cyrilzakka/clinical-trials huggingface dataset:
Acceptability of a New Paediatric Formulation of Hydroxycarbamide in Children With Sickle Cell Disease.

This is a prospective, interventional, phase II, open-label, multicentre, national, non-comparative study of a single administration of the new dispersible form of hydroxycarbamide at the usual dose in children with sickle cell disease who are already treated with the current form of hydroxycarbamide (Siklos® 100 mg and/or 1000 mg film-coated tablets).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent, signed and dated by both parents or by the legally acceptable representative(s) of the children,
* Child with sickle cell disease, treated with 100 mg and/or 1000 mg Siklos® film-coated tablets at the same daily dose for more than 4 weeks,
* Child aged between 2 and 6 years old,
* Parents capable of communicating with the investigator and understanding the requirements and constraints of the study protocol and willing to comply with the study requirements,
* Children affiliated to a social security plan (including universal health coverage) or beneficiary of a similar insurance plan.

Exclusion Criteria:

* Participation in any other clinical study for any other pharmaceutical product within 4 weeks preceding study inclusion,
* Known hypersensitivity or allergy to the excipients,
* Any surgical or medical condition or any significant illness (of which severe hepatic impairment (Child-Pugh classification C), severe renal impairment, toxic ranges of myelosuppression) that, in the opinion of the investigator, constitutes a risk or a contraindication to the participation of the patient to the study, or that may interfere with the objectives, conduct or evaluation of the study.
Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients

The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pediatric glaucoma or ocular hypertension.
* Qualifying mean IOP at the Eligibility Visit in at least one eye.
* Written informed consent, including assent when applicable, MUST be obtained from the parent or legally authorized representative prior to any procedure specified in the protocol, including screening procedures.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential who are pregnant, intend to become pregnant during the study period, breast feeding, or not using any form of birth control measures.
* History of chronic, recurrent or severe inflammatory eye disease.
* Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit.
* Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit.
* Clinically significant or progressive retinal disease.
* Severe ocular pathology (including severe dry eye) that, in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analog or a topical beta-blocker.
* Intraocular surgery in the study eye within 30 days prior to the Screening Visit.
* Any abnormality preventing reliable applanation tonometry.
* Other protocol-defined exclusion criteria may apply.
Effects of Echinacea in Children

The goal of the this study is to determine if Echinacea purpurea stimulates the immune system in children. For the study, 40 healthy children, 6-11 years old will be randomized to receive Echinacea purpurea or placebo for 10 days in 3 consecutive months. Blood samples will be obtained in the children just before starting study medication, during the first course of medication and either just prior to starting the second course of medication or 50 days following the last of the three courses of medication. Markers of immune activity in children receiving Echinacea or placebo will be compared.

This is an application to study the biologic activity of a specific formulation of Echinacea purpurea in children 6-11 years old. The goal of the study is to determine if Echinacea purpurea is associated with activation of immune markers including cytokines such as tumor necrosis factor alpha (TNF), interferon alpha, interferon gamma, and interleukins 2, 6, and 12 (IL-2, IL-6, and IL-12), as well CD25 and CD69 activation. A total of 40 study children will be randomized to receive either the Echinacea purpurea formulation or placebo for 10 consecutive days at the start of 3 consecutive 30-day periods. Blood samples will be obtained at baseline, at the time of "peak" TNF activity, and either 30 or 120 days after beginning the study medication. Prior to beginning this pediatric study "peak" TNF activity will be determined by administering the Echinacea purpurea to 3 adult volunteers for 10 days and doing frequent blood sampling during this period. If it is demonstrated that this formulation of E purpurea has biologic activity, a large randomized controlled trial is planned to determine if E purpurea can prevent upper respiratory tract infection (URI) in children 2-11 years old.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children 6-11 years old
* Parent/Caregiver who can read and speak English
* One child per family

Exclusion Criteria:

* History of allergic reaction to Echinacea or related species
* History of asthma
* History of allergic rhinitis
* History of autoimmune disease
Comparison of Different Methods of Enamel Preparation Before Pit and Fissure Sealants

This study concerns the prevention of dental caries by sealing pits and fissures of permanent molars with a photopolymerizable resin. It must compare these three techniques Microdentisty (air abrasion, abrasion and sound using small cutters) usually used to prepare micro cavities in the enamel and / or the outer third of the dentin. These three commonly used techniques have never been compared by retaining as endpoint retention of sealant. These techniques are painless and do not require local anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Affiliated with the Social Security
* Attendance at inspections
* Subject to high individual risk of caries
* Subjects with at least two pairs of molars and contralateral counterparts with the initial lesions of enamel (pits and fissures colored) or suspected of dentine caries (not highlighted by two clinical and radiographic examination usual)

Exclusion Criteria:

* Molar inaccessible, closed, sealed, or decayed (reaching the dentine
Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

The primary objective is to evaluate the clinical benefit of CureXcell® as adjunct to Standard of Care in the treatment of Chronic Venous Leg Ulcers. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 252 patients will be randomized to receive either CureXcell® or Placebo.


