cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Prophylactic Use of a Preoperative IABP in High-Risk Coronary Artery Bypass Graft Surgery

Background: The intra-aortic balloon balloon pump (IABP) has been used as a method of percutaneous circulatory assistance high surgical risk patients undergoing coronary artery bypass graft surgery (CABG); Although its applicability has been questioned by clinical trials showing poor impact to reduce the mortality due to cardiogenic shock associated with postoperative acute myocardial infarction (AMI), the real benefit reducing mortality in the postoperative context (PO) has not been determined examined through a prospective study with an adequate design.

Objective: To compare PO complications such as mortality, perioperative infarction and other complications in patients with high surgical risk undergoing CABG in comparison with controls.

Methods: Quasi-experimental, prospective, comparative, non-randomized study. The decision to place the BIAC is not part of the study and depends on the multidisciplinary decision of a Heart Team, based on the individualized risk / benefit. The study population consists on high surgical risk patients with atherosclerotic coronary disease undergoing CABG in our centre between 2014-2018. Patients are excluded if any condition is present: cardiogenic shock, with AMI 48 hours prior and / or severe aortic insufficiency. In one group BIAC will be inserted 1-6 hours before surgery (BIAC group) and a second group is control (non-BIAC group). A minimum 30-day postoperative follow-up of will be performed, with primary end points (mortality and AMI type V) and secondary end points (additional PO complications).

Analysis: An evaluation of normality distribution K-S will be performed, the means of quantitative (t-Test) and categorical variables (Fisher or χ² Pearson) will be compared. A multivariate analysis will be performed with linear logistic regression to evaluate the influence of age, sex, peripheral arterial disease (PAD) and EuroSCORE-II on the primary goal. Statistical significance will be considered when p \<0.05. Softwares: GraphPad-Prism-5.0 and SPSS-15.0

Eligibility Criteria:
Inclusion Criteria:

* All patients greater than 18 years
* Scheduled for coronary artery bypass graft (CABG) surgery were eligible
* Multiple vessel disease with or without left main coronary artery (LMCA) significant stenosis (\>50%)
* Written informed consent provided

Exclusion Criteria:

* Prior cardiogenic shock,
* Acute myocardial infarction (AMI) less than 48 hours prior to enrollment
* Previous IABP use
* AMI mechanical complications
* Aortic regurgitation greater than grade II in severity (on a scale of I to IV, with higher grades indicating more severe regurgitation)
* Tachyarrhythmia
* Other aortic procedures
* Other non-CABG surgical procedures
* Massive pulmonary embolism
* Older than 90 years of age
* Any coagulopathy
* Severe concomitant disease associated with a life expectancy of less than 6 months.
CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients

This prospective, randomized, multicenter study is performed to determine whether prothrombin complex concentrates confers any benefits over fresh frozen plasma in adult neurological patients with coagulation disorders (PT value less than 60%).

The coagulation disorders increase the risk of bleeding and are a risk factor of intracranial hemorrhagic complications in neurosurgical patients. They are diagnosed more often in emergency on a PT value less than 60% and so they should be corrected as soon as possible. Two therapeutic strategies are proposed by French or international recommendations: transfusion of fresh frozen plasma (FFP) or administration of prothrombin complex concentrates (PCC).

This prospective, randomized, multicenter study with blinded assessment of the primary endpoint, is performed to determine whether PCC confers any benefits over FFP in the neurological patients with coagulation disorders.

Eligibility Criteria:
Inclusion Criteria:

* Patient with spontaneous intracranial hemorrhage or traumatic intracranial hemorrhage or patient requiring neurological surgery
* Coagulation disorder defined by PT less than 60%

Exclusion Criteria:

* Concomitant use with oral anticoagulant drugs
* Acquired deficiency of coagulation factors whose treatment is established
* Hypersensitivity to a PCC
* History of thrombocytopenia induced by heparin
* Disseminated intravascular coagulation
* Extracranial active bleeding
* Hypersensitivity to vitamin K
Clinical Study on the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies

Clinical study on the safety and effectiveness of NK cells/combined monoclonal antibodies in the treatment of hematological malignancies

This is a single arm, open-label, single-center study. This study is indicated for hematological malignancies. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
2. Relapsed or refractory AML (meeting one of the following conditions):

   1. CR not achieved after standardized chemotherapy;
   2. CR achieved following the first induction, but CR duration is less than 12 months;
   3. Ineffectively after first or multiple remedial treatments;
   4. 2 or more relapses;
3. The number of primordial cells in bone marrow is \> 5% (by morphology), and/or \> 0.01% (by flowcytometry);
4. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
5. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
6. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
7. Estimated survival time ≥ 3 months;
8. ECOG performance status 0 to 2;
9. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.

