cyrilzakka/clinical-trials huggingface dataset:
Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients

The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab;
* Patient must have had 1 to 3 prior CTCL therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic regimen is permitted. Topical or systemic steroids are not considered a therapy;
* Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry.
* Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months.
* Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
* No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease.
* No systemic infections;
* Willingness to be randomized to a placebo treatment only arm;
* ECOG performance status 0 or 1;

Exclusion Criteria:

• Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).
An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children

To evaluate the pharmacokinetics of intravenous ganciclovir in children (ages 3 months - 12 years). To determine the safety and tolerance of a 2 to 3 week induction course of ganciclovir IV in immunocompromised children receiving treatment for life- or sight-threatening cytomegalovirus infections.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Topical acyclovir.
* Consult with the Syntex study monitor for the following:
* Cytokines.
* Soluble CD4.
* Trichosanthin (Compound Q).
* Imipenem-cilastatin.
* Other investigational drugs.

Patients must have the following:

* Congenital or acquired immune deficiency.
* Eligibility to receive ganciclovir for the treatment of life- or sight-threatening Cytomegalovirus (CMV) disease.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Mild to moderate Cytomegalovirus infection that does not satisfy the clinical severity criteria.
* Congenital or neonatal CMV infections without documented congenital or acquired immunodeficiency.

Concurrent Medication:

Excluded:

* Other myelosuppressive drugs.
* Antimetabolites.
* Alkylating agents.
* Nucleoside analogs (topical acyclovir is allowed).
* Interferons.
* Foscarnet.
* Consult with the Syntex study monitor for the following:
* Cytokines.
* Soluble CD4.
* Trichosanthin (Compound Q).
* Imipenem-cilastatin.
* Other investigational drugs.

Patients with the following are excluded:

* Mild to moderate Cytomegalovirus (CMV) infection that does not meet the clinical severity criteria.
* Absolute neutrophil count (ANC) \< 500 cells/mm3 or a platelet count \< 25000 platelets/mm3. Note:
* Exceptions may be made for patients with pre-existing neutropenia or thrombocytopenia and immediately life-threatening disease, if the investigator believes that a delay in starting ganciclovir therapy is not advisable. In such patients, the investigator should advise the parents or guardians of the risk of further bone marrow suppression and the increased risk of infection or bleeding.
* Receiving excluded medications that it is not possible to discontinue.
* Congenital or neonatal CMV infections without documented congenital or acquired immunodeficiency.
* Demonstrated hypersensitivity to acyclovir or ganciclovir.
Plethismographic Perfusion Index in Neonates

Photoplethismography will be measured and compared in newborns suffering from patent ductus arteriosus and normal controls.

Newborn babies admitted to the NICU and well baby will be connected to a specially designed photoplethismograph (PPG). Right hand (pre ductal), and and one of the legs (postductal) values will be compared, based on the formula Delta amplitude of PPG / baseline absorption (perfusion index (PI)). Normal values will be defined in healthy term and preterm babies, and clinical conditions in which the PI is expected to change (Patent Ductus Artheriosus, Persistent pulmonary hypertension of the newborn)will be compared with these normal values.

Eligibility Criteria:
Inclusion Criteria:

* PDA, PPHN and Normal babies who underwent echocardiography

Exclusion Criteria:

* Other cardiac diseases
Clinical Investigation to Assess the Performance of the Eureka Electric Breast Pump in Mothers Breastfeeding Their Healthy Term Infant

Babies are the best in class in order to get human milk out of a lactating breast. With this in mind, Philips has developed the a new electric breast pump, attempting to mimic the babies sucking behavior. The new electric breast pump includes a new vacuum profile and 2 new expression kits.

Breast pumps currently on the market function by applying vacuum directly to the breast. The effect of a build-up of pressure within the breast due to the accumulation of milk, combined with the external negative pressure introduced by the breast pump, results in the expression of milk. However, in order to express sufficient amounts of milk it is important to stimulate the Milk Ejection Reflex (MER). The MER, also called letdown, draught ejection, expulsion or pumping reflex, is described as a response of the mammary gland to oxytocin. When the nipple is stimulated, the mother's posterior pituitary gland releases oxytocin into the bloodstream. Upon reaching the breast tissue, oxytocin provokes contraction of cells within the structure of the breast causing milk flow. Without the MER successful breastfeeding or breast milk expression cannot happen. In order to stimulate the MER, Philips has developed 2 new expression kits to better mimic the suckling pattern of an infant.

