cyrilzakka/clinical-trials huggingface dataset:
Zilver® PTX® V Clinical Study

The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.


Eligibility Criteria:
Inclusion Criteria:

* Patient has signed and dated the informed consent.
* Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
* Patient agrees to return for the required follow-up assessments.

Exclusion Criteria:

* Patient is \< 18 years of age.
* Patient has significant stenosis of inflow tract not successfully treated before this procedure.
* Patient lacks at least one patent vessel of runoff with \< 50% stenosis throughout its course.
The Study of Molecular Risk Panels (70-gene Assay) in Chinese Breast Cancer Patients

This study is experimental and will prospectively assess the proportion of patients in the two (2) MammaPrint Risk categories in patients of Chinese descent.

The incidence of breast cancer in Chinese women is lower than that of a Western population. Breast cancer is the most common cancer in Chinese women and the incidence is rising. Moreover there are more premenopausal women with breast cancer where the breast cancer incidence peaks in the forties and the postmenopausal rise in incidence is less commonly seen. As the genetic predisposition to breast cancer is increasingly understood, it has been suggested that the differences in breast cancer incidence in different ethnic populations is potentially due to interactions between lifestyle and genetic characteristics. To date, the use of Agendia's gene expression assays in Chinese women has not been studied. In this study, the feasibility of the gene-expression prognostic assays for risk assessment in this specific group will be assessed. Moreover, the specific molecular characteristics and potential biomarkers will be studied, focusing especially on the large group of premenopausal breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 18 year to 70 year,
* diagnosis of Stage I or Stage II (excluding those involving more than 3 lymph nodes) Breast Cancer
* Chinese descent

Exclusion Criteria:

* Stage II Breast Cancer with more than 3 positive lymph nodes
The Effectiveness Of Intravenous TXA on Reducing Perioperative Blood Loss For Patients Undergoing PAO

In this research study the investigators want to learn more about how a medication called tranexamic acid (TXA) could help reduce bleeding during Periacetabular Osteotomy (PAO) surgery. TXA is approved by the Food and Drug Administration (FDA) for the reduction of bleeding for many types of surgical procedures. TXA works by slowing the breakdown of blood clots and helps to prevent bleeding. From previous studies, TXA has been shown to effectively prevent bleeding in patients undergoing heart, spine and skull remodeling surgeries.

As PAO surgery has been associated with significant blood loss when compared to other types of joint surgeries. In order to try and avoid bleeding that may lead to complications, different strategies can be used. In this research study the investigators want to learn more about how a medication called tranexamic acid (TXA) could help reduce bleeding during PAO surgery.

This prospective randomized placebo controlled double blind trial will enroll 80 adolescents and young adults undergoing elective peri-acetabular osteotomy (PAO). The primary aim is to determine if intravenous infusion of TXA during surgery is effective compared to standard care (no TXA) in decreasing blood loss (measured; and calculated) and blood transfusion (autologous and allogenic) perioperatively in adolescents and young adults presenting for PAO surgery. The rate of blood loss over time will be measured and compared between groups with adjustment for length of surgery (time; hours) and body weight (kg).

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2
* Age 13-35 years
* Scheduled for primary unilateral PAO +/- arthroscopy

Exclusion Criteria:

* Hematologic disorder, thrombocytopenia (Platelet count \<140,000/uL3)
* Major hepatic, renal, or vascular disorder
* Active Thromboembolic disorder
* Color vision defect
* TXA allergy
* Taking anticoagulants or antiplatelet drugs (heparin, warfarin, clopidogrel)
* Ethical and/or religious objection to receiving blood products
* International patients
* Patients undergoing revision surgery
* Patients undergoing combined PAO and other surgeries such as surgical dislocation, proximal femoral osteotomy
Study to Investigate Relative Bioavailability of Different Formulations of SHR6390 in Healthy Subjects

The purpose of this study is to investigate relative bioavailability during the new and traditional formulations of SHR6390 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

1. Execute an informed consent;
2. Male or female aged 18-45 years (including threshold) on the date of signing the informed consent;
3. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) in the range of 19.0-26.0 kg / m2 (including the critical value);
4. Physical examination, vital signs, laboratory examination , 12-Lead ECG, abdominal B-ultrasound, chest X-ray, etc. are normal or abnormal, but the researcher has no clinical significance according to NCI CTCAE 5.0 standard;
5. Fertile subjects had no family planning and had to take acceptable contraceptive measures and no plans to donate eggs and sperm within 7 months from the date of signing informed consent to the last medication; the serum pregnancy test of fertile women within 72 hours before the first administration of the study drug should be negative.

