cyrilzakka/clinical-trials huggingface dataset:
A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism

This trial is being conducted to assess the efficacy and safety of recombinant Human Prourokinase in the acute pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75 years（Include the critical value）AND
2. High-risk PE or medium high-risk PE AND
3. PE symptom duration ≤14 days AND
4. PLT≥100×10\^9/L，ALT and AST≤2.5ULN，TBIL\<ULN，Cr within the normal range AND
5. Informed consent can be obtained from subject or Legally Authorized Representative

Exclusion Criteria:

1. Hemorrhagic or unexplained stroke history
2. Ischemic stroke or transient ischemic attack (TIA) within 6 months
3. The existence of the central nervous system injury or tumor
4. Severe trauma，major surgery or head injury within 3 weeks
5. Active bleeding within 1 month
6. Clinician deems high-risk for bleeding
7. Using anticoagulants (after a washout period can be randomized)
8. Pregnancy or delivery within 1 week
9. Vascular puncture which can not be oppressed
10. Cardiopulmonary resuscitation within 10 days
11. Systolic blood pressure above 180 mmHg or diastolic blood pressure above 100mmHg
12. Severe liver dysfunction
13. Infective endocarditis
14. Arterial aneurysm or arteriovenous malformation or suspected aortic dissection
15. left atrial thrombus
16. Neurosurgery or eye surgery within 1 month
17. Hemorrhagic diabetic retinopathy
18. Serious cardiac insufficiency
19. ventricular arrhythmias
20. Known allergic to prourokinase，urokinase，recombinant tissue-type plasminogen activator，contrast agent or any drug in the trial
21. Do not allow for 30 days' study
22. Any disease or condition is not suitable for intravenous thrombolysis
23. Lactating women or plan to pregnant women during the trial，or don't want to during the study period using effective contraception or abstinence of male and female patients with possibility of fertility
24. Clinician thinks patient doesn't fit to participate in the test of other diseases or conditions
Registry of X-linked Adrenoleukodystrophy

This study is a observational study conducted through recruiting X-linked adrenoleukodystrophy (X-ALD) patients, to build a comprehensive evaluation and long-term follow-up platform for X-ALD patients, and to provide a theoretical basis for the treatment and management of X-ALD patients.

In this study, X-ALD patients will be selected as study participants. Through a longitudinal collection of genetic, imaging and clinical symptoms data of the patients and carriers. The purpose of this study is to build a comprehensive evaluation and long-term follow-up platform for X-ALD patients. Through the long-term follow-up of imaging and clinical symptoms progress and outcome of X-ALD patients, combined with genetic data, we will improve the relationships between genes and phenotypes, and explore the deep insight in the pathophysiological mechanism of X-ALD, to provide a theoretical basis for the treatment and management of X-ALD patients.

Eligibility Criteria:
Inclusion Criteria:

X-ALD group：

* Meet the diagnostic criteria of X-ALD and supported by the results of genetic and very long chain fatty acid (VLCFA) test;
* Age: 6 - 70 years old;
* Able to communicate normally, and complete the test of scale as instructed (confirmed by the field test of scale);
* Sign the informed consent.

Carrier-control group:

Healthy people who have no significant difference in age, sex and education comparing with the X-ALD group, volunteer to participate in this study, could complete the test of scale as instructed, and meet the following criteria:

* Eligible for asymptomatic carriers in genetic tests (preference of patient's mother and close relatives);
* Age: 6 - 70 years old, able to complete the test of scale as instructed (confirmed by the field test of scale);
* No history of psychiatric diseases.

Exclusion Criteria:

* Other hereditary diseases;
* Other severe central nervous diseases;
* History of surgery of brain or eye;
* Psychiatric and psychological diseases, such as anxiety and depression;
* Metal foreign body or prosthesis in the human body (such as pacemaker and insulin pump), claustrophobia, and other MRI contraindications;
* History of surgery associated with gastrointestinal tract;
* No informed consent;
* Unable to tolerate MRI or eye related tests.
Botulinum Toxin A in the Treatment of Hemifacial Spasm

Hemifacial spasm patients who received botulinum toxin A injection were divided into two groups. Group A received unilateral injection while group B received bilateral injection. Patients completed follow-up A researcher record facial videos and analyzed facial symmetry and completed 3 scales.

Hemifacial spasm patients who received botulinum toxin A injection were divided into two groups.Patients of unilateral group were injected to the affected side and the dose of botulinum toxin A was 2.5-3.75 units/per site. Patients of bilateral group were injected to the affected side with dose of 2.5-3.75 units/per site and the normal side was injected with dose of 1.25 units/per site.

