cyrilzakka/clinical-trials huggingface dataset:
Effects Exercise Training in Patients With Pituitary Adenoma

This study planned to investigate the effects of aerobic training combined with strengthening training and yoga on biochemical factors, physical performance and quality of life in people with pituitary adenoma. The hypotheses are; H1: Aerobic training combined with strengthening training is effective on biochemical factors in people with pituitary adenoma.

H2: Aerobic training combined with strengthening training is effective on physical performance in people with pituitary adenoma.

H3: Aerobic training combined with strengthening training is effective on quality of life in people with pituitary adenoma.

H4: Yoga is effective on biochemical factors in people with pituitary adenoma. H5: Yoga is effective on physical performance in people with pituitary adenoma. H6: Yoga is effective on quality of life in people with pituitary adenoma. H7: Aerobic training combined with strengthening training and yoga is effective on biochemical factors, physical performance and quality of life in people with pituitary adenoma.


Eligibility Criteria:
Inclusion Criteria:

* volunteers
* macroadenomas
* at least 1 hormonal axis affected
* Karnofsky Perfomance Scale between 70-100
* 18-65 years
* approved by cardiologists

Exclusion Criteria:

* regular exercise habit
* acute pain in many part of the body
* additional neurologic condititons
* any rheumatological and immunologic conditions
Reducing Error in ER Settings Through Attention Restoration Theory

The purpose of this research study is to find out about how looking at different types of pictures can affect people's attention spans. Attention Restoration Theory (ART) suggests that there are two types of attention. One type (directed attention) can become tired and cause people to make mistakes. The other type (involuntary attention) gives directed attention a chance to rest, so people make less mistakes. Certain types of pictures are good at capturing involuntary attention. We think that capturing involuntary attention will help emergency physicians make less mistakes on tests of attention. This study will allow us to learn more about it.

In this study, participants will be asked to do the following things:

1. Before their usual shift in the emergency department, arrive ten minutes early to rate their mood and complete a Digit Span Backwards (DSB) task that tests their memory of different sets of numbers.
2. Five hours into their shift, they will take a ten minute break.
3. During this break, they will be randomly assigned to view either a picture presentation of nature slides or urban slides.
4. After the presentation, they will complete the Digit Span Backwards task again, they will rate their mood again, then return to their shift.

Participation in this study will last up to 30 minutes. Approximately fifty individuals will participate in this study.

Eligibility Criteria:
Inclusion Criteria:

• Emergency Medicine Resident of any PGY level. (1-5)

Exclusion Criteria:

* Anybody under the age of 18
* Pregnancy
Effect of Beetroot Juice on Coronary Blood Flow and Walking Performance in PAD

In this study the investigators will test the hypothesis that short-term consumption of inorganic nitrate (supplied in concentrated beetroot juice) enhances coronary blood flow responses, large artery hemodynamics, and leg oxygenation/exercise tolerance in patients with peripheral arterial disease (PAD). Understanding and improving blood flow regulation in the heart and skeletal muscles of patients with PAD is important because exercise triggers symptoms of leg pain and substantially raises blood pressure and myocardial demand in these patients.

Peripheral arterial disease (PAD) is a strong predictor of cardiovascular mortality and negatively affects functional capacity and quality of life for as many as 14 million patients in the U.S. alone. One open-label study showed that acute consumption of beetroot juice improved 6 min walk performance, reduced blood pressure, and enhanced leg muscle oxygenation in PAD patients. However, no studies have rigorously confirmed these findings in a double-blind manner, nor have the effects of this supplement been investigated (acutely or short-term) in the coronary circulation of PAD patients.

In addition to studying its effects on graded treadmill walking performance and consequent large artery vasodilation, the present study will examine the effects of short-term beetroot juice consumption (twice/day) on both coronary and leg vasodilator (graded calf flexion) and vasoconstrictor (isometric handgrip, voluntary apnea) responses in patients with PAD. Participants will randomly consume either nitrate-rich or nitrate-depleted beetroot juice with a 7 to 14 day wash-out period between. Effects of beetroot juice consumption on plasma nitrate, nitrite and methemoglobin will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with peripheral arterial disease (PAD)
2. Capable of giving informed consent
3. Men and women age 21- 85 years
4. Diagnosed with PAD (i.e., ankle-brachial index below 0.9)
5. Fontaine stage II or less - no pain while resting
6. Satisfactory history and physical exam

Exclusion Criteria:

1. Children
2. Pregnant or nursing women
3. Patients taking nitroglycerine or nitrate preparations
4. Patients taking phosphodiesterase inhibitors such as sildenafil or tadalafil
5. Patients taking proton pump inhibitors
6. Ejection fraction \< 40%
7. Uncontrolled hypertension
8. Uncontrolled diabetes
9. Myocardial infarction within past 6 months or unstable angina
10. Severe lung disease (i.e., on supplemental oxygen or frequently use rescue inhalers)
11. Abnormality in hemoglobin or hematocrit or methemoglobin
12. Impaired renal function
13. Impaired liver function
14. History or diagnosis of Barrett's esophagus
15. Known allergy to beetroot juice or lemon juice
16. Inability to walk on a treadmill at a moderate pace (2.0 miles/hour)
Prevention of GVHD in Patients Treated With Allogeneic SCT: Possible Role of Extracorporeal Photophoresis

The main aim is to test the preventive use of extracorporeal photophoresis (ECP) against development of graft-versus-host disease (GVHD) in patients undergoing allogeneic stem cell transplantation for hematological malignancy.

Allogeneic stem cell transplantation represents the only available long-term control and possible cure of a number of hematological malignancies. A major obstacle to this treatment is the development of graft-versus-host disease (GVHD), affecting the majority of transplanted patients to some extent. Today, combinations of various cytotoxic and immunosuppressive drugs are used to prevent and treat GVHD, but many of them are associated with severe side-effects. Extracorporeal photophoresis (ECP) offers an alternative to chemo- and immunosuppressive therapy and confers apparently only mild side effects. The postulated rationale of ECP is to treat the patient's white blood cells ex vivo with ultraviolet irradiation after sensitization with 8-methoxypsoralen to dampen their immunoactivity. After engraftment the intervention group receives 2 consecutive ECP every week in 2 weeks then 1 ECP every week in 4 weeks ( a total of 8 ECP procedures).

Eligibility Criteria:
Inclusion Criteria:

* Provide written consent to participate
* Understand Norwegian or English
* No previous history of malignant disease
* No contraindication to ECP-treatment or undergone previous ECP treatment

Exclusion Criteria:

* (in addition to those regarding eligibility for transplantation itself):

  * Unwilling to provide written consent to participate
  * Unable to cooperate as judged by the responsible physician
  * ECOG status \> 2 at time of inclusion
  * Using anti-inflammatory or cytotoxic drugs other than those that are part of the treatment of the current hematological malignancy
  * Known allergy to psoralens or citrate products
  * Splenectomy
  * Pregnancy/lactating
Use of ROTEM for Multi-level Spine Surgery

The purpose of this study is to obtain coagulation profiles of patients undergoing multi-level spine surgeries with ROTEM® and routine coagulation tests. The investigators will compare the data from ROTEM® and routine coagulation tests with each other and with blood loss and transfusion therapies used.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective open spine (cervical, thoracic, and/or lumbar) surgery with anticipated blood loss of \> 1 L
* Males and females
* Age 18 to 100 years of age
* ASA physical status 1 to 3
* Arterial line indicated for the intraoperative management of the patient and in place prior to incision
* Informed consent obtained

Exclusion Criteria:

* Known pre-existing hemostatic abnormality
* Known clopidogrel use within 10 days prior to surgery
* Known warfarin use within 5 days prior to surgery
* Known pregnancy
* Has physical, mental, or medical conditions which, in the opinion of the Investigator, could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation.
* Inclusion in another clinical research study
* An investigator of this study
* Subject's refusal or inability to agree to and sign the Informed Consent form in English
Effect of Intraoperative and Awakening Electroencephalogram on Awakening Agitation After General Anesthesia in Children

The purpose of this study was to analyze the relationship between intraoperative and awakening electroencephalogram waveforms and awakening agitation after general anesthesia in children


Eligibility Criteria:
Inclusion Criteria:

1. The age of the child is 1-10 years old, regardless of gender;
2. ASA grading I to II;
3. Children undergoing hernia, appendix, or small orthopedic surgery under selective general anesthesia

Exclusion Criteria:

1. Respiratory infection occurred within 1 week before surgery;
2. Potential or existing contraindications to general anesthesia;
3. Significant abnormalities in blood routine or biochemical indicators;
4. Patients with cognitive function, mental illness, or neurodevelopmental delay;
5. Unable to cooperate in completing the test, the child's guardian refused to participate;
6. Other reasons why researchers believe it is not suitable to participate in this experiment.
Evaluation of an E-tool Designed to Facilitate Communication Between Allophone Patients and Pediatricians in Emergency Departments.

In France, over 21 million people visit emergency departments every year, 10% of whom speak little or no French. The language barrier is a problem for patient safety and quality of care. Ethical and financial aspects are also affected. Unnecessary tests are more frequent, hospital stays more numerous and longer. Patient's management may be inappropriate. Patients are less satisfied, understand and adhere less to cmanagement and recommendations.

