cyrilzakka/clinical-trials huggingface dataset:
Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial

The aim of this study is to assess if a bundle associating pressure support and positive end-expiratory pressure during spontaneous breathing trial and detection by T-piece of patients with high-risk of extubation failure can reduce the time to successful extubation in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years old or more
* Intubated and ventilated in intensive care unit for more than 24 hours
* Patient ready for weaning evaluation
* Failure of a first T-piece SBT

Exclusion Criteria:

* Chronic neuromuscular disease
* Guillain-Barré Syndrome
* Central nervous system disease with consciousness disorder
* Tracheostomy
* Chronic disease with life expectancy less than 1 year
* Pregnancy, breast feeding
* Withholding life support regarding a reintubation
* Prisoner or patient interned in psychiatric hospital
* Guardianship
* Language barrier
* Lack of medical insurance
* Lack of the patient's consent (or of the next of kin where appropriate)
* Patient under an exclusion period after enrollment in another research study
A Pilot Study to Assess the Safety, Tolerability, and Efficacy of Virtual Reality for the Treatment of Abdominal Pain in Quiescent Crohn's Disease

The purpose of this research is to see if patients with Crohn's disease (CD) and abdominal pain resulting in health-related quality of life deficits despite lack of evidence of active inflammation improve with the use of virtual reality (VR).

The goal of this research is to see if patients with Crohn's disease (CD) and abdominal pain resulting in health-related quality of life deficits despite lack of evidence of active inflammation improve with the use of virtual reality (VR). The use of VR therapy is investigational. You have been asked to take part in this research because you have been identified as an adult with CD with abdominal pain at least weekly despite normal C-reactive protein and fecal calprotectin levels in adult patients, age 18- 70 years old. Demographic information will be gathered (age, sex, race, current medication use, co-morbid conditions), as will prior tests and interventions.

Participants will be asked to participate in the two-week pre-screening evaluation for symptoms through questionnaires. The VR portion of the study will last for 8 weeks. You will be asked to use your headset on a daily basis for at least 30 minutes, but you are free to use the headset as much as you would like. You will be called on a weekly basis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of endoscopically and histologically confirmed CD with evidence of C-reactive protein \&lt; 5 mg/dL and fecal calprotectin \&lt; 150microg/g who also report any abdominal pain at least weekly will be included.

Exclusion Criteria:

* Patients will be excluded from the study if they do not have biopsy-proven CD, have a known seizure disorder, if symptoms are thought to represent an organic disorder, those with visual or hearing impairments, if symptoms represent a known pelvic floor disorder, if the patient is using opioids, has significant ongoing psychological distress (HAD score \&gt; 11 for either anxiety or depression), or if the patient can not actively participate in the study for any other reason (e.g., inability to understand English as the VR program as an English only).
Sensors Prediction Study

The purpose of this study is to test whether measures of balance and agility can help predict if a Service Member may be at risk for an injury to their legs before beginning their school and training.


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18-55
2. Active duty Service Members in the 82nd Airborne Division (ABN DIV)
3. Fluent in English speak and reading

Exclusion Criteria:

1. Service members under the age of 18 or over the age of 55 will be excluded
2. Told by a doctor that they should not exercise.
3. Orthopedic injury/surgery of the lower limb or back within the last year and that limits study compliance
4. Regular use of medications that may alter balance, coordination or agility
5. Unwilling to comply with the study protocol
US-guided Percutaneous Electrolysis (EPE®) in Shoulder Pain

