cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma

Marqibo (liposomal vincristine) is a form of vincristine preparation. Vincristine is designed to interfere with the multiplication of cancer cells, which may slow or stop their growing and spreading throughout the body. This may cause the cancer cells to die. Liposomal vincristine is formed when vincristine is placed inside of oil droplets called liposomes, which may help to improve the delivery of drug to the tumor site. The liposomal formulation results in a slow, steady release of vincristine in the tumor metastasis, exposing the cancer cells to vincristine continuously.

The goal of this clinical research study is to learn if Marqibo (liposomal vincristine) can help to control metastatic uveal melanoma. The safety of liposomal vincristine will also be studied.

Approximately 50 patients will take part in this study.


Eligibility Criteria:
Inclusion Criteria:

* Uveal melanoma with histologic or cytologic confirmation of metastatic disease.
* One unidimensionally measurable lesion. If this is a cutaneous lesion it must be at least 10 mm by caliper measure. If it is a visceral or nodal or soft tissue lesion, it must be \>20 mm with conventional techniques or \>10 mm with spiral CT scan. Bone lesions are not considered measurable.
* Must not have received any prior systemic chemotherapy, immunotherapy, vaccine or hepatic arterial chemotherapy for metastatic disease.
* Adequate liver, renal, and bone marrow function.
* Zubrod performance status of 0-2.
* Sign an informed consent form.

Exclusion Criteria:

* Major surgery within 4 weeks of enrollment.
* Advanced symptomatic central nervous system (CNS) involvement by melanoma and those on phenytoin or requiring steroids for brain metastases, spinal cord compression, or meningeal "carcinomatosis".
* History of neurological disorders unrelated to chemotherapy (including familial neurological diseases and acquired demyelinating disorders).
* Grade 2 or greater sensory, motor and/or autonomic neuropathy at screening from any cause.
* Receiving treatment with drugs known to inhibit or induce hepatic drug metabolism by cytochrome P450-3A4 isoenzymes and/or P-glycoprotein within 1 week of study enrollment.
Health-economic Evaluation of Interventional Pain Management Compared to Pain Rehabilitation

The overall aim of the study is to evaluate interventional pain management. This is done in three steps:

1. To find matched controls to the patients in the study on cost-effectiveness of IPM and compare the results.
2. To calculate cost-effectiveness of PRP during the period 2010-2016, on a national level.
3. To calculate cost-effectiveness of PRP during the period 2017-2019, after the changed guidelines for PRP in Sweden.

The two last steps are to provide a background to the results of IPM, and to see if the results in the subgroup of matched controls of PRP-patients differ from the results from the whole population.

Chronic pain is one of the major health problems globally, according to the WHO 'global burden of disease' studies. Previously, the investigators have performed a study on a feasible approach to be able to treat zygapophyseal joint pain in the thoracic region, similar to the established methods for treatment in the lumbar and cervical regions which have been published. The study showed that there was a significant improvement in health related quality of life (HRQoL) after treatment, and that there were no difference in the results depending on if it was the cervical, thoracic or lumbar region that was treated. The study had ethical approval (Dnr 2012-446-31M) and is registered here at clinicaltrials.gov.

Another study explored the health economic aspects of interventional pain management (IPM). The investigators aimed to do this in comparison with pain rehabilitation programs, and therefore further ethical approval was searched and gained (2012-446-31M, 2017-542-32, 2018- 507-32) An health-economic evaluation of only IPM was performed showing that patients after treatment of diagnosed pain-focuses in zygapophyseal joint pain not only improve their HRQoL but they also reduce their medication, reduced their health-care consumption and gained in ability to work. The cost per quality adjusted life years gained was below the threshold for cost-effective health-care according to the threshold-levels defined by the national Board of Health and Welfare in Sweden. But the investigators need a larger population to select from in order to get matched controls among patients that have been through pain rehabilitation programs.

This study therefore aims to explore the national register of pain rehabilitation both in order to find matched controls and in order to make a cost-effectiveness study of pain rehabilitation program as it is performed in Sweden.

Eligibility Criteria:
Inclusion Criteria:

Been through pain rehabilitation program

Exclusion Criteria:

-
Randomized Comparison of MynxGrip Vascular Closure Device and Manual Compression for Closure After Femoral Access Angiography. The Closure Devices Used in Every Day Practice Study, CLOSE-UP III Trial

Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the incidence of adverse access site related events in-hospital, at 30 days and at 6 months.