Exclusion Criteria:

1. Those who have previously suffered from primary diseases of important organs, including but not limited to neuropsychiatric, cardiovascular, digestive tract, respiratory system, urinary, endocrine, blood, immune and other diseases, which are judged by the researchers to be unsuitable for the trial;
2. Patients who have received any previous operation affecting gastrointestinal absorption;
3. Patients who had received any surgery within 6 months before screening, or planned to undergo surgery during the study period;
4. Those who lost blood or donated more than 400 ml or received blood transfusion within 3 months before screening;
5. HBsAg positive, HCV antibody positive, HIV antibody positive, syphilis antibody positive;
6. History of drug use or drug abuse, or drug screening positive;
7. Smoking and alcohol addict and unable to stop smoking during the test period; those with positive alcohol screening; those with positive nicotine screening;
8. Allergic constitution, including severe drug allergy or drug allergy history; known allergy to shr6390 tablets or its excipients;
9. Having swallowing resistance or disorder, affecting drug absorption;
10. Participated in other clinical trials and taken the study drug within 3 months before taking the study drug for the first time;
11. Inducers or inhibitors of CYP3A4, CYP2C9 and CYP2C8 were taken within 4 weeks before the first administration of study drug;
12. Taking any prescription drug, over-the-counter drug, traditional Chinese medicine or food supplement within 2 weeks before taking the study drug for the first time;
13. Ingestion of grapefruit containing products, fruit juice, food or beverage containing methylxanthine or alcohol within 72 hours before taking the study drug for the first time; taking strenuous exercise; or having other factors affecting the absorption, distribution, metabolism and excretion of drugs;
14. Lactating women;
15. The researchers considered that the subjects had any other factors that were not suitable for the trial.
Effect of Remote Ischaemic preConditioning on Liver Injury in Patients Undergoing LIVER Resection Surgery

Liver resection has improved health outcomes in patients with hepatocellular carcinoma (HCC) in Singapore and worldwide. However, due to acute ischaemia/reperfusion injury (IRI) to the liver at the time of surgery, patients still experience significant morbidity and mortality. Therefore, novel therapies are required to protect the liver against acute IRI during partial hepatectomy. Remote ischaemic conditioning (RIC) using transient limb ischaemia/reperfusion has been shown to protect the liver in experimental animal studies. In the ERIC-LIVER trial the investigators investigate whether RIC can reduce liver injury and preserve liver function in patients with HCC undergoing partial hepatectomy.

Liver resection has improved health outcomes in patients with hepatocellular carcinoma (HCC) in Singapore and worldwide. However, due to acute ischaemia/reperfusion injury (IRI) to the liver at the time of surgery, patients still experience significant morbidity and mortality. Therefore, novel therapies are required to protect the liver against acute IRI during partial hepatectomy. Remote ischaemic conditioning (RIC) using transient limb ischaemia/reperfusion has been shown to protect the liver in experimental animal studies. In the ERIC-LIVER trial the investigators investigate whether RIC can reduce liver injury and preserve liver function in patients with HCC undergoing partial hepatectomy.

50 patients with HCC undergoing partial hepatectomy will be randomised to receive either RIC (four-5 minute arm cuff inflations/deflations) or sham control (four-5 minute arm cuff simulated inflations/deflations) after induction of anesthesia and prior to surgical incision. The primary endpoint of the study will be acute liver injury assessed by serum transaminases measured at 24 hours post-resection. Secondary endpoints will include liver function in subset of patients (N=24, assessed by indocyanine green \[ICG\] clearance measured at 24 hours post-resection), incid ence of liver failure, episodes of confirmed sepsis, acute kidney injury, intensive care unit and hospital stay, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21 years and above
* Patients undergoing partial hepatectomy for primary HC

Exclusion Criteria:

* Patients with significant pulmonary disease (FEV1\<40% predicted).
* Patients with known severe renal failure with a GFR\<30 mL/min/1.73 m2.
* Patients on sulphonylurea or nicorandil, as these medications may interfere with the protective effect of RIC.
* Patients recruited into another study which may impact on this study. Significant peripheral arterial disease affecting the upper limbs.
* Patients undergoing repeat liver resection surgery.
International Prospective REgistry on Pre-pectorAl Breast REconstruction

This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer. The aim of the study is to collect data on the surgical, aesthetic and oncological results, as well as on the quality of life of the patients who will undergo breast reconstruction with a pre-pectoral approach.