Eligibility Criteria:
Inclusion Criteria:

* Have an age between 18 and 50 years
* Have delivered a healthy, term singleton infant (with birth weight above 2.5kg and at least 37 weeks gestation)
* Have a baby with an age between 1 and 4 months
* Exclusively breastfeeding at the time of the study
* Have signed the Informed Consent form

Exclusion Criteria:

* Pregnant at the time of the study
* Suffer from known side effects (sore nipples, nipple trauma, bruising, engorgement, clogged mammary ducts, lactostasis, mastitis) at the time of the study
* Suffer from syndrome of Raynaud
* When providing complementary foods to their baby at the time of the study
* When providing donor milk and/or formula milk to their baby at the time of the study
* When having their period at the time of the study
* When taking oral anticonception at the time of the study
Cysteine-lowering Treatment With Mesna

The primary objective of this study is to determine the efficacy of the drug Mesna® (Uromitexan) in healthy participants with overweight or obesity with respect to change in plasma concentrations of total cysteine, following single ascending doses of oral Mesna.

In both animal experiments and human studies, cysteine in the blood is strongly associated with obesity. In rodents, changes in cysteine induced by dietary means are accompanied by changes in fat mass.

In this phase I, single ascending dose study the investigators will determine the effects of Mesna in healthy volunteers with overweight and obesity with focus on its effects on plasma total cysteine concentrations. The aim of this dose-finding clinical trial is to determine the lowest single oral Mesna dose that will lower plasma total cysteine concentrations by 30% using pharmacokinetic (PK)/ pharmacodynamic (PD) modelling. The investigators will further evaluate the effect of Mesna on plasma cysteine fractions and related metabolites, urinary cysteine excretion, safety and adverse drug reactions, and plasma biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* BMI between BMI 27-40 kg/m2
* Age between 18-55 years
* Male
* Healthy as determined by medical evaluation, medical history, physical examination, 12-lead ECG, and laboratory tests

Exclusion Criteria:

* Presence of chronic disease
* Chronic drug use
* Past or intended use of over-the-counter or prescription medication including herbal medications within 14 days prior to dosing
* Veganism
* Strenuous physical activity ≥3 times every week
* Smoking
Effect of HIV and/or Active Tuberculosis on the Immune Responses to Trivalent Influenza Vaccine (TIV) in Adults

Prospective, open-labelled study which will enrol 360 participants in four groups of 80 participants including: HIV-uninfected adults without evidence of TB; HIV-infected adults without any evidence of TB; HIV-uninfected adults with concurrent microbiologic confirmed TB, HIV-infected adults with concurrent microbiologic confirmed TB.

Participants will receive the recommended seasonal 2013 un-adjuvanted Trivalent Influenza Vaccine (TIV). At 3 visits, blood will be collected for determination of immune responses.

Objective:

• To determine the effect of HIV-infection, tuberculosis (TB) and HIV-TB co-infection on immune responses


Eligibility Criteria:
Inclusion Criteria:

* for HIV-infected subjects: a Cluster of Differntiation4 (CD4+) cell count of \>100/ul within the previous 3 months;
* able to attend the clinic for immunogenicity and illness visits;
* for subjects with TB: having a microbiologic confirmed diagnosis of TB (defined as the presence of acid-fast-bacilli (AFB) on a sputum smear or other specimen and/or a positive culture for M. tuberculosis) within the past 120 days;
* Aged 18 to 55 years.

Exclusion Criteria:

* any contraindication to influenza vaccine;
* any contraindication to intramuscular injections;
* any existing grade 3 or grade 4 laboratory or clinical toxicity as per Division of Acquired Immune Deficiency Syndrome (DAIDS) toxicity tables;
* systemic steroid treatment for \>21 days within the past 30 days.
* pregnancy (a urine Human Chorionic Gonadotropin (βHCG) will be performed on all women of childbearing age to exclude pregnancy)
Assessment of the Effects of Sheffield Support Snood in MND Patients

The aim of this study is to evaluate the effects on MND patients of a new collar specifically designed for people affected by neck weakness: the Sheffield Support Snood.

