cyrilzakka/clinical-trials huggingface dataset:
MiDura-Study (Neuro-Patch in Duraplasty)

The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age \> 18 years
* Duraplasty using Neuro-Patch® according to the Instructions for Use

Exclusion Criteria:

* Use in infected regions
* Use in open cerebrocranial traumata
* Use in open spina bifida
* Known hypersensitivity to implant materials
* Pregnancy
* Representation by a legal guardian or under involuntary commitment
Capsule Endoscopy in Cystic Fibrosis

Cystic Fibrosis patients continue to have bowel problems even after adequate pancreatic enzyme supplementation. There may be pathology of the lining of the bowel. Capsule endoscopy will be used to photograph the entire bowel.

The capsule endoscope system (Given Imaging, Ltd.) consists of 3 elements: a disposable capsule (PillCamTM SB) that acquires video images during natural propulsion through the digestive system.

The video-capsule PillCamTM SB has been cleared by the FDA for use in patients over 10 years of age for the detection of small intestinal disorders. It has been used in patients under age 10 and has been placed with the use of a gastroscope in patients unable to swallow the capsule. In fact, a new delivery device has been introduced recently that facilitates placement of the video-capsule in pediatric patients.For the purposes of this study, only patients over age 10 years who are able to swallow the capsule would be enrolled.

There are approximately 450 CF patients in the registry in Israel, with about 300 above the age of 10. Study subjects would be enrolled from this registry population and would be screened for the presence of the contraindications noted above. Patients would be assessed for symptoms of possible small bowel lesions at the time of enrollment including gastrointestinal bleeding, palpable abdominal mass, weight loss, diarrhea, and abdominal pain. Markers of inflammation including stool calprotectin will be assessed in all patients. These data would be recorded for further analysis.

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Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria would include those subjects with known CF who are able to give informed consent to undergo capsule endoscopy and whose guardians provide consent as well, if applicable. -

Exclusion Criteria

Subjects would be excluded if they were felt to be poor surgical candidates as patients may need to undergo surgery in the rare event of retention of the capsule. Patients genotype and lung function will be noted; patients will be excluded if FEV1 \< 40%.

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EXTERNAL SLT Treatment in Patients With Uncontrolled OPEN ANGLE GLAUCOMA

The purpose of this study is to evaluate the advantages and disadvantages of external selective laser trabeculoplasty (SLT) in treating open angle glaucoma,compared to traditional SLT.

glaucoma is the 2nd leading cause for blindness in the western world.at the time approximately 60 million people are diagnosed as glaucoma patients with an estimated rise of 30% in the next decade. glaucoma is defined as a progressive damage to the optic nerve ,followed by a damage to the visual field. high intraocular pressure (IOP) is considered a main risk factor.lowering IOP can be done in several ways ,including medication ,laser treatment and operations.

medical treatment is effective in most cases ,but requires high daily compliance,side effects and availability of medication in living areas.

laser trabeculoplasty treatment for reducing IOP is a first line treatment for patients with open angle glaucoma (OAG).with success rate of 70-90%, it can be done as an additive treatment or as a sole treatment.

SLT or "cold" laser is a non-invasive treatment in which short wave lengths are being transduced in short intervals ,through a gonioscopic lens to the area of filtering angle. thec wave length is specific to cells rich in melanin (located in the filtering angle). the mechanism of action is regeneration of cytokine surge -causing macrophages recruitment and breakage of inter-cell connections at the trabecular meshwork (filtering area) and allows rise in fluid shift. the treatment requires several lasering to areas at the surrounding the wave does not cause rise in tissue heat or scaring of tissue and can be repeated.among its disadvantages are reduction in affect during time,causing new elevation of IOP , potential peripheral anterior synechia (PAS), corneal erosion or oedema,requires experience in treating through gonioscopic lense.

previous reports in the literature regarding external low intensity laser (LIL)show less complication rate.

our study evaluates the use of external SLT by using a standard retinal laser machine ,with procedure performed on the outer sclera-above the trabecular meshwork with laser parameters similar to those used in retinal surgeries.

this is a prospective, randomized, comparative clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Primary Open Angle Glaucoma
* clinical appearance of pigment at the angle
* angle assessed as \>3 by a professional glaucoma expert
* IOP above target pressure under full anti-hypertensive treatment with a good compliance for treatment or IOP above target pressure and poor compliance to medical treatment due to: allergic reaction , side effects,physical inability etc.
* able to sign independently on an informed concent

Exclusion Criteria:

* pregnancy/breast feeding
* glaucoma not specified as primary open angle glaucoma
* sensitivity to on or more of the medications in the study
* current /past intraocular inflammation
* primary open angle glaucoma with out appearance of pigment at the angle
* s/p laser trabeculoplasty at treatment eye
* inability to sign an informed concent
Safety and Pharmacokinetics of AVL-292 Following Multiple Doses and the Effect of Food on the Single-dose Pharmacokinetics of AVL-292

This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate the effect of food on the pharmacokinetics of a single oral dose of AVL-292.