3 scales for measurement were used.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of hemifacial spasm
* Scott grading III to IV
* hemifacial spasm duration of half or more years
* last botulinum toxin A application at least 3 months before the start of the study

Exclusion Criteria:

* history of facial trauma, congenital facial asymmetry, facial nerve microsurgical decompression
* bilateral hemifacial spasm
* allergies to botulinum toxin A or to any component of the drug
* previous treatment with botulinum toxin A fewer than 3 months
* the use of drugs that could interfere with neuromuscular transmission or spasm
Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes

The purpose of this study is to assess the long term safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* Not currently on drug therapy for type 2 diabetes
* Blood glucose criteria must be met
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* History of type 1 diabetes
* Evidence of significant diabetic complications
* Serious cardiovascular events within the past 6 months
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply
European Home Mechanical Ventilation Registry

The European Home Mechanical Ventilation Registry (EHMVR) will enable a thorough evaluation of HMV by documenting the characteristics of HMV patients and their treatment. This will facilitate a prospective, observational study to identify the primary indications for HMV, describe patterns of HMV use in European countries, and characterize changes in the initiation and utilization of HMV over time. The registry will target all adult individuals who have an indication for HMV. In the EHMVR, patient data from routine clinical care will be documented using an electronic case report form (eCRF). The eCRF will record: patient demographic data; diagnostic information (including primary diagnosis, 6-minute walk time, the presence of depression, and quality of life); blood gases; ventilation treatment (including type of ventilator, modes and settings, interfaces used); follow-up data (including failure rates, side effects, technical issues). An initial Pilot Phase will be launched with the aim to enrol at least 200 patients over a 6-month period to determine the feasibility of the registry. Steering committee members and their institutions will be the main participants in the Pilot Phase. After completion of the Pilot Phase, the registry will be expanded across Europe with the goal of enrolling approximately 10,000 patients over 5 years.

The data (baseline and follow-up) should be collected as part of routine clinical care. In clinical practice, after HMV initiation, the first control examination (follow-up number one) with nocturnal diagnostics should take place within the first 4-8 weeks. Annual follow-up is required, and it is recommended that subsequent control visits should be performed 1-2 times a year. Each patient will be included for 5 years (total duration of the registry).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years with an indication to receive HMV as part of routine clinical care
* Patient is able to fully understand the study information and is willing to give informed consent
* Patient, or the patient's legal guardian, signing the consent form

Exclusion Criteria:

- No exclusion criteria have been defined because only data from routine clinical care are needed, plus a separate healthcare questionnaire
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System

The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).


Eligibility Criteria:
Inclusion Criteria:

1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
2. RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram
3. Frontline endovascular treatment with the Indigo Aspiration System per IFU
4. Patient is ≥ 18 years of age
5. Informed consent obtained per Institutional Review Board/Ethics Committee requirements

Exclusion Criteria:

1. Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)
2. Stage IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation
3. Known serious, uncontrolled sensitivity to radiographic agents
4. Life expectancy \< 180 days
5. Patients on ECMO
6. Pregnant patients
7. Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies
8. Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
Requirements and Functional Schedule as a Part of Painrehabilitation.

Requirements and functional Schedule also calen Demand Ability Protocol (DAP) is an intervention that has been tested and found useful in occupational health service. The intervention aims to strengthen the collaboration between Health care, employers and employee. The intervention is based on a structured interview about the employers demands at work. This intervention (DAP) will in the present study be evaluated in pain rehabilitation both qualitatively and quantitatively.

Description of the intervention: Demand and Ability Protocol Demand and Ability Protocol (DAP) is an intervention linked to the International Classification of Functioning, Disability and Health, and is based on the Dutch Functional Ability List and knowledge about disability in working life (Brouwer et al, 2002). The intervention has been further developed and modified in Norway and is primarily used in occupational health care services for collaboration between an employee and his or her immediate manager (Engbers \& Furuland, 2006).

The intervention consists of a structured conversation between the patient and his immediate manager under the guidance of licensed medical staff (in this case REKO) with knowledge of the requirements of the patient's work and his/her current functional ability. The intervention takes about 90 minutes excluding preparation time for REKO.

DAP consider the following domains; 1) mental and cognitive ability, 2) basic skills and social ability, 3) tolerance for physical conditions, 4) ability to work dynamically, 5) ability to work statically and 6) to be able to work certain times.

Based on the above domains, a structured review is made of the balance between requirements and function in current work in order to identify possible adaptations and measures at the workplace. During the intervention, the work requirements and the patient's function/ability are identified on a three-point scale and in domains where the rating of requirements and function/ability does not match, there is thus an imbalance, and here adjustments or changed tasks may be relevant to consider increasing work ability and reducing sick leave. The intervention concludes with a summary of the situation and joint development of appropriate measures/adaptations to promote the patient's RTW. This is documented on a form, which is signed by both the patient and the manage

Eligibility Criteria:
Inclusion Criteria:

Chronic pain, has an employment

Exclusion Criteria:

no longer than 6 month of total sick-leave
Efficacy of a Stage-Matched Intervention Based on The Transtheoretical Model of Change in Dietary Fat Reduction

This study aims to examine the efficacy of a Stage-Matched Intervention based on The Transtheoretical Model of Change in dietary fat reduction among female high school students.

