cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Efficacy of MSENC1 Soft Hydrophilic Contact Lenses and Oxypure Color Soft Hydrophilic Contact Lenses

This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of MSENCI soft hydrophilic contact lenses with Oxypure color soft hydrophilic contact lenses used as the control product.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, no gender limitation;
2. Soft hydrophilic contact lenses worn should be from 0.00D to -12.00D;
3. Subjects should have normal binocular conditions without any abnormality or diseases except for ametropia;
4. The optimal binocular CVA with glasses ≥ 1.0;
5. The astigmatism should be ≤1.5D;
6. Binoculus BUT \&gt;5s;
7. should accept follow-ups for at least 90 days and wear the contact lens as required in the protocol;
8. should understand the purpose of the trial, volunteer to attend and sign the Informed Consent Form by the subjects themselves or their legal guardians.

   .

Exclusion Criteria:

1. Patients who suffer from systemic diseases that prohibit contact lens use or receive treatment that may affect the vision or contact lens use;
2. Patients who have worn hard contact lenses within 4 weeks or soft contact lenses within 7 days before being included in the trial;
3. Patients who are allergic to contact lenses or suffer from systemic allergy;
4. Patients who have keratoconus or other cornea irregularity;
5. Patients who always stay at places that are dry, dust-heavy, having volatile chemicals or otherwise affect the use of soft hydrophilic contact lenses;
6. People who are pregnant, during their lactation or prepare for the pregnancy while being included;
7. People who have only a single eye qualified for the trial;
8. People who have attended a clinical trial of medicine or medical devices other than contact lens within 3 months before being included in this trial;
9. People who have attended a clinical trial of medicine or medical devices other than contact lens within 3 months before being included in this trial;
10. Other cases where investigators determine the soft contact lens should not be used or the candidate should be excluded.
GENetic & Immunologic Abnomalies in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease for which the aetiology includes genet-ic and environmental factors. It is rare in children as compared to adults. The severity may be related to greater involvement of genetic factors in children. The impact of genetics in the development of SLE is important, and the risk of recurrence in siblings evaluated by lambda S ratio is 30 in SLE, while it is 15 for type-1 diabetes and 8 rheumatoid arthritis, thereby indicating high impact of genetics in SLE.

Recently, the group of Professor Yanick Crow in Manchester and other teams has identified new forms of lupus Mendelian genetics. The TREX1 and genes involved in the SAMHD1 frostbite lupus.

Nearly 2 % of all adult subjects with SLE have a heterozygous mutation in the TREX1 gene, which therefore represents the first genetic cause of SLE. The team of Professor Crow also identified the ACP5 gene that is responsible for SLE associated with Spondylo-epiphyseal enchondro-epiphyseal dysplasia (syndromic lupus). Other groups have identified mutations in two genes encoding a DNAse (DNAse1 and DNAse1L3) responsible for familial monogenic forms of SLE. These new genes SLE were identified through research of germ-line mutations in cases of lupus syndromic or family. In collaboration with Professor Crow, we are currently undergoing characterization of a novel gene of SLE in a family and we have identified a second locus identified in another family. The identification of these genes provides a better understanding of the mechanisms regulating immune tolerance in humans. The frequency of these genetic forms is not known. There is very little data on the immunological phenotype of these patients.

This is a clinical study to investigate the genetic and immunological abnormalities associated with pediatric SLE. The aim are to:

* study the genetics of pediatric SLE (or syndromic or family) and to search for mutations in the known genetic lupus or new genes in collaboration with Professor Yanick Crow.
* study the lymphocyte subpopulations and serum cytokines in pediatric patients with SLE (or syndromic or family) in the large Rhône- Alpes- Auvergne area.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject, major or minor of any age with SLE (defined according to the ACR criteria)

   * Onset pediatric (\<18 years) OR
   * Syndromic Lupus (associated with growth retardation, neurological deficit not related to lupus, frostbite, lymphoproliferation, the kidney malformations, heart, lung, brain calcifications) OR
   * Lupus in context with familial consanguinity OR
   * Familial cases (2 cases of SLE related first degree relative) OR related topic of the first degree to a lupus patient participant (if family lupus or related parents) OR
   * mother/father's lupus patient (in cas of simplex lupus)
2. A person or beneficiary entitled to a social security scheme or similar
3. Informed consent signed by the person (or parent / holding parental authority for minors)

Exclusion Criteria:

- none
Study Of Single Dose Of ATN-103 Administered To Healthy Japanese Male Subjects

To assess the safety and tolerability of ascending single SC and IV doses of ATN-103 in healthy Japanese male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male subjects aged 20 to 45 with health determined by the study investigator.
* BMI in the range of 17.6 to 26.4.
* Nonsmoker or male who smokes fewer than 10 cigarettes per day.