Scientific evidence of conservative management of subacromial pain syndrome is conflicting. There is evidence that eccentric exercise programs are effective at medium term for this pain condition. The inclusion of other therapeutic modalities is still controversial. A recent study suggests that the inclusion of US-guided percutaneous electrolysis combined with eccentric exercises can be effective at short-term for this condition. The objective of this randomized clinical trial is to determine the effectiveness at short- and long-term of the inclusion of US-guided percutaneous electrolysis (EPE®) into a eccentric exercise protocol for the management of patients with subacromial pain syndrome for pain, function, disability and pressure pain sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* unilateral shoulder complaints with duration of at least 3 months;
* an intensity of at least 4 on an 11-point numerical pain rating scale (NPRS) during arm elevation;
* a positive painful arc test during abduction
* at least one positive of the following tests: Hawkins-Kennedy test, Neer's sig, empty can test, drop arm or lift-off test

Exclusion Criteria:

* bilateral shoulder symptoms
* younger than 18 or older than 65 years
* history of shoulder fractures or dislocation
* cervical radiculopathy
* previous interventions with steroid injections
* fibromyalgia syndrome
* previous history of shoulder or neck surgery
* any type of intervention for the neck-shoulder area during the previous year
Effect of Tidal Volume Change on Pressure-based Prediction of Fluid Responsiveness in Children

This study evaluates predictability of fluid responsiveness of pressure-based dynamic variables such as pulse pressure variation and systolic pressure variation, according to tidal volume change in patients undergoing cardiac surgery.

Pressure-based dynamic variables such as pulse pressure variation(PPV) and systolic pressure variation(SPV) are known to be unreliable for prediction of fluid responsiveness in children.

The hypothesis is that tidal volume change in mechanically ventilated children undergoing anesthesia would affect reliability of aforementioned dynamic variables in prediction of fluid responsiveness, especially in the way that reliability increases for high tidal volume.

In children undergoing cardiac surgery, tidal volume is changed to 6mL/kg, 10mL/kg and 14mL/kg after closure of sternum, followed by measurement of PPV, SPV. We also measure the respiratory variation of aortic blood peak velocity(△Vpeak) via transesophageal echocardiography, which is known to best predict fluid responsiveness.

Afterward, 10mL/kg of crystalloid solution is administered for fluid loading. 'Fluid responder' is defined as subjects with increase of stroke volume index more than 15% after fluid loading of 10mL/kg.

With these data, whether the predictability of fluid responsiveness of PPV and SPV changes according to change in tidal volume is evaluated by comparing the area under the curve of the receiver-operating characteristics curve between themselves and △Vpeak.

Eligibility Criteria:
Inclusion Criteria:

* Children younger than 6 years old planned to undergo ventricular septal defect closure or atrial septal defect closure under general anesthesia

Exclusion Criteria:

* Children with other complex cardiac defects
* Children with arrhythmia
* Children with preoperatively measured ejection fraction of less than 30%
* Children with underlying pulmonary disease
Integrative Care for Type 2 Diabetes

A two year, two arm pragmatic trial to investigate the integration of naturopathic care with conventional medical care to provide additional benefit beyond that of conventional medical care alone in achieving adequate control of diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, enrolled as a patient with WE-FHT
* Ages 21-75 years old
* Diagnosed with type 2 diabetes and not adequately controlled (HbA1c \> 7.0mmol/L)
* Currently seeking care with a medical doctor, nurse practitioner and/or physician assistant
* Willingness to adhere to randomized treatment with availability for follow-up
* Ability to answer self- and interviewer- administered questions in English or have an English speaking caregiver who can aid in answering self- and interviewer- administered questions
* Ability to provide written informed consent or give informed consent through substitute decision maker
* Capacity to maintain a diary and log of treatments and recommendations given during study

Exclusion Criteria:

* Lacking capacity for consent
* Pregnancy or an intention to become pregnant in the following two years
* Breastfeeding
* History of myocardial infarction within the past 6 months
* Chronic kidney (eGFR \<30 mL/min) or liver disease
* Actively receiving care from a complex care diabetes clinic
* History of severe hypoglycemia in the last year resulting in hospital emergency care \[where hypoglycemia is defined to be: 1) development of autonomic or neuroglycopenic symptoms, 2) low plasma glucose level (\<4.0mmol/L for patients treated with insulin or an insulin secretagogue) and 3) symptoms responding to the administration of carbohydrate\] or hypoglycemia unawareness
* Current bolus or pre-mixed insulin treatment
* Limited life expectancy (\< 6 months)
* High level of functional dependency (inability to perform common activities of daily living)
* In participants aged 65yoa to 75yoa, the following also serve as exclusion criteria:

  1. Recent MI or stroke (within last 6 months)
  2. NYHA CHF Functional Capacity Stage III or above
  3. NYHA CHF Objective Assessment Stage C or greater (http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/Classes-of-Heart-Failure_UCM_306328_Article.jsp)
  4. Planned revascularization procedure (PCI or coronary artery bypass graft) or coronary angiogram within 90 days after screening or randomization
The Coflex®COMMUNITY Study: An Observational Study of Coflex® Interlaminar Technology

The purpose of the coflexCOMMUNITY observational study is to collect information on patients with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their outcomes and the cost-effectiveness of this procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is skeletally mature and has at least moderate impairment in function, experiences relief in flexion from his/her symptoms of leg/buttocks/groin pain, with or without back pain, and has undergone at least 6 months of non-operative treatment;
2. Patient is treated surgically at 1 or 2 contiguous lumbar motion segments with the coflex Interlaminar Device from L1-L5 after decompression of stenosis at the affected level(s), where such use is not contraindicated as noted below.

Exclusion Criteria:

1. Prior fusion or decompressive laminectomy at any index lumbar level;
2. Radiographically compromised vertebral bodies at any lumbar level(s) caused by current or past trauma or tumor (e.g., compression fracture);
3. Severe facet hypertrophy that requires extensive bone removal which would cause instability;
4. Grade II or greater spondylolisthesis;
5. Isthmic spondylolisthesis or spondylolysis (pars fracture);
6. Degenerative lumbar scoliosis (Cobb angle of greater than 25°);
7. Osteoporosis;
8. Back or leg pain of unknown etiology;
9. Axial back pain only, with no leg, buttock, or groin pain;
10. Morbid obesity defined as a body mass index \> 40;
11. Active or chronic infection - systemic or local;
12. Known allergy to titanium alloys or magnetic resonance imaging (MRI) contrast agents;
13. Cauda equina syndrome defined as neural compression causing neurogenic bowel or bladder dysfunction;
14. Vulnerable population including pregnant women, prisoners, students and employees of treating physicians, and others who can be subject to coercion;
15. Patient is unwilling to complete his/her surveys.
Photodynamic Therapy (PDT) Versus Transpupillary Thermotherapy (TTT) in Occult Choroidal Neovascularization (CNV) in Age-related Macular Degeneration (AMD)

The purpose of this study is to compare the effect of PDT and TTT for the treatment of subfoveal occult CNV in age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* \> 55 years of age,
* Subfoveal occult only CNV due to AMD,
* \< 4 disc areas or \> 4 disc areas
* VA \< 0.4

Exclusion Criteria:

* Sign of classic CNV,
* CNV in other diagnoses than AMD,
AEG35156 in Combination With High-dose Cytarabine and Idarubicin in AML Following Failure of a Single Standard Dose Cytarabine Based Frontline Induction Regimen

To determine if AEG35156 can enhance the combined complete remission (CR) and CR with incomplete platelet recovery (CRp) rate of high-dose cytarabine and idarubicin in AML following failure of a single standard dose cytarabine based frontline induction regimen.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AML, except those with APL (acute promyelocytic leukemia), failing a single standard dose cytarabine based frontline induction regimen. The diagnosis of refractory AML is based on the presence of either \> 10% blasts in marrow or blood or 5-10% blasts in either site together with cytopenia (Hb \< 10 g/dL, or platelets \< 100 x 109/L, or neutrophil count \< 1.0 x 109/L).
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
* Male, or female patients who are post-menopausal (amenorrheic for at least 12 months), or surgically or biologically sterile.
* Patients must have adequate organ and immune function as indicated by the following laboratory values:

Parameter Laboratory Values Serum creatinine; ≤2.0 mg/dL (≤ 177 μmol/L Total Bilirubin ≤2.0 mg/dL (≤ 34 μmol/L) AST (SGOT) and ALT (SGPT) ≤3 X ULN

* The patient must understand, be able and willing and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.

