cyrilzakka/clinical-trials huggingface dataset:
A Study of Penpulimab and Anlotinib Plus Nab-paclitaxel and Gemcitabine for Metastatic Pancreatic Cancer.

It is a trial to assess the efficacy and safety of Penpulimab and Anlotinib in Combination With Nab-paclitaxel Plus Gemcitabine as first-line Therapy in Patients (Pts) With Metastatic Pancreatic Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Ages ≥18 years，ECOG ≤ 2，Estimated survival time \> 3 months
* Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma
* Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion
* Patients have never received systematical anti-cancer therapy
* Laboratory examination meets the following requirements:White blood cell (WBC) ≥3.0×109/L; absolute neutrophil count (ANC) ≥1.5×109/L; Hemoglobin (HB) ≥90g/L; platelet count(PLT) ≥75×109/L; Total bilirubin (TBIL) ≤1.5× normal upper limit (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN, if accompanied by liver metastasis, ALT and AST≤5×ULN; Serum creatinine (Cr) ≤1×ULN or creatinine clearance (CCr)≥50ml/min;
* Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) \> 50%
* Patients of childbearing age should take appropriate protective measures before enrollment and during the trial
* Volunteer to join the study, sign the informed consent, have good compliance, and cooperate with follow-up
* Ability to follow the study protocol and follow-up procedures.

Exclusion Criteria:

* Patients have ever received any systematical anti-cancer therapy in the past
* Patients who participated in other clinical trials in the past 4 weeks
* According to the investigator, patients who surgically available or potentially treatable(Patients who voluntarily give up surgical treatment can be enrolled after evaluation by the investigator)
* Patients with moderate ascites requiring drainage
* Patients with CNS metastases and/or carcinomatous meningitis
* Patients with history of other primary malignancies except: 1) complete remission before enrollment for at least 2 years and requiring no additional treatment during the study period; 2) Adequately treated non-melanoma skin cancer or lentiform malignancy with no evidence of disease recurrence; 3) Adequately treated carcinoma in situ with no evidence of disease recurrence;
* Patients with autoimmune disease or immune deficiency who are treated with immunosuppressive drugs
* Patients with bleeding tendency.
* Pregnant or lactating women.
* Drug abuse, clinical or psychological or social factors that impact informed consent or the conduct of the study
* Patients who may be allergic to PD-1 monoclonal antibody, anlotinib, albumin-bound paclitaxel and gemcitabine
Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast Cancer

A broad range of prognostic and predictive tools are available for patients with newly diagnosed early stage breast cancer. These range from free and publicly available mathematical algorithms, through to expensive genomic tests. It is not known how the use of these different scores affects physician decision making with respect to ordering genomic tests, nor how well these algorithms predict for the results of Oncotype DX ® in the real-world setting. This pragmatic study will help to answer these questions.

A broad range of prognostic and predictive tools are available for patients with newly diagnosed early stage hormone receptor positive, Her2 negative breast cancer. These range from free and publicly available mathematical algorithms (e.g. NHS Predict, Magee formulae, Gage and Tennessee equations) that incorporate standard pathology results, through to expensive genomic tests (e.g. Oncotype DX ® and Endopredict ®). It is not known how the use of these different scores affects physician decision making with respect to ordering genomic tests, nor how well these algorithms predict for the results of Oncotype DX ® in the real-world setting. This pragmatic study will help to answer these questions.

In summary: Month 1 to 3: pathology and chemotherapy data is collected, no physician questionnaires given. Month 4 to 6: pathology and chemotherapy data collected, plus physician questionnaire administered. Intervention teaching after 6 months of study activation. Month 7 to 9: pathology and chemotherapy data collected, PREDICT 2.1 tool used, no physician questionnaire given. Month 10 to 12: pathology and chemotherapy data collected, PREDICT 2.1 tool used, plus physician questionnaire administered.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary breast cancer
* No prior chemotherapy
* Eligible for Oncotype DX ® testing as per current Ontario funding criteria including: ER positive, PR positive or negative, HER2 negative, lymph node status negative or micro-invasive disease, tumor \>1 cm in size (or if equal or \<1 cm, must be grade 2/3 or have lymph node micrometastasis).

Exclusion Criteria:

* Neoadjuvant treatment including window of opportunity trials
* Recurrent breast cancer
Ultrasound-guided Combined Spinal-epidural Anesthesia: Pre-procedure Versus Real-time Scan

The investigators will compare the success rate, the consumed time, the number of needle passing, the depth and angle of the needle, the anesthetic effect, complications, pain and patient's satisfaction between 'Real-time scan' and 'Pre-procedure scan', when we performing spinal/epidural combined anesthesia.