Some solutions are available to the emergency physician, but their contribution is limited. A professional interpreter is reliable and takes cultural aspects into account, but his or her cost is high and availability incompatible with emergency care. Translation by a close relative poses the problem of confidentiality. Telephone interpreting is available at any time, but is expensive and less satisfying than direct interaction. Computerized machine translation is economical and easy to access, but does not take into account all medical terms. It also poses a data protection problem. Phraselators translate predefined phrases with precision, but are time-consuming and unsophisticated.

In addition, these aids are used during the consultation. They are therefore difficult to combine and take up care time.

This care time is mainly devoted to establishing medical history essential for the diagnosis, prognosis and treatment decisions.

MARTI is a digital tool for pediatric emergency room consultations. Its aim is to enable the emergency physician to start the consultation with a medical history completed autonomously by the parents during their waiting time. Its content has been developed by emergency physicians.

Language and cultural barriers are overcome through the use of simple phrases and pictograms developed with linguists, language schools and Immigrant organizations.

MARTI was used in a pediatric emergency department. Feedback from patients and carers indicates that it is ready to be tested in real-life conditions.

This pilot study is designed to evaluate how MARTI improves communication with an allophone or a person with comprehension difficulties, according to the emergency physician in charge of the consultation.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Person responsible for a child admitted to pediatric emergency.
* Person with a language barrier.
* Person speaking one of the 11 languages proposed by MARTI.
* Signed informed consent indicating that the subject has understood the purpose and procedures of the study and agrees to participate in the study and to abide by the requirements and restrictions inherent in the study.
* Affiliation with a health insurance

Exclusion Criteria:

* Person who shares a common language with the physician.
* Illiterate person.
* Person accompanying a child with a life-threatening emergency.
* Subject without health insurance.
* Pregnant women.
* Subject in the exclusion period of another study or in the "national volunteer file".
Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma

RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic T-cell lymphoma.

PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma.

OBJECTIVES:

Primary

* Determine the response rate (complete and partial) in patients with recurrent or refractory angioimmunoblastic T-cell lymphoma treated with cyclosporine.

Secondary

* Determine the disease-free, progression-free, and overall survival of patients treated with this drug.
* Determine the toxicity of this drug in these patients.

OUTLINE: Patients receive oral cyclosporine twice daily for up to 36 weeks in the absence of unacceptable toxicity or disease progression during weeks 1-6. Patients experiencing disease progression during weeks 7-36, receive an additional 36 weeks of therapy.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 2.5 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of angioimmunoblastic T-cell lymphoma (recurrent or refractory) based on histologic examination.
* At least one objective measurable or evaluable disease parameter.
* Have failed at least one type of treatment: chemotherapy, auto-transplant, or steroid treatment. Patients may not receive concurrent chemotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Adequate renal function as indicated by creatinine \<= 1.5 the upper limit of normal (ULN).
* Adequate liver function as indicated by alkaline phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) \<= 2x the upper limit of normal.
* Total bilirubin \<= 2x the upper limit of normal.
* Age 18 or older.

Exclusion Criteria:

* Prior cyclosporine or Tacrolimus (FK506).
* Prior allogeneic transplant.
* Evidence of active infection.
* Congestive heart failure, kidney failure, liver failure, or other severe co-morbidities.
* Evidence of active neurological impairment.
* Previous history of hypersensitivity to cyclosporine and/or Cremorphor EL (polyoxyethylated oil).
* History of other malignancies (other than cured carcinomas in situ of the cervix or basal cell carcinoma of the skin).
* pregnant or breastfeeding women.
* Human immunodeficiency virus (HIV) positive.
Study On Pazopanib When Given With FOLFOX6 (Fluorouracil, Oxaliplatin, Leucovorin) Or CapeOx (Capecitabine, Oxaliplatin)

This study will test the safety of treating colorectal cancer with a combination of drugs. The current standard treatments of FOLFOX6 or CapeOx will be give in combination with the GSK investigational drug pazopanib.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of locally advanced or metastatic colorectal cancer.
* No prior chemotherapy for metastatic disease.
* Presence of radiologically and/or clinically documented disease.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Adequate bone marrow, hepatic, renal function, Urine Creatinine Ratio (UPC) of \<
* A female subject must not be pregnant or breast feeding.
* Able to swallow and retain oral medications.

Exclusion Criteria:

* Has had any major surgery, chemotherapy, hormone therapy, investigational agent, or radiotherapy within the last 28 days
* Prior treatment with pazopanib, or oxaliplatin.
* Known contraindications to the use of oxaliplatin, capecitabine, 5-fluorouracil, or folinic acid.
* Participation in any investigational study within 28 days prior to study treatment.
* Women who are pregnant or lactating.
* Poorly controlled hypertension.
* A history of cardiovascular disease, arrhythmias, or significant ECG abnormalities.
* Any history of stroke.
* Current use of therapeutic warfarin.
* Known brain metastases.
* History of disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel.
* Active infections or other serious illness.
* History of allergy to platinum compounds or heparin.
* Poor venous access.
Effect of Opioid Shortage on Drug Selection

This study will look at the effects of fentanyl shortage in laparoscopic cholecystectomy cases. The opioid shortage, specifically hydromorphone and fentanyl, caused a decrease in administration of opioid analgesia for laparoscopic cholecystectomy intraoperatively.

