cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Prolonged Apnea Supported by High Frequency Non-invasive Ventilation.

The purpose of the study is to assess the efficacy of high-frequency non-invasive ventilation on apnea duration, carbon dioxide clearance and oxygen delivery in healthy subjets and patients with lung disease.

High frequency ventilation (HF-V) allows to ensure oxygen delivery and carbon dioxide clearance despite the absence of thoracic movement in anesthetized, invasively ventilated subjects. This same technique could be applied by a non-invasive interface (HF-NIV), allowing to obtain a prolonged apnea (absence of thoraco-abdominal respiratory movements) in awaken subjects. Such an application would be of interest for several clinical applications, e.g. lung imaging and radio-therapy treatment on lung cancer. The purpose of the study is to assess the effect of different HF-NIV setting on the apnea duration, carbon dioxide clearance and oxygen delivery in healthy subjets and patients with lung diseases.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjets : normal respiratory function and no known lung disease
* lung disease patients : chronic obstructive pulmonary disease, Sarcoidosis, Cystic fibrosis
* age \>=18y

Exclusion Criteria:

* increased pneumothorax risk under positive pressure ventilation
* pregnancy
Prognostic Impact of Increased Lymph Node Yield in Colorectal Cancer Patients With Synchronous Distant Metastasis: a Population-based Study of the US Database and a Chinese Registry

The National Quality Forum has endorsed at least 12 lymph node yield (LNY) as a surgical quality indicator in colorectal cancer (CRC), but the prognostic value of adequate lymphadenectomy has rarely been investigated for CRC patients with distant metastatic disease.

Data on CRC patients with synchronous liver metastasis (LM) were derived from the US Surveillance, Epidemiology, and End Results (SEER) and a Chinese registry (from two Chinese tertiary centers: The Second Affiliated Hospital of Harbin Medical University and National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College) between January 2010 and December 2017. Individual level data on patients with incident CRC were consecutively collected in both registries. The primary tumor site was divided into three subsites according to International Classification of Diseases for Oncology (ICD-O-3) topography codes: proximal colon (C18.0, C18.1, C18.2, C18.3 and C18.4), distal colon (C18.5, C18.6, C18.7) and rectum (C19.9 and C20.9). The synchronous LM were identified by imaging or histopathological examinations. Synchronous LM refers to liver lesions found within 6 months after the diagnosis of primary CRC. Patients were excluded if they did not undergo surgery for CRC, did not have data on number of LNs retrieved and their survival status was unknown.

Eligibility Criteria:
Inclusion Criteria:

* Data on CRC patients with synchronous liver metastasis (LM) undergo surgery for CRC, have data on number of LNs retrieved and their survival status was known

Exclusion Criteria:

* Patients were excluded if they did not undergo surgery for CRC, did not have data on number of LNs retrieved and their survival status was unknown
Cerebral Near Infrared Spectroscopy During Blood Sampling From a Peripheral Artery Catheter in Preterm Infants

Preterm infants often need peripheral artery catheters for invasive blood pressure recording and to facilitate blood sampling. Near infrared spectroscopy is a method to evaluate cerebral oxygenation and as well as cerebral blood flow. Sampling procedures with identical sampling volumes are performed at a short (40 seconds) and a long (70 seconds) time intervall while changes of cerebral oxygenation are measured. The investigators hypothesise that slower sampling decrease changes in cerebral blood flow.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infant (Gestational Age \<37+0)
* Peripheral arterial catheter (ulnary or radial artery)

Exclusion Criteria:

* Complex organ malformation
Epidural Analgesia Use in Pancreatic Resections

The rationale for this study is to investigate the benefits of epidural analgesia in pancreatic resections in a prospective, single blind, randomized control trial. This study will evaluate both short and long-term outcomes related to epidural analgesia, providing a longitudinal and comprehensive perspective to the advantages and disadvantages of this technique. The investigators hypothesize that the use of epidural analgesia reduces a patient's consumption of morphine or morphine-equivalent in the post-operative period following pancreatic resections.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing pancreatic resection.
* Age ≥18 years old.
* Able to understand and sign an Institutional Review Board (IRB)-approved informed consent form.