Part 2 is an open-label, randomized, 2-period, 2-way crossover study to evaluate the effect of a standard high-fat breakfast on the pharmacokinetics of AVL-292. Ten subjects will be enrolled to receive 2 single doses of 200 mg AVL-292, one with food (i.e., fed) and the other without (i.e., fasted), in a randomized sequence.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects of any ethnic origin between ages of 18 and 65 with a body mass index between 18 and 33

Exclusion Criteria:

* Recent history (i.e., within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, ophthalmological, allergic or other major disorders;
* Use of any prescribed systemic or topical medication within 30 days of the first dose;
* Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements and herbal medicines, e.g., St. John's Wort) within 7 days of the first dose administration;
* Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration
Cisplatin Disposition and Kidney Injury

This study is being done to determine 1) whether drugs to treat cisplatin-related nausea can influence harm to the kidneys, 2) whether cisplatin levels in the body can influence the risk of harm to the kidneys, and 3) whether a person's genetic make-up can increase or decrease the likelihood of kidney injury due to cisplatin therapy.

Cisplatin (cis-diamminedichloroplatinum, Platinol®) is commonly utilized in chemotherapy regimens for the treatment of solid cancers including lung, head and neck, and cervix. Its main mechanism of action is through binding of DNA to form cross-links, leading to arrest of DNA synthesis and replication. A major adverse consequence of cisplatin therapy is acute kidney injury (AKI). It is reported that between 30 and 38 percent of patients develop signs of nephrotoxicity (toxicity in the kidneys) after a single cisplatin dose, despite strategies such as hydration to limit renal exposure. This is problematic for patients as kidney injury can delay further treatment and limit the total number of chemotherapy cycles received, thereby reducing the overall efficacy of cisplatin-containing regimens. Furthermore, it is apparent that cisplatin will remain a central component to the treatment of solid tumors in the foreseeable future. New approaches to identify patients at risk of acute kidney injury (AKI) and prevent its development and progression are urgently needed. Cisplatin causes nausea and vomiting, which requires treatment with 5-HT3 antagonists (5-HT3A) to control. Associations between the clinical use of the 5-HT3A antiemetic drugs and the risk of cisplatin AKI have recently been discovered. This study will interrogate relationships between 5-HT3A drugs (granisetron, ondansetron, and palonosetron) and cisplatin AKI.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient prescribed cisplatin at a dose of \>25mg/m\^2
* Age 18-80 years
* Hemoglobin \>/=9 g/dl
* No consumption of grapefruit juice or alcohol within 7 days
* No history of alcohol consumption of \>14 drinks/week
* No history of organ transplantation or kidney dialysis
* Willingness to comply with study
* Not pregnant or lactating
* No changes in chronic medications within 2 weeks
* Estimated glomerular filtration rate (eGFR) \> 60 ml/min\^2
* Normal liver function (ALT and AST \<2x ULN)

Exclusion Criteria:

* Diagnosis of kidney cancer
* Previous exposure to platinum-based chemotherapy with the exception of one previous dose as part of the current course
* Herbal supplement use beyond marijuana
* Exposure to other known nephrotoxins (including contrast agents) within the previous 2 weeks
* Severe gastrointestinal disease with fluid losses
* Diagnosis of a rapidly progressive glomerulonephritis
* Allergy or contraindication to 5-HT3 Antagonists
A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas

The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458, a bifunctional cereblon-dependent ligand-directed degrader (LDD) of BCL6 (BCL6 LDD), as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-Hodgkin Lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Participants ≥ 18 years of age with R/R NHL (including DLBCL \[ie, DLBCL not otherwise specified (NOS) and diffuse large B-Cell lymphoma/high-grade B-Cell lymphoma with MYC and BCL2 rearrangements\], and FL):

  * For R/R DLBCL (de novo) and FL 3b: following at least 2 prior lines of therapy (eg, first-line combination chemotherapy regimen containing rituximab, anthracycline, an alkylating agent, and steroids and at least one additional treatment).
  * For R/R DLBCL (transformed lymphoma): following at least 2 prior lines of therapy which must have been administered after transformation.
  * For R/R FL (except for FL 3b): following at least 2 prior lines of therapy and meeting treatment criteria at the time of enrollment based on investigator´s assessment.
* Participant must have measurable disease (defined by at least one FDG-avid lesion for FDG-avid disease and one bi-dimensionally measurable disease on cross sectional imaging by computed tomography or magnetic resonance imaging with at least one lesion \> 1.5 cm in the transverse diameter).
* Participants must accept and follow pregnancy prevention plan.

