cyrilzakka/clinical-trials huggingface dataset:
Yliver as a Test to Early Diagnose HCC

Liver cancer (HCC) is the second cause of death related to cancer worldwide, with about 750,000 deaths from this cause in 2012. Although the early diagnosis of liver cancer increases the available treatment options, the methods currently used for screening are not sufficiently sensitive for this purpose.

The investigators provide a high-performance and highly reliable in vitro platform that allows the identification and quantification of autoantibodies in serum for use as biomarkers of liver cancer, using an ELISA test (Yliver).

The aim of the study is to demonstrate whether the Yliver test can be used as a biomarker for the early diagnosis of hepatocellular carcinoma with a collection of samples from 58 patients diagnosed with HCC, 42 cirrhosis, 40 normal controls and the inclusion of 25-50 patients with chronic liver disease without cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

EASL Clinical Practice Guidelines \& Practice Guidance by the American Association for the Study of Liver Diseases for diagnosis of HCC, liver cirrhosis, chronic hepatitis without cirrhosis

Exclusion Criteria:

* Age under 18 years
* Very advanced disease (patient in a terminal state that is not indicated analytical determinations).
* Hepatic encephalopathy that prevents the correct understanding of informed consent.
* Refusal to carry out the determination or to sign the informed consent.
* Patients affected by another neoplastic disease
The Inspection Campaign of French Phase I/II Research Sites Following the BIA 10-2474 Accident

Following the serious adverse events that occurred in January 2016 during the BIA 10 2474 First-in-Human study, the French Ministry of Health asked the Regional Health Agencies to inspect operations at all Authorized Research Centers (ARC) conducting phase I/II clinical trials of experimental drugs.

Following the serious adverse events that occurred in January 2016 during the BIA 10 2474 First-in-Human study, the French Ministry of Health asked the Regional Health Agencies to inspect operations at all research sites conducting phase I/II clinical trials of experimental drugs.

All 30 sites of Île-de-France region fully authorized to perform phase I/II trials will be inspected by a physician and a public health pharmacist. Their reported list of observations will be submitted to three physicians with longstanding experience of early pharmacology studies performed in academic or private research facilities. These physicians will be asked to adjudicate each observation according to their perceived medical importance regarding safety. Adjudications will be first performed separately and disagreements will be later settled during a final adjudication meeting.

Eligibility Criteria:
Inclusion Criteria:

* Being one of the 30 sites of Île-de-France region fully authorized to perform phase I/II trials

Exclusion Criteria:

* None
Feasibility of Obtaining Pulse Oximetry Readings from the Oropharynx

This is a prospective study to evaluate the feasibility of obtaining a pulse oximetry ready from the oropharynx with a standard oximeter probe that has been attached to an oral airway or a tongue blade. The study will compare the values from the peripheral pulse oximeter on a finger, toe, foot or hand with the that from the oropharyngeal oximeter. The study will also compare the saturation from an arterial blood gas (ABG) collected as standard of care with that obtained from the oropharyngeal oximeter.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a surgical procedure with general anesthesia and requiring an invasive arterial cannula

Exclusion Criteria:

* Patients in whom an arterial cannula is not indicated for the surgical procedure
* Patients in whom a peripheral pulse oximeter value cannot be obtained
* Patients in whom an invasive arterial cannula cannot be placed
* Patients with any type of intra-oral pathology or injury
* Patients in whom access to the oropharynx is restricted or not feasible for any clinical reason
MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer

NeoPulsar is a prospective, randomized phase II trial. 46 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with MR-guided adaptive radiotherapy (30Gy/6Fx) combined with 6 cycles of Toripalimab and CAPOX. TME surgery is scheduled after TNT. The primary endpoint is pathological complete response (pCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal function, surgical complication, 3-year LRFS rate, 3-year DFS rate, 3-year OS rate, etc.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years old, male or female
2. Pathologically confirmed rectal adenocarcinoma
3. The distance from anal verge ≤ 10 cm
4. Clinical stage T3-4 and/or N+
5. No evidence of distance metastases
6. MSI/MMR status: MSS/pMMR
7. Karnofsky score \>=70
8. Adequate organ function and have no contraindications to surgery, radiochemotherapy, or immunotherapy
9. No chemotherapy or any other anti-tumor therapy prior to enrollment
10. No immunotherapy prior to enrollment
11. With good compliance during the study
12. Signed written informed consent

Exclusion Criteria:

1. Known history of other malignancies within 5 years， except cured skin cancer and cervical cancer in situ
2. Pregnancy or breast-feeding women
3. Individuals with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders that, in the judgment of the investigator, are of such clinical severity that they may prevent the signing of an informed consent form or affect the patient's adherence to oral medications
4. Individuals with clinically serious (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months
5. Individuals with a history of organ transplantation requiring immunosuppressive therapy and long-term hormone therapy
6. Individuals with autoimmune diseases
7. Individuals with severe uncontrolled recurrent infections，or other severe uncontrolled concomitant diseases
8. Baseline hematology and biochemistry not meeting the following criteria: Hb≥90g/L; NEU ≥1.5×109/L; PLT ≥100×109/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; TB \<1.5 times the upper limit of normal; Cr \<1 time the upper limit of normal; Alb ≥30g/L
9. Individuals with dihydropyrimidine dehydrogenase (DPD) deficiency
10. Individuals allergic to any drug component of the study
Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

Clostridium Butyricum might be an effective drug in treating irritable bowel syndrome


Eligibility Criteria:
Inclusion Criteria:

* the presence of Rome III criteria for IBS ;
* Aged between 18 and 65 years old

Exclusion Criteria:

* Antibiotic, probiotic or laxative usage within 4 weeks.
* organic gastrointestinal diseases
* Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
* pregnancy or lactation.
* previous major or complicated abdominal surgery.
* severe endometriosis and dementia
Influence of Foam Rolling on Elbow Proprioception, Strength, and Functional Motor Performance

The purpose of this study is to investigate the long-term effects of foam rolling on elbow proprioception, strength and functional motor performance with healthy participants . Study group will receive foam rolling exercise. Control group will receive no foam rolling exercise. Control group will be given a brochure including information about proprioception and foam rolling.

There is no information in literature about the effects of foam rolling on elbow proprioception, strength and functional motor performance. The purpose of this study is to investigate long-term effects of foam rolling with healthy participants. Study group will receive foam rolling exercise actively by themselves on elbow.

Foam rolling exercise will be applied 10 times each for 1 minute. These exercises will be performed as 2 sets. After each set will be a resting period for 30 seconds.A total of 12 sessions of exercise will be performed three times a week. Second evaluation will be performed after 4 weeks. Then the follow up evaluation (third evaluation) will be performed 4 weeks later. Control group will receive no foam rolling exercise. They will be handed a brochure about the proprioception and its role in injury prevention and foam rolling. Control group will be evaluated for the first time. Afterwards, second evaluation will be performed after 4 weeks and follow up after 4 more weeks.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and above healthy participants
* No pain in elbow area within 6 months and at the time of measurement
* To be able to complete all evaluations and applications to be carried out

Exclusion Criteria:

* Having previous foam rolling and self-myofascial relaxation applications on the target area
* Having acne and similar skin problems, open wounds
* Having upper extremity injury, history of fracture or surgery
* Having any systemic musculoskeletal disease
* Having diagnosis of diabetic mellitus or peripheral neuropathy
* Having osteoporosis diagnosis
* Having any cardiovascular disease
* Having vertigo
* Being pregnant
Performance of Aspheric Hydrogel Lenses After a Refit With Sphere Silicone Hydrogel Lenses for 4 Weeks

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A aspheric lenses after a refit with fanfilcon A sphere lenses for 4 weeks of daily wear.


Eligibility Criteria:
Inclusion Criteria:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft contact lens wearer
* Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)
* Have no less than -0.75D (Diopter) of astigmatism in both eyes
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter
* Patient contact lens refraction should fit within the available parameters of the study lenses
* Is willing to comply with the wear schedule (at least 5 days per week, \>8 hours/day assuming there are no contraindications for doing so)
* Is willing to comply with the visit schedule

Exclusion Criteria:

* Has a Contact Lens (CL) prescription outside the range of the available parameters of the study lenses
* Has a spectacle cylinder of ≥ 1.00D (Diopter) in either eye
* Has a history of not achieving comfortable Contact Lens (CL) wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye
* Presence of clinically significant (grade 2-4) anterior segment abnormalities
* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear
* Slit lamp findings that would contraindicate contact lens wear such as:

  * Pathological dry eye or associated findings
  * Pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Giant papillary conjunctivitis (GCP) worse than grade 1
  * Anterior uveitis or iritis (past or present)
  * Seborrheic eczema, Seborrheic conjunctivitis
  * History of corneal ulcers or fungal infections
  * Poor personal hygiene
Alefacept Mechanism of Action in Psoriasis

To determine the mechanism of action of alefacept in patients with psoriasis.

The purpose of the study is to better understand the mechanism of action of an FDA approved drug (alefacept). Subjects enrolled will be given alefacept 7.5 mg intravenously on a weekly basis for 12 weeks. Response is assessed by improvement in the PASI score. The responders will get no further treatment and the nonresponders will receive additional 4 weeks of therapy. Skin biopsies will be obtained throughout the study and T-cell apoptosis will be correlated to clinical response. There is no placebo group. The duration of the study is approximately 1 year.

