cyrilzakka/clinical-trials huggingface dataset:
The COAT Trial: Cequa's Onset of Action Trial

Cequa's Onset of Action Trial: an Investigation of CEQUA's Speed of Onset in Improving Ocular Surface Health in Dry Eye Patients

The purpose of this study is to examine the speed of onset of CEQUA ™ in improving the ocular surface among patients with dry eye.

Eligibility Criteria:
Inclusion Criteria:

\*Patients with the following signs: Central or inferior corneal fluorescein staining defined by the Oxford Scale Reduced tear break up time (TBUT) ≤ 10 seconds.

* Able to comprehend and sign a statement of informed consent.
* Willing and able to complete all required postoperative visits.

Exclusion Criteria:

* Ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
* Clinically significant ocular trauma.
* Active ocular Herpes simplex or Herpes Zoster infection
* Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
* Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
* Active, systemic, or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the study findings.
* Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
* Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
* Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis).
* Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
* Participation in this trial in the same patient's fellow eye
* Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.
Study Evaluating the Effect of Moving Virtual Scenes on Postural Balance in a Stroke Rehabilitation Setting

This is an interventional, prospective, randomized, monocentric study designed to develop medical knowledge.

Virtual reality is increasingly used in rehabilitation. The aim of virtual reality is to investigate motor interactions in a fictitious, configurable environment, in order to train specific functions and transpose improvements into everyday life.

The main objective of this study is to investigate the influence of different moving virtual scenes on the general spatiotemporal parameters of pressure centers, in a sub-acute stroke rehabilitation context.

This would help health professionals to assess the most suitable VR exercise in function of patient's difficulties.

During this study, patient movements while viewing 8 different virtual reality scenes will be recorded using a motion platform during a single session.


Eligibility Criteria:
Inclusion Criteria:

* Age: over 18
* Adult patient in rehabilitation stay (day or full hospitalization) following a first stroke less than 6 months old.
* One of the rehabilitation objectives is to improve balance
* Ability to understand exercise instructions
* Ability to stand for at least one minute with eyes closed, safely and without technical assistance
* Ability to walk at least with technical assistance and/or supervision
* Patient having given their informed consent
* Patient affiliated to a social security scheme

Non -inclusion criteria :

* Patients with epilepsy, controlled or not
* Patients undergoing rehabilitation following a stroke in the posterior fossa
* Known history of vestibular or cerebellar balance disorders
* Patients with orthopedic or traumatological impairment preventing stabilometric measurement on a force platform without footwear
* Patient under legal protection measure
* Severe phasic disorders that may prevent the expression of the will to stop viewing virtual scenes or to respond to numerical scales
* Pregnant or breastfeeding woman
* Known history of motion sickness
* Patient participating or having participated in the balance rehabilitation program with virtual reality within the rehabilitation center during their stay

Exclusion Criteria :

* Cyberkinetosis represented by a score greater than or equal to 15 on the Fast Motion Sickness scale
* Poor tolerance for wearing a virtual reality headset
* Significant visual impairment preventing the perception of the stimulus visual
A Study of NeoRecormon in Patients With Chronic Kidney Disease.

This 2 arm study will compare the level of anemia, and the decline in renal function, between patients receiving NeoRecormon, and those not receiving it. Patients with chronic kidney disease, stage 2-4, and not receiving dialysis, will be randomized 2:1 to a group receiving NeoRecormon (at a dose determined by the investigator to achieve and maintain an Hb level of 120-135 g/L), or to a control group not receiving NeoRecormon. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients,18-75 years of age;
* end-stage renal disease, not on dialysis;
* Hb \<110g/L.

Exclusion Criteria:

* unstable hypertension;
* acute infections;
* use of i.v. NeoRecormon, or use of any other ESA beside NeoRecormon;
* myocardial infarction, unstable angina or venous thrombosis within 6 months before start of treatment.
Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - Iberis-HTN Registry

The purpose of this study is to document safety and efficacy of renal sympathetic denervation treatment in subjects with uncontrolled hypertension by using Iberis renal denervation system.

