cyrilzakka/clinical-trials huggingface dataset:
RESOLUTE ONYX China Single Arm Study

It is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de novo lesions amenable to treatment with Resolute Onyx™ Stent System in China.

This study is a pre-Market, prospective, multi-center, single arm trial. Subjects will be enrolled and followed through 5 Years (screen, implant procedure(including post-procedure assessment),30-Day, 6 Months, 9 Months-subjects implanted with fringe size, and annual assessments from 1-5 years).

Eligibility Criteria:
Key Inclusion Criteria:

* The subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, and the IB of Resolute Onyx stent.
* The subject requires treatment of up to 3 target lesions in up to 2 separate target vessels \[2 target lesions in 1 vessel (including its side branches) and 1 target lesion in a separate vessel (including its side branches)\] amenable to treatment with stents with diameter from 2.25 mm to 5.0 mm

Key Exclusion Criteria:

* Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
* PCI of the target vessel within 9 months prior to the procedure
* Active bleeding
* Subjects with a life expectancy of less than 12 months
* Participation in another clinical study
* Pregnant, or lactating women
Impact in Off-spring of Mothers After Perinatal Daily Intake of a Probiotic

A probiotic (Lactobacillus rhamnosus GG) supplement to pregnant women the last four weeks of pregnancy and three months after birth is expected to give a 40% reduction in risk of atopic sensitisation and allergic disease at two years of age, compared to placebo.

To investigate how probiotics given to pregnant women during the last 4 weeks of pregnancy and the first 4 months after birth influence the establishment and composition of the gut microflora in children from birth until two years of age.

At the same time to investigate the relationship between gut flora composition and the development of the immune system.

To investigate the relationship between supplement of probiotics to pregnant and breast-feeding women, the microbial composition of the gut flora in their children, the development of the childrens' immune system, and the prevalence of atopic sensitisation and atopic disease at two years of age.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women understanding Norwegian language and who has signed an informed consent form, can be included.
* Inclusion must take place before week 36 in the pregnancy.
* The woman must plan to breast-feed the first 4 months after birth.
* She must live in Trondheim.

Exclusion Criteria:

* Not being able to fill in the questionnaire in Norwegian language
* Lactose intolerance
* Consumption of probiotics earlier in the pregnancy.
* Intention to move from Trondheim in the next 25 months.
* Pregnant women in risk of eclampsia, or other serious disease that can influence beast-feeding or care for the child.
Adjunctive Role of PRF After Free Gingival Graft Harvesting - Case Series

Free gingival grafts are important to increase zone of attached gingiva and root coverage. This case series reveals role of platelet-rich fibrin (PRF) as adjunctive therapy in palatal wound healing. The superior healing observed at the PRF membrane sites supports its use in accelerating soft-tissue healing. PRF membrane as a palatal bandage is an efficacious approach to protect the raw wound area of a palatal donor site to reduce healing time and patient discomfort.

Introduction:

Free gingival grafts are one of the common treatment modalities used to increase the zone of keratinized tissue (KT) around implants or prior to ridge augmentation and root coverage. The palatal donor sites had many complications as pain, discomfort and healing by secondary intention. Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors fasten the healing and decrease the pain.

Materials and methods:

Ten patients requiring augmentation of KT participated in this case series. The palatal donor sites of 7 of these patients were covered with PRF membranes with a new suturing technique without palatal stent, the other 3 had palatal stent. Palatal tissue will examined clinically after 3, 7, 10 and 14 days. Considerably very fast healing with 0 pain score was observed during one week in the group with PRF.