Eligibility Criteria:
Inclusion Criteria

* Alefacept is indicated for the treatment of adult patients (18 years or older) with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Patients must have at least one plaque of least 2.5 cm in diameter (for biopsies).

Exclusion Criteria

* CD4 \< 400/ml
* WBC less than lower level of normal for the reporting laboratory
* \< 5% Body Surface Area involved with psoriasis
* Serious infection e.g., latent or active tuberculosis
* History of AIDS or Hepatitis B,C, all internal cancers, lymphoma, untreated cutaneous basal or squamous cell carcinoma
* Systemic anti-psoriasis medications and phototherapy within 28 days of the first dose of Alefacept
* Topical anti-psoriasis medications within 14 days of the first dose of Alefacept, except for moisturizers, tar shampoos (exception, Elidel is permitted to be applied on the face, groin and axillae areas. These areas are not biopsied.)
* Inability to understand consent form or comply with study requirements
* Pregnancy or lactation
* Concurrent medical illness that would make participation in this clinical trial ill-advised
* Any contraindications to using alefacept
Exercise Intervention for Pts With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide

This randomized pilot study will be conducted in men with metastatic castration resistant prostate cancer (mCRPC) within 3 months of initiating abiraterone or enzalutamide. The purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in mCRPC patients who have recently started on additional androgen suppression therapy.

This randomized pilot study will be conducted in men with metastatic castration resistant prostate cancer (mCRPC) within 3 months of initiating abiraterone or enzalutamide. The purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in mCRPC patients who have recently started on additional androgen suppression therapy. The investigators will also explore the effects of the exercise training on biomarkers of inflammation-hormonal status and their potential association with changes in lean mass and function.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age
2. Metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of \< 50 ng/dL)
3. No prior chemotherapy
4. Initiated therapy with either abiraterone plus a glucocorticoid or enzalutamide within the 3 months prior to randomization
5. Ability to engage safely in moderate exercise as determined by their treating physician
6. Not previously engaged in regular exercise training (\>1-2 d/wk for \> 30 min/d) in the past 6 months
7. Be able to speak and read English

Exclusion Criteria:

1. Any condition that causes severe pain with exertion
2. History of bone fractures
3. Active cardiovascular disease including any of the following:

   * New York Heart Association (NYHA) Grade II or greater congestive heart failure
   * History of myocardial infarction or unstable angina within 6 months prior to Day 1
   * History of stroke or transient ischemic attack within 6 months prior to Day 1
4. Acute or chronic respiratory disease
5. Acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise
6. Neurological conditions that affect balance and, or muscle strength
7. Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent
Pain Perception Comparison of Computerized vs Conventional Injection Methods

This study was conducted to a Comparison of Pain Perception for Nerve Block and Infiltration Injection Using the Conventional Method and Two Computerized Control Systems.

The study evaluates and compares pain perception of the inferior alveolar nerve block (IANB) and buccal infiltration anaesthetic in children using a Conventional syringe, STA Single Tooth Anesthesia® System and Star Pen anaesthesia device.

Eligibility Criteria:
Inclusion Criteria:

1. Apparently healthy children (5-8) years old, and free from systemic diseases.
2. Children who require local anesthetic injection for any dental treatment.
3. Cooperative children (positive or definitely positive on Frankel's scale).
4. Children who have no contraindications to the usage of selected local anesthetic agents.

Exclusion Criteria:

* All that does not correspond to inclusion criteria.
Prostate Testing for Cancer and Treatment

RATIONALE: Radical prostatectomy is surgery to remove the entire prostate. Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Sometimes the tumor may not need treatment until it progresses. In this case, active surveillance may be sufficient. It is not yet known which treatment regimen is more effective for localized prostate cancer.

PURPOSE: This randomized phase III trial is studying active monitoring to see how well it works compared with radical prostatectomy or radiation therapy in treating patients with localized prostate cancer.

OBJECTIVES:

* To assess survival of patients with localized prostate cancer at 10 years and 15 years after treatment.
* To investigate disease progression (i.e., biochemical and clinical), treatment complications, and lower urinary tract symptoms in these patients.
* To investigate the psychosocial impact of cancer detection and treatment on these patients, including generic health status, quality of life, and sexual function.
* To estimate the resource use and costs of detection, treatment, and follow-up.
* To compare costs and outcomes of treatment in terms of survival and health-related quality of life.
* To collect samples suitable for basic science research (ProMPT study).

OUTLINE: This is a multicenter study. Patients are stratified by age (50-55 vs 56-59 vs 60-65 vs 66-69 years), Gleason score (6, 7, 8-10), and average result of recruitment and first biopsy prostate-specific antigen (PSA) tests (\< 6 vs 6-9.9 vs ≥ 10 ng/mL). Patients are randomized or select a treatment to be followed up in a cohort study.