This study is a prospective, multi-center, single-arm, non-interventional and open-label registry to collect descriptive data from patients who receive renal sympathetic denervation treatment in accordance with routine hospital practice using Iberis system.

This registry will collect data prospectively from patients that receive renal sympathetic denervation treatment with use of Iberis renal denervation system and treatment will be applied according to the routine hospital practice. No additional tests are required specific to this registry. The registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, efficacy and functionality of the Iberis system in patients with resistant hypertension.

A minimum of 30 patients will be enrolled in Europe

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years or minimum age as required by local regulations.
* Patient has been thoroughly informed about this registry and signed Informed Consent Form.
* Patient with true resistant hypertension defined as:

  * Office systolic BP higher than 160 or 150mmHg in case of type 2 diabetes
  * Ambulatory BP with average BP\>130mmHg or mean daytime\>135mmHg in more than 70% of the measurements.
* Patients should be on stable hypertension therapy for at least 8 weeks before procedure, including spironolactone if they are supposed to be respondent as indicated by the specialized center/excellence unit on hypertension.

Exclusion Criteria:

* Previous renal artery intervention (balloon angioplasty or stenting).
* Evidence of renal artery atherosclerosis (defined as a renal artery stenosis \>50%).
* Main renal arteries of less than 4mm diameter or less than 20mm in length.
* Presence of multiple main renal arteries in either kidney.
* Estimated glomerular filtration rate \<45ml/min per 1,73m2
* Recent myocardial infarction, unstable angina pectoris or cerebrovascular accident within the past 3-6 months.
* False resistant hypertension (pseudo resistance) by using 24h ambulatory BP monitoring (ABPM).
* Secondary arterial hypertension.
* Pregnancy.
* There is another pathological process with well-known life expectancy of less than 5 years.
* Patient unable to do correct FU.
* Unable to take correct ambulatory BP.
* Primary hyperaldosteronism.
* Known lack of adherence to medical treatment.
Tai Chi for Osteopenic Women

This study will assess the effectiveness of Tai Chi to affect the rate of bone loss in post-menopausal women who have been diagnosed with the initial stages of bone thinning.

Osteopenia is a serious and growing public health concern for women. Osteopenic women are at greater risk for fractures than women with normal bone mineral densities (BMD). Low BMD-related fractures are associated with significant long-term impairment, high morbidity rates and high medical costs. Optimal preventive and sustainable interventions for osteopenic women are not yet well-defined.

Tai Chi, a mind-body exercise that is growing in popularity in the U.S., shows may be an effective, safe and practical intervention for women with low bone density. Preliminary studies suggest Tai Chi can reduce rates of BMD decline in post-menopausal women. While suggestive, these studies have numerous design limitations.

We propose a pilot randomized controlled trial to assess the efficacy and feasibility of Tai Chi as an adjunct to standard care for post-menopausal osteopenic women. Eight-six osteopenic women ages 45-70 will be recruited from a large multi-specialty group practice. Our primary aim is to assess the feasibility for recruiting and retaining osteopenic women into a randomized controlled trial of 9 months of Tai Chi. Our secondary aim is to collect preliminary data on the efficacy of Tai Chi in reducing rates of bone loss in osteopenic women using sensitive markers of bone turnover and dual-energy x-ray absorptiometry. The results of this study will inform the design of a future trial evaluating the benefits and safety for Tai Chi for osteopenic women, as well as the physiological and biomechanical mechanisms through which Tai Chi may impact BMD and fracture risks associated with osteopenia.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 45-70 years
* BMD T-scores of the hip (femoral neck or trochanter) and/or spine between -1.0 and -2.5
* Post-menopausal w/out menses for ≥ 12 months
* Sedentary, i.e. do not regularly participate in physical exercise on average 1 or more times per week

Exclusion Criteria:

* Osteoporotic (T-score \< -2.5) or a fracture in the past 2 years not caused by motor vehicle accident
* Prior or current use of use of medication that increase risks of fracture (e.g. steroids, anti-convulsants, anticoagulants, lithium)
* Prior or current use of medications that modify bone metabolism (e.g. bisphosphonates, selective estrogen receptor modulators such as Raloxifene)
* Use of calcium supplements above levels suggested within the recommendations of standard care (i.e., above 1200-1500 mg)
* Current or prior year use of estrogen or calcitonin
* Malignancies other than skin cancer
* Diagnosis of anorexia along with a BMI of \< 17.5
* Conditions that cause secondary osteoporosis (e.g. Cushing's syndrome, Marfan's syndrome)
* Tobacco use in past year
* Physical or mental disabilities that will preclude informed consent or active study participation
* Geographic or scheduling limitations that would preclude required participation in weekly Tai Chi classes and study procedures
* Current regular practice of Tai Chi
Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice

The study addresses the safety, utilisation and effectiveness of Obizur in the treatment of bleeding episodes in real-life clinical practice in Europe and the United States.


Eligibility Criteria:
Inclusion Criteria:

* Adult participant (or legal representative) is willing to provide informed consent
* Participant is being treated or was treated (treatment initiation within 30 days) with Obizur in routine clinical practice

Exclusion Criteria:

* Participant has known anaphylactic reactions to the active substance, hamster protein or to any of the following excipients: Polysorbate 80; sodium chloride; calcium chloride dihydrate; sucrose; Tris Base; Tris HCl; Tri-sodium citrate dihydrate; sterilized water for injections
* Participant has participated in a clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device at study entry
Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED)

This study determines recommended clinical dose, to evaluate the safety, tolerability and pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors who have failed standard therapy or for whom no standard therapy exists, in two dosing schedules in Japan.


Eligibility Criteria:
Inclusion Criteria

* Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
* Participant must have Performance Status 0 or 1.
* Participant must have adequate organ function.

Exclusion Criteria

* Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
* Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
* Participant has known hypersensitivity to the components of study drug or its analogs.
* Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.
Support Through Remote Observation and Nutrition Guidance (STRONG) Program for Gastroesophageal Cancer (GEC) Patients

The purpose of the study is to assess the feasibility and patient satisfaction with the Support through Remote Observation and Nutrition Guidance (STRONG) program. The program provides nutrition support for participants living with gastroesophageal cancer who are receiving chemotherapy and radiation treatment


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Locally advanced or metastatic GEC diagnosis
* Planned to initiate chemoradiation and/or radiation therapy with a plan to have surgery or a plan to have definitive treatment at Moffitt.
* Able to speak and read English
* Able to provide informed consent

Exclusion Criteria:

* Documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse)
* Undergoing concurrent treatment for a secondary primary cancer
* Use of feeding tubes before enrollment (The last exclusion criterion was included because investigators do not anticipate these participants would benefit from a dietary monitoring intervention)
Assessment of Nutritional Status and Role of Insulin-like Growth Factor-1 in Children

Many studies done on children with thalassemia have shown a variable prevalence of defective IGF-I concentrations have been shown to be low in the majority of children, with or without GH deficiency. The Aim of this study to assess nutritional status and role of Insulin-like growth factor 1 (IGF-1) and its associating factors in children with thalassemia major


Eligibility Criteria:
Inclusion Criteria:

* Children in the age group of 2-18 years with confirmed diagnosis of Beta thalassemia major.

Exclusion Criteria:

* Children with other chronic diseases (cardiac, renal, vascular)
* Children with malignancy
Feasibility of Biodynamic Imaging for Predicting Therapeutic Effect in Metastatic Adenocarcinoma of the Pancreas

The purpose of this study is to determine if you can use an assay on tumor samples to see different patterns in response to the same chemotherapy treatment.