Eligibility Criteria:
Inclusion Criteria:

* Systemic free, Good oral hygiene and insufficient attached gingiva prior to ridge augmentation

Exclusion Criteria:

* High arched palate, medically compromised
To Assess the Safety of a Sunscreen Product

The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor use conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females, 18 to 65 years of age with no medical conditions of the skin as determined by the subjects' dermatological medical history.
* The subject must have Fitzpatrick skin types I to VI.
* During the selection process, potential subjects must agree to restrict their sun exposure activities for at least 5 days immediately preceding participation in the study. Subjects must be willing and physically able to spend approximately 3 continuous hours in the sun, must agree to immerse their entire body under water (including face and hair) at least 2 times during the water activity phase, and must agree to refrain from taking any medications during the study that might alter their response to sun exposure
* Subjects must agree to refrain from alcohol and tobacco use during the course of the study
* Subjects must obey all rules of the test facility
* Subjects must agree to refrain from tanning bed usage and significant non study related sun exposure during the study
A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer

The purpose of this study to test an alternative treatment approach that involves giving participants radiotherapy before their mastectomy (preoperative radiotherapy) and performing immediate reconstruction surgery at the time of mastectomy. The immediate reconstruction surgery is called an immediate autologous reconstruction (IR) and is different than the standard reconstruction surgery people with T4 breast cancer have. IR is a surgical procedure where immediately following your mastectomy, the surgeon takes tissue from another part of your body and uses it to re-create your breast. The standard reconstruction surgery occurs later and can be done with an implant or tissue from your body.

The main purpose of this study to find out if the alternative treatment approach shown above is feasible. The study will see how safe this alternative treatment approach is compared with the standard treatment approach.


Eligibility Criteria:
Inclusion Criteria:

* Female sex, aged ≥18 years, with biopsy-proven invasive breast cancer
* cT3-4 cN0-3 tumor
* Partial or complete response to NAC on imaging and clinical examination using the Response Evaluation Criteria in Solid Tumors (RECISTv1.1) definition.
* Desire to undergo autologous reconstruction and assessed to be an appropriate candidate by a plastic and reconstructive surgeon
* Able to read and understand English

Exclusion Criteria:

* Prior ipsilateral breast cancer
* Bilateral breast cancer
* Pregnant
* Stage IV disease at presentation
* Stable disease or progressive disease after NAC
* Surgically unresectable breast disease
* BMI \>40
* Prior history of thoracic radiotherapy
Differential Diagnosis Between Granuloma and Radicular Cyst: Effectiveness of Magnetic Resonance Imaging.

The radiolucent periapical jaw lesions of 34 patients, which were surgically enucleated, were investigated by two radiologists using MRI, based on the same six criteria, to categorize the lesions as granulomas or radicular cysts. After apicoectomies, two oral pathologists (blinded to the radiologist's diagnoses) analyzed all specimens by referring to seven specific parameters and diagnosed the specimens as granulomas or radicular cysts. The inter-rater agreements between the radiologists and pathologists in terms of MRI and histological diagnoses, respectively, along with the discriminant power of the adopted criteria and the accuracy of the MRI assessments compared with the histopathologic results, were calculated.

A strong inter-rater reliability was observed between the two radiologists (k-statistic = 0.86, p = 0.0001) and the two pathologists (k-statistic = 0.88, p = 0.0001). Reliability was higher for the radiological (Guttmann's lambda lower bound \> 0.6) than histopathological criteria. The accuracy (true positives plus true negatives) of the radiologists was higher than that of the pathologists based on receiver operator characteristic analysis (area under the curve = 0.87 and 0.91, respectively). MRI reliability and accuracy were high and comparable to histopathological reliability, highlighting the usefulness of this non-invasive exam as a pre-treatment diagnostic method for periapical endodontic lesions.


Eligibility Criteria:
Inclusion Criteria:

* patient age ≥ 18 years
* the diameter of the lesion ≥ 5 mm, assessed based on periapical x-ray,
* an acceptable endodontic treatment for the involved tooth.

