cyrilzakka/clinical-trials huggingface dataset:
The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis

As an important management of severe acute pancreatitis (SAP), enteral nutrition (EN), especially early enteral nutrition (EEN) increases the blood flow of gut mucosa and stimulates the intestinal motility. Moreover, EEN maintains the gut integrity, prevents bacterial and endotoxin translocation and thereby theoretically reduces the incidence of infections. Therefore, EEN has the ability to reduce the infectious complications, length of hospital stay and mortality of patients with SAP.

However, the role of EEN is considered to be influenced by intra-abdominal hypertension (IAH) in patients with SAP. The previous studies showed that gut was the most sensitive splanchnic organ to the increase of intra-abdominal pressure (IAP). When IAH occurs, it reduces the blood flow of gut, and then results in the development of intestinal ischemia and edema. The hypoxia and hypoperfusion of intestine leads to the increase of permeability of the intestinal mucosal barrier, and then leads to bacterial translocation. Therefore, IAH could result in the gastrointestinal dysfunction. Nevertheless, the different impacts of specific IAP values on the tolerance of EEN have not been reported.

Furthermore, the effects of early enteral feeding on the IAP in SAP also remain unknown. Due to the severe inflammatory response of SAP, could EEN increase the burden of bowel, cause expansion of intestinal cavity, thus increase IAP? However, there were rare literatures up to date reporting the association between EEN and IAH in patients with SAP. Therefore, the present study aimed to investigate the influence of specific IAP on the tolerance of early enteral feeding, as well as the effects of EEN on IAP in SAP patients. Moreover, the impacts of EEN on the disease severity and clinical outcome of SAP were also researched.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of acute pancreatitis accords with the Atlanta criteria in 1992
* Within 3 days from the onset of the disease
* Hemodynamics stable

Exclusion Criteria:

* Decompressive measures and enteral nutrition was performed before admission
* Ileus of lower digestive tract
* Pregnant pancreatitis
* Chronic organs dysfunction
* Immunodeficiency
Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response

To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or later.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥ 18 years of age.
2. ECOG 0, 1, or 2.
3. Have been diagnosed with Ph+ CML-CP and receiving imatinib therapy.
4. Patients with suboptimal molecular response to imatinib treatment continued for at least 18 months (first line therapy)

   Suboptimal molecular response defined as all of the following conditions:
   1. Patients who have achieved CCyR (0% Ph+ chromosomes).
   2. Patients who don't achieve MMR (MMR defined as BCR-ABL/ABL ratio of ≤ 0.1% on the International Scale as detected by RQ-PCR).

   The treatment with imatinib defined as:

   Dose of 300 mg or higher daily must be maintained for a minimum of 3 months prior to study entry.
5. Patients who meet the following laboratory tests criteria:

   1. total bilirubin \< 1.5 x ULN,
   2. SGOT and SGPT \< 2.5 x ULN,
   3. creatinine \< 1.5 x ULN,
   4. Serum amylase and lipase ≤ 1.5 x ULN,
   5. Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related.
   6. Serum potassium, phosphorus, magnesium and calcium ≥ LLN or correctable with supplements prior to the first dose of study drug.
6. Written informed consent prior to any study related screening procedures being performed.

Exclusion Criteria:

1. Prior accelerated phase or blast crisis CML.
2. Previously documented T315I mutations.
3. Presence of chromosomal abnormalities other than Ph+.
4. Previous treatment with any other tyrosine kinase inhibitor except imatinib.
5. Impaired cardiac function including any one of the following:

   1. Complete left bundle branch block
   2. Congenital long QT syndrome or family history of long QT syndrome
   3. History of or presence of significant ventricular or atrial tachyarrhythmias
   4. Clinically significant resting brachycardia (\<50 bpm)
   5. QTcF \> 450 msec on screening ECG
   6. Use of a ventricular-paced pacemaker
   7. Myocardial infarction during the last 12 months
   8. Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, unstable angina).
6. Treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St John's Wort), and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. See Section 6.4.3 for complete list of these medications.
Urgent vs. Early Endoscopy in High Risk Patients With Upper Gastrointestinal Bleeding (UGIB)

Acute upper gastrointestinal bleeding (UGIB) is one of the commonest medical emergencies. The condition accounts for 150 per 100,000 populations. A National United Kingdom reported a crude overall mortality rate of 10%. While bleeding stops spontaneously in majority of patients at their presentation, there remains a subgroup of patients who continue to bleed or develop recurrent bleeding. In these patients, the mortality increases manifolds. If these high-risk patients can be identified, early interventions may improve their outcomes.