Eligibility Criteria:
Inclusion Criteria:

* Ankle Brachial Pressure Index (ABI) ≥ 0.80
* Venous insufficiency confirmed by duplex Doppler ultrasound
* Presence of a venous leg ulcer, unresponsive to Standard of Care treatment for at least 4 weeks and between ≥ 1 cm2 and ≤ 17.1 cm2 at screening; and between ≥ 1 cm2 and ≤ 12cm2 at the Baseline Visit

Exclusion Criteria:

* Target Ulcer has decreased \>30% in size from Screening to Baseline
* Documented history of osteomyelitis at the Target Ulcer location within 6 months preceding the Baseline Visit.
* Patients who are unable to tolerate multi-layer compression therapy.
* Ulcer, which in the opinion of the Investigator is suspicious for cancer.
* Any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases.
* History of radiation at the Target Ulcer site in previous 12 months prior to Baseline Visit.
* Patients with clinically significant claudication
* Current sepsis
* Patients with known history of significantly compromised immunity for any reason including radiation therapy, chemotherapy or HIV
Effects of Roux-en-Y Gastric Bypass on Gastro-intestinal Hormone Secretion and Brain Responses Food Pictures

This is a cross-sectional study enrolling

* 11 weight-stable, formerly obese female patients 1-5 years after Roux-en-Y gastric Bypass (RYGB)
* 11 age- and weight-matched female subjects
* 10 normal weight (Body Mass Index 19-25 kg/m2) subjects The following measurements will be performed in each participants in basal conditions (after an overnight fast) and after ingestion of a standard meal
* electroencephalographic recordings of visually evoked potential after presentation of food- or non-food pictures
* plasma concentration of metabolites (glucose, fatty acids), glucoregulatory hormones (insulin, glucagon), gastro-intestinal hormones (Gastric Inhibitory Polypeptide (GIP), Glucagon-like Peptide-1 (GLP1), ghrelin,Cholecystokinin (CCK), and bile acids Aims of this observational study are
* to evaluate the effects of RYGB on brain perception of food related visual stimulation
* to search for relationships between RYGB effects on brain responses and gastro-intestinal hormone secretion


Eligibility Criteria:
Inclusion Criteria:

* good apparent health
* gender: female
* age 18-50
* non-smoker

Exclusion Criteria:

* diabetes or antidiabetic medication
* consumption of more than 50g alcohol per week
* vegetarian or any special diet
Rescue Stenting for Failed Endovascular Thrombectomy in Acute Ischemic Stroke (ReSET)

This study is a prospective, open-label, multi-center, registry study, designed to show that rescue stenting is safe and effective for emergency large vessel occlusion (ELVO) patients who have mechanical thrombectomy failure. Participants with ELVO will initially underwent mechanical thrombectomy usig stent retriever, contact aspiration or both. After failure of mechanical thrombectomy, rescue stenting will be performed.


Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects experiencing acute ischemic stroke due to large vessel occlusion (intracranial internal carotid artery and middle cerebral artery M1 segment)
* 2. Age 19 or greater
* 3. mRS before qualifying stroke, 0 or 1
* 4. Baseline NIHSS score 4 or more
* 5. CT ASPECTS \> 6 or MR ASPECTS \> 5
* 6. Good collateral statues on CT angiogram (collateral grade by Calgary group, 4 or 5) or corresponding to DEFUSE 3 or DAWN trial on perfusion imaging.
* 7. Onset (last-seen-well) time to femoral puncture time \< 24 hours
* 8. Failure of mechanical thrombectomy with stent retriever, contact aspiration or both
* 9. Subjects who received rescue stenting after failure of mechanical thrombectomy
* 10. Anticipated life expectancy of at least 12 months
* 11. Signed informed consent for study enrollment

Exclusion Criteria:

* 1. Any contraindication to antiplatelet medication
* 2. Multiple simultaneous large vessel occlusions
* 3. Pregnancy
* 4. Severe contrast allergy or absolute contraindication to iodinated contrast agent
* 5. Patient has a severe or fatal combined illness that will prevent improvement of follow-up or will render the procedure unlikely to benefit the patient.
Ab Interno Gelatin Stent With Mitomycin C Using Targeted Supra-tenon's Placement

The Xen-45 gelatin microstent is a novel, bleb-forming microinvasive glaucoma surgery (MIGS). Despite demonstrating similar efficacy and safety to trabeculectomy (traditional surgery), the Xen-45 gelatin microstent continues to suffer from occasional surgical failure due to fibrosis of the filtering bleb, and obstruction of the stent. During surgery, placement in a surgery known as supra-tenon's space is believed to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. Despite the theoretical merits, long-term data of outcomes after targeted supra-tenon's placement is needed to fully assess its potential in improving Xen-45 microstent outcomes.

