cyrilzakka/clinical-trials huggingface dataset:
To Evaluate the Safety and Tolerability of Combined Administration of SHR2285 Tablets With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects

The study is a single-center，randomized, doubled-blinded, placebo-controlled, Only for SHR2285 Phase I trial. This study intends to enroll 52 healthy subjects, regardless of gender. The subjects are divided into three groups: A, B, and C, with 16 cases in each of groups A and B, and 20 cases in group C.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects, aged 18-55 (including boundary);
2. Body mass index (BMI) between 19 to 28 kg/m2 (including boundary), male body weight ≥50 kg and \<90 kg , female body weight ≥45kg and \<90kg;
3. Participant with no clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters，etc.
4. Understand the study procedures and methods, voluntary to participate in the study and signed the informed consent.

Exclusion Criteria:

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin \> 1.2 fold ULN during screening/baseline.
2. Serum creatinine\> ULN during screening/baseline.
3. Positive faecal occult blood
4. Abnormal coagulation function.
5. A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
6. Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.
7. Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.
8. Human immunodeficiency virus antibody, syphilis serological examination, hepatitis b virus surface antigen, hepatitis c virus antibody were positive.
9. 3 months prior to screening involved in any drug or medical device clinical studies. .
10. Female subjects who did not receive contraception at least 30 days before administration and etc.
Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine

The purpose of this study is to evaluate safety of GC3111 and to describe immunogenicity of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19 to \<65 years of age.

To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap) vaccine in healthy adults.

To evaluate safety (solicited adverse events) of GC3111 in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged between 19 and 64 years at the time of vaccination
* Informed consent and assent forms have been signed and dated

Exclusion Criteria:

* Known or suspected receipt of any Tdap vaccine
* Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence
* Receipt of any vaccine within 30 days before receiving study vaccine
* Any condition that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
Engaging Diverse Underserved Communities to Bridge the Mammography Divide

Breast cancer is the second most common cause of cancer death in the U.S.1 in spite of being preventable, easily detectable, and curable.2-11 Breast screening continues to be underutilized by the general population and especially by traditionally underserved minority populations. Two of the least screened minority groups are American Indians/Alaska Natives (AI/AN) and Latinas. American Indian/Alaska Native women have the poorest recorded 5-year cancer survival rates of any ethnic group and the lowest (or near-lowest) screening rates for major cancers.12 Furthermore, breast cancer is the number one cause of cancer mortality among Latina women.13 While breast cancer screening rates have increased nationally, there has been an increase in the gap in breast cancer screening utilization between individuals from minority versus majority racial/ethnic groups.

If you decide to participate in the program, your participation will last 4 months. You will complete the Healthy Living Kansas-Breast Health survey by computer. The survey will take about 20 minutes to complete. You will be randomly assigned (like flipping a coin) to one of two groups. The groups will receive different breast health information. After completing the survey, you agree to be contacted by telephone in 4 months to answer questions. You will be asked for your name, home address, and phone number.

You will be given information about breast cancer and mammography. You may or may not benefit from the information provided. Care will be taken to safeguard the information you provide but under rare circumstances confidentiality breaches may occur.

Eligibility Criteria:
Inclusion Criteria:

* Latina or AI/AN woman residing in one of participating communities
* Aged ≥40 years of age
* Not up to date on mammography screening
* Home address \& access to a working telephone
* Responded to 120-day post randomization follow-up call

Exclusion Criteria:

* Receipt of mammogram within past year
* Acute medical illness, history of breast cancer, 1st
* Cognitive impairment or inappropriate affect or behavior
* Another household member enrolled in the study
Intra-abdominal Pressure and Insufflator Effects in Robotic Surgery

The main aim of this study is to compare the perioperative effects of different intra-abdominal pressures and different insufflators in patients undergoing robotic surgery at a 30-45 degree trendelenburg position.