This study aims to examine the efficacy of a Stage-Matched Intervention based on The Transtheoretical Model of Change in dietary fat reduction among female high school students.

The study intervention will be designed based on each Stage of Change of the Transtheoretical Model of Change in that participants in each Stage of Change will receive the intervention that matches the Stage of Change they would be in.

A 12-week interval would be considered between administering the intervention and posttest 1 and the same interval would be used between posttest 1 and posttest 2.

Eligibility Criteria:
Inclusion Criteria:

* High school male students who do not experience any psychiatric-mental disorder.

Exclusion Criteria:

* High school male students who experience any psychiatric-mental disorder.
A Randomized, Prospective, Multicenter Study for the Role of Primary Tumor Resection in Colorectal Cancer Patients With Asymptomatic, Synchronous Unresectable Metastasis

Short description for lay public, include brief statement of the study hypothesis


Eligibility Criteria:
Inclusion Criteria:

* Age : between 20 and 90 years old
* Histologically confirmed adenocarcinoma of the colon or the upper rectum
* Patients with resectable primary colon or upper rectal cancer and unresectable metastatic lesions.
* Patients with no primary cancer related symptoms.
* ECOG performance status of 0 - 2
* Appropriate organ functions (hepatic transaminases - less than 5 times the normal range; bilirubin - less than 2 times the normal range; creatinine serum - less than 1.5 times the normal range; thrombocyte - more than 100,000/µl; neutrophil - more than 1,500/µl)
* ASA score of \< 3
* An informed consent form has been signed by the patient.

Exclusion Criteria:

* The patient received adjuvant chemotherapy within the past 6 months.
* The patient received chemotherapy for metastatic colon cancer.
* The patient was planning to have curative surgery for the metastatic lesions.
* The primary cancer is unresectable.
* Patients with peritoneal carcinomatosis.
* Patients with mid and low rectal cancer (\< 10cm)
* Patients with primary tumor related complications such as intestinal obstruction, intractable bleeding, and perforation, that needs to be treated.
* ASA score of \> 4
* The patient has chronic hepatitis or cirrhosis. An asymptomatic HBV or HCV carrier can participate.
* Patients with an active infection, which need antibiotic therapy, during the randomization period.
* Pregnant or breastfeeding women
* Patients who were enrolled in another clinical trial during the time of enrollment (within the 28 day randomization period).
* Patients with another different malignant tumor during the past 5 years. Patients with treated non-melanoma skin cancer or cervical cancer can be enrolled in this study.
Utility of Interface Pressure Mapping

To determine if a device that measures and displays pressure that the patients feel when in bed can help nurses reposition the patient effectively and thereby reduce bedsores in the intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older,
* care giver trained on mapping system

Exclusion Criteria:

* Less than 18 years,
* pregnant women,
* weight greater 550 lbs, and subjects requiring a specialty mattress
Perspective on Thoughts and Feelings as a Predictor of Psychological Well-being in Daily Life, in a Community Sample

This project examines the psychological construct of decentering - a mindfulness-related construct marked by an observer perspective on one's ongoing mental processes. Specifically, this project seeks to explore the extent to which decentering modulates the relationship between people's affective states and their momentary mental health and well-being, and to test the psychological processes by which decentering might exert these effects. This study includes a baseline assessment followed by a 7-day study completed from home where participants respond to brief surveys about their current experiences six times per day (i.e., an Ecological Momentary Assessment \[EMA\] design).

The investigators hypothesize that decentering moderates the association of extreme affect with related symptoms (i.e., elevated negative affect with depression and anxiety; elevated positive affect with mania, narcissism, and histrionic traits) and well-being, such that the association is attenuated at high levels of decentering. This will be examined using the EMA data, analyzing between-person levels (i.e., trait) as well as momentary within-person processes (i.e., concurrent and prospective states).

Further, the investigators predict that broadened attentional focus and improved self-regulation are mechanisms that contribute to the beneficial effects of decentering in daily life. This hypothesis will be examined in two ways:

1. as individual differences, wherein greater self-regulatory abilities (e.g., higher heart rate variability) and less attentional biases towards emotional stimuli mediate the association between trait decentering and subsequent daily well-being/symptoms, and
2. as within-person momentary levels, wherein broader attentional processes and greater self-regulation in daily life mediate the concurrent and prospective association between momentary decentering and well-being/symptoms.