Exclusion Criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1.
Assessment of Frailty in Elderly Patients With Advanced Cancers

This study is looking at the feasibility of performing frailty assessments on elderly patients with advanced cancers

This study is primarily looking to see if it is feasible to assess frailty in patients age 70 years and above with advanced cancers. it is also evaluating whether there may be any correlation between these assessments and toxicity and treatment and outcome.

The assessments include: Frailty score, nutritional assessment, comorbidity score and quality of life. In addition sarcopenia will be assessed using timed walk, grip strength and muscle mass measurement from imaging performed as part of routine clinical care.

The assessments will be performed at baseline, week 12 and week 24.

There is the option for patients to also donate blood samples for research purposes.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of advanced carcinoma - not suitable for curative treatment
* Age 70 years or over
* seen by an oncologist for consideration of palliative systemic medical therapy and decision regarding management already made
* WHO Performance Status 0-2
* Written informed consent

Exclusion Criteria:

* Hepatocellular cancer
* Prostate cancer
* Breast cancer
Nobel Procera Crown Shaded Zirconia and NobelProceraTM Full Contour Crown IPS e.Max CAD

Open, controlled, 5-year, prospective, clinical, multi-center study. A total of 143 adult patients will be treated. Female or male, with an age range from 18 (or age of consent) to 70 years, provided they fulfill the inclusion criteria and need two single tooth restorations on contralateral teeth in the same arch. Each patient will receive in minimum one NobelProceraTM Crown Shaded Zirconia and one NobelProceraTM full contour crown IPS e.max CAD in lithium disilicate on the 1st or 2nd molar randomly allocated to the same tooth position contra-laterally in the maxilla or mandible. The patients will be followed for 5 years after receiving their final prosthetic restorations. Possible dropouts and withdrawals, as well as possible adverse events, will be carefully monitored during the entire investigation period.


Eligibility Criteria:
Inclusion Criteria:

* The subject must be at least 18 (or age of consent) and less than 70 at the time of inclusion.
* The subject is healthy and compliant with good oral hygiene.
* The subject is in need of at least two paired contalateral single-tooth full coverage molar restorations in the maxilla and/or mandible.
* The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
* Obtained informed consent from the subject.
* No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
* Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
* The subject is available for the 5-year term of the investigation.

Exclusion Criteria:

* The subject is not able to give her/his informed consent to participate.
* Alcohol or drug abuse as noted in patient records or in patient history.
* Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history.
* An existing condition where acceptable retention of the restoration is impossible to attain
* Mobility of the tooth to be restored.
* Pathologic pocket formation of 4 mm or greater around the tooth to be restored.
* Severe bruxism or other destructive habits.
* Amount of attached soft tissue is insufficient (no attached gingiva on the buccal side of the tooth).
* Health conditions, which do not permit the restorative procedure.
Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients

This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs and/or colchicine. The efficacy of ACZ885 will be compared to the corticosteroid triamcinolone acetonide.


Eligibility Criteria:
Inclusion Criteria:

* History of at least 1 gout flare prior to the Screening Visit
* Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout.
* Presence of acute gout flare for no longer than 5 days.
* Baseline pain intensity \> or = to 50 mm on the 0-100 mm VAS.
* Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both.

Exclusion Criteria:

* Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
* Presence of severe renal function impairment
* Contraindication to intramuscular injection
* Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment
* Evidence of active pulmonary disease
* Live vaccinations within 3 months prior to the start of the study
* Use of forbidden therapy

Other protocol-defined inclusion/exclusion criteria applied
Using CTA Measures to Define Cardiac Risk In NFL Alumni

The GAMEFILM Registry is a post-market, multi-center, data collection study assessing the presence of CAD in NFL alumni.

The GAMEFILM Registry is a post-market, multi-center, data collection study assessing the prevalence and severity of CAD in NFL alumni. A retired NFL player is defined as any former player who made either a practice squad or an active NFL roster. Approximately 300 participants will be included from approximately 20 sites in the US.