The goal of this study is to look at the clinical impact of the drug shortage of intravenous (IV) opioids from 2016 to 2018. IV opioids are used in the hospital setting ranging from the Emergency Department to the Intensive Care Unit (ICU) to the Operating room. This study will look at the usage of IV opioids in the operating room setting and determine how practice has change in the setting of drug shortage. The study team hypothesizes that the average monthly consumption of fentanyl and hydrophone would have been decreased for laparoscopic cholecystectomy intraoperatively during the opioid shortage period as compared to before the shortage period.

Eligibility Criteria:
Inclusion Criteria:

* All Genders
* History of laparoscopic cholecystectomy
* American Society of Anesthesiologist classification (ASA) 1-4 emergent and Non emergent
* Adult \>18 years old
* Wake Forest Baptist Medical Center Main Operating rooms

Exclusion Criteria:

* Regional Anesthetic
* ASA 5 and 6
Efficacy and Safety of SHR3824 as Monotherapy in Subjects With Type 2 Diabetes

The purpose of this study is to obtain information on efficacy and safety of SHR3824 over 24 weeks and 52 weeks in Chinese patients with Type 2 Diabetes. This will be done by comparing the effect of SHR3824 to placebo when given in oral doses.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of type 2 diabetes mellitus;
* Patient either has not been previously treated with antihyperglycemic medication or has not been treated with antihyperglycemic in the last 8 weeks;
* FPG\<=15mmol/L;
* Hemoglobin A1c levels \>=7.0% and \<=10.5%;
* Body mass index (BMI) 19 to 35 kg/m2;

Exclusion Criteria:

* Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);
* Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);
* Systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg on the start or end day of the run-in period;
* History of myocardial infarction, unstable angina, or cerebrovascular disorder within 6 months before the start of the run-in period;
* Past or current history of malignant tumor;
* Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;
* Pregnant women, lactating mothers, or women of childbearing potential;
* Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).
Foot Perfusion by Dynamic Contrast Enhanced MRI in Patients With Peripheral Artery Disease

We investigate the peri-operative foot perfusion through dynamic contrast enhanced MRI in patients with peripheral artery disease


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old;
* PAD patients with Fontaine grade II-IV or Rutherford grade 2-6 and underwent a successful revascularization;
* Patients completed both pre- and post-operative MRI workups;
* Patients signed the informed consent form and be able to complete the clinical follow-up for 1 months.

Exclusion Criteria:

* Patients has participated in other clinical studies;
* Patients with Heart failure (NYHA III/IV)/right to left shunt heart disease/ severe aortic and mitral insufficiency/acute coronary syndrome/malignant arrhythmia/severe pulmonary hypertension (pulmonary artery pressure at least 90 mmHg)/moderate to severe renal insufficiency (creatinine clearance rate\<60 ml/min)
* Any allergic constitution;
* Pregnancy and childbirth;
* Life expectancy\<12 months.
The Role of Postoperative Immobilization After Arthroscopic Rotator Cuff Repair

The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair.

Rotator cuff tendon injury ranks among the most prevalent of shoulder disorders causing pain and impaired function, and is a major socioeconomic burden on society. The study is a prospective randomized controlled non-inferiority trial where we elucidate the role of postoperative immobilization after arthroscopic rotator cuff repair. Our primary goal is to compare clinical and structural results after rotator cuff repair and to compare a restrictive and an active postoperative rehabilitation protocol. Our secondary goal is to establish guidelines for optimized rehabilitation after rotator cuff repair to ensure the best possible outcome for this large group of patients. Our aim is also to establish guidelines for timing of return to work. The major complications following rotator cuff repair and the current rehabilitation regimens are rotator cuff retears and postoperative stiffness. The information obtained in this study may enable development of targeted, cost-effective treatment and rehabilitation with good, lasting long-term results.

Eligibility Criteria:
Inclusion Criteria: Repairable partial- or full-thickness rotator cuff tear affecting supraspinatus and/or upper infraspinatus tendon -

Exclusion Criteria: Irreparable or incomplete repairable tears of supraspinatus and/or infraspinatus tendon.

Large/massive rotator cuff tear. Diabetes mellitus. Systemic inflammatory disorder. Fatty muscle infiltration \>grade 2 (Goutallier). Subscapularis tendon tear. Adhesive capsulitis. Concomitant labral repair. Revision repair.

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