cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease

The study was planned to be conducted in 2 parts: Part 1 to determine the efficacy and safety of ECF843 vs vehicle, followed by Part 2 with additional exploratory assessments of ECF843 vs Vehicle. Both parts of the study included a double-masked study design, with randomization stratified for subjects with Sjogren's Syndrome.

Part 1 of the study was a double-masked, randomized, parallel design in which participants were assigned to one of the following five treatment arms/groups in a ratio of 1:1:1:1:1.

* ECF843 0.45 mg/mL three times daily (TID) or vehicle
* ECF843 0.15 mg/mL TID or vehicle
* ECF843 vehicle TID
* ECF843 0.15 mg/mL twice daily (BID) or vehicle
* ECF843 vehicle BID The planned duration of double-masked treatment during Part 1 was 56 days. For subjects randomized to ECF843, the maximum drug exposure was up to 28 days. At some point during Part 1, all participants received vehicle.

The study was terminated after completion of Part 1 and Part 2 of the study was not therefore initiated.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment
* Adult male or female subjects 18 years of age or older
* At least 6 months history of dry eye disease in both eyes
* Must use, or feel the need to use, artificial tears/gels/lubricants on a regular basis
* Composite corneal fluorescein staining score \>= 4 (modified National Eye Institute (NEI) scale) in at least one eye
* Schirmer score \>= 1 and =\< 10 mm after 5 minutes in at least one eye
* Patients with Sjögren's Syndrome must have dry eye

Exclusion Criteria:

* Ocular infection in either eye within 30 days prior to Screening
* Use of artificial tears, gels, lubricants within 4 hours of the Screening Visit
* Use of contact lenses in either eye within 14 days of Screening
* Uncontrolled ocular rosacea
* Clinically significant conjunctivochalasis in either eye
* Other Corneal conditions affecting the corneal structure
* Severe ocular conditions such as herpes, graft versus host disease, Stephen's Johnson Syndrome, sarcoidosis
* Currently active, or history of ocular allergies during the time of year the patient will be participating in the study
* Patients with current punctal plugs or punctal cauterization or occlusion
* Chronic medications (both over the counter and prescription) that have not been stable for at least 30 days prior to Screening.
* Use of Restasis®, Cequa®, or Xiidra® within 30 days prior to Screening
* Use of ocular, nasal, inhaled, or systemic corticosteroids within 30 days of Screening
* History of malignancy of any organ system within the past five years
* Pregnant or nursing women
A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza

This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2 years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10 doses). For patients whose conditions no longer merit continued iv dosing, therapy may be switched to oral Tamiflu to complete their prescribed course of treatment. If medically necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days. Anticipated time on study treatment is 5 to 10 days.


Eligibility Criteria:
Inclusion Criteria:

* children, 1-12 years of age
* diagnosis of influenza
* duration of influenza symptoms \</=96 hours prior to first dose of study drug

Exclusion Criteria:

* evidence of severe hepatic decompensation
* patients taking probenecid within 1 week prior to first dose of study drug
A Study to Evaluate Solrikitug in Participants With COPD (ZION)

A Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (COPD).

This is a 12-week randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 2 dose levels of solrikitug versus placebo on top of standard of care in participants with COPD.

Approximately 171 eligible participants with COPD will be randomized at approximately 60-90 sites. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 12-week treatment period. The study also includes a post-treatment follow-up period of 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* At least 40 years of age and no older than 75 years.
* Documented diagnosis of COPD for at least 12 months prior to Screening, defined by the GOLD Guidelines (2023), and elevated blood eosinophils at screening.
* At Screening FEV1/FVC ratio must be \<0.70, and Post-bronchodilator FEV1 must be ≥40% to \<80% predicted normal value calculated using Global Lung Function Initiative (GLI) reference equations (Cooper et al 2017).
* Symptomatic (COPD Assessment Test \[CAT\] Score ≥10) at Screening Visit 1.
* Participants must be on 2 or more inhaled maintenance medications for management of their COPD, for at least 3 months prior to screening.

