cyrilzakka/clinical-trials huggingface dataset:
French Registry of Acute Coronary Syndrome With or Without ST Elevation 2010

The observatory FAST MI 2010 proposes to establish a cohort of 3500 patients recruited prospectively over a period of 2 months.

Patients will be followed up at 1 month and then followed annually for 10 years.

Patients should have agreed to participate in the study, participation in the protocol, or refusal to participate will not affect the therapeutic approach of the physician. The study of genotypic or phenotypic characteristics will not change the therapeutic approach of health care teams.

This is a multicenter observational study, given to 300 prospective medical facilities, CHU, CHG, CHR, health facility of the Army, including a clinic or intensive care unit entitled to receive emergency ACS. (See attached list 10-6) A questionnaire will be sent to each center before the recruitment center on the type and number of beds (Appendix 10-5)

Patients will be recruited consecutively in the CIAU member during a period of 2 months.

The 1-month follow-up will be done by the referring physician of each ISB, by mail or telephone contact with the treating physician and / or patient.

Annual follow-ups will be conducted during 10 years of clinical research technicians of the French Society of Cardiology, mail and / or telephone contact with the municipalities of birth, treating physicians and patients.

Eligibility Criteria:
Inclusion Criteria :

* Patients over 18 years old
* Admitted patient for a myocardial infarction (MI) of less than 48 hours, characterized by the typical rise and fall of troponin or CPKMb associated with at least one of the following: symptoms of myocardial ischemia or appearance of pathological Q waves or repolarization disorders related to ischemia (in addition to or NSTEMI)
* Patient who consented to participate in the study

Exclusion Criteria:

* Refusal of consent
* MI occurring within 48 h after a therapeutic intervention (angioplasty or coronary bypass or other surgery)
* Diagnosis of SCA reversed in favor of an alternative diagnosis
Effect of Xiaoer Jiebiao Oral Liquid on Hand-foot-mouth Disease

This is a single-blinded randomized trial aiming to evaluate the effectiveness of Xiaoer Jiebiao Oral liquid in combination with Ribavirin treatment on patients with hand-foot-mouth disease compared with the controlgroup that recieve only libavirin treatment.


Eligibility Criteria:
Inclusion Criteria:subjects should meet all of the following

* diagnosed as hand-foot-mouth disease grade I or grade II;
* body temperature at admission T\>38℃，fever length\<48 hours;
* no need for hormonotherapy or immunoglobulin therapy.
* signed written informed consent form

Exclusion Criteria:subjects should be excluded if meet any of the following

* with history of any heart, lung, kidney or liver diseases; under any hormonotherapy, immunoglobulin therapy or any other therapy.
Patient Reported Outcomes/Metrics Program Trial

This is an observational study to investigate if it is feasible to recruit 100 patients receiving radiotherapy (RT) to metastatic disease to wear Hexoskin and if Hexoskin will facilitate the monitoring, detection and early treatment of RT-related side effects.

Radiotherapy is an important adjunct in the interdisciplinary care of the palliative patient population, providing the potential for improved quality of life and symptom control, often translating into improved well-being, function and mobility. Changes in pain and QOL are frequently measured subjectively using patient-reported questionnaires. Objective measures such as respiratory rate, pulse rate, activity level and sleep duration and quality, may complement the currently available tools. Such tools may lead to better evaluation of the effects of palliative RT with real-time detection of potential complications and toxicity and the acute need for analgesic adjustments that can result from successful palliative RT.

Eligibility Criteria:
Inclusion Criteria:

* Planned to receive palliative radiotherapy for pain
* Known cancer diagnosis
* Able to wear Hexoskin Medical Shirt
* Ability to use and populate the mobile app (Zamplo) with or without assistance
* ECOG: 0-3
* Willing to provide a list of analgesic (pain relief) medication
* Willing to complete questionnaires
* Life expectancy of at least 3 months

Exclusion Criteria:

* Receiving whole brain radiotherapy
* Major cognitive or psychiatric impairments
* Pregnant women
* Allergies to: polyester, synthetic fibers
* Patients with pacemakers or implantable cardioverter-defibrillator (ICD)
* Patients on a Holter Monitor
Comparison of the Supervised and Home-Based Progressive Resistant Training in Female Total Knee Arthroplasty Patients

Early postoperative rehabilitation programs after TKA aims to provide optimal functional recovery. The current rehabilitation process in TKA typically includes 2 to 3 months post-surgery, as the greatest declines in strength and functional performance occur immediately after surgery. Yet, the content, duration, and intensity of the rehabilitation programs for the reorganization of physical function after surgery have not yet been fully clarified. Whether home-based rehabilitation is comparable to supervised rehabilitation in the midterm period requires further research, as practices after TKA vary. The purpose of this study is to compare the effectiveness of supervised and home-based progressive resistance training (PRT) in the midterm postoperative period in female patients undergoing TKA.