Exclusion Criteria:

1. History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;
7. Previously treated with any CAR-T cell product or other genetically- modified T cell therapies;
8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
9. Other uncontrolled diseases that were not suitable for this trial;
10. Patients with HIV infection;
11. Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.
Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 1 of 7)

NOTE: This is the first of in total 7 sub-studies related to the Ethics Committee of the Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 5 arms, in total 350 participants will be assessed in all 7 sub-studies.

General study information: This is a randomized, cross-over, quantitative study, which investigates physiological variables, mood, and affect of healthy participants in response to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored light only, or are additionally asked to solve cognitive tasks during the colored light exposure. Primary aim is to measure the change in several physiological variables, mood, and affect during colored light exposure of 15 or 45 minutes. The risk for the participants is negligible and comparable to the risk during daily life.


Eligibility Criteria:
Inclusion Criteria:

* Normal color vision
* Right handed
* Written informed consent

Exclusion Criteria:

* Smoking
* Any kind of diagnosed sleep disorder or neurological or psychiatric disorder in the last 3 months
* Acute severe traumas
* Chronic diseases with the necessity for medication
* Use of recreational drugs
* Regular intake of medication that would affect the outcome measures
* Regular excessive alcohol use (\> 18 standard units / week)
* Transmeridian travel in the last month (crossed \> 1 time zone border)
* Night shift word during the last month
A Study of Different Formulations of the L-PPDS in Subjects With OH or OAG

The purpose of this study is to evaluate the safety and preliminary efficacy of two formulations of the Latanoprost-PPDS in subjects with ocular hypertension or open-angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18 years of age diagnosed with ocular hypertension or open-angle glaucoma
* Subjects who have a best corrected visual acuity of 20/100 or better

Exclusion Criteria:

* Subjects who wear contact lenses
* Subjects who have uncontrolled medical conditions
* Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic ocular topical medications
* Subjects who have a history of chronic or recurrent inflammatory eye disease
Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane

The purpose of this research study is to determine whether early administration of Dexrazoxane prevents Doxorubicin induced cardiotoxicity.

This is a study on volunteers to determine effective dose of dexrazoxane in degrading Topoisomerase 2 b in human blood samples. Each participant will receive one dose of dexrazoxane. Blood samples will be collected to determine the time course and degradation of Topoisomerase 2b and Topoisomerase 2a

Eligibility Criteria:
Inclusion Criteria:

* Women,
* Age 18-65,
* Not pregnant, Not currently breast feeding
* No current illness,

Exclusion Criteria:

* Pregnancy, currently breast feeding
* Current illness,
* History of cardiac, or renal disease
The Use of Residual De-identified Specimens and/or Samples From Patients for Clinical Research

Acquire residual human specimens and/or samples from patient samples which were sent for testing at LabPMM, LLC for Clinical Research

Residual specimen/sample collection study where peripheral blood (PB), bone marrow (BM), genomic (gDNA), and/or formalin-fixed paraffin-embedded tissue (FFPE) specimens/samples are obtained from patient samples sent to LabPMM, LLC for clinical testing. Samples may be used for Clinical Research at LabPMM, LLC or at partner institutions

Eligibility Criteria:
Inclusion Criteria:

1. Specimen/sample, peripheral blood (PB), bone marrow (BM), genomic DNA (gDNA) and/or formalin-fixed paraffin-embedded tissue (FFPE) from patients whose specimens/samples have been sent to LabPMM for clinical testing
2. Donor Age ≥ 18 years

Exclusion Criteria:

1. Sample/specimen has been obtained from a third-party vendor with a Materials Transfer Agreement (MTA) on file with LabPMM
2. The specimens/samples have previously been enrolled in a clinical study
Motor Function Assessment System Based on Video Tracking and Artificial Intelligence Technique

The goal of this clinical trial is to develop a motion recognition system based on video tracking technology and combine it with artificial intelligence technology to form a motion recognition and function evaluation system in in healthy people and patients with cervical spondylotic myelopathy. The main questions it aims to answer are:

* The development of this motion recognition system,
* In the scenario of hand motor dysfunction, the key parameters of hand movement in healthy people and patients with cervical spondylotic myelopathy were evaluated, and the hand motor function model was established to achieve an objective, highly sensitive, highly specific, repeatable and easy-to-use system in clinical hand motor function evaluation.

Participants will recieved the evaluation of this system and mJOA before the surgery.

If there is a comparison group: Researchers will compare the evaluation results of healthy people to see if this system could recognized the hand motor dysfunction of patients with cervical spondylotic myelopathy.