Traditionally, spinal/epidural combined anesthesia has been performed by palpation of the landmark like Tuffier's line. There are some studies that using ultrasound improves the success rate to regional anesthesia. There are two methods of using ultrasonography, 'Real-time scan' and 'Pre-procedure scan'. Direct comparison of these two methods is not yet studied. So investigators will compare the success rate, the consumed time, the number of needle passing, the depth and angle of the needle, the anesthetic effect, complications, pain and patient's satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Spinal/Epidural combined anesthesia is required.

Exclusion Criteria:

* Skin infection or trauma
* Abnormal coagulation lab
* History of spine surgery
* Pregnancy
* Abnormal structure of spine
Study on OsseoSpeed™ TX Short Implants in a Chinese Population

The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and maxilla up to 3 years after loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the posterior region is safe and predictable.


Eligibility Criteria:
Inclusion criteria:

1. Provision of informed consent
2. Female and male aged 20-75 years at enrolment
3. In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region)
4. History of edentulism in the study area of at least four months
5. Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s)
6. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge/crowns
7. Deemed by the investigator to be suitable for implants of 6 mm length and to have a bone height of at least 6 mm and a bone width of minimum 6 mm
8. Deemed by the investigator as likely to present an initially stable implant situation

Exclusion criteria:

1. Unlikely to be able to comply with study procedures, as judged by the investigator
2. Earlier graft procedures in the study area
3. Uncontrolled pathologic processes in the oral cavity
4. Known or suspected current malignancy
5. History of radiation therapy in the head and neck region
6. History of chemotherapy within 5 years prior to surgery
7. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
8. Uncontrolled diabetes mellitus
9. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
10. Smoking more than 10 cigarettes/day
11. Present alcohol and/or drug abuse
12. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
13. Previous enrolment in the present study
14. Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
15. Subjects that are unable to give informed consent
A Study Comparing the Differences Between Young and Non-young Breast Cancer

To collect data on diagnosis, treatment, survival prognosis, and intrinsic molecular detection of breast cancer in China from January 2000 to December 2024.Compare the difference between young and non-young breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* During the period from January 2000 to December 2024, the first breast cancer diagnosed and treated in several hospitals in China was in the age range of 18-75 years.

Exclusion Criteria:

* Breast cancer patients under 18 years of age or over 75 years of age; Combined with other malignant tumors; Patients with chronic infectious diseases or chronic infectious diseases; Patients with severe comorbidities, with serious dysfunction of vital organs (heart, liver, kidney); Known history of human immunodeficiency virus; The investigator concluded that patients should not be included in other conditions of this trial.
Assessment of 14-3-3 η (Eta) Protein Antibodies in the Serum of Rheumatoid Arthritis Patients and Its Relation to Atherosclerosis.

The aims of this study are: • To assess 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients and its relation to disease activity and severity. • To investigate the role of 14-3-3 η (eta) protein in the diagnosis or assessment of subclinical carotid artery atherosclerosis.

All the patients will be interviewed for demographic and clinical data (age, sex, occupation, age at onset of the disease, joints affected, extra-articular features, disease duration, family history and treatment regimen). • Assessment of medical and rheumatologic history.

* Careful general and musculoskeletal examination.
* Assessment of disease activity will be performed using the Disease Activity Score (DAS28) including 28 tender and swollen joint count, ESR and visual analogue scale.
* X-ray both hands and feet
* Larsen Score
* Assessment of Body Mass Index (BMI)
* Laboratory investigations:
* Complete blood count (CBC) • Rheumatoid factor (RF) by latex method • Anti citrullinated protein antibodies ACPA by enzyme-linked immunosorbent assay (ELISA) • 14-3-3 η (eta) protein by (ELISA) • Erythrocytic sedimentation rate (ESR) • Quantitative C-reactive protein (CRP) • fasting blood glucose • lipid profile • Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques) • ECG

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:

  1. Patients with RA classified according to the revised American College of Rheumatology (ACR)/EULAR RA classification criteria 2010 for RA.
  2. Age ≥ 18 years.
  3. Patients who are able and willing to give written informed consent.
  4. Disease duration more than one year

     Exclusion Criteria:

  <!-- -->

  1. Any other autoimmune disease rather than RA.
  2. Patients with any disease affecting the cardiovascular system other than RA.
  3. Patients with known risk factors for atherosclerosis as diabetes, hypertension, hyperlipidemia and obesity.
Evaluation of the Performance and Safety of the Atoldys/ Lexilens Glasses Developed to Improve the Reading of Dyslexic Subjects

The aim of this study is to evaluate the efficacy and safety of a new medical device (Atoldys/ Lexilens glasses) on the improvement of reading skills of young dyslexic subjects.