Motor Neurone Disease (MND) is neurodegenerative disorder that leads to progressive weakness of limb, bulbar and respiratory muscles. The most common form of the disease is the Amyotrophic Lateral Sclerosis (ALS). Severe weakness of the neck extensor muscles is common in patients with ALS. Those patients are advised to wear a cervical collar, to improve their neck posture and social interaction. However the main limit of commercially available collars is that they are designed to immobilize the neck, which makes them uncomfortable and strenuous to wear for long time. The aim of this study is to evaluate the effects on MND patients of a new collar specifically designed for people affected by neck weakness: the Sheffield Support Snood. The assessment will be performed through the use of inertial sensors since they allow the measurement to be performed in real life settings (clinics/home) with reduced discomfort to the patient. Subjects will be asked to perform a series of active head movements (flexion, extension, axial rotation, lateral bending) with and without the collar and the range of movement measured in the two cases will be used to assess the support offered by the collar. Since in MND patients difficulty in perform active head movements is due to a severe weakness of the extensor muscles, with or without involvement of the neck flexors, this study will also investigate the activation of these muscles while the subject is performing the active head movements. A wireless surface electromyographic system (sEMG) will be used to this purpose. Patients able to perform a series of activities of daily living (ADL, ie: drinking, eating, washing hands) will be asked to perform the tasks both with and without the collar. The support perceived by the subjects while they are performing the ADL will be evaluated through a questionnaire specifically developed for this study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical status consistent with MND
* Capability to understand instructions
* Capability to perform testing procedures
* Ability to give informed consent

Exclusion Criteria:

* Presence of any inflammatory or other disease involving joint or muscle pathology that might affects testing results
* Unable to give informed consent
Comparing Postoperative Analgesic Techniques for Umbilical Hernia Repair: A Randomized Trial of Ultrasound Guided Caudal, Erector Spinae, and External Oblique Interfascial Plane Blocks

The aim of this study is to evaluate the efficacy of ultrasound guided Erector block versus caudal block versus external oblique intercostal plane block perioperatively

umblical hernia repair surgeries have been performed in the practice of pediatric surgeries, ensuring adequate perioperative analgesia is crucial for perioperative care as pain in pediatric patients can cause functional recuperation and lead to negative behavioral changes and family dissatisfaction. (1) Various studies are made to improve postoperative analgesia and facilitate recovery in pediatric patients.(1) Day-case surgery is defined as the planned day admission of a patient to hospital for a surgical procedure, after which there is subsequent successful and safe discharge back home on the same day in a safe and timely manner instead of spending prolonged periods within the hospital.(2) This has significant implications, including reducing hospital stay, hospital-acquired infection, and healthcare-related costs while also improving patient experience and service efficiency. Surgical, anesthetic, and patient factors should be considered for successful day case surgery.(2) External oblique intercostal plane block (EOIPB) is a novel fascial plane block which aims to provide upper midline and lateral abdominal wall analgesia thereby reducing perioperative opioid consumption , LA is deposited into the fascial plane beneath the external oblique muscle (EOM) and superficial to the sixth rib or external intercostal muscle. It targets anterior and lateral cutaneous branches of the thoracoabdominal nerves from the ventral rami of spinal nerves.(3)

Caudal block is the most frequently performed regional technique for pain management in children undergoing lower abdominal surgeries. Ultrasound guidance has resulted in enhanced reliability and safety profiles for caudal blocks.(4) The erector spinae plane block (ESPB), multiple studies demonstrated its potential as a practical approach for managing postoperative pain in the last decade, involves an ultrasound-guided injection of a relatively large volume of local anesthetic into the fascial plane beneath the erector spinae muscle. (5)

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients of both sexes undergoing elective umblical hernia surgeries aged from 2 year to 7 years belonging to ASA I or II.

Exclusion Criteria:

* Parents refusal.
* Coagulopathy.
* Allergy to local anesthesia.
* Local infection at the site of injection.
* Neurological anomalies.
GRX With ReMOTE: First in Human in India

To evaluate the safety and performance of CorPath GRX POP System, in the ReMOTE (location outside hospital) delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.

Prospective, single-arm, single center, non-randomized feasibility study of the CorPath GRX POP System to examine its performance during remote angioplasty (ballooning) and stenting and patient outcomes through 48 hours post-PCI procedure hospital discharge, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years;
2. Patients with coronary artery disease with clinical indication for PCI;
3. Patient deemed appropriate for robotic-assisted PCI; and
4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Angiographic Inclusion:

1. Study lesion is a single de novo native coronary artery lesion (i.e. a coronary lesion not previously treated).
2. The lesion reference vessel diameter is between 2.50 mm and 4.0 mm by visual estimate.
3. Study lesion length less or equal to 20 mm by visual estimate.
4. The study lesion length can be treated with one stent. The stent should be able to cover the whole length of the lesion with at least 2 mm of normal segments on proximal and distal edges of the lesion.
5. Study lesion diameter showing significant stenosis of at least 50% by visual estimate.

Exclusion Criteria:

1. Failure/inability/unwillingness to provide informed consent; or
2. The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.