Note that the study uses a multimodal assessment of each of the proposed processes. For attentional processes, a variety of parameters extracted from an emotional eye tracking paradigm will be examined. For self-regulatory abilities, assessments will include self-report, physiological (heart rate variability), and behavioral ("go / no-go" task) measures of such abilities.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65, fluency in English

Exclusion Criteria:

* current cognitive impairments (i.e., intellectual disability, dementia, current psychotic symptoms) that preclude giving informed consent and accurately answering study questions
Regulation of Emotions and Coping Behaviour in Patients With Chronic Recurrent Low Back Pain

This study investigates effects of a multidisciplinary rehabilitation program or physical therapy in patients with chronic low back pain on emotion regulation and coping behaviour.

Hypothesis: Significant differences of negative emotions pre and post treatment and between groups after intervention.

Standardised questionnaires are used for investigation

Emotionsregulations-Inventar ERI Emotion Regulation Questionnaire ERQ Positive and Negative Affect Schedule PANAS Brief Symptom Inventory BSI-18

Eligibility Criteria:
Inclusion Criteria:

* chronic low back pain \> 3 months
* VAS \>= 2
* understanding of german language

Exclusion Criteria:

* retired
* psychiatric disorders
* dementia
* sick headache
* chronic pain disease other than chronic low back pain
* patients with general contraindications of the therapy
The Clinical Study on Combizym and Bifidobacteri to Prevent the Recurrence of Colon Polyps

The study hypothesis is whether digestion enzyme(Combizym) and intestinal flora drugs(Bifidobacteria) can decease recurrence rate of colon polyps

Colon polyps has high recurrence rate in the digestion diseases. However, the reasons are not clear. The possible reasons for the recurrence of colon polyps include intestinal inflammation (e.g., Ulcerative colitis), intestinal flora imbalance (the benefit intestinal bacteria reduced, which lead to diarrhea or constipation), long-term indigestion. The investigators propose to examine whether digestion enzyme (Combizym) and intestinal flora drugs(Bifidobacteria) can decease recurrence rate of colon polyps

Eligibility Criteria:
Inclusion Criteria:

-Patients who have cutted colon polyps in one month, and the diagnosis were proved by pathological analysis

Exclusion Criteria:

* have organic or other functional disease
* pregnant or breast-feeding
Technical Evaluation of Cardiovascular Magnetic Resonance Imaging and Spectroscopy

Magnetic resonance imaging (MRI) and spectroscopy are diagnostic tools that create high quality images of the human body without the use of X-ray (radiation). MRI uses different levels of magnetic fields to create images of the body and organs. Occasionally, researchers will give patients undergoing a MRI an injection of a contrast substance. The contrast substance works by brightening areas of the magnetic resonance image.

In this study researchers plan to use magnetic resonance imaging with contrast substances and exercise on normal volunteers in order to evaluate different aspects of its performance. Information gathered from this study may be used to develop more specific research studies involving MRI....

Technical evaluation of magnetic resonance imaging and spectroscopy will be performed on normal volunteers. These studies will be conducted in the NIH MRI systems located in Suburban Hospital in Bethesda, Maryland. These studies may involve the intravenous administration of commercially available MR contrast media and exercise. The results will be used to evaluate the performance of various pulse sequences, gradient coils, and RF coils on human subjects and will provide essential ground work for specific patient protocols.

Eligibility Criteria:
* INCLUSION CRITERIA:

Any normal volunteer above the age 18 who is capable of giving informed consent will be included.

EXCLUSION CRITERIA:

A subject will be excluded if he/she has a contradiction to MR scanning.

1. Brain aneurysm clip
2. Implanted neural stimulator
3. Implanted cardiac pacemaker implanted defibrillator
4. Cochlear implant
5. Ocular foreign body (e.g. metal shavings)
6. Insulin pump
7. Pregnant women (when uncertain, subjects will undergo urine or blood testing).
8. Kidney
9. Paralyzed hemidiaphragm
10. Morbid obesity
11. Claustrophobia
12. Any condition in the PI's judgement which present unncessary risk

EXCLUSION CRITERIA FOR GADOLINIUM ENHANCED STUDIES:

1. Lactating women
2. Subjects with hemoglobinopathies
3. Asthma
4. Renal or hepatic disease

Subjects will be excluded if it is deemed that they have a condition that would preclude their use for technical development (e.g. paralyzed hemidiaphragm, morbid obesity, claustrophobia etc.) or present unnecessary risk (e.g. pregnancy, surgery of uncertain type, etc.).

Lactating women and subjects with hemoglobinopathies, asthma, or renal or hepatic disease will be excluded from studies involving the adminstration of contrast agents.