Exclusion Criteria:

* Clinical evidence of ongoing grade 3 or 4 non-hematological toxicities from the initial standard dose cytarabine-based induction chemotherapy
* Patients with a prior history of peripheral neuropathy of grade 2 or higher.
* Clinical evidence of active CNS leukemic involvement.
* Active and uncontrolled infection. Patients with an infection who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.
* Current evidence of invasive fungal infection (blood or tissue culture).
* Current evidence of an active second malignancy except for non-melanoma skin cancer.
* Uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair a patient's ability to give informed consent or unacceptably reduce the safety of the proposed treatment.
* Neurological or psychiatric disorders that would interfere with consent or study follow-up.
* Known or suspected intolerance or hypersensitivity to the study drugs \[or closely related compounds\] or any of their stated ingredients. Study drugs being the antisense, cytarabine and idarubicin.
* History of alcohol or other substance abuse within the last year.
* Use of another investigational agent within the last 14 days prior to enrolment. Patients who have received a previous antisense agent in the last 90 days will be excluded.
* Female patients who are pregnant, lactating, or with a positive pregnancy test at screening must be excluded.
Proteomic Analysis of Human Hepatocellular Carcinoma

This is a pilot study to evaluate the difference between the protein expression between hepatocellular carcinoma and tumor with vessel invasion in Asian patients with hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

Arm A: Hepatocellular carcinoma with vessel invasion:

* hepatocellular carcionoma, pathologic diagnosed.
* image documented vessel invasion, including portal vein thrombosis
* eligible for surgical intervension.

Arm B: hepatocellular carcinoma without vessel invasion:

* hepatocellular carcinoma, pathologic diagnosed or clinical diagnosed according to EASL criteria.
* no vessel invasion on image.

Arm C: Healthy hepatitis carrier:

* patients age \>18 years old with hepatitis B or C
* normal liver function.
s086 Tablets in the Treatment of Mild to Moderate Essential Hypertension

Efficacy and Safety of s086 Tablets in the Treatment of Mild to Moderate Essential Hypertension:a Randomized,Double-blind,Placebo-controlled,Multicenter Phase II Clinical Trial


Eligibility Criteria:
Inclusion Criteria:

* For mild to moderate essential hypertension
* not receiving treatment or being treated with antihypertensive drugs (single drug or combination therapy of two drugs, including compound preparations containing 2 drug components)
* not receiving treatment (newly diagnosed Essential hypertension or a history of hypertension but not taking any antihypertensive drugs at least 4 weeks before screening), during the screening period (V1) and before randomization (V4), the mean sitting systolic blood pressure (msSBP) ≥ 150mmHg and \<180mmHg;
* patients who are receiving antihypertensive drugs (treated with antihypertensive drugs within 4 weeks before screening), at the end of the wash period (V2), must meet the average sitting systolic blood pressure ≥140mmHg and \<180mmHg; before randomization (V4), the average sitting systolic blood pressure must be ≥150mmHg and \<180mmHg;
* the patient's average sitting systolic blood pressure before randomization (V4) must be the difference between the previous average sitting systolic pressure (at the end of the washing period (V2)) ≤15mmHg; voluntarily participate in the trial and sign an informed consent form.