Prospective, randomized (1:1), controlled, non-blinded, single center study in 2000 patients comparing the MynxGrip (test device) and manuel compression (standard comparator). Safety and efficacy endpoints will be reported for in-hospital, 30 days and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* \>18 year
* Should be able to provide valid informed signed consent
* CAG, possibly including intracoronary measurement (FFR) or intracoronary imaging (IVUS, optical coherence tomography (OCT), NIRS)

Exclusion Criteria:

* Percutaneous coronary intervention (PCI) procedure and/or implantation of stents
* ST-Elevations Myocardial Infarction (STEMI)
* Multiple punctures
* Active infection
* Groin haematoma before the closure procedure
* Known pseudoaneurysm or arteriovenous (AV) fistula in the ipsilateral groin
* Cardiogenic shock
* Prior peripheral arterial surgery in abdomen or lower extremities
* Sheat size \>7 F
* Life expectancy less than one year
* Possible pregnancy or positive pregnancy test or breastfeeding women
* Simultaneous or planned subsequent femoral vein access
* Allergy to any of the components in the closure material left in the groin
* Puncture or closure with closure device at same site \< 30 days
* Puncture or closure with manuel compression at same site \< 5 days
* Patients with peripheral artery disease can be included at operators discretion except if heavy calcification is present at the access site, which at the operators discretion precludes insertion of the closure device
To Investigate the Real-world Efficacy and Safety of Sacituzumab Govitecan for HER2 Negative Metastatic Breast Cancer Patients in China.

To investigate the real-world efficacy and safety of Sacituzumab govitecan for HER2 negative metastatic breast cancer patients in China.

This study will conduct a multicenter, open, prospective clinical trial to investigate the real-world efficacy and safety of Sacituzumab govitecan for HER2 negative metastatic breast cancer patients in China.

Eligibility Criteria:
Inclusion Criteria:

Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.

HER2-negative breast cancer(according to 2018 ASCO/CAP HER2 test guideline). 18-75 years old. ECOG PS 0～2. life expectancy is not less than 12 weeks. at least one measurable lesion according to RECIST 1.1. received at least two cycles of SG. Signed informed

Exclusion Criteria:

Patients who did not receive sacituzumab govitecan treatment for two or more cycles Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.

Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial History of neurological or psychiatric disorders Researchers believe that patients are not suitable for any other situation in this study.
Remimazolam for Cataract Surgery

The goal of this study is to assess any post operative cognitive changes following benzodiazepine administration during cataract surgery. The investigators will compare effects of Midazolam vs. Remimazolam on cognition at the time of discharge from the post operative care unit and the next day following surgery.

Cognitive changes will be assessed by administration of Montreal Cognitive Assessment (MoCA).

Participants will:

1. Complete MoCA testing prior to surgery
2. Randomize in either Midazolam or study drug Remimazolam
3. Complete MoCA testing after surgery at the time of discharge in the post anesthesia care unit and the next day of surgery at the time of post operative surgical visit.
4. Complete Patient Satisfaction Survey at the time of discharge from the Post Anesthesia Care Unit (PACU)

Cataract surgery (clouded natural lens of eye removed and clear artificial lens implanted) is the most common eye surgery performed in elderly patients. Although cataract surgery is a minor surgery, many patients are anxious and therefore benzodiazepine such as midazolam is administered during surgery to allay a patient's anxiety.

The purpose of this study is to look at any difference in postoperative cognitive changes as well as recovery times in the PACU following administration of midazolam or remimazolam.

Patients will be asked to participate in a clinical trial where they will be randomly assigned to midazolam or remimazolam group. Cognitive changes will be assessed by administration of MoCA test. MoCA test is a validated, objective short (about 10-15 minutes) screening tool for detection of mild neurocognitive dysfunction. Given the short half life of remimazolam, investigators hypothesize that any cognitive changes will be less with remimazolam compared to midazolam.

Patients will be asked to complete MoCA prior to surgery, in the recovery room following surgery, and the next day during their post-operative clinic visit. In addition, patients will be asked to rate their satisfaction of their anesthetic during their surgery.

The participant will be in this research study from the day of surgery until the first post-operative visit, the following day.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients age \> 65 years undergoing first eye cataract surgery under local topical anesthesia at the University of California, Los Angeles (UCLA).
2. Both male and female patients
3. American Society of Anesthesiologists Class 2, 3, and 4.