Exclusion Criteria:

* general medical contraindications for classification of the patient as level III or higher according to the American Society of Anesthesiologists,
* teeth involved in the lesion, the function of which could not be salvaged after enucleation of the lesion and apicoectomy. The radiological exclusion criteria were
* contraindication undergoing magnetic resonance: presence of a pacemaker or any metallic devices that could interfere with the magnetic field;
* severe claustrophobia,
* weight ≥ 130 kg
* intolerance to gadolinium-DTPA as a contrast agent;
Clinical Efficacy and Safety of NEOIAL HC for Intra-articular Use in the Treatment of Severe Knee Osteoarthritis

Osteoarthritis (OA) is one of the most frequent causes of pain and disability in adults. According to the Osteoarthritis Research Society International (OARSI), at least 40% of people over the age of 65 suffer from symptomatic osteoarthritis of the hip or knee. Knee osteoarthritis (OA) is the eleventh leading cause of years lived with disability according to the World Health Organization.

The guidelines show that treatment with intra-articular injections of hyaluronic acid (HA) leads to a slow, prolonged pain relief (up to six months after the first injection); On the other hand, there is little evidence in the literature about the intra-articular use of isolated collagen or in combination with hyaluronic acid in the treatment of knee osteoarthritis.

The present study showed a clinically good safety profile and provided preliminary evidence of the efficacy of NEOIAL HC for the treatment of symptomatic knee OA


Eligibility Criteria:
Inclusion Criteria:

* Age
* Knee OA
* VAS \> 3
* Kellegren radiographic stage 3-4

Exclusion Criteria:

* presence of joint effusion,
* VAS score \<3 according to the American College of Rheumatology Criteria
* neoplasms,
* haematological diseases,
* specific rheumatological pathologies,
* bleeding disorders, local infections,
* refusal or non-compliance of the patient,
* candidacy for knee joint replacement or any intra-articular injection during the previous year,
* addiction to opioid drugs,
* recent heart attack or stroke.
Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors

MELODIC trial is an prospective, multicenter, non-randomized, open-label, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in unresecable CRC liver-only metastases, compared with a matched cohort of patients bearing the same tumor characteristics, and treated with chemotherapy. Synthesis of Inclusion parameters: "10;10;10;100"


Eligibility Criteria:
Inclusion Criteria (Sythesis: 10;10;10;100):

* ≥ 18 and \<70 years
* Performance status, ECOG 0-1
* Histologically proved adenocarcinoma in colon or rectum.
* BRAF wild-type CRC on primary tumor or liver metastases
* High standard oncological surgical resection of the primary tumor
* Liver metastases not eligible for curative liver resection confirmed by the validation committee
* At least one line (3 months) of chemotherapy
* No signs of extra hepatic metastatic disease or local recurrence on CT, MRI and Pet-CT within 4 weeks prior to the faculty meeting at the transplant unit
* Before start of chemotherapy no lesion should be larger than \> 10 cm
* Objective response according to RECIST 1.1 or SD at two consecutive CT without CEA increase
* Patient with less than 10% response on chemotherapy may be included if they obtain al least 20% response after TACE (DEB-IRI) or by 90Y-spheres
* At least 10 months time span from CRC resection and date of being listed on the transplantation list.
* Satisfactory blood tests Hb \>10g/dL, neutrophils \>1.0, Bilirubin\<2 x upper normal level, AST, ALT\<5 x upper normal level, creatinine and albumin in normal level.
* CEA\<100 ng/ml
* Signed informed consent and expected cooperation of the patients for the treatment and follow up

Exclusion Criteria:

* Weight loss \>10% the last 6 months
* Patient BMI \> 30
* Participation refusal
* General contraindication to LT
* Prior extra hepatic metastatic disease or primary tumor local relapse.
* Other malignancies in the previous 5 years
* Pregnancy or breast feeding
* Any reason why, in the opinion of the investigator, the patient should not participate.
Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

To obtain safety, efficacy, pharmacokinetic and dosing information for meloxicam oral suspension in children with Juvenile Rheumatoid Arthritis (JRA)


