cyrilzakka/clinical-trials huggingface dataset:
Stem Cell Injection for Peripheral Vascular Disease

Severe peripheral vascular disease of the legs causes narrowing of the blood vessels in the legs, which keeps the blood from flowing adequately through these vessels. This study is designed to examine whether treating patients with their own previously collected blood stem cells will improve blood flow in the most severely affected leg. Blood stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream.


Eligibility Criteria:
Inclusion Criteria:

* Atherosclerotic ischemic peripheral vascular disease with rest pain defined as pain that occurs at night or at rest that involves the foot and is a sign of end stage vascular disease and / or ischemic lower extremity ulcers due to infra-inguinal disease and/or peak walking time of 1 to 6 minutes on two exercise tests separated by 2 weeks on graded treadmill.
* Either a or b

  1. Ankle brachial index (ABI) \< 1.0.
  2. Doppler waveforms at posterior tibial artery and dorsalis pedis artery are monophasic with toe pressure \< 30 mmHg.
* A non-surgical candidate for revascularization e.g. prior vascular reconstruction, inability to locate a suitable vein for grafting, diffuse multi- segment disease, or extensive infra-popliteal disease not amenable to a vascular graft.
* Age \> 18 years old.

Exclusion Criteria:

* Popliteal vascular entrapment syndrome
* Lower Extremity infection or infected ulcer
* Hypercoagulable state
* HIV positive
* HBsAg positive
* Uncontrolled arrhythmia, that is, persistence of an arrhythmia despite medical therapy
* Unstable angina
* Thrombocytopenia \< 100,000/ul
* Anemia that cannot be transfused to a hemoglobin greater than 10 g/dl
* Leukemia or myelodysplasia
* Allergy to E coli or its products
* Patients with metal in their bodies cannot undergo MRIs (MRA). Therefore, patients with, cochlear implants, or aneurysm clips are not eligible. Coronary artery stents are not a contraindication. Patients with pacemakers are still candidates provided they have normal creatinine (\< 1.1 mg/dl) and can receive contrast dye (no allergy) for angiogram instead of MRA.
* Patients who are pregnant
* Poorly controlled diabetes (HbA1c \> 6.5)
* Current malignancy, except squamous cell or basal cell skin cancers thought to be easily controlled.
* AST, ALT, or bilirubin more than twice the upper limit of normal.
* WBC \< 2.5 / ul.
* Any patient who is actively bleeding, including blood on urine dipstick or fecal occult blood.
* No patient may be re-treated until at least 5 patients have completed 6 months of follow-up with no notable safety findings and evidence of therapeutic efficacy (improved ABI or healing ulcer) occurred at stem cell doses higher than the patient received in this dose escalation study or response occurred in the treated leg and the untreated leg meets eligibility criteria. Re-treated patients must meet eligibility criteria.
* Patients who smoke unless stop smoking at least two weeks before enrollment and agree not to smoke thereafter.
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

The study comprises of a 12 week double-blind, vehicle-controlled (DBVC) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period During the double blind period, all PN-affected areas identified at baseline will be treated, and during the open label period, only active PN-affected areas will be treated.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PN ≥ 3 months before screening.
* ≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) at screening and baseline having a treatment area \<20% BSA.
* IGA-CPG-S score of ≥ 2 at screening and baseline.
* Baseline PN-related WI-NRS score ≥ 7.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Chronic pruritus due to a condition other than PN
* Total estimated BSA treatment area (excluding the scalp) \> 20%.
* Neuropathic and psychogenic pruritus
* Active atopic dermatitis lesions within 3 months of screening and baseline.
* Uncontrolled thyroid function
* Concurrent skin or other serious or unstable medical conditions which may interfere with the evaluation of PN such as immunocompromised status, acute/chronic infections, active malignancy, history of TB, history of DVT/VTE, etc Protocol defined abnormal laboratory results.
* Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching.
* Psoralen and ultraviolet A or ultraviolet B therapy within 4 weeks before baseline or Ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (within 2 weeks before baseline
* Pregnant or lactating, or considering pregnancy.
* History of alcoholism or drug addiction within 1 year
* Known allergy or reaction to any of the components of the study drug.
* Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.
* Employees of the sponsor or investigator or otherwise dependents of them.
* The following participants are excluded in France:

  1. Vulnerable populations according to article L.1121-6 of the French Public Health Code.
  2. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
  3. Individuals not affiliated with the social security system.
Nifty Feeding Cup Versus Generic Medicine Cup Preterm Infants Who Have Difficulty Breastfeeding

The investigators will establish an evidence base for the Nifty Feeding Cup by evaluating its effectiveness and caregiver satisfaction. The investigators will conduct a randomized crossover trial that compares the Nifty Feeding Cup to a standardized, generic medicine cup used to feed preterm infants with breastfeeding difficulties at Komfo Anokye Teaching Hospital (KATH) in Kumasi, Ghana.

The investigators aim to compare the Nifty Feeding Cup to a standardized, generic cup in up to 200 preterm infants. The aim and hypotheses were selected based on the most informative outcomes given the scope of the funding. The investigators will test the hypotheses that Nifty Feeding Cup feeding compared to generic cup feeding will result in:

1. Less spillage
2. Greater caregiver satisfaction
3. Shorter duration of feeds

Eligibility Criteria:
Inclusion Criteria:

Infant

* Born preterm (\<37 weeks gestational age) at time of birth
* Corrected gestational age is \<37 weeks per the modified Dubowitz score on date of enrollment
* Diagnosed with feeding difficulties
* Patient in the mother-baby unit at KATH
* Clinically indicated to start cup feeding (including an infant who has a nasogastric tube and is cup feeding or indicated to start cup feeding)
* Has an anticipated hospital stay that is at least 48 hours

Caregiver:

* At least 18 years of age
* One of the following biologic family members of the infant (Mother, Grandmother, Aunt)
* Self-identifies as the primary feeder of the infant
* Prior experience feeding the potential infant participant with nipple feeding (e.g. breast feeding, bottle feeding) or nasogastric \[NG\] tube
* Verifies willingness to comply with all study procedures

Exclusion Criteria:

Infant

* Congenital anomaly except for minor anomalies (e.g. an extra digit or ear tag is okay)
* Other condition or situation that makes infant unlikely to be able to comply with study procedures. Examples include the infant anticipated to not be in hospital long enough, infant has a suspected intestinal obstruction, or necrotizing enterocolitis.
* No mother, grandmother, or aunt caregiver available to participate in study
* Enrolled in another study at KATH that would interfere with his/her ability to participate in this study.
Longitudinal Registry Including Patients Treated with Heavy Particles

The purpose of this registry is to collect retrospective and prospective standardized data of patients treated with particle therapy, either with protons or carbon ions, at the National Center for Oncological Hadrontherapy (CNAO) based in Pavia.

By keeping track of the patients treated, it will allow the investigators to periodically analyze and evaluate data collected of daily clinical activity. This will help gathering more information on the results of particle therapy and will provide the basis for in depth evaluation of patients' outcome with respect to the delivered treatment.

Hadrontherapy is a unique radiotherapy (RT) that uses positively charged particles, namely protons and carbons, rather than photons used in conventional RT, to treat cancer.

Particle therapy represents a coming together of physics research applied to oncology and it is currently the most advanced form of radiotherapy for the treatment of tumors that are particularly radio resistant or located nearby sensitive structures.The strength of hadrontherapy lies in the unique physical and radiobiological properties of these particles. Indeed, protons and carbon ions have several biological advantages compared to conventional photon radiotherapy.

In this scenario we aim at constructing a patient registry to retrospectively and prospectively collect real-world data on all cancer patients treated at CNAO, either with protons or carbon ion radiation, independently of their disease (multiple cohorts will be included) for which they were treated.