Exclusion Criteria:

* Have a history of allergies to relevant components of the test drug, known or suspected to be allergic to S086, sacubatril, valsartan sodium or olmesartan medoxomil and related drugs (ARB, ACEI, and renin inhibitors);
* currently in pregnancy, breastfeeding Female subjects whose pregnancy or pregnancy tests are positive; or those whose subjects or their partners cannot guarantee effective contraception during the trial period (acceptable methods of contraception: true abstinence; intrauterine contraceptive devices; barrier contraceptives; or partners accepted Sterilization surgery. Unacceptable contraceptive methods: periodic abstinence, such as contraception based on calendar, ovulation, symptomatic body temperature);
* or those who have a childbirth plan within 6 months after the end of the trial;
* have a history of drug abuse or alcohol abuse within 6 months before screening History: Participated in any drug or medical device or other clinical trial within 3 months before screening, or participated in any drug or medical device or other clinical trial during the planned trial or within 3 months after the end of the trial.
Education and Counseling Program on Patients With CIEDs and Low HL

The goal of this RCT (randomized controlled trial) is to investigate the effect of education and counseling program that researches developed on patients with cardiac implantable electronic devices (CIEDs) and low health literacy.

The main questions are; Is there a difference between the health literacy scores of intervention and control groups after education and counseling program? Is there a difference between the CIEDs knowledge scores of intervention and control groups after education and counseling program? Is there a difference between the daily life activity scores of intervention and control groups after education and counseling program?

Researches offer an education and counseling program about living with CIEDs to patients that having CIEDs for the first time. Participants answers questions in Health Literacy Survey European Questionnaire 16, cardiac implantable electronic devices knowledge scale (researches developed) and Duke Activity Index before education and counseling program, at first month, third month and sixth month after implantation.

Reseraches compare scores between intervention and control groups, also different times in same groups.


Eligibility Criteria:
Inclusion Criteria:

* no communication problems in Turkish
* implanted any type of CIED for the first time
* having low score of HLS EU Q16
* willingness to participate in the study

Exclusion Criteria:

* Not literate
* having vision or hearing problem
* having psychiatric and cognitive impairment
A Clinical Trial Assessing the Impact of Inhaled Insulin on Glucose Disposition

To assess the impact of inhalation of insulin on glucose disposition in patients with type 1 diabetes

The study was terminated on Oct. 28, 2007. The protocol was undergoing implementation and methodological issues with major revisions that qualified this trial as a new trial. Pfizer decided to cancel new trials because of the decision to withdraw Exubera due to lack of market performance and not for safety reasons.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus Type 1

Exclusion Criteria:

* Asthma, COPD
* Smoking
Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and Rituximab in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL

Multicenter, Randomized, Double-blind, Parallel, Phase III Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL


Eligibility Criteria:
Inclusion Criteria:

* Untreated CD20-positive DLBCL confirmed.
* IPI score of 1 to 2, Stage I \~ IV, Score 0 needs to accompanied by bulky disease, which is defined as the presence of a tumor mass with a diameter of more than 7.5 cm.
* ECOG performance status of 0 to 2.
* More than 6 months life expectancy.
* At least one measurable lesion: For nodal tumor mass, more than 1.5 cm in the long axis and more than 1.0 cm in the short axis; For extranodal tumor mass, more than 1.0 cm in the long axis.
* 18 years to 70 years; Male or female patients.

Exclusion Criteria:

* Known allergic reactions against human or murine monoclonal antibody, murine products, or foreign proteins.
* Known allergic reactions against any component of CHOP regimen.
* Previous treatment for NHL, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, monoclonal antibody therapy or surgical treatment (excluding lymph node biopsies and surgical resection for non-lymphoma lesions).
* History of cytotoxic drugs treatment or anti-CD20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis).
* Prior use of any monoclonal antibody within 3 months.
* Primary central nervous system(CNS) lymphoma, secondary CNS involvement, grey zone lymphoma (GZL) between burkitt and DLBCL, primary effusion lymphoma, plasmablastic lymphoma, primary cutaneous DLBCL, anaplastic lymphoma kinase(ALK) positive DLBCL or transformed lymphoma.