Eligibility Criteria:
Inclusion Criteria:

* Retired NFL player

Exclusion Criteria:

* CCTA not successfully processed for FFRct and AI-Plaque
Efficacy and Safety of Camrelizumab for Injection, Apatinib Mesylate and Tegio for First-line Refractory Patients With Advanced Gastric Cancer

This is a prospective, single-center, single-arm, open-label clinical study, aiming at evaluating the efficacy and safety of camrelizumab for injection, apatinib mesylate and tegio for first-line refractory patients with advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1. Aged 18-75;
* 2. ECOG score 0-2;
* 3. Pathologically diagnosed late-stage adenocarcinoma of stomach or gastroesophageal junction, with extra-gastric measurable lesions (spiral CT scan≥10 mm, meeting RECIST 1.1 criteria);
* 4. Patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma that are refractory to first-line chemotherapy;
* 5. Patients who received no previous treatment with apatinib or other VEGFR inhibitors, e.g. sorafenib and sunitinib;
* 6. Normal blood routine examination: Neutrophil count ≥ 1.5 × 109 / L; Hemoglobin ≥ 80 g / L; Platelet count ≥ 100 × 109 / L; Total bilirubin ≤ 1.5 × ULN; ALT, AST≤2.5×ULN；
* 7. Without severe dysfunction of heart, lung, liver or kidney, without jaundice and digestive tract obstruction, and without acute infection.

Exclusion Criteria:

* 1. KPS \< 60, or estimated survival \< 3 months;
* 2. Patients with cardiovascular and cerebrovascular events within half a year; patients with uncontrollable hypertension (systolic pressure \> 140 mmHg, diastolic pressure \> 90 mmHg), coronary heart disease above grade I, arrhythmia (including QTc interval prolongation \> 450 ms in men, 470 MS in women) and grade I cardiac dysfunction; patients positive of urine albumin;
* 3. Patients with definite tendency of gastrointestinal bleeding, local active ulcer focus, and occult blood in stool (+ +); patients with history of black stool and hematemesis within 2 months;
* 4. Abnormal coagulation (INR \> 1.5, APTT \> 1.5 ULN), with bleeding tendency;
* 5. Patients with factors that can affect the absorption of oral-intake drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
* 6. Patients with nervous and mental diseases or with severe infection;
* 7. Pregnant or lactating women or those who have fertility requirements during the study period.
Registry Study on Cystic Fibrosis in Chinese Children

This study is a multicenter, prospective cohort study of patients diagnosed with cystic fibrosis, the clinical information of recruited patients, including clinical manifestations, lung function, chest imaging, quality of life and other indicators, will be followed for 10 years.

All new cases of cystic fibrosis which was confirmed or probably diagnosed at each center from the beginning of the study are made the investigation of the clinical manifestations, sweat test and CFTR mutations by the standard diagnostic process.Then all the patients' following clinical data will be followed for 10 years (once per six month): clinical manifestations, lung function, chest imaging (once per year), quality of life and other indicators.

Eligibility Criteria:
Inclusion Criteria:

* Age 0\~18 years old
* Any organ system symptoms consistent with CF, such as chronic sinopulmonary disease, gastrointestinal and nutritional abnormalities, obstructive azoospermia or having siblings with CF
* CFTR dysfunction indicated by elevated sweat chloride levels ≥60 mmol/L twice, or one sweat chloride levels ≥40 mmol/L plus presence of two pathogenic CFTR mutations on different alleles
* Probable CF patients with sweat chloride levels among 40\~59 mmol/L plus with presence of 0-1 pathogenic CFTR mutation
* Consent to provide the related clinical specimen to the certain hospital
* The guardians of the patients fully understand the purpose of the study, volunteer their children to participate in this study and sign informed consent.

Exclusion Criteria:

* Subject will be excluded if she or he has one of the following:
* It is unable to provide complete medical records or the current condition can not accept the diagnosis process.
* She or he does not agree to participate in the test.
The Association of G9a Protein and Clinical Outcome of Patients With Vulvar Cancer

To assess the G9a expression in vulvar cancer

Vulvar cancer can be treated with surgery, radiotherapy or chemoradiotherapy. Recurrence of vulvar cancer generally can be detected by imaging study. Currently, there is a paucity of sensitive marker to detect the recurrence of vulvar cancer. G9a is a recently identified protein with histone lysine methyltransferase activity. The role of histone methyltransferases in promoting tumorigenesis and progression of human cancers has been noted in some cancers, such as ovarian cancer, endometrial cancer and cervical cancer. The role of G9a protein in vulvar cancer remains obscure.