Exclusion Criteria:

* Participants must not have an Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
* Participants with an inability to comply with listed restrictions, precautions and prohibited treatments.
* Participants must not have prior CAR-T, Cereblon-modulating drug or radiotherapy ≤ 4 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, allogeneic SCT ≤ 6 months or autologous SCT ≤ 3 months prior to study intervention initiation.
* Participants must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.
* Participants must not have known or suspected central nervous system involvement.
PMCF-study Using Novosyn® Quick Suture Material for Perineal Repair After Episiotomy

The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for episiotomy. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature. Study population consists of women with a spontaneous vaginal delivery who required perineal repair due to an episiotomy.


Eligibility Criteria:
Inclusion Criteria:

* Primiparous women who require perineal repair due to an episiotomy after spontaneous vaginal delivery.
* Singleton birth between 37 and 42 weeks gestation
* Written informed consent

Exclusion Criteria:

* Age\< 18 years
* Previous perineal surgery
* Instrumental vaginal deliveries
* Multiparous (at least 1 previous perineal delivery)
* Episiotomy involving the anal sphincter or the rectum
* Medical consumption that might adversely affect healing
* Women with active infection at the time of delivery
Study to Compare the Bioavailability of Extended Release Metformin HCl Tablet Versus Glucophage XR® Tablets in Healthy Human Volunteers Under Fasting Condition

Objective: To compare the bioavailability of Extended Release Metformin HCl Tablet(Test formulation, Torrent Pharmaceuticals Ltd.,India) versus Glucophage XR® Tablets ( Reference formulation, Bristol-Myers Squibb Company, USA) in Healthy Human Volunteers under fasting condition.

Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment,Crossover Study under fasting condition.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all of the following criteria in order to be included in the study:

  1. Sex: male.
  2. Age: 18 - 45 years.
  3. Subject with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
  4. Healthy and willing to participate in the study.
  5. Subject willing to adhere to the protocol requirements and to provide written informed consent.
  6. Non-smokers or smoker who smokes less than 10 cigarettes a day.

Exclusion Criteria:

* The subjects will be excluded from the study based on the following criteria:

  1. Clinically relevant abnormalities in the results of the laboratory screening evaluation.
  2. Clinically significant abnormal ECG or Chest X-ray.
  3. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
  4. Pulse rate less than 50/minute or more than 100/minute.
  5. Oral temperature less than 95°F or more than 98.6°F.
  6. Respiratory rate less than 12/minute or more than 20/minute
  7. Addiction to alcohol or history of any drug abuse within the past 2 years.
  8. Recent History of kidney or liver dysfunction.
  9. History of allergy to the test drug or any drug chemically similar to the drug under investigation.
  10. Administration/ Intake of prescription or OTC medication for two weeks before the study.
  11. Patients suffering from any chronic illness such as arthritis, asthma etc.
  12. HIV, HCV, HBsAg positive Subjects.
  13. Opioids, tetra hydrocannabinoids, amphetamine, barbiturates, benzodiazepine, Cocaine positive Subjects based on urine test.
  14. Subjects suffering from any psychiatric (acute or chronic) illness requiring medications.
  15. Administration of any investigational products in the period 0 to 3 months before entry to the study.
  16. Intake of barbiturates or any enzyme-inducing drug in last three months.
  17. History of significant blood loss due to any reason, including blood donation in the past 12 weeks. The total blood loss in last 3 months including for this study will not exceed 350ml.
  18. History of any bleeding disorder.
  19. Existence of any surgical or medical condition, which, in the judgement of the Chief investigator and/or clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of Subjects.
  20. Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Testing Latest Version of NidekRS3000Adv

The investigators would like to know if different imaging devices can improve the quality of images and visualization of imaged tissues. Also, the investigators would like to find out whether these changes are useful in the diagnosis and treatment of eye diseases. Using images of previous participants will allow us to demonstrate the advancement of different technologies, as well be used to allow comparisons between current technologies.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* 18 years old or older