The objective of this study is to compare the pain, quadriceps strength, knee function, joint awareness, and quality of life between supervised or home-based PRT at 3 months after the total knee arthroplasty.

The study design is a single-blinded randomized trial. Both groups received standard physiotherapy for three months. In the third month postoperatively, supervised and home-based PRE, which consisted of sixteen sessions of exercise lasting eight weeks initiated. The clinical outcomes were compared at baseline (third month postoperatively) and the fifth month postoperative.

The clinical outcomes consisted of pain, range of motion (ROM), quadriceps and hip abductor muscle strength, and WOMAC (Western Ontario and McMaster University Arthritis Index ) score. The performance-based activity limitation test consisted of the 30-second sit-to-stand test, the 40-meter fast-paced walk test and the 9-step stair climb test. Joint awareness was assessed with Forgotten Joint Score-12 (FJS12). The quality of life was evaluated with the World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF).

Eligibility Criteria:
Inclusion Criteria:

* being a woman between the ages of 50-70
* underwent unilateral primary TKA surgery due to knee osteoarthritis three months ago
* understanding verbal and written instructions

Exclusion Criteria:

* revision TKA surgery
* neurological disease
* rheumatoid arthritis
* psychiatric problems
* severe limitation of knee ROM (knee flexion range \< 90°)
* regular hypnotic or anxiolytics usage
* dementia.
A Multivitamin Comparison Study in Kidney Transplant Recipients.

This study is being done to compare arteriosclerotic cardiovascular disease in kidney transplant recipient taking a standard multivitamin versus those taking a multivitamin augmented by a high dose combination of folic acid, vitamin B12, and vitamin B6.

This is a multicenter, randomized, double-blind controlled clinical trial. The trial has been designed to determine whether total homocysteine lowering treatment with a standard multivitamin augmented by a multivitamin containing no folic acid B12, and vitamin B6, versus treatment with an identical multivitamin containing no folic acid, will reduce the pooled rate of recurrent or new cardiovascular disease outcomes or events. Participants will have a brief visit, at which the participant will have physical measurements, blood pressure and history taken. Urine and blood tests will be performed to determine the levels of homocysteine, vitamins and creatinine. Qualifying participants will be randomly assigned to receive multivitamins containing a high dose of folic acid, vitamin B6, and vitamin B12, or an identical multivitamin containing no folic acid, and estimated average requirement amounts of vitamin B6 and vitamin B12. The participant will be required to return annually throughout the next five years for physical exams, blood and urine tests.

Eligibility Criteria:
Participants with elevated homocysteine levels that are between the ages of 35-75 years old and have had a kidney transplant with stable renal graft function.
High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)

This was a prospective, open-label, non-controlled, non-randomized multicenter Phase III study of 2 multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks, continuing the patient's infusion interval in the main study NCT01012323 \[NGAM-01\]) for 3 months. The primary objective of the study was to assess the safety and tolerability of high infusion rates of NewGam.

Patients received NewGam via an infusion pump to control precise infusion rates. All NewGam infusions started at a rate of 0.01 mL/kg/min (60 mg/kg/h) for the first 30 minutes followed by 0.03 mL/kg/min (180 mg/kg/h) for the next 15 minutes. If tolerated, further increments were made at predefined patterns with the following maximum rates: 0.10 mL/kg/min (600 mg/kg/h) in the first infusion; if this was tolerated, 0.12 mL/kg/min (720 mg/kg/h) in the second infusion; if this was tolerated, 0.14 mL/kg/min (840 mg/kg/h) in all subsequent infusions.

If an adverse event occurred during an infusion, the rate was reduced to half the rate at which the event occurred or the infusion was interrupted until symptoms subsided. The infusion was then resumed at a rate tolerated by the patient.

Eligibility Criteria:
Inclusion Criteria:

* Completion of the main study NGAM-01.
* At each of the last 3 infusions in the main study NGAM-01, administration of NewGam at the maximum infusion rate of 0.08 mL/kg/min and without the need for premedication.