Exclusion Criteria:

* Female participant who is pregnant or breastfeeding.
* Participant has a known hypersensitivity to any component of the formulation of solrikitug, including any of the excipients, or a history of anaphylactic reaction to any therapeutic monoclonal antibody.
* Participant has history or evidence of any clinically significant cardiovascular, hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the Investigator or Medical Monitor might obfuscate the study data.
* Any other pulmonary disease than COPD that in the opinion of the Investigator, the severity of the disorder would impact the conduct of the study.
* Undergone major lung surgery, within 1 year of Screening Visit 1.
* Participant has a lower respiratory tract infection that required antibiotics within 6 weeks prior to Screening.
Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular Hypertension

The purpose of this study is to evaluate the safety and efficacy of BETOPTIC S and Timolol Gel-forming solution in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.


Eligibility Criteria:
INCLUSION:

* Children 5 years old and younger
* require treatment for glaucoma or ocular hypertension
* whose vision is 20/80 or better
* have a cup-to-disc ratio of 0.8 or less

EXCLUSION:

* do not have abnormal fixation
* IOP greater than 36 mm Hg
* significant retinal disease
* penetrating keratoplasty
* severe ocular pathology
* optic atrophy
* eye surgery in the past 30 days
* cardiovascular abnormalities
* hypersensitivity to beta blockers
Electromagnetic Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder

The purpose of this study is to collect data on the safety and efficacy of using an electrical field stimulation device, compared to a sham (placebo) device, to treat urinary urgency, urinary frequency and urge incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Urinary Urge Incontinence
* Urinary Frequency

Exclusion Criteria:

* Primary complaint of Stress Incontinence
* Neurogenic bladder
* Overflow Incontinence
* Functional Incontinence
Minimally Invasive Sinus Lift Through the Interradicular Septum

This study aims to describe a new approach for the reconstruction of the alveolar process in the sinus area. This minimally invasive approach will access the maxillary sinus through the alveolar process, elevating the sinus membrane in the area immediately above it. The regeneration may be achieved in the specific area required for dental implant placement, reducing the morbidity of the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years.
* Plaque index and bleeding index less than 30%.
* Invagination of the sinus cavity in the interradicular area of the upper first molar.
* Upper first molar not restorable and with height of the interradicular remnant less than 5 mm.

Exclusion Criteria:

* Presence of systemic disease contraindicating the intervention.
* Pregnant women.
Performance Evaluation of ANI in Patients Under General Anesthesia With Remimazolam

The purpose of this study is to determine whether Analgesia Nociception Index (ANI) can effectively reduce the dose of opioid in patients who underwent general anesthesia using remimazolam.


Eligibility Criteria:
Inclusion Criteria:

Patients

* aged 20-79 years under general anaesthesia with remimazolam
* scheduled to undergo robotic surgery
* in American Society of Anesthesiologists physical class 1, 2 or 3
* voluntarily agree in writing to participate in this clinical study

Exclusion Criteria:

* Conditions affecting the autonomic nervous system
* other conditions or disease that may cause acute or chronic pain
* the NRS before induction of anesthesia is 1 or over
* When taking medications that may affect the autonomic nervous system
* In other cases where the investigator deems the subject unsuitable for this trial
Autophagy Bladder Cancer

• Bladder cancer is the most common malignancy of the urinary tract. It represents the 7th most commonly diagnosed cancer in male population worldwide and drops to the 11th when both genders are considered . According to the American cancer society's estimates of bladder cancer in 2017, the number of the new cases of bladder cancer is 79,030, and the mortality figures reached 16,870 .