Exclusion Criteria:

1. Patients who are unable to consent for the study
2. Patients who are unable to cooperate with the cognitive assessment such as patients with significant visual, auditory, language or other impairment.
3. Patients who are unable to understand simple English commands.
4. Patients who do not wish to have benzodiazepine medication during surgery
5. Patients with a history of severe hypersensitivity reaction to dextran 40 or products containing dextran 40.
6. Patients with chronic pain on opiates.
7. Patients with a history of drug, alcohol abuse/dependence.
8. Patients with BMI \> 40.
9. Patients with obstructive sleep apnea (moderate to severe).
"Online Surveys" in Perioperative Knee Anterior Cruciate Ligament (ACL) Reconstruction

To monitor the quality of health care systems, patient-reported outcome measures (PROMs) should be collected and analyzed before and after medical interventions. The development of information technology and software along with an exponential increase in the use of the Internet now allows new modalities for collecting PROMs. Online survey has become one of the most popular methods of data collection. tHE hypothesis is that providing a "brace cold therapy" to patients undergoing knees surgeries will generate an increasing in Response Rate to Online surveys.

In the setting of anterior cruciate ligament reconstruction (ACLR), an alternative to standard clinic-based follow-up is used in our institution via the utilization of Web-Based follow-up platform (OTHENSE) that allows surgeons to monitor a patient's subjective quality of recovery, including symptoms of pain and limitations in activities of daily living. This tool has the potential to enhance quality of care by providing weekly updates about the patient's physical impairment. We started using it in 2018.

From a single orthopedic surgeon, a total of 100 patients who were planned to undergo an ACLR requiring formal post-operative follow-up were participated.

The process began upon preop consultation, where the patient is offered a description of the survey and asked to use a link allowing direct access to the Online Surveys (ORTHENSE Platform).

• Participants were divided in two groups :

* First group: patients operated for ACLR
* Second group: patients operated for ACLR, and received a "knee brace cold therapy" to use it in the post op recovery rehabilitation, sent to patient's home directly during pre-op phase.

A standardized follow-up protocol for both groups.

The surveys included questions related to rehabilitation and questions from standard patient-reported-outcome-measures PROMs. They were asked to complete the following surveys pre-operatively and post-operatively:

J -14 / J-7 / J -5/ J-2 / J+3 / J+7 / J+14 / J+21 / J+28 / J+35 / J+45

For both groups, data was collected for up to 6 weeks following Surgery (J+45), for a total of 11 surveys

Eligibility Criteria:
Inclusion Criteria:

* Patients performing knee surgeries (ACL)
* 6 Weeks minimum of F/U (J+45)
* In University Hospital Toulouse

Exclusion Criteria:

* F/U = 6 weeks
Birth Cohort Study of China Medical University

The CMUBCS is a birth cohort study located in Shenyang, China. Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology. Data are collected regarding environmental factors, family and lifestyle, clinical experimental outcomes and imaging results of pregnant women and children from birth to 18 years old. Biological samples including blood and tissue samples are also collected from the children and their parents.

Early life phase (fetal and infant) is a critical period for the development of health and disease in a person's life. Many adult chronic diseases, such as diabetes, cardiovascular and cerebrovascular diseases, all come from the exposure of negative environmental and behavioral factors during this period. By collecting the lifestyle data and clinical data of pregnant women at different periods, the appropriate indicators are anticipated to be selected to predict and evaluate the outcome of pregnancy and the health of the mothers and children in the long term. The status of overweight and obesity of children in Shenyang and its surrounding areas are anticipated to be analyzed by descriptive and etiological analysis through collecting the lifestyle data and clinical data of different periods of pregnant women and the lifestyle data of different developmental stages of children.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women, \<13 gestational weeks
2. Permanent residents or families intended to remain in Shenyang and surrounding areas
3. Pregnant women who are planned to be examined and delivered in Shengjing Hospital.

Exclusion Criteria:

1. Pregnant women who refuse to take part in the study
2. Pregnant women have diseases that might affect the results of researches, including neuropsychiatric disorders.
TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

This trial is a multi-center, single-arm phase 2 study to evaluate the efficacy and safety of TJ202 combined with dexamethasone in subjects with relapsed or refractory multiple myeloma (RRMM) who received at least 2 prior lines of treatment.

A total of 82 subjects with relapsed or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of treatment will be enrolled in this study. Prior lines of treatment must include a proteasome inhibitor (PI) and an immunomodulator (IMiD). All subjects will receive TJ202 and dexamethasone (DEX) in the study. The treatment will continue until endpoint events such as intolerance or progressive disease (PD).