Dyslexia is defined as a specific learning disability that is characterized by reading difficulties, in the absence of intellectual disability, neurological or psychiatric disorder, uncorrected sensory disturbance (sight, hearing) or an educational deficiency.

Dyslexia appears in the child from the earliest stages of learning in the form of a difficulty in mastering the learning of reading. This disorder is manifested by a generally hesitant reading, slowed down, full of errors, requiring a lot of effort for the child and may impact his reading comprehension. The dyslexia-related deficiency is of variable intensity depending on the individual; it may be accompanied by calculus disorders (dyscalculia), oral language (dysphasia), motor coordination (dyspraxia) or attention disorders with or without hyperactivity. In nearly 40% of cases, a child affected by Dys disorders presents several learning disorders.

To date, the causes of dyslexia are not yet clearly established. The wide variety of symptoms and disorders associated with dyslexia does not facilitate the identification of precise neurobiological / psycho cognitive mechanisms. There are therefore several theories: phonological, visual, temporal, cerebellar or proprioceptive auditory processing.

Recently, following work published in 2017, an anatomical cause based on Maxwell's spots could also be a cause of dyslexia.

The aim of this study is to evaluate a new medical device (class I CE marked) to compensate this probable anatomical cause: the Atoldys/ Lexilens glasses

Eligibility Criteria:
Inclusion Criteria:

* Schooled in CM1, CM2 or 6ème,
* French mother tongue,
* For whom developmental dyslexia has been diagnosed by a health professional who specializes in this learning disorder,
* With near vision, without optical correction, equivalent to P5 or better according to the Parinaud scale (distance: 30-40 cm),
* Presenting an IQ ≥ 80 and ≤130 according to the WISC-V test performed by a psychologist,
* For whom a written consent was obtained regarding his study participation.

Exclusion Criteria:

* With medical history or presenting a neurological pathology,
* Presenting a developmental disorder (autism, ADHD, ...),
* Presenting hearing disorders,
* Presenting an astigmatism of more than one uncorrected diopter,
* Presenting other visual disorders,
* Any other condition that, in the opinion of health professionals, could impair its ability to complete the study or could pose a significant risk.
Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone

Although it is well known that the presence of uncontrolled inflammation in upper airways may compromise the control of asthma and may favor the progression of asthma toward more severe grades of disease, few studies addressed whether therapies aimed to control both upper and lower airway inflammation may be more effective in controlling asthma. Markers of oxidative stress and of inflammation such as Nitrotyrosine and IL-5 are increased in the airways of children with atopic asthma and correlated with the levels of oral and nasal FeNO, and with the grade of atopy. We hypothesize that the treatment with Beclometasone nebulized with a facial mask (for treating both upper and lower airways) will be able to reduce the production of oxidants as well as of IL5 in both districts thus promoting clinical and functional improvements in mild intermittent asthmatic children. The results provided by this study will contribute to further clarify the relationship between nasal and bronchial inflammation.


Eligibility Criteria:
Inclusion Criteria:

* children with intermittent asthma and allergic rhinitis

Exclusion Criteria:

* children with acute respiratory symptoms in the last 4 weeks
* children with nasal polyposis or bronchial or respiratory tract infections
* children with a severe exacerbation of asthma resulting in hospitalization during the last month
Sleep Apnea: Mechanism and Cerebrovascular Consequences

This study will determine the effect of ventilatory stimulation on obstructive sleep apnea in selected patients with stroke. We will select a subset of patients with stroke in the prior 3 months who are most likely to have ventilatory instability as a cause of the upper airway obstruction as indicated by the absence of obesity, an abnormal hypocapnic apnea threshold and resolution of obstructive apnea during CO2 administration. Following baseline polysomnography, patients will be randomly assigned to acetazolamide (250 mg hs \[at bedtime\]) versus placebo for 7 days. Polysomnography will be repeated and then subjects will cross-over therapies for another 7 days followed by a final nocturnal polysomnography.

This study never enrolled patients. It was a component of a larger VA Merit grant and the other aims of the grant were completed but due to logistic issues and recruitment challenges this particular protocol was never made active.