Exclusion Criteria:

* Any condition or circumstance that would have led to the exclusion of the subject from the NGAM-01 study.
* Administration of any immunoglobulin infusion other than NewGam between conclusion of the NGAM-01 study and the beginning of the present study.
* A deviation of the subject's treatment interval of more than 7 days between the last infusion of NewGam in the NGAM-01 study and the first infusion of NewGam in the present study.
Performance Comparison of a New Fetal/Maternal Monitor With an FDA-cleared Method

This is a prospective clinical trial involving the use of the FDA-cleared Fetal ECG tracing in labor with the AN24 (Fetal Monitoring device marketed by Monica Healthcare) to the Novii (a newer device also created by Monica Healthcare) using the same technology with different monitor placement.

This study has one arm, in which Both the FDA - Approved AN24 (Fetal Monitoring device marketed by Monica Healthcare) and the new device (Novii, being investigated in this clinical trial) will be placed on the patient's abdomen. After delivery of the patient's infant, the data will be abstracted from the second device. This data will be compared to the data from the first device for accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Term Laboring Patients

Exclusion Criteria:

* Preterm Labor
* Fetal Anomaly
* Imminent cesarean
A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Tablet in Healthy Adults

This study will compare the bioavailability of a novel powder for oral suspension formulation of delafloxacin, intended for treatment of community acquired bacterial pneumonia, to that of the licensed delafloxacin oral tablet in healthy adults.


Eligibility Criteria:
Key Inclusion Criteria:

* Must agree to adhere to the protocol-specified contraception requirements.
* Body mass index of 18.0 to 32.0 kilograms (kg)/meter squared as measured at screening.
* Weight ≥50 kg at screening.

Key Exclusion Criteria:

* Any history of hypersensitivity to delafloxacin or any other fluoroquinolones or previous history of tendon disorders related to fluoroquinolone administration.
* History of clinically significant cardiovascular, renal, hepatic, respiratory, or particularly gastrointestinal disease.
* Participant has a medical condition that may adversely affect taste or smell activity including but not limited to mouth ulcers, significant gum disease, and respiratory and/or sinus infection or cold.
* Clinically significant abnormal clinical chemistry, hematology or urinalysis as judged by the Investigator. Participants with Gilbert's Syndrome are not allowed.
* Participants who do not agree to eat a high-fat breakfast.

Note: Other inclusion/exclusion criteria may apply.
Detecting EGFR T790M Mutations From Circulating Tumor Cells

The purpose of this research study is to determine if the EGFR mutation can be detected in CTCs. CTCs are cancer cells that are shed from solid tumors and float freely in the bloodstream. A device called the CTC-chip has been developed to find CTCs in the blood of patients with cancer. This is an experimental device. Using this device, the investigators will test participants' blood to try and find CTCs with the EGFR mutation and compare them with the results from the biopsy your doctor has recommended. The long-term goal of this research is to develop a way to test for the EGFR mutation that is less invasive than a tumor biopsy.

In order to participate in this study you need to have a diagnosis of NSCLC that has spread or is unable to be surgically removed. In addition, your cancer must have an EGFR mutation and you must have a scheduled (or recently performed) biopsy to check on the presence of any other mutations related to targeted drug resistance.

After you sign consent to participate in this study we will draw a blood sample (three tubes of blood). This is about 6 teaspoons of blood.

The number of CTCs in your blood will not be reported to you since it is not known if this number has any meaning or if it impacts your medical care in any way. These results will not become part of your medical record. They will be kept in a separate, secure location.

We will collect information from your medical records and store it in a research record that we create about you. The study team will use this information to compare details about your medical history with the results of the experiments done on your blood.

Genetic material (DNA) will be removed from the CTCs found in your blood. This genetic material will be stored at the Massachusetts General Hospital and studied along with samples from other participants on this research study. Your samples will not be labeled with your name or any information that identifies you. Your samples will have a study-specific code number on them. The code linking your name to the sample will be kept in a secure location, available only to the investigators of the study and select study team members.

After the blood draw we will follow your status every 6 months by reviewing your medical records.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed NSCLC that is metastatic or unresectable
* Have agreed to undergo a clinically recommended invasive repeat tumor itssue biopsy

Exclusion Criteria:

-
Clinical Trial of Adjuvant Chemotherapy Followed by Concurrent Chemoradiotherapy Compared With Adjuvant Chemotherapy Alone in Patients With Gallbladder Carcinoma and Extrahepatic Cholangiocarcinoma

The present study is designed to determine whether adjuvant concurrent chemoradiotherapy improves overall survivals.

The role of adjuvant radiotherapy in gallbladder carcinoma (GBCA) or extrahepatic cholangiocarcinoma (EHCC) is unknown. A retrospective study suggested that chemoradiotherapy provides greater benefit than chemotherapy alone in GBCA patients. SWOG S0809, a phase II study showed that adjuvant chemoradiotherapy has promising efficacy in GBCA or EHCC. The present phase III clinical trial is designed to compare adjuvant concurrent chemoradiotherapy with chemotherapy alone.