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of juvenile idiopathic arthritis (JIA) by International League of Associations for Rheumatology (ILAR) criteria; pauciarthritic, extended pauciarthritic, or polyarthritic current course of disease;
* active arthritis of at least 2 joints
* at least 2 other abnormal variables of the 5 remaining core set parameters
* require nonsteroidal anti-inflammatory drugs (NSAIDs)
* children aged 2-17 years

Exclusion Criteria:

* systemic course of juvenile idiopathic arthritis
* all rheumatic conditions not included in inclusion criteria; any clinical finding or abnormal clinically relevant lab (not due to JIA) that could interfere with conduct of clinical trial
* weight of 9 kg or less
* pregnancy or breast feeding
* females of childbearing potential who are sexually active and not using adequate contraception for at least 3 mos prior to and for duration of study
* history of bleeding disorder, gastrointestinal bleeding, or cerebrovascular bleeding
* peptic ulcer past 6 months
* more than 1 disease modifying anti-rheumatic drug (DMARD) or change in DMARD during 3 months prior
* change corticosteroids during 1 month prior
* systemic corticosteroids greater than 10 mg/d, hydroxychloroquine greater than 10/mg/d, cyclosporine greater than 5 mg/kg/d., methotrexate greater than 15 mg/m2/wk, cytotoxic agents, gold, D-penicilamine, sulfasalazine, glucosamine, and investigational products
* etanercept during 1 month prior; infliximab during 2 months prior; intra-articular corticosteroids during 1 month prior
* patients requiring concomitant other NSAID including topical (excluding ophthalmic)
* requirement for use of other NSAIDs, anticoagulants, phenothiazine, lithium, or ACTH
* insufficient effect or intolerability to naproxen or meloxicam
* known or suspected hypersensitivity to trial meds or their excipients
* requirement of chronic H2 antagonist
* history of asthma, nasal polyps, angioneurotic edema, or urticaria with aspirin or NSAIDs
* planned surgical procedures during study
* investigational drug exposure during this trial or within 30 days (or 6 half lives, whichever greater) prior
* previous participation in this trial
* patients with known drug or alcohol abuse
* patient, parent or legal representative unable to understand and to comply with protocol
Comparison of 22Mhz and 18Mhz High-frequency Probes for the Ultrasound Study of Temporal Arteries in Patients Suspected of Having Giant Cell Arteritis

Evaluation of the structural features of temporal arteritis using two frequencies probes: 18 and 22Mhz.

Comparison of the results obtained by using 2 different frequencies probes in the diagnosis of giant cell arteritis

Eligibility Criteria:
Inclusion Criteria:

* sedimentation rate\> 50 mm/h or recent unusual headache or unusual fever, recent visual trouble or jaw claudication, or induration temporal arteritis

Exclusion Criteria:

* previous diagnosis of giant cell arteritis and relapse of the giant cell arteritis and opposition to participate
LIBERATE International

This is a prospective, randomized, double-blind, sham-controlled clinical study. The study is designed to demonstrate that active is superior to sham for the efficacy endpoints and is deemed to have appropriate safety as compared to sham.

Approximately ninety-nine (99) subjects meeting the inclusion/exclusion criteria will be randomized in a 2:1 ratio to either the active or sham group. Randomization will be stratified by study site, with a maximum of 21 subjects randomized in an individual site. Subjects will be followed up with at 10 days and at 3 and 6 months post-treatment. Subjects will be assessed for adverse events at all study contacts and visits from the time the informed consent is signed.

Eligibility Criteria:
Key Inclusion Criteria:

* Signed and dated ICF
* Pre-menopausal females
* Documented diagnosis of SUI

Exclusion Criteria:

* Pregnant or planning to become pregnant within the year
* Undergone other SUI treatments (excluding Kegels)
One Year Drug Treatment in First-Episode Schizophrenia

Prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in first-episode schizophrenia.

The objective of this multi-center study is to optimize the long-term treatment of patients with first episode schizophrenia. This investigation should contribute to the issue of effective relapse prevention in first-episode patients. 1-year maintenance neuroleptic treatment is done with low dose haloperidol or risperidone (target dose 2-4 mg/die).