To examine the feasibility of using biodynamic imaging (BDI) as a chemosensitivity assay on fresh tumor samples obtained by core needle biopsy from patients planned to receive routine care gemcitabine and nab-paclitaxel for treatment of metastatic adenocarcinoma of the pancreas.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and willingness to sign an informed consent and authorization for release of health information for research
2. ≥ 18 years old at time of consent
3. Patients with a diagnosis of metastatic pancreatic cancer (mPC) who have not received prior combination chemotherapy. Exception: prior adjuvant chemoradiation with fluorouracil or gemcitabine is allowed.
4. Patients considered for routine care treatment with gemcitabine and nab-paclitaxel (allowed to receive other experimental therapy with gem/nab backbone if participating in another clinical trial)
5. Measurable disease by RECIST v1.1 criteria
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
7. Willingness to undergo transcutaneous core needle biopsy of metastatic tumor for research purposes
8. Women are eligible to participate if they are of non-childbearing potential or have documentation of a negative pregnancy test (serum or urine β-hCG) within 1 week of the start of protocol treatment.
9. Women and men of childbearing potential must agree to use adequate, highly effective contraceptive measures during protocol treatment
10. Laboratory values: Platelets ≥ 100 K/mm3 international normalized ratio (INR) \< 1.2, Partial thromboplastin time (PTT) in normal range, Cr \< 2.0, Total bilirubin \< 2 times upper limit normal (ULN), transaminases \< 5 times ULN

Exclusion Criteria:

1. History of abnormal bleeding with minor procedures or documented platelet aggregation disorder such as VonWillebrand disease
2. Women who are pregnant or breastfeeding
Study Evaluating The Prevalence Of Undiagnosed Psoriatic Arthritis In Patients With Plaque Psoriasis

This study aims to collect Australian data on the prevalence of undiagnosed psoriatic arthritis in patients with plaque psoriasis. In addition the study will assess disease severity and quality of life in Australian patients with psoriasis attending specialist dermatology clinics.

Consecutive psoriasis patients seen at each site will be invited to participate in the study

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of plaque psoriasis
* \>= 18 years of age
* Able to complete English-language questionnaires

Exclusion Criteria:

* Participation in an interventional clinical trial in previous 3 months
* Known rheumatologist-confirmed psoriatic arthritis
A Phase IV Study to Assess the Safety of EupentaTM Inj

A prospective, open-label, interventional phase IV study to assess the safety of EupentaTM Inj.{fully liquid pentavalent vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA \[recombinant-deoxyribonucleic acid\])-Haemophilus influenzae type b conjugate vaccine}


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained from the parents or legally acceptable representatives (LARs) of the subject who have been informed of the purpose, method, effects, etc., of the study
2. A male or female 6 to 8 weeks of age, inclusive, at the time of the first vaccination
3. In good health as determined by medical history, physical examination, and judgment by the Investigator
4. Body weight 3.2 kg and over at the time of screening
5. Subjects for whom the Investigator believed that their parent(s)/LAR(s) could comply with the requirements of the protocol (e.g., completion of the Subject Diary Cards, return for site visits)

Exclusion Criteria:

1. Past or present medical history of known or suspected diphtheria, tetanus, pertussis, polio, HB and/or Hib diseases
2. Any history of allergy to any of the components or excipients of EupentaTM Inj., including aluminum hydroxide, sodium hydrogen phosphate heptahydrate, monobasic sodium phosphate dihydrate, polysorbate and thimerosal
3. Any medical condition which can compromise the infant's safety, as per Investigator's discretion
4. History of seizures or abnormal cerebral signs in the newborn period or other serious neurological abnormality
5. History of bleeding tendencies
6. Household contact and/or intimate exposure with a confirmed case of diphtheria, pertussis, HB, polio and/or Hib diseases within in 30 days prior to screening
7. History of fever ≥ 38°C/ 100.4°F within 3 days prior to screening and/or intake of anti-pyretic/analgesic medication. Subjects who meet this criterion will be rescreened to check the temperature after the temporary condition has resolved and if they are within the window period for age of first vaccination at the time of re-scheduled visit
8. History of previous diphtheria-tetanus-pertussis (DTP), and/or Hib vaccination doses
9. History of previous or concurrent vaccinations other than Bacillus Calmette-Guérin (BCG), HB vaccination at birth, Polio, Rotavirus and Pneumococcal vaccines
10. Known or suspected immune disorders, or, received immunosuppressive therapy
11. Participation 30 days prior to screening in the study or simultaneously in another study and/or received any investigational product