Eligibility Criteria:
Inclusion Criteria:

* The patients with pathologic diagnosis of gallbladder carcinoma (GBCA) or extrahepatic cholangiocarcinoma (EHCC) after radical resection.
* The patients with pathologic stage T2-4 or N1 in R0 resection or positive resection margins (R1).
* Aged 18 to 70 years old, male or female, body condition score generally ECOG 0～2, expected survival ≥ 6 months.
* Subjects were no major organ dysfunction, blood, liver, kidney and heart function was normal, the specific requirements of laboratory indicators:

  * Blood: Absolute neutrophil count \> 1.5 × 109 / L, Platelet count \> 100 × 109 / L, Hb \> 8.0g/dl.
  * Liver function: serum bilirubin less than 1.5 times the upper limit of normal; ALT and AST less than 2.5 times the upper limit of normal.
  * Renal function: creatinine less than 1.5 times the upper limit of normal.
* Patients who can understand the circumstances of this study and signed informed consent.

Exclusion Criteria:

* Pregnancy, breast-feeding patients；
* Patients received prior anticancer therapy for the current malignancy or upper abdominal radiotherapy or chemotherapy at any time.
* Patients with malignant ascites.
* Patients with purulent and chronic infected wounds which delayed healing.
* Patients with liver, kidney and heart failure and coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease;
* Patients has a history of mental illness and difficult to control;
* Patients who was considered inappropriate to participate in the trials by the researchers.
Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy

The purpose of this study is to determine which stent type is effective in the decrease of postoperative stay and complications across pancreaticojejunostomy after pancreaticoduodenectomy.

This study compared the postoperative hospital stay and complications of lost stent with external stent after pancreaticoduodenectomy. The complications of pancreaticoduodenectomy are important to affect the postoperative course, and, a stent tube often places across pancreaticojejunostomy to reduce complications. However, there is no report that demonstrates the postoperative course between pancreatic stent types. We conducted a prospective randomized trial on 100 patients who underwent pancreaticoduodenectomy comparing external stent and lost stent.

The primary endpoint was defined as postoperative hospital stay. The secondary endpoints were mortality and morbidity, including pancreatic fistula, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated at WMUH for pancreatic head and periampullary disease, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients who were diagnosed inadequacy for this study by a physician, 3) patients who could not be placed a pancreatic stent tube, and 4) patients without an informed consent.

Eligibility Criteria:
Inclusion Criteria:

* On the basis of whether pancreatic head resection was anticipated at WMUH for pancreatic head and periampullary disease, and appropriate informed consent was obtained.

Exclusion Criteria:

* Patients with severe complications which were possible to prolong hospital stay
* Patients who were diagnosed inadequacy for this study by a physician
* Patients who could not be placed a pancreatic stent tube
* Patients without an informed consent.
Parenteral Nutrition With Intravenous and Oral Fish Oil for Intensive Care Patients

The primary objective is to assess the effect of fish oil-enriched enteral and parenteral nutrition on blood oxygenation in critically ill patients.


Eligibility Criteria:
Inclusion: - signed informed consent

* mechanically-ventilated adults (age 18-80) admitted to Intensive Care Unit,
* enteral nutrition does not meet the nutrition goal (at least 80 % of the resting energy expenditure) within the past 36 hours
* APACHE II score above the median value of the intensive care unit (id est \> 20)

Exclusion: - do not resuscitate status

* cardiogenic pulmonary edema
* previous (\< 1 month) or ongoing need for corticosteroids \> 0.1 mg/kg prednisolon- equi-valent or other immune suppressive treatment
* serum triglycerides \> 300 mg/dl at screening
* alterations of coagulation (platelets \<100.000 mm3), PTT \> 60 sec, INR ≥ 2.5 without therapeutic intervention
* pregnancy
* participation in a clinical study with an investigational drug within one month prior to the start of this clinical trial
* known or suspected drug abuse
* general contraindications for infusion therapy such as acute pulmonary oedema, hyper-hydration and decompensated cardiac insufficiency
* known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients
* autoimmune disease or HIV
* uncompensated hemodynamical failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure)
* uncompensated ketoacidosis caused by Diabetes mellitus within 7 days prior to onset of study
* uncompensated renal insufficiency with serum creatinine \> 1.5 mg/dL (\> 133 µmol/L)
* patients with severe liver dysfunction with bilirubin \> 2.5 mg/dL (\> 43 µmol/L)
* necrotizing pancreatitis