1,236 patients undergoing mastectomy for breast cancer and subsequent pre-pectoral breast reconstruction will be enrolled. Being an observational study, the diagnostic-therapeutic path of the patients will not be modified in any way. Therefore, no risks are anticipated for the patients who will participate in this study. Potential benefits deriving from the study will be for future patients for whom good quality data will be available which can guide the choice of the type of breast reconstruction to be performed, in particular the most appropriate type of technique in the pre-pectoral approach.

Eligibility Criteria:
Inclusion Criteria:

* Female patients older than 18 years old
* Signed informed consent form
* Patients undergoing mono or bilateral therapeutic mastectomy
* Patients undergoing pre-pectoral implant-based breast reconstruction with implant or expander with or without mesh

Exclusion Criteria:

* Male patients
* Patients not suitable for surgical treatment
* Patients undergoing subpectoral reconstruction
* Patients undergoing breast reconstruction with autologous tissue.
Patient Satisfaction in the Critical Care Unit: A Qualitative Phenomenological Study

To explore issues patient experience and satisfaction with a sample of patients recently discharged from critical care.

Patients' perceptions of their medical care are of increasing importance to educators, researchers, and clinicians. The emphasis on patient experience and satisfaction is consistent with the trend towards holding health care professionals accountable to their consumers. Our understanding and advancement of patients' experience and satisfaction with care forms a pivotal role in ensuring individuals engage with healthcare services, adhere to therapies, and maintain ongoing relationships with providers. Experiences are best explored using interview techniques such as phenomenological interviewing. In our study we propose to use a hermeneutic phenomenological approach. Phenomenology is a way of qualitatively exploring a person's experience and their personal meanings from those experiences. It is an approach that considers the structure of a person's subjective experience and explores areas that might be hidden. A phenomenological approach looks for patterns that are shared by particular instances or experiences. The evaluation of patient satisfaction and experience is based on valuing patients' subjective perception of an experience. In our study, a phenomenological approach will generate a comprehensive description of a phenomenon or lived experience (i.e. stay in the Critical Care Unit). We will interview a sample of patients to explore experiences and to gain their meanings of their stay in critical care. This will hopefully lead to thinking around ways of improving patient experiences, satisfaction and care.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients who were admitted to the Critical Care Unit at the Royal Marsden Hospital
* Patients who are not now at the End of Life or palliative.
* Adults (i.e. patients \>18 years of age.
* Patients staying more than 24 hours.

Exclusion Criteria:

* Very short stay patients (\<24 hours)
Assessment of Dermatologic Family Impact Scale in the Parents of Children With Psoriasis

The Dermatological Diseases Family Impact Scale (DeFIS) was developed to assess different aspects of health-related quality of life in the relatives of the patients with various skin diseases. The preliminary validation of this instrument was performed for the Turkish population. In the pilot study, this 15-item-questionnaire was shown to be easy to complete and score, and reliably help to evaluate the family members' quality of life.

Psoriasis is a chronic disease which can be expected to have a significant impact on the quality of life of the patients and parents/family members alike. In line with this assumption, previous studies demonstrated that psoriasis psychosocially affects not only the patients, but also their close relatives. The psoriasis family index has been developed in an effort to objectively measure the health-related quality of life of the family members of patients with psoriasis. Nevertheless, data regarding the health-related quality of life of the parents of pediatric patients with psoriasis in the Turkish population are relatively scarce.