Eligibility Criteria:
Inclusion Criteria:

* Study Group: 1. Patients with cervical spondylotic myelopathy diagnosed by clinical symptoms and cervical spine imaging examination (including cervical flexion and extension X-ray, cervical spine CT and cervical spine MRI).
* Control Group: 1. Healthy people without clinical and imaging manifestations of cervical spondylotic myelopathy.
* Age 18-80 years old.
* Can complete the informed consent process.

Exclusion Criteria:

* Patients with hand dysfunction caused by other reasons (such as rheumatoid arthritis, history of hand trauma, history of hand surgery, etc.).
* Patients who cannot complete the assessment process due to various reasons.
Two-dose Schedule of Quadrivalent HPV Recombinant Vaccine in 11-year-old Boys in Mexico City

In the genital tract human papilloma virus (HPV), especially types 6 and 11 cause genital warts, the commonest viral sexually transmitted disease. The HPV 16 and 18 are the most common oncogenic "high-risk" genotypes and cause approximately 70% of all cervical cancers despite the fact that are associated with other anogenital cancers, anus, vagina, vulva and penis, and cancers of the head and neck. Current estimates are that 5.2% of all cancers are HPV associated. A large number of studies, including both adult and young females, have demonstrated that HPV vaccines are highly immunogenic and induce a long lasting protection against infection. Immunogenic vaccination results in young men and boys are equally satisfactory with the quadrivalent HPV (types 6, 11, 16, 18) vaccine recommended for men. The recommended vaccination scheme includes three shots giving the second at two months and the third at six months after the initial shot. Recently, it has been shown that the use of a two shot scheme (0 and 6 months) is equally effective among girls. The purpose of this study is to determine that the immunogenicity is non-inferior in boys using a two shot scheme compared with young women and girls.


Eligibility Criteria:
Inclusion Criteria:

* All those children whose parents accept their participation in the study.

Exclusion Criteria:

* Fever,
* previous vaccination against HPV,
* allergy to vaccine components,
* thrombocytopenia,
* immunosuppression,
* diarrhea,
* vomiting,
* dyscrasia,
* administration of another anti-viral vaccine in the previous 15 days.
Mesalamine and Reproductive Health Study

The purpose of this study is to investigate the relationship of high exposure to dibutyl phthalate (DBP) from the use of Asacol with clinical and intermediate markers of male fertility, including semen quality, sperm DNA damage, transcript profiles of sperm mRNA and sncRNAs, and reproductive hormones.

Hypothesis 1: High exposure to DBP from the use of Asacol is associated with decreased sperm concentration and motility, and increased sperm DNA damage.

Hypothesis 2: High exposure to DBP from the use of Asacol is associated with decreased serum testosterone, altered LH:testosterone ratio, and decreased inhibin-B.

Hypothesis 3: High exposure to DBP from the use of Asacol is associated with altered transcript profiles of sperm mRNAs and sncRNAs.

There are 2 ways you can participate in the study.

OPTION 1 involves 6 one-hour visits to the Massachusetts General Hospital (MGH) Andrology Clinic over a 9 month period. At each visit you would be asked to fill out questionnaires and to provide a urine, semen, and blood sample. Following Visit 2, you are asked to switch your brand of mesalamine medication. After 4 months, you change back to your original brand of medication. The change in medication will be done in consultation with your primary GI doctor. If the cost of co-payment is greater for the new brand of medication, we will provide compensation to cover the difference. In the case you do not have prescription drug health insurance coverage, the study will reimburse up to $4000 to cover the cost for Asacol, Pentasa or Lialda medication taken during your study participation.

OPTION 2 involves 4 one-hour visits to MGH Andrology clinic. At each visit you complete questionnaires and provide a blood, urine and semen sample. You are eligible for Option 2 if you are currently taking Asacol or Asacol HD and do not want to change your medication.

Eligibility Criteria:
Inclusion Criteria:

* Must be taking mesalamine medication. Willing to switch brand of medication for 4 months or currently taking Asacol or Asacol HD.
* Has not taken steroid medication within the previous 3 months. Is able to come to MGH hospital for 6 visits.

Exclusion Criteria:

* Is not taking mesalamine medication. Unwilling to switch brand of medication for 4 months.
* Is or has taken steroid medication within the past 3 months. Is unable to come to MGH hospital for 6 visits.
* Has had a vasectomy or has documented infertility.
Feasibility and Outcomes of Complete Coronary Revascularization Using BVS in All-comer Patients With Angina

The aim of the study is feasibility of complete coronary revascularization with bioresorbable vascular scaffold (BVS) implantation and assessment of treatment outcomes in a group of consecutive patients with stable and unstable angina in Russian population.