* In Egypt, Bladder Cancer is the most prevalent malignancy among Egyptian males (16%) producing more than 7900 deaths annually . The majority of patients with bladder cancer about (70-80%) present with non-muscle invasive bladder cancer .
* Autophagy is a highly conserved catabolic process that degrades cellular organelles and proteins to maintain cellular biosynthesis during stress ; cancer cells induced autophagy to counteract with anticancer therapy by helping them to evade apoptotic pathway .Autophagy is achieved by many autophagy-related genes .
* Previous studies found that human bladder cancer cell lines exhibit high basal level of autophagic activity that may contribute to resistance to current anticancer treatment, so targeting basal autophagy may help to develop novel therapeutic strategies . Autophagy is potently induced by activating transcription factor 6(Endoplasmic Reticulum stress marker) , and Malondialdehyde (oxidative stress marker) .
* Recently several studies demonstrated the role of autophagy in Bladder Cancer progression as evidenced by detection of microtubule associated protein and its relevance with muscle invasion beside its grade dependency . Autophagy was grade dependent process . Autophagy related gene 7 is a key protein involved in autophagosomes biogenesis, Knockdown of Autophagy related gene 7 induced apoptotic cell death in bladder cancer cell lines measured by increased caspase 3 level, Based on these previous studies autophagy plays a role in bladder cancer progression so interruption of its pathway may serve a novel target for future therapies.

Eligibility Criteria:
Inclusion Criteria:

* 1)patients confirmed histopathologically to have bladder cancer. 2) Both sexes. 3) Patients who will accept to participate in the study.

Exclusion Criteria:

* Patients with past history of Bladder Cancer with previous chemotherapy or any other types of cancer in the last 5 years.
Efficacy of Systane Ultra in Post Menopausal Women With Dry Eye

To evaluate the efficacy of Systane Ultra in post menopausal women with dry eye.


Eligibility Criteria:
Inclusion Criteria:

1. Post-menopausal (menses ceased more than 12 months prior to the start of the study).
2. Diagnosed for dry eye

Exclusion Criteria:

1. History of Sjögren's Syndrome or evidence of chronic dry eye syndrome. Confirmed autoimmune connective tissue diseases such as rheumatoid arthritis, fibromyalgia or scleroderma.
2. Active and severe blepharitis, rosacea and associated ocular sequelae.
3. Has any significant eyelid abnormality affecting lid function.
Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients

The aim of this 6-month randomized multi-regional double-blind parallel group placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between the ages of 18 85 years, inclusive.
* Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2015 criteria.
* Subjects who are currently on urate-lowering therapies (ULT) with an sUA level ≥6.0 mg/dL at screening (Visit 1); or subjects who are currently not on ULT with an sUA level ≥7.0 mg/dL at screening (Visit 1). Subjects currently on ULT will undergo washout and must have an sUA level ≥7.0 mg/dL at Visit 3 to be randomized and participate in the study.
* Subjects with a Body Mass Index ≤50 kg/m2 and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening (Visit 1).

Exclusion Criteria:

* Subjects with secondary hyperuricemia, enzymatic defects.
* Subjects experiencing an acute gout attack (intense pain, swelling, or/and tenderness in the joint area) within 2 weeks prior to screening (Visit 1).
* Subjects who have received pegloticase to treat gout which has not responded to the usual treatments.
* Subjects who have not been receiving stable doses of drugs known to affect sUA levels for the last 3 weeks prior to screening (Visit 1).
* Subjects with a history of xanthinuria (elevated levels of xanthine in the urine) and rheumatoid arthritis
Randomized Controlled Trial Comparing Different Closure Methods for Laparoscopic Port Sites

This study wishes to compare patient satisfaction and cosmesis of two different closure methods of laparoscopic ports. One method uses tissue adhesive (Dermabond) with a deep sub-cutaneous stitch and a Band-Aid dressing. The comparison method uses a 3.o undyed vicryl transcutaneous stitch, with a Bacitracin and Tegaderm dressing.


Eligibility Criteria:
Inclusion Criteria:

* gynecologic laparoscopy patients

Exclusion Criteria:

* known sensitivity to tissue adhesive, antibiotic ointment
Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy ￼

This is a prospective trial evaluating dose escalation using an SBRT boost to poor- responding tumors by interim functional imaging (PET/CT and fMRI) to improve the local control of HNCSCC.