In study, the investigators primarily aim to utilize DeFIS to assess the impact of childhood psoriasis on the quality of life of the patients' parents. Further, the investigators attempt to investigate the relation between the quality of life of the patients and their parents, and reveal disease characteristics which might influence the quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients diagnosed with psoriasis by the dermatologists within the study period

Exclusion Criteria:

* Patients with an equivocal diagnosis
* Parents unable to complete the questionnaire
* Patients with a serious medical disorder or in an emergency condition
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Linagliptin Compared With the Free Combination of Empagliflozin Tablet and Linagliptin Tablet in Healthy Male and Female Subjects

The primary objective of this trial is to investigate the bioequivalence of one fixed dose combination tablet of empagliflozin/linagliptin (Test, T) compared with the free combination of one empagliflozin tablet and one linagliptin tablet (Reference, R) administered as single dose under fasted conditions.


Eligibility Criteria:
Inclusion criteria:

* Healthy male or female subjects according to the investigators assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure \[BP\], Pulse Rate \[PR\]), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (incl.)
* Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and local legislation
* Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:
* Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device
* Sexually abstinent
* A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
* Surgically sterilised (including hysterectomy)
* Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH (Follicle Stimulating Hormone) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion criteria:

* Any finding in the medical examination (including Blood Pressure \[BP\], Pulse Rate \[PR\] or Electrocardiogram \[ECG\]) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* Further exclusion criteria apply
IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma

The proposed Phase IIb clinical study aims to investigate the safety and efficacy of the active immunotherapy IMP321 in combination (adjunctive) with paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer.

This is a multicentre, placebo-controlled, double-blind, 1:1 randomised Phase IIb study in female hormone receptor-positive metastatic breast cancer patients. The study comprises of two stages.

Stage 1 is the open-label, safety run-in stage consisting of cohort 1 and 2 to confirm the (RPTD) of IMP321 in combination with paclitaxel.

Stage 2 is placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Able to give written informed consent and to comply with the protocol
2. Metastatic oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or metastasis
3. Female of age 18 years or above
4. Patients who are indicated to received first line chemotherapy with weekly paclitaxel
5. Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1

6 Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.

Exclusion Criteria:

1. Prior chemotherapy for metastatic breast adenocarcinoma
2. Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
3. Inflammatory carcinoma
4. Candidate for treatment with trastuzumab (or other Her2/neu targeted agents)
5. Systemic chemotherapy, radiation therapy or any other investigational agent within 4 weeks, endocrine therapy within 1 week prior to first dose of study treatment or CDK4/6 inhibitors within 5 times half-life (acc.to SPC) prior to first dose of study treatment and until completion of study treatment
6. Symptomatic known cerebral and/or leptomeningeal metastases
7. Serious intercurrent infection
8. Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment
9. Active acute or chronic infection
10. Active autoimmune disease requiring immunosuppressive therapy
11. Previous malignancies within the last three years other than breast carcinoma
12. Patients with prior organ or stem cell transplantation
13. Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.
Evaluation of Template Assisted Monochromatic Structural Colored Versus Universal Multi-Shade Direct Composite Veneers

The aim of this study was to conduct a clinical trial utilizing a modified split-mouth, double-blinded, randomized strategy to clinically assess template assisted one shade structural colored versus universal multi-shade direct composite veneers

The superior mechanical qualities, superb aesthetics, and versatility of resin-based composites (RBCs) make them popular choices for direct restorative applications. Compared to their predecessors, nanocomposites have shown superior qualities since nanotechnology was introduced in the production of dental RBCs.

A restoration's aesthetic integration is mostly the result of its chromatic characteristics. Pigments included in the composition of the restorative material typically control the selective reflection of wavelengths to emulate the natural tooth. In order to better reflect the broad color range that characterizes real dentition, RBCs have more recently employed the phenomena of "structural color" .

Thanks to the novel property of resins, color differences between the tooth and the restoration are eliminated or balanced out as perceived color of a region moves toward the color of the surrounding area . Additionally, as opposed to multi-shade RBCs, single-shade RBCs eliminate the need to select between various resin shades, streamlining the color choosing procedure and cutting down on time lost during the clinical resin selection process. The Vita Classic Shade Guide's shades can all be matched with these materials.

Eligibility Criteria:
Inclusion Criteria:

* better dental hygiene
* discolored vital anterior teeth

Exclusion Criteria:

* Para functional activities
* Non-vital teeth