Several prognostic indices are in use for the purpose of patient stratification. They include the Rockall, Glasgow-Blatchford (GBS) and the Baylor scores. The Rockall score is a composite score which incorporates clinical parameters as well as findings during endoscopy which was derived to predict mortality. The GBS is a pre-endoscopy or a clinical score for the prediction for the need of further intervention loosely defined as the need for transfusion, endoscopy or surgery. It has been shown to be accurate in identifying low risk patients for early discharge.

The GBS, being a pre-endoscopy score with clinical parameters, is more suitable for patient triage leading to urgent endoscopy and a higher level of care. A GBS of 0 has been shown to identify patients with upper gastrointestinal bleeding who may be managed safely as outpatients. The proportion of patients requiring endoscopic therapy increases with a higher score. A cut-off score that identifies "high-risk" patients who may benefit from urgent intervention however has not been determined. Guidelines from Societies around the world recommend early endoscopy within 24 hours of presentation for acute upper gastrointestinal bleeding (AUGIB). The guidelines also state that a proportion of patients need emergency "out-of-hours" endoscopy, without defining the "high-risk" group. A recent international consensus on the management of NVUGIB recommended early endoscopy within 24 hours for Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB), and noted no additional benefit associated with urgent endoscopy (\<12 hours) vs. early endoscopy (\>12 hours) in unselected patients with NVUGIB. However, there are only limited data on the role of urgent endoscopy in the "selected" subgroup of patients with high-risk NVUGIB.

Eligibility Criteria:
Inclusion Criteria:

1. Overt signs of upper gastrointestinal bleeding (i.e., melena or hematemesis with or without hypotension)
2. GBS of ≥12
3. In-patients admitted for reasons other than AUGIB who develop bleeding are also considered for trial enrollment.
4. Patients in Hypotensive shock (SBP ≤90 mmHg or pulse ≥110 bpm) are initially resuscitated and then considered for trial entry if their condition can be stabilized.

Exclusion Criteria:

1. continued shock despite initial volume resuscitation (refractory shock) undergo urgent endoscopy
2. \< 18 years of age
3. Unable to provide written informed consent
4. Pregnant or lactating women
5. Moribund patients from terminal illnesses. (active treatment not considered)
The Posturing After Retinal Detachment (Post RD) Trial

A randomised controlled trial to evaluate the effect of face-down posturing on retinal displacement and distortion following retinal detachment repair.

During the surgical repair of a retina detachment, a gas bubble is inserted into the eye to keep the retina flat. Following this, it is common to ask patients to adopt a certain head position for a set period of time after their operation. This is known as posturing. It is thought that by adopting a certain head position/posturing, the bubble aids re-attachment of the retina. However, when the retinal detachment involves the macula (central portion of the retina) it has been shown that the retina can shift (or displace) post-operatively, leading to distortion in the patient's vision.

The purpose of this study is to investigate whether adopting different head positions following surgery for macula involving retinal detachments, can reduce retinal displacement and visual distortion. The investigators plan to recruit 368 patients. Patients will be in follow up for a period of six months. The study will be operational at two different hospitals in the United Kingdom.

Eligibility Criteria:
Inclusion Criteria:

* Fovea-involving rhegmatogenous retinal detachment
* History of central visual loss within the past 14 days
* Patients undergoing vitrectomy and gas surgery, under local anaesthetic
* Able to give informed consent
* 18 years old and over

Exclusion Criteria:

* Previous vitrectomy or cryo-buckle surgery
* Retinal detachment surgery requiring silicone oil tamponade
* Existing ophthalmic condition which limits the patient's visual acuity (BCVA 6/36 or worse)
* Inability to posture post-operatively or commit to follow-up visits
Phase II Trial of SBRT + or - IMRT in Treatment of Patients With Clinically Confined Prostate Adenocarcinoma

Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA \<10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA \>10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy.

Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA \<10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA \>10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy. All patients will be assessed for toxicity at periodic time points following completion of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically determined adenocarcinoma is required.
* All other histologies are excluded.
* Tissue for diagnosis must be obtained by transrectal ultrasound biopsy.
* Gleason scoring classification of the biopsy specimen is required and must be greater than or equal to 7.
* 2002 AJCC clinical cancer stage as determined by either urologist or radiation oncologist must be T1c - T2b, N0, M0.
* N0 stage may be assigned following either negative imaging or negative pathologic assessment.
* Prostate volume as assessed by TRUS must be less than 60 cc. 3.1.5.
* PSA must be less than 20 ng/ml. ,
* Age ≥ 18,
* IPSS voiding symptoms score must be less than 18,
* Study consent form must be signed by the patient.