Eligibility Criteria:
Inclusion Criteria:

* More than or equal to 18 years old. ECOG Performance Scale (0-2). Histological confirmation of SCC of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx.

Clinical stage II-IVB (AJCC, 8th edition). Multidisciplinary decision of radical radiation or concurrent chemoradiotherapy (CCRT).

Informed consent obtained, signed and dated before specific protocol procedures.

Exclusion Criteria:

* Stage I/II glottic cancer. Patients who underwent surgery for the primary tumor location. Distant metastases. Inability to undergo PET-CT or MRI. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease- free for a minimum of 5 years. Prior radiotherapy to the region of the head and neck that would result in overlap of radiation fields. Any psychological, familial, sociological or geographical condition that hamper compliance with the study and/ or follow up schedule.
A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders

The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.


Eligibility Criteria:
Inclusion Criteria:

* Meet the 2015 international consensus diagnostic criteria for Neuromyelitis Optica Spectrum Disorders and astrocyte water channel aquaporin-4 (AQP4) antibody positivity.
* EDSS 0-7.5
* Clinical evidence of at least 2 relapses within the first two years of randomization and/ or 1 relapse within the first one year of randomization
* Consent to use effective contraception during the study period (women of childbearing age)
* Voluntarily signed informed consent

Exclusion Criteria:

* Abnormal laboratory parameters need to be excluded, including but not limited to:
* Currently suffering from active hepatitis or serious liver disease and medical history
* Patients were treated with rituximab or other monoclonal antibodies within 6 months prior to randomization .
* Any concomitant disease other than neuromyelitis optica（NMO）/ neuromyelitis optica Spectrum disorders（NMOSD）that required treatment with lucocorticoid.
* pregnant , lactating women and men or women who have birth plans during the research;
* Have a history of allergic reaction to contrast agent for parenteral administration and human biological medicines.
* Receipt of intravenous immune globulin （ IVIG） within 28 days prior to randomization.
* Receipt of any of the following prior to randomization: Azathioprine,Cyclosporin, Methotrexate Mitoxantrone,Cyclophosphamide,Tocilizumab,Tacrolimus,Mycophenolate,and Patients discontinued more than 5 times the half-life of the drug before they could get into the group .If the patients taking leflunomide and teriflunomide,they should need to take colestyramine for elution.
* Have participated in any clinical trial in the first 28 days of the initial screening or 5 times half-life period of the study compound (taking shorter time ).
* The patients have severe psychiatric symptoms and are not compatible with clinical studies
* Malignant tumor patients ;
* patients experienced any of the following events within 12 weeks before screening : myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association class IV heart failure
* Patients can't accept magnetic resonance imaging inspection during the trial.
* Infection with herpes zoster or HIV virus at the screening;
* The anti-hepatitis C virus （anti-HCV） of patients show positive;
* Investigator considers candidates not appropriating for the study.
Evaluation of the Roll of IV Fluids in the Treatment of Renal Colic

A randomised controlled trial to evaluate the role of IV fluids in renal colic.

A RCT (Randomized Controlled Trial)to evaluate the role of 0.9% NACL (sodium chloride) IV fluids during an acute renal colic. The 2 arms will include -

1. 2 liters of 0.9% NACL IV fluids with pain killers
2. only pain killers The object is to find out if the IV fluids has any advantage in the care of renal colic. Does it helps to relive the pain? Does the stone eject earlier? Will there be fewer interventions?

Eligibility Criteria:
Inclusion Criteria:

* above 18 years
* clinical renal colic
* a radiological proof (CT,US) to urolithiasis

Exclusion Criteria:

* below 18 years
* has a contraindication for IV fluids (such as CHF (Congestive Heart Failure)etc.)
Tyrosine Allergoid Paediatric and Adult Study

The primary objective of this 5-year study is to demonstrate non-inferiority of children compared to adults by exploring long-term effectiveness after treatment with TA Bäume (trees) and TA Gräser (grass) following a perennial posology.