Angiographic Exclusion:

1. Target lesion that cannot be fully covered by a single stent.
2. Subject requires treatment of multiple lesions
3. Any previous stent placement within 5 mm (proximal or distal) of the target lesion
4. The study lesion requires planned treatment with DCA, laser, rotational atherectomy, or any device except for balloon dilatation prior to stent placement
5. The study vessel has evidence of intraluminal thrombus or moderate to severe tortuosity (\> 90°) proximal to the target lesion
6. The study lesion has any of the following characteristics:

   1. Total occlusion
   2. Within 2mm of a side branch \> 2.0 mm vessel diameter
   3. Not ostial in location
   4. Is located at ≥ 45° bend in the vessel
   5. Is severely tortuous
   6. Is severely calcified
   7. Severe calcification at the part of the vessel proximal to target lesion
   8. Target lesion that is located in a native vessel distal to an anastomosis with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass and is approached through the by-pass graft
7. Unprotected left main coronary artery disease (an obstruction greater than 50% diameter stenosis in the left main coronary artery)
Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions

To determine the safety and efficacy of Amniotic and Umbilical Cord Tissue for the treatment of the following condition categories: Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions. The hypotheses are that the treatments are not only extremely safe, but also statistically beneficial for all conditions. Outcomes will be determined by numerous valid outcome instruments that compile general quality of life information along with condition-specific information as well.

The study will be ongoing for patient inclusion and data acquisition. Patients who have Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions will be included.

The study has been approved by an Alion accredited Institutional Review Board, Solutions IRB, as of March 2019.

Depending on the condition, patients may receive a series of therapies via one or more of the following methods: intravenous, injection, intra-nasal and/or nebulizer. R3 has several "best practice" therapy protocols that participating practices will follow. Should a patient have conditions that fall into more than one condition category, he or she can still be included with the protocols being received for each condition(s).

Here is a specific administration for each condition category:

1. Orthopedic Condition = Injection
2. Neurologic Disease = IV Infusion and Intranasal Procedure. The exception is with Peripheral Neuropathy, where participants receive a series of injections along with an IV Infusion Procedure.
3. Urologic = Injection
4. Autoimmune = IV Infusion
5. Cardiac = IV Infusion
6. Pulmonary = IV Infusion plus Nebulizer
7. Renal = IV Infusion

Pre, Intra and Post procedure data acquisition will occur at various time frames up to 10 years. Follow up time-frames will measure changes occurring from baseline post procedure at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, 36 months and then on average each year, up to 10 years. Patients will pay for procedures, and no randomization will occur.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and over.
2. Ability to attend follow up visits or at least converse on phone or complete email follow up forms.
3. Competent to understand the study protocol and provide voluntary informed consent.
4. Patients with any of the following conditions: Arthritis (Degenerative, Rheumatoid, Psoriatic, Lupus, Gout), Sports or Overuse Injuries (e.g. Rotator Cuff injury, Tennis Elbow), Chronic Kidney Disease (may be on dialysis), Back/Neck Pain, Erectile Dysfunction, Peyronie's Disease, Alzheimer's Disease, Parkinson's Disease, Neuropathy, Post-Stroke, Post-Concussion Syndrome, COPD, Emphysema, Pulmonary Fibrosis, Post myocardial infarction (at least 6 months out), Cardiomyopathy, Congestive Heart Failure.

Exclusion Criteria:

1. Active Cancer
2. Pregnancy, Lactating
3. Severe Clotting disorder
4. Myocardial Infarction less than six months ago.
Novel Blood Test to Predict Safe Foods for Infants and Toddlers With Food Protein-induced Enterocolitis Syndrome (FPIES)

The aim of this study is to validate a blood test that can identify safe foods for food protein-induced enterocolitis syndrome (FPIES). This study proposes a solution to the problems of FPIES by developing a new blood assay that screens a large number of foods (more than 20) in a culture plate. If this blood test is successful it may be able to identify safe foods more quickly.

The study will recruit 10 participants that will have more than 2 trigger foods.

Participants will complete surveys and have blood draws during the study. Additionally, participants will be asked to keep track of their diet as well as introduce safe foods identified by the researchers.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of FPIES
* Have to have documented reactions to 2-3 trigger foods with recurrent delayed vomiting or documented reactions to 4 or more trigger foods with recurrent delayed vomiting.

Exclusion Criteria:

* Patients who are currently on medications that suppress the immune system
* Patients who do not have at least 2 trigger foods identified.
* Patients who have a history of an organic Gastrointestinal (GI) disease (e.g., inflammatory bowel disease, celiac disease, biliary disorders, bowel resection), cardiac, pulmonary, neurologic, renal, endocrine, or gynecological pathology
* Lack of parental or guardian informed consent.