Eligibility Criteria:
Inclusion Criteria:

* After the acute treatment of the first-episode in schizophrenia (according ICD-10 F20)
* Age between 18 and 55
* Informed consent

Exclusion Criteria:

* Residence outside of the catchment area
* Legal reasons
* Insufficient knowledge of the German language
* Substance abuse or addiction
* Pregnancy
* Serious physical illness
* Organic brain disease
* Contraindication to neuroleptic treatment
Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Fixed Dose Combination in Hypertensive Patients Not Controlled by the Free Combination of an Angiotensin Receptor Blocker Plus Hydrochlorothiazide

Recruiting in Germany only:

This study will evaluate the safety and efficacy of valsartan plus HCTZ in fixed dose combination in hypertensive patients not responding to treatment with the free combination of Candesartan plus HCTZ. In an optional extension patients with uncontrolled BP at the end of the core study can be treated with valsartan plus HCTZ in fixed dose combination plus amlodipine 5 mg for additional 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients (\>=18 years)
2. Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. intra-uterine device, hormonal contraceptives).
3. Patients with moderate essential hypertension (WHO):

Exclusion Criteria:

1. Severe hypertension (WHO)
2. Pregnant or nursing women
3. Treated hypertensive patients with controlled hypertension under current therapy (MSDBP \< 90 mmHg and MSSBP \< 140 mmHg)
4. A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
Effect of Omega-3 Index on Cellular Metabolism and Quality of Life

Determine whether personal optimization of the Omega-3 index improves cellular metabolism and quality of life (according to the SF-36 form).


Eligibility Criteria:
Inclusion Criteria:

* Participant aged 19 or over
* Available for the entire duration of the study and willing to participate on the basis of the information provided in the FIU duly read and signed.

Exclusion Criteria:

* Allergy known to fish
* Pregnant women who breast-feed or test positive for pregnancy
Mechanism and Early Intervention Research on ALI During Emergence Surgery of Acute Stanford A Aortic Dissection

The morbidity rate of Stanford A type Acute Aortic Dissection（AAD） has been increasing, about 5-10/100,000\* per year. Emergency surgery has been the main treatment for Acute Aortic Dissection, however perioperative mortality rate can be as high as 15\~30%. Acute lung injury (ALI) is one of the main complications that happen during the perioperative period, which by itself covers 30%-50% of the overall mortality rate. Both domestic and foreign countries lack researches on risk factors, pathogenesis, disease progression and outcome of ALI, which happen during the perioperative period of Acute Aortic Dissection patients.

This topic study follow projects in the preoperative of Acute Aortic Dissection'surgery

1. hemodynamic changes (aortic dissection resulting in acute aortic regurgitation, cardiac tamponade and proximal high blood pressure)
2. ischemia - reperfusion injury of aortic dissection distal organ
3. Aortic intima-media exposure cause coagulation / fibrinolytic system function disorder
4. systemic inflammatory response syndrome; use relevant clinical radiographic parameters, indicators of respiratory mechanics (oxygenation index and lung injury index) and biochemical indicators.

To discuss risk factors and possible mechanisms of ADD patients with pre-operative ALI and observe their influences on the progress and prognosis of AAD, to explore early intervention in the preoperative for possible risk factors and mechanisms and to evaluate their influences on the prognosis, to achieve the purpose of reducing AAD perioperative mortality of ALI and medical expenses.


Eligibility Criteria:
Inclusion Criteria:

* AAD patients within 48 hrs of onset who are prepared for aortic surgery
* Age between 18 and 70
* Willing to sign the informed consent

Exclusion Criteria:

* A history of chronic respiratory disease before onset
* A history of chronic heart failure or coronary heart disease before onset
* A history of chronic liver or kidney dysfunction before onset
* Severe central nervous system syndrome after admission
* Refuse to sign the informed consent