The hypothesis of this registry study: 1) Complete coronary revascularization with BVS implantation will be feasible to perform in at least 70 percent of patient population with stable and unstable angina qualified for revascularization after coronary angiography, 2) Complete revascularization with BVS is as safe and effective as revascularization with standard BMS (Bare Metal Stent BMS/ Drug Eluting Stent DES stent implantation (published literature comparators in matched populations).

Up to 2500 patients will be enrolled in 13 Russian high volume invasive cardiology centres. 12 month clinical observation and 5-year clinical follow-up is expected.

Study design: Data regarding all consecutive patients qualified for revascularization (PCI Percutaneous Coronary Intervention or CABG Coronary Artery Bypass Grafting) will be collected in this prospective study. Information regarding revascularization strategy will be collected as detailed information concerning PCI procedure. In case of PCI with other than BVS stent implantation (BMS or/and metallic DES) information collected in the study will contain at least:

* Reason why BVS was not implanted
* Final result of baseline treatment
* Acute and long-term outcome of treatment (12 month clinical observation); NB. 5-year clinical follow-up is also expected.

The enrollment phase of the registry is not expected to last longer than 12 months.

Eligibility Criteria:
Inclusion Criteria:

Patient characteristics

* Age \> 18 years
* Able and willing to give informed consent
* Willing to comply with specified follow-up evaluations
* Clinical manifestation of coronary artery disease: stable angina or unstable angina
* Indications for coronary revascularization

Exclusion Criteria:

Patient characteristics

* Acute Myocardial infarction
* Cardiogenic shock
* Any reason for patient's inability to comply with 12-month double antiplatelet therapy (DAPT)
* Absolute contraindications to DES or BVS implantation
Function-metabolism Coupling in Decision-making Confidence Neural Network of Obsessive-compulsive Disorder

This study, a case-control study, aims to investigate the function-metabolism coupling in decision-making confidence neural network of obsessive-compulsive disorder.

OCD shows various abnormalities in cognitive function. Decision-making confidence is a burgeoning research focus on cognitive abnormality of OCD. Gamma-aminobutyric acid (GABA) is a type of inhibitory amino acid. Some studies have indicated that GABA shows metabolic abnormality in OCD.

Repetitive transcranial magnetic stimulation (rTMS) is a safe and noninvasive treatment for OCD. This study intends to explore the differences of the function-metabolism coupling in decision-making confidence neural network between OCD and HC. And investigating the dynamic changes of the function-metabolism coupling after rTMS treatment (6 weeks) for OCD is another goal.

Eligibility Criteria:
Inclusion Criteria:

OCD group:

1. Age between 18 and 50 years.
2. Satisfied with the diagnostic criteria for OCD in DSM-V.
3. Taking medication or unmedication stably for 8 weeks or drug-naive.
4. YBOCS score ≥16.
5. Education level was limited to above middle school.
6. Has sufficient audiovisual skills to complete the necessary examinations for the study.
7. Right-handed (this criterion is for fMRI subjects only).
8. Subjects understood the study and signed informed consent.

HC group:

1. Match with the OCD group on age, gender, education years.
2. Unsatisfied with the diagnostic criteria for any mental disorder in DSM-V.
3. No history of taking psychotropic drugs.
4. No family genetic history of mental disorder.
5. Has sufficient audiovisual skills to complete the necessary examinations for the study.
6. Right-handed (this criterion is for fMRI subjects only).
7. Subjects understood the study and signed informed consent.

Exclusion Criteria:

OCD group:

1. Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD.
2. HAMD-17 score ≥ 17.
3. IQ \< 70.
4. Obsessive-compulsive symptoms were too severe to participate in the experiment.
5. Hoarding symptom.
6. High risk of negative thought and suicide.
7. Severe central system or physical disease or drug abuse.
8. Pregnant women or women that getting ready for being pregnant and lactating.
9. With metal implants in the body, such as pacemakers, intracranial silver clips, metal dentures, arterial stents, arterial clips, joint metal fixation, or other metal implants, etc. (this criterion is for fMRI subjects only)

HC group:

1. High risk of negative thought and suicide.
2. HAMD-17 score ≥ 17.
3. IQ \< 70.
4. Severe central system or physical disease or drug abuse.
5. Pregnant women or women that getting ready for being pregnant and lactating.
6. With metal implants in the body, such as pacemakers, intracranial silver clips, metal dentures, arterial stents, arterial clips, joint metal fixation, or other metal implants, etc. (this criterion is for fMRI subjects only)