All female patients with vulvar cancer or vulvar intraepithelial neoplasm II /III who underwent surgery at Far Eastern Memorial Hospital from January 2003 will be included. All patients' clinical characteristerics including age, stage, pathologic finding, and follow-up data will be recorded from chart review.

The archived specimens will be used for immunohistochemical staining of G9a protein. Tumor size, local invasion, lymph node metastasis, and final disease stage will be determined. Correlation will be performed between G9a and clinical outcome of vulvar cancer.

Eligibility Criteria:
Inclusion Criteria:

* All female patients with vulvar cancer or vulvar intraepithelial neoplasm II /III who underwent surgery at Far Eastern Memorial Hospital from January 2003 were included.

Exclusion Criteria:

* N/A
ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM)

This is a phase I/II, single-arm, open-lable study of autologous stem cell transplantation in combination with C-CAR088, an autologous BCMA CAR-T cell product, for patients with ulta high-risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features.

Patients with ultra high-risk multiple myeloma will undergo leukapheresis, stem cell mobilization and collection (could omit if collected before screening), conditioning, ASCT and C-CAR088 infusion. Patients receive a single dose of C-CAR088 three days post-ASCT. Two conditioning protocols and two dose levels of C-CAR088 will be used based on the investigator's discretion. Patients will be evaluated closely for safety of efficacy during the first three months, then less frequently in the following months until 24 months post-ASCT.

Eligibility Criteria:
Inclusion Criteria:

* Transplantation eligible patients, male or female, aged 18 to 65 years
* Ultra high risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features
* Adequate liver, renal, bone marrow, and heart function
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.
* Male and female of reproductive potential must agree to use birth control during the study.

Exclusion Criteria:

* Known allergies to the components or excipients of the C-CAR088 cell product
* Prior allogenic HSCT, or ASCT
* CNS involvement
* Stroke or convulsion history within 6 months prior to signing ICF
* Autoimmune disease, immunodeficiency or disease requiring immunosuppressants treatment
* Uncontrolled active infection; active HBV, HCV infection; HIV or syphilis Infection
* Severe heart, liver, renal or metabolism disease
* Inadequate wash-out time for previous anti-tumor treatments prior to apheresis
* Previous CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment history
* History or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial
Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation of CT Guided Bone Biopsy

This study aims to compare the effectiveness and safety of a dexmedetomidine-propofol combination and a ketamine-Propofol combination for sedation of CT guided bone biopsy.

Assessment of boney lesions is an common activity in the care of cancer patients. CT guided Percutaneous needle biopsies have a low complication rate. usually, this procedure is done under sedation.

Propofol is a non-barbiturate hypnotic and sedative. It facilitates gamma-aminobutyric acid mediated inhibitory neurotransmission. It's known to have anti-emetic, antipruritic, anticonvulsant and amnestic effects. Despite being effective and potent, Propofol's main disadvantages is its dose-dependent hypotension and respiratory depression .Ketamine is a phencyclidine derivative which acts as a N-methyl-D-aspartate (NMDA) receptor antagonist. It is a dissociative anesthetic and provides some analgesia. It maintains airway reflexes and spontaneous respiration. Combining Propofol and ketamine preserves the sedative and analgesic efficacy while reducing their adverse effects. Dexmedetomidine is a highly selective α2-agonist. It is eight times more specific compared with clonidine. It has a perioperative anxiolytic, sedative properties as well as some analgesic properties .Dexmedetomidine is usually used for mild to moderate sedation and Propofol could be added to deepen the level of sedation

Eligibility Criteria:
Inclusion Criteria:

* Stated willingness to comply with all study procedures and availability for the duration of the study .
* Age between 18 to 60 years old
* American Society of Anesthesiologists (ASA) physical I-III
* Scheduled for CT guided bone biopsy with sedation.

Exclusion Criteria:

* Severe heart, lung, and liver disease
* kidney failure
* Bleeding diathesis Allergy to drugs to be used
Five-year Incidence of Age-related Macular Degeneration in the Central Region of Portugal

To assess the five-year incidence of AMD in a population from the central region of Portugal, previously phenotypically characterized.

Subjects who participated in the Epidemiologic Coimbra Eye Study (NCT01298674) between 2009 and 2013 will attend a single visit, after giving informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who participated in the Epidemiologic Coimbra Eye Study (NCT01298674) and that were phenotyped;
* Subjects capable of understanding the information about the study and to give their informed consent to enter the study;
* Subjects willing and able to comply with the study procedures.

Exclusion Criteria:

- Not applicable