Exclusion Criteria:

* Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging
* subjects who are unable to maintain retinal fixation on a specified target
* subjects unable to achieve sufficient pupil dilation and alignment stability for imaging to take place
* subjects with media opacity which preclude high quality imaging will be excluded.
* vulnerable subjects
* subjects under 18
* pregnant subjects
* economically and educationally disadvantaged subjects
* decision impaired subjects
* homeless subjects
Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia

The purpose of this study is to determine if creation of a skin wheel with bacteriostatic normal saline, which includes 0.9% benzyl alcohol, is less painful and provides a similar level of anesthesia compared to 1% lidocaine. Participants will receive both types of anesthesia, in random order.

Most chronic pain procedures or injections utilize medications (e.g. local anesthetics) to numb the skin in an effort to reduce procedure-related pain; however, they can also be a significant cause of pain leading the patient to abort the procedure. Studies have looked at alternative medications and techniques that lessen the pain but still provide similar levels of anesthesia ("numbing"). One such alternative medication is normal saline that includes benzyl alcohol. Studies researching this specific medication have usually examined procedural pain related to drawing blood or placing an intravenous (IV) catheter but not for chronic pain related procedures.

This is a single site randomized double-blinded clinical trial that will compare the standard of care (1% lidocaine) with bacteriostatic normal saline (saline with benzyl alcohol) administered as a skin wheal during a diagnostic procedure in patients with chronic low back pain. The order of administration of the medication will be randomized and the medication will be blinded to both the subject and the investigator performing the procedure. Skin wheals will be created with each medication, and the subject's level of pain will be assessed after each one to measure how painful the creation of the skin wheal was. Then, a spinal needle for the diagnostic procedure will be placed through the skin wheal and the subject's level of pain will be assessed after each one to measure the level of anesthesia (or numbing) that each one provides. The objectives of this study are to determine if administration of bacteriostatic normal saline causes less discomfort than 1% lidocaine and provides a similar level of anesthesia/numbing for the procedure.

The study will take place at the Grady Pain clinic and participants will be identified from patients that are scheduled to undergo a specific low back procedure - diagnostic lumbar medial branch block. This research study will help identify potential alternatives to the standard of care for numbing of skin during chronic pain procedures that may reduce procedure-related pain and discomfort thus making the procedure more tolerable.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for an initial lumbar medial branch block

Exclusion Criteria:

* Allergy to local anesthetics
* Fibromyalgia
* Inability to provide informed consent in English
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Identification and Analysis of Immunomodulatory Molecules in Patients With Hematologic Disorders and Healthy Volunteers

This research study goal is to analyze the plasma and the cells that make up part of the immune system. We want to learn how the plasma and cells work. These may influence why one person will develop an infection and another will not, or why one person develops severe symptoms of a disease while others remain without symptoms.

This research study goal is to analyze the plasma and the cells that make up part of the immune system. These cells, called white cells or leukocytes, are present in blood. We want to learn how these cells work to prevent infection and how they respond after an infection occurs. We also want to study certain molecules present on the plasma, on or in these cells, and the genetic material that allows these molecules to be made. These molecules may influence why one person will develop an infection and another will not, or why one person develops severe symptoms of a disease while others remain without symptoms. This study may increase our understanding of a variety of diseases including infections such as HIV, allergic diseases such as asthma, joint diseases such as rheumatoid arthritis, certain cancers, and the rejection process that sometimes occurs after transplantation of an organ.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to give blood
* Must be able to give informed consent
* Signed, written informed consent

Exclusion Criteria:

* Individuals with a history severe anemia, inadequate venous access, severe blood or coagulation disorders.
* Pregnant women are excluded because it is a unique immunotolerant state and will alter the profile of immunomodulatory molecules.
A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma

A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist

This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a history of asthma exacerbations. Approximately 770 subjects will be randomized globally. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Age 12 -75
2. Documented physician-diagnosed asthma.
3. Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA
4. Morning pre-BD FEV1 value of ≥40 and \<80% value (\<90% for patients 12 to 17 years of age) of their PNV.
5. Post-BD reversibility of ≥12% and ≥200 mL in FEV1
6. ACQ-6 score ≥1.5

Exclusion Criteria:

1. Pulmonary disease other than asthma
2. History of anaphylaxis following any biologic therapy
3. Hepatitis B, C or HIV
4. Pregnant or breastfeeding
5. History of cancer
6. Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years
7. Previous receipt of tralokinumab