We aim at collecting data on the natural history of the disease (how the disease presents, develops and progress, its association with other conditions). Those data will allow us to assess prognostic and predictive factors to evaluate treatment effects and toxicities and to provide evidence of the role of radiation oncology in a multidisciplinary approach.

Such registry will be used to generate clinical evidence and high-quality data that could better define the indications for heavy particles therapy and become a resource for the wider scientific community.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with heavy particles at Fondazione CNAO, Pavia
* Patients who have the ability to understand and be willing to sign a written informed consent document

Exclusion Criteria:

* Patients or legal guardians who are unable to understand informed consent document
A Long-term Follow Up Study of EXG102-031 in Patients with WAMD (Everest LTFU)

In neovascular (wet) age-related macular degeneration (nAMD), the macula, or the part of the eye that provides the clear, detailed central vision, is being affected by abnormal blood vessel growth and leakage. This leakage affects the vision over time and can lead to severe blurriness or blinding. EXG102-031 was made to block the extra vessel formation which would lead to less leakage affecting the vision. Before EXG102-031 can be tested for its efficacy (if it makes vision better), it must be tested to see if it is safely tolerated to confirm it can continue to be studied in more patients with nAMD. This study is designed to fulfill the long-term safety monitoring of EXG102-031. Participants that enroll in this long-term follow-up study have been treated with EXG102-031 under the main study (EXG102-031-211).

Age-related macular degeneration (AMD) is a major cause of blindness and visual impairment in older adults. The wet form of AMD, also called neovascular AMD (nAMD) usually causes faster vision loss than the dry form. The most common current treatments of nAMD are products that inhibit vascular endothelial growth factor (VEGF) (including ranibizumab (LUCENTIS®, Genentech) and aflibercept (EYLEA®, Regeneron) and are delivered by intravitreal injections at 4 to 16 week intervals and continued indefinitely. The Phase I, open-label, multiple-cohort, dose-escalation study designed to evaluate the safety and tolerability of EXG102-031 gene therapy in subjects with previously treated nAMD (EXG102-031-211). In the main study safety was assessed over 52 weeks after the administration of EXG102-031. This long-term follow-up study will assess safety for an additional 36 months for all participants enrolled in the main study. Participants will return to the clinic regularly for ocular assessments including assessment of whether supplemental therapy with aflibercept is needed.

Eligibility Criteria:
Inclusion Criteria:

* Must have been previously enrolled in the parent study (EXG102-031-211) and must have received subretinal EXG102-031 in the parent study;
* Are willing and able to sign the study written informed consent form;
* Must be willing and able to comply with all study procedures.

There are no exclusion Criteria in this study.
Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy

There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.

Primary objective The primary objective of this study is to identify the appropriate dose and duration of propranolol treatment and demonstrate its superiority over placebo based on the complete/nearly complete resolution of target IH at W24.

Eligibility Criteria:
Inclusion Criteria:

* Proliferating IH (target hemangioma) requiring systemic therapy anywhere on the body except on the diaper area with largest diameter of at least 1.5 cm

Exclusion Criteria:

- The patient presents with one or more of the following medical conditions: Congenital hemangioma; Kasabach-Merritt syndrome; bronchial asthma; bronchospasm; hypoglycaemia (\< 40 mg/dl or at risk); untreated phaeochromocytoma; hypotension (\< 50/30 mmHg); second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia (\< 80 bpm); severe peripheral arterial circulatory disturbances; Raynaud's phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal's angina; documented PHACES syndrome with central nervous system involvement

* The patient has previously been treated for IH, including any surgical and/or medical procedures (e.g. laser therapy)
* The patient is known to have a hypersensitivity to propranolol and/or any other beta-blockers
* One or more of the following types of IH are present:

  * Life-threatening IH
  * Function-threatening IH (e.g. those causing impairment of vision, respiratory compromise caused by airway lesions, etc.)
  * Ulcerated IH (whatever the localisation) with pain and lack of response to simple wound care measures
* The patient was born prematurely and has not yet reached his/her term equivalent age (e.g. an infant born 2 months prematurely cannot be included before the age of 2 months)
* LVEF (left ventricular systolic function) ≤40% and/or cardiomyopathy and/or hereditary arrhythmia disorder
Primary Vitrectomy With Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment

Comparing primary PPV with 360° endolaser photocoagulation with primary PPV with an encircling band for patients with RRDs.

published

Eligibility Criteria:
Inclusion Criteria:

* Primary rhegmatogenous retinal detachment with or without macula-off detachment phakic or pseudophakic eyes
* Multiple breaks, inferior and posterior located breaks or unclear hole formation
* Proliferative vitreoretinopathy (PVR) stage A and B

Exclusion Criteria:

* Previous retinal detachment surgery
* Giant tears
* PVR stage C
* Age less than 18 years
The Collaborative Care PrTNER Study

A randomized controlled trial to assess the ability of a Collaborative Care Prevention, Treatment, Navigation, Engagement, Resource (PrTNER) intervention to increase initiation of preexposure prophylaxis (PrEP) (for those at-risk for HIV) and decrease viral load (for those living with HIV) among young Black and Latino men who have sex with men (YBLMSM) aged 15 to 24 through engagement in SU treatment.

The Collaborative Care (CC) PrTNER is a multi-component intervention developed by members of the research team specifically for YBLMSM aged 15 to 24 who are at-risk for or living with HIV. This model moves beyond the individual to consider the broader context in which, substance use (SU), and HIV risk are (re)produced.

Enhanced models that integrate SU treatment into HIV and PrEP primary care services (using a collaborative care approach that incorporates feedback from a psychiatrist and support from a peer coach) are needed to address the nuance of substance use in this population. We, therefore, are proposing to conduct a randomized trial to evaluate an integrated collaborative care model (CC PrTNER).

Eligibility Criteria:
Inclusion Criteria:

Aim 1:

* 15-24 years old;
* Cisgender male;
* Self-identified Black/African American race or Latino/Hispanic ethnicity;
* Report prior oral/anal sex with another male;
* At-risk for HIV (condomless anal sex or positive sexually transmitted infection (STI) in last 6 months);
* Moderate-to-high risk SU behaviors based upon a Car, Relax, Alone, Forget, Friends, Trouble (CRAFFT) score ≥2,
* Living in Philadelphia, PA or Baltimore, MD, and surrounding areas;
* Able to read and write in English

Aim 2:

* 15-24 years old;
* Cisgender male;
* Self-identified Black/African American race or Latino/Hispanic ethnicity;
* Report prior oral/anal sex with another male;
* Living with a diagnosis of HIV;
* CRAFFT score ≥2,
* Living in Philadelphia, PA or Baltimore, MD, and surrounding areas;
* Able to read and write in English

Aim 3

• All randomized study participants will be included in Aim 3.

Exclusion Criteria:

Aim 2:

* Participants will be excluded if they are:
* Assigned female sex at birth
* Identify as transgender
* Outside the age criteria (\<15 or \>24 years old)
* Cognitively unable to complete study requirements
* Living outside of the two geographic areas
* Do not screen positive for SU
* No prior substance use history
* No prior oral or anal sex;
* Unable to read or write in English,
* Plan to move in the next 12 months.
Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department

ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is improvement in pain scales between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Acute migraine headache

Exclusion Criteria:

* Pregnant
* Hypertension
* Chest pain
* \< 18
* Allergy to any of the meds
Autogenous Demineralized Dentin Block Graft Versus Particulate Deproteinized Bovine Bone Graft for Alveolar Ridge Preservation

The aim of this trial is to compare the effect of autogenous demineralized dentin block graft (ADDBG) versus particulate deproteinized bovine bone graft (PDBBG) on alveolar ridge preservation after extraction of non-restorable single rooted teeth