Eligibility Criteria:
Inclusion Criteria:

* Patients from 5 years of age who are treated with TA Gräser top or TA Bäume top due to rhinitis, conjunctivitis and/or mild to moderate bronchial asthma, which are caused by an IgE-mediated allergy to grass and rye pollen or birch, alder and hazel pollen according to the respective SmPC.
* Patients will only be included in this study after the decision on the treatment has been made.

Exclusion Criteria:

* History of allergen-specific immunotherapy (SIT) for trees or grass within the last 5 years
* If it´s intended to treat the patient with only a preseasonal therapy
* A patient should also not be included in the presence of any of the conditions listed in the respective SmPC
Respiratory Physiotherapy as a Tool to Increase the Number of Solid Organ Donors

The main objective of the project is to determine the variation of PaO2 / FiO2 (PaFi) after the use of mechanical insufflation-exsufflation (MI-E) or mechanical cough assistant in the donor in brain death (DBD) and in the potential donor in control donor after circulatory death (cDCD) It is a randomized prospective multicentre study. Four centres with a solid organ donation program will participate in the study, the Hospital Clínic i Provincial de Barcelona (HCB), the Germans Tries y Pujol Hospital (HGTP), the Marqués de Valdecilla Hospital (HMV) and the Vall d'Hebron Hospital (HVH). One hundred and sixty consecutive eligible donors will be included in DBD and cDCD older than 18 years.

* P1: Eighty donors will be maintained following national guidelines.
* P2: Eighty donors will be maintained following national guidelines and:
* Manual techniques of secretion drainage
* Two sequences separated for 1 min of 6 cycles each of MI-E(Cough Assist E70, Respironics Philips.

Demographic variables of the donor and recipient will be collected, as well as differences in PaFi, static compliance, and radiographic changes between P1 and P2 donors. The percentage of lung donors recovered by P2 with respect to P1 will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Organ donor older than 18yo

Exclusion Criteria:

* Absolute contraindications for MIE's use
* Absolute contraindications for organ donation
The Effect of Vırtual Realıty Glasses on Heart Faılure Patıents

Anxiety and sleep disorders are among the most common symptoms in heart failure patients. In addition to pharmacological methods for anxiety and sleep disorders, non-pharmacological methods can also be used. Among these, anxiety and sleep disorders can be prevented with virtual reality glasses aimed at distraction. This study will be conducted to evaluate the effect of breathing exercises performed with virtual reality glasses on anxiety, sleep quality, and respiratory parameters. The study will be conducted with a total of 45 patients, 15 virtual reality glasses + breathing exercises, 15 breathing exercises, and 15 controls. Those in the virtual reality glasses + breathing exercises group will perform breathing exercises with virtual reality glasses once a day for 7 days. Those in the breathing exercises group will perform only breathing exercises once a day for 7 days. Anxiety, sleep disorders, and respiratory parameters of the patients will be examined.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* Verbal communication,
* Place and time oriented,
* Without any psychiatric illness,
* Patients diagnosed with HF with NYHA class III-IV symptoms,
* Left ventricular ejection fraction ≥50% (LVEF-CF/HFpEF), between 40-49% (SEF-CF/HFmrEF), HF below 40% (DEF-CF/HFrEF),
* High levels of natriuretic peptides (BNP\&gt;35 pg/mL and/or NTproBNP\&gt;125 pg/mL),
* There is no deformity or diagnosis related to the musculoskeletal system that may prevent breathing exercise,
* Chronic diseases such as hypertension (Stage 1 and 2 HT) and diabetes mellitus are stable and the treatment for these diagnoses has not been changed in the last month,
* Who have not previously received respiratory exercise training and have not participated in a rehabilitation program,
* Patients who volunteer to participate in the study will be included in the study

Exclusion Criteria:

* Life signs are so abnormal as to preclude intervention,
* Patients with migraine, vertigo, active nausea-vomiting, headache, dizziness will not be included in the study.