Eligibility Criteria:
Inclusion criteria:

1. Age ≥ 18, male or female;
2. Subject must have had documented MM;
3. At screening phase, subject must have measurable disease;
4. Subject is in a state of progressive disease (PD);
5. Subject must have life expectancy of no less than 6 months;
6. Subject must have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0\~2;

Exclusion criteria:

1. Subject has received anti-CD38 monoclonal antibody treatment previously;
2. Subject has received CAR-T cell therapy previously;
3. Subject has previously received allogenic stem cell transplant, or subject has received autologous stem cell transplant within 3 months before administration of the study agent;
4. Primary refractory multiple myeloma (subject failed to generate any minimal response or any degree of response to any therapy);
5. Subject has received anti-myeloma treatment (radiotherapy is excluded) within 4 weeks or 5 PK half-lives of the treatment, whichever longer, before the first study agent administration.
Treatment of Late Abortion: Evacuatio Uteri or Conservative Treatment

A randomize trial: expectation or evacuatio uteri for the treatment after late abortion

A randomize trial adressing 200 women consecutively recruited from clinical practice at Rigshospitalet.Expectation: administration of 800 microgram Cytotec half an hour after delivery. Surgery: Evacuation of the uterus

Eligibility Criteria:
Inclusion Criteria:

abortion at gestational age (ultrasound) 14+0 - 20+0

Exclusion Criteria:

Allergy to cytotec
Improving Attention Skills of Children With Autism

Toddlers with autism have poor joint attention skills. Joint attention skills include pointing to objects, following another person's gaze, and responding to invitations to join in a social interaction. Improved joint attention skills may lead to better verbal ability as the child ages. This study teaches caregivers how to help their toddlers with autism develop joint attention skills.

Young children with autism show impairment in joint attention. The impairment affects their ability to sustain a shared interest in social interaction and to use specific joint attention skills, such as pointing and showing. The importance of joint attention is underscored by data suggesting these skills are important to later language skills. Targeting joint attention deficits in developmentally young children using familiar caregivers may result in better child language outcomes. This study will teach caregivers how to initiate and maintain episodes of joint engagement with their children.

Participants will be randomized to either the intervention group or to a wait list control group. Each caregiver and child in the intervention group will participate in 24 1-hour sessions, 3 times a week for 8 weeks. In these sessions, caregivers will be taught 10 different modules for teaching joint attention skills to their children. Outcome measures will include language and joint attention skills in the child and caregiver adherence to the intervention protocols. Children and caregivers will be assessed at baseline, during the course of the 8-week intervention, and 10 weeks after the end of the intervention. Participants assigned to the wait list group will begin the intervention at Week 12.

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of autism based on Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS) criteria

Exclusion Criteria

* Seizures
* Medical or psychiatric diagnoses other than autism that potentially contribute to developmental delay (e.g., genetic syndromes)
NovaTears® Eye Drops Observational Study

This observational pilot-study is intended to collect outcome data from a cohort of 30 patients suffering from hyper-evaporative dry eye disease who are treated with the medical device NovaTears® eye drops for a duration of 5 to 7 weeks.


Eligibility Criteria:
Inclusion Criteria:

* According to NovaTears® instruction for use
* ≥ 18 years
* Patients with mild to moderate disease and hyper-evaporative dry eye disease applying eye lid hygiene for at least 14 days
* Ability and willingness to provide written Informed Consent
* Ability and willingness to participate in all examinations
* Willingness and ability to return for follow up visit

Exclusion Criteria:

* Patients with hypersensitivity to any of the components of NovaTears®
* Patients with contact lenses, pregnancies, or who are breast feeding
* Patients with non evaporate dry eye disease
* Patients taking lipid containing eye drops or requiring pharmacologic treatment of dry eye disease
Supra-spinatus Rehabilitation Program Comparison

Through a prospective randomized study the aims of this study is to analyze the impact of 3 types of rehabilitation protocols on the Optimization of the post-operative clinical and anatomic healing of the rotator cuff. After an arthroscopic repair of a stage 1 or 2 supra-spinatus tendon rupture, patients will be included in 3 groups (98 patients per group):

* strict immobilization for 6 weeks then active rehabilitation,
* or 3 weeks of immobilization then 3 weeks of passive motion before active rehabilitation,
* or immediate passive motion for 6 weeks and then active rehabilitation.

Patients will be evaluated clinically at 6 weeks, 3 months, 6 months and 1 year and an arthro-CT will be performed at 1 year.

The investigators will evaluate: constant score and rate of tendon healing.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 40 and 65 years old
* non-retracted supra-spinatus tendon tear-pre-operative clinical examination and ct
* scan-arthroscopic single-row tendon repair

Exclusion Criteria:

* patient with a stiff shoulder
* previous surgery of the shoulder
* stage 3 or 4 fatty infiltration
* insufficient repair of the cuff