Exclusion Criteria:

* Gleason score of 8 - 10,
* Clinical stage T3 - T4,
* Age ≤ 18,
* Any evidence of nodal (N1) or distant (M1) disease,
* Prostate volume as assessed by TRUS \> 60 cc,
* PSA \> 20 ng/ml,
* IPSS voiding symptoms score \> 18,
* Prior TURP,
* Prior pelvic radiotherapy or chemotherapy,
* Prior prostatectomy,
* Prior cancer other than basal cell or squamous cell skin carcinoma unless free of disease for \> 5 years,
* Current medical or psychiatric illness that may interfere with treatment completion and followup,
* Hip prosthesis,
* Unable or unwilling to give informed consent
7-Day, Multi-Site Study of an Investigational Multi-Purpose Disinfecting Solution for Contact Lens Wearers

The purpose of this study is to clinically evaluate solution-related corneal staining with an investigational multi-purpose disinfecting solution (MPDS) in hydrogel and silicone hydrogel contact lens wearers.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Wear contact lenses a minimum of 8 hours per day for at least 7-10 days prior to Visit 1 (screening visit).
* Vision correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses at Visit 1.
* Must discontinue contact lens wear for at least two consecutive days before Visit 2 (baseline visit).
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude safe administration of test article or safe participation in the study.
* Known sensitivity or intolerance to any protocol-specified contact lens solutions, eye drops, or products containing similar ingredients (e.g., generic products).
* Monocular vision (only one eye with functional vision) or fit with only one contact lens.
* Use of topical ocular over-the-counter or prescribed topical ocular medication, with the exception of rewetting drops, within 7 days prior to screening visit.
* Current or history of ocular infection, inflammation, disease, structural abnormality or conditions within the last 6 months that could affect study participation or may preclude safe administration of the investigational lens care solution, in the opinion of the investigator.
* Any corneal surgery, cataract surgery, intraocular lens implants or glaucoma filtering surgery within the last 12 months.
* Any slit-lamp finding score of 1 (or rated 3 or 4 for limbal and bulbar conjunctival injection) at screening or baseline visits.
* Corneal staining area assessment ≥ 20% in any corneal region in either eye at baseline visit.
* Corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye at baseline visit.
* Participation in any investigational clinical study within 30 days of baseline visit.
* Other protocol-defined exclusion criteria may apply.
Evaluation of Memantine in the Preservation of Memory and Neurocognition Following CSI

The goal of this clinical trial is to evaluate the role of memantine in preservation of memory and neurocognition in patients undergoing craniospinal irradiation. Participants will be randomised into two arms and the interventional arm will receive memantine along with the standard treatment. Researchers will compare the neurocognitive tests of participants in both the arms to see if memantine leads to significant preservation of memory and cognition post radiation therapy.

Craniospinal irradiation (CSI) involving radiation (RT) of brain and spine, along with tumor-bed boost with or without chemotherapy, is the current standard treatment for medulloblastoma and other primitive embryonal tumors of the central nervous system (CNS). The delayed side effects following CSI include memory loss, hearing and balance difficulties, hormonal imbalance, and secondary cancers. Decline in memory severely affects the quality of life in long term survivors of these diseases. Hence, various strategies are being tried to prevent it. Memantine has been proven to effectively prevent the memory decline induced by RT. It is FDA-approved for Alzheimer's disease and is widely used in the children for several developmental disorders. With this study, we are trying to investigate the role of memantine in patients receiving CSI to prevent memory decline.

After screening for the study, eligible patients will be randomly allocated (by computerised system) to one of the two arms that are described as follows. Patients in the experimental arm (memantine) will be started on memantine, starting dose of the same will be 5mg once daily at bedtime for 1 week, followed by 5mg twice daily for 1 week, and finally increased to the full dose of 10 mg twice daily for 6 months. Patients will continue on radiation and chemotherapy (when indicated) as per schedule. All patients in the study will undergo neurocognitive evaluation, the time points for which will be pre-radiation (baseline), 6 months post-RT, 1-year post-RT, and annually after that for 5 years from radiation. Following completion of RT or treatment, standard follow-up protocols will include a clinical examination 3 monthly for the first 2 years, followed by 6 monthly visits till 5 years post-RT. No additional risk is expected from the current study other than the common side effects of the standard treatment. Based on the results from the study, if primary endpoints are achieved, it will establish the role of memantine in preventing memory decline from CSI, which can be used as a standard treatment measure to help patients in the future.

