach is the primary aim of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in the Survivor Cohort of the PCS2 study at The Hospital for Sick Children at the time of enrollment.
2. Aged \< 20 years at enrollment.
3. Weight ≥ 25kg at enrollment
4. LVPW Z-score ≤-2.0 at any of the 0, 12 or 24 month PCS2 echocardiography assessments, on two consecutive echocardiograms at least 3 but no more than 15 months apart.
5. EF greater than 50% at enrollment
6. Serum potassium (to be ˃5.0mMol/l) at Initiation

Exclusion Criteria:

1. Known associated cardiac conditions for which angiotensin converting enzyme therapy is contraindicated (such as aortic stenosis, severe coarctation of the aorta, or hypertrophic cardiomyopathy with LV outflow tract obstruction)
2. Active malignancy detected within last 2 years (i.e. must be at least 2 years in remission)
3. Prior radiation therapy to a field that involved the heart
4. Prior symptomatic heart failure, or prior reduction in EF below 50% detected on surveillance echocardiography.
5. Use of any cardioactive medications including diuretics within the last 6 months
6. Concurrent serious or life threatening disease or extracardiac organ compromise which would limit participation in the trial or potentially have secondary effects on cardiac function, as determined by the treating physician.
7. Renal dysfunction precluding ACEi therapy, defined as serum creatinine greater than the 95th percentile for age or eGFR by the modified Schwartz formula of less than the 5th percentile prior to recruitment to the interventional trial (within 30 days of recruitment date)
8. Hypertension requiring treatment.
9. History of angioedema or ACEi hypersensitivity
10. Patients with hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the Lapp lactase deficiency.
11. Upper airway obstructive lesions
12. Pregnancy
13. Breast-feeding
Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome

The twin pregnancies monochorionic are specifically explained to two main types of complications: the anomalies of the embryo affecting a symmetry and in particular the median line on one hand and malformative sequences of vascular origin on the other hand. This last category of anomalies (twin-to-twin syndrome, TTTS) develops because of the presence of a division of the foeto-placentary circulation between both twins through the pooling of certain placentary cotyledons. The latter are then vascularized by an arterial and venous foot belonging to both foetuses (anastomoses arteria-venous or veinous-arterial). It results from it an imbalance moderate but very early hemodynamic which is going to return a hypovolume twin (the donor) and its plethoric co-twin (the recipient).

These anomalies in utero could not only have consequences during the fetal life, on the born weight and the later development of newborns, but also on the organization and the functioning of a whole series of physiological systems. So these anomalies of the pregnancy could have also consequences which exceed by very far from the perinatal period, by favoring the development of the atheroma, the high blood pressure, the resistance in the insulin, and many other metabolic and endocrine functions were known for their importance in human pathology.

For these reasons the investigators suggest estimating the tensional, cardiac and metabolic status of children ex-transfusers and of children ex-transfused in 2 different age classes: between 4 and 8 years then when these children will have between 12 and 16 years.

There are also some evaluation clinical and biological of the puberty (only at the age of 12-16)

To understand a possible effect of the prenatal status of these children on the endocrinology of the puberty, the measures and the following dosages will be realized:

* Test in the GnRH (T0, T30, T60, T90): dosages of LH and FSH (relationship of peaks to determine the puberty evolution),
* Dosages of the sexual steroids, the oestradiol for the girl and the testosterone for the boy,
* Clinical examination looking for the signs of puberty

This if study leans on the big originality of the physiopathological model of TTTS in which the children present the peculiarity to have an identical genetic and postnatal status and a different prenatal environment.

The follow-up of these children should allow:

* To understand better the postnatal impact anomalies on these children in the course of pregnancy
* To anticipate and thus to improve their care in case of appearance of biological or clinical signs


Eligibility Criteria:
Inclusion Criteria:

* Child (ren) from (s) of a twin pregnancy with fetal transfusion syndrome fetal
* Child (ren) age (s) 4 years 0 months to 6 years 12 months
* Child (ren) fasting
* Consent signed by the parents or legal representative

Exclusion Criteria:

* Child (ren) not derived (s) of a twin pregnancy with fetal transfusion syndrome fetal
* Child (ren) age (s) under 4 years 0 months or more than 6 years 12 months
* Child (ren) nonfasting
Reduction of COVID 19 Transmission to Health Care Professionals

When the COVID-19 virus infects a person, it enters the lung epithelial cells of its host and uses its genetic material to replicate.

The pulmonary epithelial cells of a part of the population, known as "secretors", are capable of expressing the antigens of the "ABO" system on their surface. This secretory status can be established by determining the antigens of the Lewis blood group system. When the virus replicates in an "secreting" individual, the antigens of the "ABO" system of the infected individual will be present on the surface of the viruses formed in his/her lungs.

It was shown in 2003 that the response of a given individual to the transmission of a virus depends on his/her blood group and on the antigens of the "ABO" system carried by the virus. A patient of group "O" would thus defend himself much better against a virus carrying antigens of blood group "A", the natural antibodies "anti-A" of the patient reducing the ability of the virus to bind to its specific receptor on pulmonary epithelial cells, to penetrate them to replicate itself. The first data collected in Wuhan (China) seems to confirm this hypothesis. A COVID-19 virus transmission model can therefore be established on the basis of blood groups.

In order to reduce the spread of the virus among nursing staff, it is possible to establish a preferential algorithm for patient management based on the "ABO" and "Lewis" blood groups of patients and "ABO" of nursing staff in health care units, if operational and human conditions allow.


Eligibility Criteria:
Inclusion Criteria:

* COVID19 positive patients admitted within the CHU Brugmann Hospital

Exclusion Criteria:

* None