Adult patients scheduled for robotic genitourinary or colorectal surgery are going to be enrolled in this study. Patients will be randomized in three groups. In group I, conventional insufflators will be used with 12 mmHg intra-abdominal pressure; in group II, valveless insufflators will be used with 12 mmHg intra-abdominal pressure and in group III, valveless insufflators will be used with 8 mmHg intra-abdominal pressure. Intraoperative data regarding airway pressures, lung compliance, hemodynamic parameters, arterial blood gas analysis, times of pressure loss and camera cleaning will be gathered. Each patient will receive a standardized anesthesia and analgesia procedure with a intravenous morphine patient controlled analgesia (PCA). Postoperative pain will be monitored at 1st, 3rd, 6th, 12th and 24th postoperative hours and morphine consumption rates will be recorded. Patient length of stay, time to first flatus, urine output, postoperative complications(graded by Clavien Dindo classification), preoperative and postoperative hemoglobin and creatinine levels will be filed.

Eligibility Criteria:
Inclusion Criteria:

* Elective robotic surgery with intraabdominal insufflation and trendelenburg position (prostatectomy, hemicolectomy etc.)
* ASA (American Society of Anesthesiologists) Physical Status I-II-III

Exclusion Criteria:

* Patients without consent
* Emergency surgery
* Bleeding diathesis
* Pregnancy or lactation
* Prior history of major abdominal/pelvic surgery
* Chronic kidney disease
* Chronic opioid consumption for chronic pain
* Inability to communicate with the patient due to language barriers or mental status
Light Diffraction Glasses in Preventing and Controlling Myopia in Adolescents

This study aims to evaluate the effectiveness of lenses with light diffraction glasses in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective design, and apply personalized frame lenses for myopia prevention and control.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 6-8 years old;
2. After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within 0.00D\~-1.75D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, the progression of myopia in the past year is greater than 0.5D, the best corrected far vision is at least 4.8, and the near vision is at least 5.0;
3. Within 6 months, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used;
4. The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.

Exclusion Criteria:

1. Diagnosed constant strabismus;
2. Diagnosed pathological myopia;
3. Other congenital eye diseases;
4. Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.
Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo

Patients receive study drug for one year (Part A). If, after the initial run-in phase, a sustained remission is reached they will be randomly split into one of three dose groups for another year (Part B). The maintenance of the sustained remission will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) with at least 3 months' symptom duration and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA and symptom duration of less than 5 years prior to the participation of this study
* Active disease at Screening as defined by

  * Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥ 2.1
  * Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4
  * Spinal pain \> 4 on a 0 to 10 Numerical Rating Scale (NRS) (from BASDAI Item 2)
  * for modified New York (mNY) -negative subjects only: C-reactive Protein (CRP) \> upper limit of normal (ULN) and/or current evidence for sacroiliitis on the Screening Magnetic Resonance Imaging (MRI)
* Inadequate response to, or contraindication to, or intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Exclusion Criteria:

* Presence of total Spinal Ankylosis ('bamboo spine')
* Diagnosis of any other Inflammatory Arthritis
* Prior treatment with any experimental biological agents for treatment of Axial SpondyloArthritis (SpA)
* Exposure to more than 1 TNF-antagonist or primary failure to TNF antagonist therapy
* History of or current chronic or recurrent infections
* High risk of infection
* Recent live vaccination
* Concurrent malignancy or a history of malignancy
* Class III or IV congestive heart failure - New York Heart Association (NYHA)
* Demyelinating disease of the central nervous system
* Female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product
* Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study
German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute lymphoblastic leukemia (pro B, pre B, c-ALL or T-ALL), proved by morphology and immunophenotyping
* Age \> 55 yrs (no upper age limit)
* Written informed consent

Exclusion Criteria:

* Severe leukemia associated complications, not controllable before therapy onset e.g.
* life threatening infections as sepsis, pneumonia, hypoxia, shock, life threatening bleeding)
* Severe comorbidity e.g.
* decompensated renal failure if not caused by leukemia with Creatinine \> 2x ULN
* heart failure (NYHA II/IV), instable Angina, significant coronary stenosis
* hepatic insufficiency e.g. liver cirrhosis or chronic active hepatitis with bilirubin \> 1,5 x ULN and/or ASA, ALA, AP \> 2,5 ULN
* decompensated metabolic disturbances (e.g. not controllable diabetes)
* severe obstructive or restrictive pulmonary disease with hypoxaemia
* Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
* Active second neoplasia
* HIV infection
* Severely reduced general condition
* Cytostatic pre-treatment of ALL
* Chemotherapy treatment of any other malignancy during the last 5 years
* Participation in other clinical trials interfering with the study therapy
Local Anaesthesia Used During Fast-track Colonic Surgery: Evaluation of Bupivacaine and Levobupivacaine in Practice