Eligibility Criteria:
Inclusion Criteria:

* Age at irradiation: 5 to 39 years
* Planned for CSI (with or without boost dose) with or without systemic chemotherapy
* Informed consent or assent taken
* Karnofsky Performance Status / Lansky Performance Status ≥ 60

Exclusion Criteria:

* Re-irradiation
* Prior exposure to memantine
* Inability to undergo Wechsler test
Increasing Health Insurance Enrollment Among Uninsured Americans

This randomized evaluation used behaviorally-informed letters to increase health insurance take-up on the Affordable Care Act (ACA) Marketplaces.

During Open Enrollment Periods for the ACA Marketplaces, qualifying individuals can purchase health insurance plans through the Federal Health Insurance Marketplace (FHIM). As of early February 2015, many people had visited HealthCare.gov and started an online account, but not yet selected a plan. The Department of Health and Human Services (HHS), in collaboration with the Office of Evaluation Sciences (OES), developed and sent letters to assist these individuals with completing their enrollment before the deadline.

To evaluate the effect of the letters, the team used a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Those with an English language preference; those who had not enrolled in an ACA plan as of early February 2015

Exclusion Criteria:

* Those with a Spanish language preference

This intervention was a program evaluation and did not go through Human Subjects Protection Review.
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis

To evaluate the efficacy and safety of tacrolimus capsules in patients with myasthenia gravis who are inadequately treated by glucocorticoid.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed as myasthenia gravis (MG) by clinical diagnosis
* QMG scores ≥7 at the time of enrollment
* basic treatment drugs are mainly glucocorticoids, and the efficacy of glucocorticoid therapy was not sufficient

Exclusion Criteria:

* receiving blood purification therapy or immunoglobulin therapy within 8 weeks before the study
* QMG swallowing function score ≥ 2 points or QMG vital capacity = 3
* abnormal hepatic functions
* uncontrolled diabetes patients
* hyperkalemia patients
* immuno-inhibitors are forbidden due to malignancy, history of malignancy or history of HIV infection
* patients who are allergic to Tacrolimus or macrolide antibiotics
* receiving other immuno-inhibitors within 12 weeks
Effect of Metformin on Lactate Metabolism

The main objective of this study is to evaluate the influence of metformin on lactate metabolism.

The main outcome is the lactate production following an exogenous lactate overload in healthy male subjects without metformin and one week later with metformin.

Study design: Physiological study, controlled, open, non randomised

Healthy male subjects, 18 to 30 years old

Principal objective : To evaluate the influence of metformin on lactate metabolism (production) following exogenous lactate overload.

* Objective 2: To evaluate the influence of metformin on lactate metabolism (production) after muscular exercise.
* Objective 3: To evaluate the influence of metformin on lactate metabolism (elimination) after exogenous lactate overload.
* Objective 4: To evaluate the influence of metformin on lactate metabolism (elimination) after muscular exercise.

Principal outcome : Lactate production following exogenous lactate overload.

* Outcome 2: Production of lactate following muscular exercise test.
* Outcome 3 and 3': Parameters modelizing elimination of lactate following exogenous lactate overload (bi-exponential model).
* Outcome 4 and 4': Parameters modelizing elimination of lactate following muscular exercise test (bi-exponential model).

Inclusion criteria:

* Healthy male subjects, 18 to 30 years
* Body mass index (BMI) between 21 and 25 kg/m2 inclusive
* Informed consent

Exclusion criteria :

* Ward of court or under guardianship (sheltered adults)
* Adult unable to express their consent
* Person deprived of freedom by judicial or administrative decision
* Person hospitalised without their consent
* Person under legal protection
* Existence of a previously diagnosed pathology
* Existence of a metabolic condition (obesity, diabetes) or a family history of such
* Ongoing medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects, 18 to 30 years
* Body mass index (BMI) between 21 and 25 kg/m2 inclusive
* Informed consent

Exclusion Criteria:

* Ward of court or under guardianship (sheltered adults)
* Adult unable to express their consent
* Person deprived of freedom by judicial or administrative decision
* Person hospitalised without their consent
* Person under legal protection
* Existence of a previously diagnosed pathology
* Existence of a metabolic condition (obesity, diabetes) or a family history of such
* Ongoing medical treatment