Eligibility Criteria:
Inclusion Criteria:

* We will select non-obese patients (body mass index \[BMI\] \<30 kg/m2) with stroke diagnosed during the 3 previous months and obstructive sleep apnea on screening sleep study (apnea-hypopnea index \[AHI\] \>15 events/hr of study time).
* Patients with stroke will be selected based on the following criteria: 85 years old or less with a history of ischemic stroke within 3 months resulting in mild to moderate neurological impairment (Rankin scale \< 3)

Exclusion Criteria:

* Hemorrhagic stroke,
* A history of chronic obstructive lung disease,
* Left ventricular ejection fraction (LVEF) \<55%
* Evidence of nasal or pharyngeal obstruction on physical examination.
A Post-marketing Surveillance Study on Erbitux in Combination With Platinum-based Chemotherapy in Metastatic/Recurrent Squamous Cell Cancer of the Head and Neck

This is a prospective post-marketing surveillance (PMS) study to collect safety information from more than 600 subjects with recurrent and/or metastatic squamous cell cancer of the head and neck (SCCHN) treated with Erbitux as final evaluable cases. This PMS study is requested by the Korean Regulatory Authorities. After approval of new indication in Korea, there is a requirement to investigate more than 600 subjects during six years, to continue monitoring and provide further information about safety and toxicity in clinical practice.

The PMS study is planned to be conducted within 6 years from the approval date of the new indication in approximately 50 institutions in Korea.

OBJECTIVES

Primary objective:

* To obtain safety information on the use of Erbitux in subjects with recurrent and/or metastatic SCCHN in terms of frequency and severity of adverse events (AEs)

Secondary objectives:

* To gather clinical efficacy information of the treatment

During the PMS period, each subject's background, subject's medical history (surgery, anti-cancer treatment), Erbitux treatment status, concurrent medication, response evaluation, status and reason of discontinuation, all AEs (regardless of the causal relationship to Erbitux), and abnormal results of laboratory tests will be collected. The PMS will be based on all cases treated with Erbitux at least once.

Erbitux will be prescribed to recurrent and/or metastatic SCCHN subjects according to the approved national label as in routine clinical practice under the supervision of an investigator experienced in the use of antineoplastic medicinal products. Prior to the first infusion, subjects will receive pre-medication with an antihistamine and a corticosteroid. The initial dose of Erbitux is 400 mg/m2 body surface area and the subsequent weekly doses are 250 mg/m2 each administered intravenously via in-line filtration with an infusion pump, gravity drip, or a syringe pump. The recommended infusion period for the initial dose is 120 minutes and for the subsequent weekly doses is 60 minutes with the maximum infusion rate not exceeding 10 mg/min, equivalent to 5 ml/min of Erbitux 2 mg/ml or 2ml/min of Erbitux 5mg/mL.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux. The national label approved by Korea Food \& Drug Administration is "Erbitux in combination with radiation therapy is indicated for the treatment of subjects with metastatic/recurrent SCCHN.
Measurement of Viral Load Reduction in the Oral Cavity After a Regimental Use of OC Toothpaste Products

SARS COVID 2 has caused a pandemic of proportions unparalleled in the past 100 years. The virus has an uncanny ability for transmission and as such has been difficult to control. The spread of the virus has affected everything from education, business, politics and survival. While the investigators have learned a great deal in the last 9 months they still face an uncertain day to day existence. Health care workers are particularly vulnerable to transmission of this virus because of their close contact with patients. Moreover, dentists are particularly vulnerable because the virus is spread via aerosols which are generated quite easily in the dental office putting dentists and their associates at risk. The oral cavity appears to be a likely domain for viral carriage particularly since both taste and smell are hallmark effects of the virus. With these issues at hand it will be of great advantage to have a simple routine oral hygiene method in the effort to reduce the oral viral load. There is some reason to expect that oral hygiene procedures with known anti-microbial effects could have some use in our efforts to reduce or control the oral viral load. With this issue in mind investigators feel that stannous fluoride could modify the virus in such a manner as to effectively reduce the oral viral load.

Study will measure reduction of SARS-CoV-2 levels in the oral cavity after brushing for up to an hour. Subject sampling will occur at baseline, 15 min, 30 min, and 60 min

Eligibility Criteria:
Inclusion Criteria:

* Enrolled subjects between the ages of 18-64 and have tested positive for Covid19.

Exclusion Criteria:

-