The standard treatment for post operative pain is now bupivacaine + sufentanil. The use of this combination during fast-track colonic surgery leads frequently to post-operative nausea and vomiting and limited mobilisation possibilities. Therefore the department anaesthesiology wants to evaluate the use of a different local anaesthetic: levobupivacaine combined with morphine on demand. The expectation is that the use of levobupivacaine leads to less side effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo fast-track colonic surgery and with post operative epidural pain treatment

Exclusion Criteria:

* Patients who are admitted to an other ward
* Patients with a spinal catheter
Macular Buckle With Three-armed Silicone

High myopia is characterized by prolonged axial length and posterior staphyloma, which result in choroid-retinal degeneration and vision decrease. At present, vitrectomy can lead to anatomical improvements, but an higher axial length and the presence of a sever posterior staphyloma remains to be the two most important risk factors for poor visual outcomes. For these reasons, a different surgical approach, including macular buckling, might be considered in those patients with extremely high degree of myopia, in order to counteract the traction exerted by the posterior staphyloma. Macular buckling with or without pars plana vitrectomy had been proved to be an effective way to resolve myopic staphyloma related foveoschisis, macular hole, and associated retinal detachment. In this study, we sought to investigate the safety and efficacy of a macular buckling technique using a three-armed silicone capsule to support the posterior staphyloma in high myopia.

1. This study plans to recruit 11 participants with 6 months follow-up to assess the safety and efficacy of a newly designed macular buckle device;
2. The macular buckle device, surgical procedure, and participants registry had been reviewed and approved by Ethics committee of Zhongshan Ophthalmic Center;
3. Only those patients are diagnosed with severe posterior staphyloma are registered.
4. All participants are fully informed before register;
5. All the surgeries are performed by single qualified doctor (Lin Lu);
6. After operation, all participant could contact the researcher via telephone, and could be assessed for any surgical related complications. If there is severe complication happened, or any person that could not tolerant the macular buckle, the implanted device will be removed;
7. Specially assigned staff (Jinge Lu) is responsible for data collection, data management, adverse events reporting, and participant communication.

Eligibility Criteria:
Inclusion Criteria:

* high myopia over -8.0 Diopter
* axial length over 26.5 mm
* posterior staphyloma

Exclusion Criteria:

* single eye patients
* retinal detachment beyond macular area
* a history of posterior scleritis
* a history of Glaucoma
* active hemorrhage in the surgical eye
* active inflammation in the surgical eye
* any situation that might hinder the observation of macular
Exercise for Preventing the Metabolic Syndrome in Latinoamerican Amerindians

Despite exercise training decrease blood fasting glicaemy in 'average' terms, there is a wide inter-individual variability after exercise training explored mainly in adults but not in adults with prediabetes comorbidities. Thus, is yet unknown the effects and influence of the concurrent training (CT) eliciting responders (R) and non-responders (NR) cases (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Interested in improving health and fitness

Exclusion Criteria:

* Cardiovascular contraindications to exercise
* History of stroke, asthma or chronic obstructive pulmonary disease, muscle-skeletal disorders
* Smoking
* A compliance rate to the exercise program ≥ 70% was required for the participants in the intervention group to be included in the statistical analyses.
The Effect of Time on the Outcome of Periodontal Treatment.

Re-evaluation after non-surgical periodontal treatment remains an integral part of comprehensive periodontal therapy. This re-evaluation determines if a patient is in need either of surgical periodontal therapy or a personalized program of supportive periodontal treatment. However important, this time point is yet to be determined.This interventional study aims to clarify which is the best time to re-evaluate the therapeutic result after non-surgical periodontal treatment.