The Xen-45 gelatin microstent (Allergan, Dublin, Ireland) is a novel, bleb-forming microinvasive glaucoma surgery (MIGS). Creation of a filtering bleb through the gel stent and under the conjunctiva lowers intraocular pressure (IOP) by bypassing the natural outflow pathway of aqueous. A recent retrospective cohort study showed comparable safety and risk of failure to trabeculectomy. Amongst the main advantages of this device is the ability to create a bleb without dissecting and disrupting tissue, thus decreasing the amount of wound healing and potentially limiting bleb failure. However, despite demonstrating similar efficacy and safety to trabeculectomy,2 the Xen-45 gelatin microstent continues to suffer from occasional surgical failure due to fibrosis of the filtering bleb, and obstruction of the stent. Although antimetabolites, such as mitomycin C, have decreased reactionary wound healing that can result following surgery, fibrosis may still occur, especially when the components of the Xen-45 gelatin microstent are in close proximity to the fibroblastic structures of tenon's fascia.Tenon's capsule resembles a sponge-like layer with multiple adhesions to the overlying conjunctiva and underlying episclera. Implantation of the XEN within this space creates a higher risk of obstruction and subsequent failure. To ensure the lowest potential for occlusion, bleb scarring, and failure, one must ensure careful placement of the device in the subconjunctival space, avoiding intra-tenon's placement. Placement in the supra-tenon's space is believed to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. Despite the theoretical merits, long-term data of outcomes after targeted supra-tenon's placement is needed to fully assess its potential in improving Xen-45 microstent outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 30-90 with primary or pigmentary/pseudoexfolliative open angle, primary closed angle, or combined mechanism glaucoma with IOP of 18-40 mmHg on maximum tolerated medical therapy who received a gelatin stent with MMC at Prism Eye Institute from June 2012 to August 2019.

Exclusion Criteria:

* Other forms of glaucoma
* Prior incisional glaucoma surgery
* CPC
* Prior corneal graft (PKP, DALK, DSAEK, DMEK).
Effect of Diclofenac Sodium Versus Calcium Hydroxide as Intracanal Medication on the Intensity of Postoperative Pain, Bacterial Load Reduction and MMP-9 Levels in Patients With Necrotic Pulp.

the aim of this study is to compare the effect of using Diclofenac Sodium Versus Calcium Hydroxide as Intracanal medication on intensity of postoperative pain, bacterial load reduction after root canal preparation and periapical matrix metalloproteinase 9 level (MMP-9) post-instrumentation and pre-obturation in teeth with necrotic pulp

To compare the effect of diclofenac sodium versus calcium hydroxide as intra canal medication on:

- Primary Outcome Intensity of postoperative pain will be measured using numerical rating scale (NRS) at 6, 12, 24 and 48- hours post-instrumentation and at 6, 12, 24 and 48 hours post-obturation.

Secondary Outcome 1 Bacterial load reduction will be determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml).

Secondary Outcome 2 Periapical MMP-9 level will be determined post-instrumentation and pre-obturation by ELISA.

Eligibility Criteria:
Inclusion Criteria:

-

Inclusion criteria:

* Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
* Age between 18-50 years.
* Males \& Females.
* Mandibular single rooted permanent premolar teeth:

  * Diagnosed clinically with pulp necrosis.
  * Absence of spontaneous pain.
  * Positive pain on percussion denoting apical periodontitis.
  * Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2\*2 mm radiographically.
* Patients' acceptance to participate in the trial.
* Patients who can understand pain scale and can sign the informed consent

Exclusion Criteria:

* Medically compromised patients
* Pregnant women.
* If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
* Patients reporting bruxism or clenching.
* Teeth that show association with acute periapical abscess and swelling.
* Greater than grade I mobility or pocket depth greater than 5mm.
* Non-restorable teeth
* Teeth with vital pulp.
* Immature teeth.
* Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
The Effects of Cupping Massage in Patients With Chronic Neck Pain - A Randomized Controlled Trial

The study aims to investigate the influence of 5 cupping massage treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group. Before and after the intervention the investigators evaluate the neck pain (VAS), the neck related disability (NDI), pain on movement (POM) and the quality of life (SF36) and safety. To investigate neurophysiological effects of cupping the investigators also measure mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain threshold (PPT) and the two point discrimination threshold at pain related and control areas.