Eligibility Criteria:
Inclusion Criteria:

Fit for the treatments and estimates life expectancy of 10 years Registration with eligible primary care practice

Exclusion Criteria:

Unable to give written informed consent. Concomitant or past malignancy.
Pilot Study for Evaluation of the Need for Protective Ileostomy After Low Anterior Resection Due to Rectal Cancer

The purpose of this study is to determine whether protective ileostomy is required after low anterior resection due to rectal cancer

Since introduction of total mesorectal excision prognosis and quality of life of patients with rectal cancer of the middle or lower third of the rectum could be improved significantly. There is no valid data about the need of protective ileostomy in these patients. About 10% of the patients develop insufficiency of the anastomosis and might benefit from ileostomy whereas about 90% would not have required protective ileostomy retrospectively. Aim of the study is to show that protective ileostomy is not required if several criteria are fulfilled and early measures in case of clinical impairment are defined. Therefore eligibility criteria include safely performed stapler anastomosis with complete rings and control of impermeability by air insufflation. In the event of clinical impairment in the postoperative course CT scan with KM filling of the rectum to exclude insufficiency of the anastomosis will be performed. In case of insufficiency protective ileostomy will be created. 40 patients will be included.

Comparison: Patients with resectable rectal cancer of the middle or lower third will be intraoperatively randomized to either protective ileostomy or no ileostomy at all.

Eligibility Criteria:
Inclusion Criteria:

* radical resectable rectal cancer
* low sphincter-preserving resection of carcinomas of the lower and middle third
* preoperative normal continence
* preoperative normal sphincter function
* complete rings after stapler anastomosis
* impermeability of anastomosis for air
* written informed consent

Exclusion Criteria:

* reduced cooperation or drug abuse
* pregnancy
* psychosis
* age under 18 years
Construction and Application of a Risk Prediction Model Forepistaxis After Pituitary Tumor Resection

(1) Objective to establish an evaluation system for predicting the risk of epistaxis after endoscopic transsphenoidal pituitary surgery（ 2) Objective to determine the risk factors of epistaxis after endoscopic transsphenoidal pituitary adenoma surgery. Referring to domestic and foreign literature, combined with experts' opinions, the related risk factors that may cause postoperative nosebleed of pituitary adenoma are: 22 patients and surgical factors. 3) Objective to establish a risk prediction model of epistaxis after endoscopic transsphenoidal pituitary tumor resection. According to the occurrence of epistaxis, the patients in the modeling group were divided into epistaxis group and non epistaxis group. The risk factors of epistaxis were taken as the independent variable, and the occurrence of epistaxis was taken as the dependent variable. The variables with statistical significance in univariate analysis were included in the multivariate logistic regression model, and the risk prediction model of epistaxis after pituitary tumor resection was established by back LR method.(4) Objective to verify the risk prediction model of endoscopic transsphenoidal pituitary adenoma epistaxis. The validation model is used to validate the prediction model, and the Hosmer-Lemeshow degree is used to match the model. The area under the receiver operating characteristic curve (ROC) was used to evaluate the validity of the model.(5) Application of risk prediction model.


Eligibility Criteria:
Inclusion Criteria:

Those who met the diagnostic criteria of pituitary tumor and received transsphenoidal endoscopic surgery during hospitalization; Patients with informed consent; Age ≥ 14 years old.

Exclusion Criteria:

quitters; patients with incomplete clinical data;
Sexual Health Empowerment for Cervical Health Literacy and Cancer Prevention

The purpose of this study is to learn if a cervical health literacy program is a practical and helpful way of improving women's cervical health knowledge and improving cancer screening behaviors, and ultimately preventing cervical cancer.

Women in the criminal just system are 4-5 times more likely to have cervical cancer than non-incarcerated women. Little is known about how to close this gap. The few investigators that have studied cervical cancer risk and disease among women in jails and prisons have found that while many women get screened for cervical cancer, less than half get follow-up care.

The investigator's pilot research suggests the most important contributor to cervical cancer risk, and perhaps lack of follow-up, is incarcerated women's low health literacy about both cervical cancer and broader reproductive health issues. This study is testing a sexual health empowerment intervention (SHE Project) to see if it improves incarcerated women's reproductive health literacy.

Eligibility Criteria:
Inclusion Criteria:

* Women sentenced or anticipate a sentence of one year or less
* Ability to follow participants post-jail release
* Able to read and understand English

Exclusion Criteria:

* Women who have been treated for cervical cancer with procedures that would obviate the need for regular screening
* Exhibit severe psychological distress