This randomized clinical trial aims to clarify which is the best time to re-evaluate the therapeutic result after non-surgical periodontal treatment. For this purpose the participants will be recruited among people who come to the Periodontal Department of 251 Hellenic Air Force Hospital for periodontal treatment. Each participant is going to submit informed consent in order to be included in the study. Patients with the diagnosis of Periodontitis will be submitted to non-surgical periodontal treatment with ultrasonic and manual scalers within two sessions, under local anaesthesia. The result of the treatment is going to be evaluated at 6, 12 and 24 weeks after treatment completion.

Eligibility Criteria:
Inclusion Criteria:

* Systematically healthy adults
* Informed consent form completion
* Periodontitis Diagnosis
* Patients not having received periodontal treatment since 12 months before

Exclusion Criteria:

* Medical History that interferes with wound healing
* Antibiotic and anti-inflammatory drugs intake
* Medication that induces gingival enlargement
* Pregnancy/ Lactation
Brain Changes in Severely Depressed Patients Before and After Treatment With Electroconvulsive Therapy

Electroconvulsive therapy (ECT) is a non-pharmacological treatment used in resistant depression whose effectiveness has been demonstrated. However, the brain mechanisms underlying this therapeutic effect remain unclear. Many animal studies show a neurotrophic action of ECT on the hippocampus: increased neurogenesis, synaptogenesis, proliferation of glial cells. In addition, functional imaging of "resting state" type have shown, among depressed patients after ECT, increased functional connectivity . These results were reinforced by the recent work of Perrin (2012). In view of this a priori contradictory, it seems appropriate to continue research neuroanatomical correlates subtending neurofunctional processes responsible at the same time improving the clinical depressive. The investigators suggest using an original technique never used in this type of population: Functional magnetic resonance imaging (fMRI) or multimodal structural-functional. This method will allow us to study the impact of ECT on brain structures involved in major depressive disorder: hippocampus.


Eligibility Criteria:
Inclusion Criteria:

* diagnostic and Statistical Manual of Mental Disorders-V (DSM) diagnosis of major depressive disorder
* indication of ECT and signing the consent for conducting a ECT
* right-handed
* be of French mother tongue
* belong to a social security scheme
* sign an informed consent

Exclusion Criteria:

* against indication for MRI
* against indication to anesthesia
* processes brain expensive
* pregnant woman
* refuse to be informed of an abnormality detected during MRI
* Patients holders of stimulation electrodes
* presence history of neurological disease
* presence history of head injury
* Mini-Mental State Examination (MMSE) \<15/30
* presence of neurodegenerative disease
* patients who have had ECT treatment in the last 6 months
Improving Cancer Patients' Insurance Choices

The goal of this research study is to find out if a decision aid (DA) created by investigators, I Can PIC, is effective in helping cancer patients make decisions about their health insurance. The investigators will evaluate I Can PIC compared to an attention control condition (existing website created by the American Cancer Society Cancer Action Network). The study hypothesis is that those randomly assigned to I Can PIC will have higher knowledge about health insurance terms and details, more certainty about the best health insurance plan for them, and more confidence in their health insurance decisions compared to those randomly assigned to the control condition.

In a prior study, the investigators created a consumer-friendly online tool, Show Me Health Plans (SMHP), for those enrolling in health insurance in the ACA marketplace. I Can PIC was developed based on SMHP, with input from an advisory board, and incorporating feedback from semi-structured qualitative interviews with cancer survivors. The investigators created I Can PIC to focus on unique needs of cancer patients and survivors considering health insurance. In this study, the investigators will examine the effectiveness of I Can PIC by conducting a randomized experiment with 275 participants. The trial will compare the I Can PIC to an attention control website developed by the American Cancer Society Cancer Action Network. Primary outcomes include knowledge, decision self-efficacy, certainty about plan choice, and the match between plan choice and preferences. The investigators will also explore whether financial toxicity, cancer type, and time since diagnosis relate to outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Ability to read English
* Diagnosed with cancer in the past 5 years
* Residing in Missouri or Illinois

Exclusion Criteria:

* Eligible for Medicaid or Medicare in Missouri or Illinois
* Enrolled in the following types of health insurance plans: Medicare, Medicaid, TRICARE or other military healthcare, or Indian Health Services