The treatment group receives 5 cupping treatments over a period of 3 weeks.

see above

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 75
* permanent neck pain for at least three months in a row
* a minimum of 40mm of neck pain on a 100mm visual analogue scale (VAS)

Exclusion Criteria:

* neck pain caused by trauma, inflammatory or malignant disease, by congenital malformation of the spine or if pain was accompanied by radicular symptoms such as radiating pain, paresis, prickling or tingling.
* invasive treatments within the last 4 weeks, surgery to the spine within the last year, corticosteroid or opioid treatment.
* serious acute or chronic organic disease such as diabetes or cancer, mental disorders, pregnancy, and haemorrhagic tendency or anticoagulation treatment.
* non steroidal pain medication and physiotherapy were allowed if the treatment regimen was not altered for four weeks before and continued during the study.
Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-resistant Ovarian Cancer

The purpose of this trial is to determine the tumor response rate of NOV-002 plus carboplatin in a cohort of women with platinum resistant cancer of ovarian origin.

The purpose of this research study is to learn if adding NOV-002 to the chemotherapy drug carboplatin works in treating ovarian cancer. Platinum containing drugs such as carboplatin are the standard treatment for ovarian cancer, and are effective for many women. However, in many women the cancer eventually stops responding to the chemotherapy (becomes resistant).

The active part of NOV-002 is a substance made by the body that is involved in many chemical reactions in cells. NOV-002 does not directly kill cancer cells, but previous research has shown that it may make cancer cells more likely to be killed by chemotherapy drugs. Specifically, it may help platinum chemotherapy kill cancer that has become resistant to platinum chemotherapy. Previous trials have also shown that patients receiving NOV-002 in addition to carboplatin may have tolerated chemotherapy better than those who received chemotherapy alone. NOV-002 has been used in other research studies on various types of cancer. It is approved for use in Russia. It is not approved by the US Food and Drug Administration (FDA) for use outside of research studies.

In this research study, the investigators are looking to see if adding NOV-002 to the chemotherapy drug carboplatin works in treating ovarian cancer in women whose cancer has stopped responding to carboplatin chemotherapy alone.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube cancer
* ECOG 0-1
* Platinum resistant or refractory disease defined as progressive disease within 6 months of completing or while receiving their last platinum containing regimen
* Measurable disease

Exclusion Criteria:

* History of other malignancies within 2 years except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, incidental stage I endometrial cancer, basal or squamous cell skin cancer
* Major surgery within 2 weeks of study entry
* History of anaphylactic shock with prior platinum chemotherapy
* Known history of central nervous system (CNS) metastases unless subject has had treatment with surgery or radiation therapy and is neurologically stable
* Treatment with more than 3 lines of chemotherapy
* Chronic use of systemic corticosteroids
Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome

Researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with hypoplastic left heart syndrome (HLHS) or HLHS variant. Researchers want to see if there are changes in the heart's structure/function following this stem cell-based therapy and compared to children that have not had cell-based therapy.

This is a Phase IIb trial to determine if the delivery of the autologous UCB-MNC product into the myocardium of the right ventricle of the heart at the time of Stage II surgical repair will provide an improvement in cardiac function, reaching growth and developmental milestones, and quality of life, while also providing a reduction in the cumulative days of hospitalization following Stage II surgical repair. Long-term improvement in cardiac function, reaching growth and developmental milestones, reaching Stage III surgical repair pre-op work-up, prolonging time to cardiac transplantation or death, and improving quality of life will also be determined.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HLHS or HLHS variant with single right ventricular dependent CHD having undergone Stage I surgical repair and undergoing Stage II surgical repair.
* Less than 13 months of age at time of Stage II surgical repair
* Previous participation in the UCB collection protocol with autologous UCB-MNC product that is acceptable for use (treatment arm only)

Exclusion Criteria:

* History of DMSO reaction (treatment arm only).
* Parent(s) and/or legal guardian(s) unwilling to have their child participate or unwilling to follow the study procedures.
* Severe chronic diseases at the discretion of the treating physician.
* Extensive extra-cardiac syndromic features.
* Known history of cancer.
* Any of the following complications of his/her congenital heart disease:

  1. Any condition requiring urgent, or unplanned interventional procedure within 15 days prior to Stage II surgical repair, unless complete and full cardiac recovery is documented by site investigator
  2. Severe pulmonary hypertension (reported in the medical record as \>70% systemic pressure)
  3. Other clinical concerns as documented by a site investigator that would predict (more likely to happen than not to happen) a risk of severe complications or very poor outcome, not directly related to the stem cell product or its injection procedure, during or after Stage II surgical repair.