Many studies have reported an approximately 50% reduction in alveolar bone both the horizontal and vertical directions over 12 months with more than two-thirds of the reduction occurring in the first three months after extraction. Alveolar ridge preservation is a procedure that attempts to reduce bone dimensional changes that naturally take place following tooth extraction. During the last decade, efforts have been made to confirm procedures that can prevent bone resorption after extraction. The use of bone grafts aim to promote bone healing and assist bone regeneration. Various types of materials are used for socket preservation, such as autogenous bone, allograft bone, xenograft materials, and alloplast materials. The deproteinized bovine bone has been tested in vitro and in vivo in the alveolar ridge preservation and plays a positive role in osteoconductive function. Guided bone regeneration (GBR) procedure has been developed to counteract alveolar ridge bone resorption. GBR technology with xenografts, such as the deproteinized bovine bone mineral, could lead to bone regeneration.

Moreover, root dentin block is composed of Type I collagen matrix with several osteoinductive non-collagenous proteins such as bone morphogenetic proteins (BMP) and dentin matrix proteins. Geometrically, alveolar bone morphology was maintained by dentin block graft as well as it has micropores (dentinal tubules) of 3-5 μm diameter and macropores of 0.2-0.3 mm diameter for enhancing osteoinductive and osteoconductive functions.

Both demineralized dentin block and particulate deproteinized bovine bone grafts with or without collagen membrane have been utilized for alveolar ridge preservation or augmentation but the superiority of one form over the other is not yet clear

Eligibility Criteria:
Inclusion Criteria:

* Non-restorable tooth indicated for extraction
* Single-rooted teeth
* Motivated patients, agree to sign informed consent and complete the follow-up period

Exclusion Criteria:

* Pregnant females
* active infection at extraction site
* Smokers
* systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)
Use of Insulin Glargine to Treat Diabetic Ketoacidosis

The purpose of this study is to determine the effects of the addition of insulin glargine during the early phase of moderate to severe Diabetic Ketoacidosis (DKA) in children.

The investigators hypothesize that the addition of insulin glargine during the early phase of management of DKA will accelerate acidosis correction, decrease the length of insulin infusion, and decrease the total intensive care unit time in children admitted to the ICU.


Eligibility Criteria:
Inclusion Criteria:

* Ages 6-18 y.o. presenting to Vanderbilt Children's Hospital (VCH) Emergency Room with:
* Established history of insulin dependent diabetes

AND:

* Chief c/o hyperglycemia or vomiting
* Venous pH \< 7.24
* Serum Bicarbonate \< 18
* Blood glucose \> 150
* Urinary Ketones

Exclusion Criteria:

* Age \< 6y.o.
* New onset diabetes
* Received IV insulin bolus prior to arrival to VCH Emergency Room (ER)
* Venous pH \> 7.24
* Serum Bicarbonate \> 18
* Pregnancy
* Received glargine within 12 hours prior to arrival to VCH Emergency Room/Pediatric Critical Care Unit
NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn

Neonatal pulmonary hypertension is a rare but serious condition resulting from a lack of adaptation to extra-uterine life in some newborns. In the short term, the risk of death requires rapid and appropriate management of this transient pathology.

In the long term, these newborns present a greater brain vulnerability, a consequence of the pathology itself with cerebral hypoxia but also invasive and aggressive therapies. Although current scientific evidence indicates a correlation with the existence of neurological developmental disorders, the understanding of the long-term neurological outcome of these babies remains poorly documented. Better knowledge of remote neuro-psychomotor development of the critical period


Eligibility Criteria:
Inclusion Criteria:

* All parenting authority holders of children aged 1 to 5 years, born after 34 weeks of amenorrhea and having been cared for neonatal PAH in paediatric resuscitation

Exclusion Criteria:

* Holders of parental authority who cannot answer the questionnaire because they do not speak French.
* Opposition of one of the two holders of parental authority
* Minor parental authority holders
* Holders of parental authority under safeguarding of justice, guardianship or guardianship
* Newborns with neonatal PAH with an associated diagnosis of diaphragmatic hernia or cyanogenic congenital heart disease
* Newborns with neonatal PAH not treated with nitrogen monoxide