Exclusion Criteria:

* Indication for operative intervention being chronic pancreatitis.
* Currently on warfarin with an INR≥1.4 or clopidogrel that cannot be discontinued 7 days prior to surgery;
* Most recent INR prior to surgery \>1.4
* Most recent platelet count prior to surgery \<70,000/mcl
* Chronic opioid use as defined by use of more than 20mg oxycodone, or equivalent, daily.
* History of pre-existing neuropathic pain conditions.
* Not giving consent for study participation.
* Known medical history of significant psychiatric or cognitive impairment
* History of HIV, Hepatitis B, and/or Hepatitis C
Phase 2 Study of TLK286 Administered Weekly in Advanced Non-Small Cell Lung Cancer

The purpose of this study is to determine the effectiveness of TLK286 in the treatment of advanced non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of non-small cell lung carcinoma
* Progressed while on or after treatment on platinum-based regimen
* Patients may not have had more than one prior cytotoxic chemotherapy regimen
* Stage IV or IIIB
* Age at least 18 years
* Adequate liver and kidney function
* Adequate bone marrow function

Exclusion Criteria:

* Pregnancy or lactation
* Unstable medical conditions
* Chemotherapy, hormonal therapy, radiotherapy, radiopharmaceuticals or immunotherapy within 3 weeks of TLK286
* CNS metastasis unless controlled by treatment
Phase III Study of PI-88 in Post-resection Hepatocellular Carcinoma

The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.

Primary liver cancer (hepatocellular carcinoma or HCC) is the fifth most common cancer worldwide. Surgery to remove the tumour remains the principal form of treatment for liver cancer, however recurrence of the disease after surgery is common and survival after recurrence is poor. At the moment there is no recommended standard treatment for HCC immediately after the tumour has been removed surgically. PI-88 is a new experimental drug which blocks the growth of new blood vessels in tumours to stop the tumour growing (starves it of food) and also stops tumour cells spreading. Previous experience with PI-88 has shown it has been well tolerated and has shown some benefit in delaying the time it takes for the hepatocellular carcinoma to reappear after surgery. The purpose of this study is to determine if PI-88 is effective and safe in patients who have had surgery to remove primary liver cancer.

Eligibility Criteria:
Key Inclusion Criteria:

* Histologically-proven primary hepatocellular carcinoma with curative resection performed in the 4 - 6 weeks prior to randomisation.
* ECOG performance status 0 to 2
* Child Pugh classification A or B

Key Exclusion Criteria:

* Any evidence of tumour metastasis or co-existing malignant disease
* Any prior recurrence of HCC or any liver resection prior to the most recent procedure
* History of prior HCC therapy
Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms

The investigators aim to evaluate effects of an outpatient rehabilitation program based on Acceptance and Commitment Therapy compared to usual care on function in patients with post-concussion syndrome (PCS) and post-traumatic headache (PTH). This study builds on the investigators' previous observational studies and treatment studies in this patient group.

The study is run in an outpatient setting at the Department of Physical Medicine and Rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Norway. All patients are also participants in the observational study: "Minimal and mild head injury: an exercise and outpatient follow-up study at St. Olavs Hospital" (REK number 2018/2159).

Eligibility Criteria:
Inclusion Criteria:

* Having sustained a minimal HI or MTBI
* PCS/ PTH had evolved within 1 week after the head trauma.
* At least one post-concussion symptoms of at least moderate degree, that affects daily life.
* \> 6 months post-injury.
* First line treatment has been tried, e.g. psychoeducation, increase of physical activity and pharmacological treatments for headache

Exclusion Criteria:

* More than 5 years since last injury.
* Symptoms are better explained by other conditions.
* Severe communication problems, typically due to poor knowledge of Norwegian.
* Severe psychiatric, neurological, somatic or substance abuse disorders that will make it problematic to function in a group and/or will complicate follow-up and outcome assessment.
S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer

Patients with advanced esophageal cancer will receive thoracic radiation therapy 60Gy over 30 fractions,and concurrent with s-1 and nedaplatin.

Purpose: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 in combination with nedaplatin and thoracic radiotherapy in patients with advanced esophageal Cancer.

Methods: Thoracic radiation therapy was administered in 2Gy fractions five times weekly to a total dose of 60 Gy.Concurrently, nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1, and s-1 was given on Days 1-14,repeated every 4 weeks for four cycles. The dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.

Eligibility Criteria:
Inclusion Criteria:

* Histologic proof of primary squamous cell or adenocarcinoma of the esophagus
* Locoregionally advanced carcinoma of esophagus without systemic metastases
* Zubrod Performance Status 0-1;
* Patients ≥ 18 years of age;
* No hypersensitivity to E. coli -derived products;
* AGC ≥ 1500/mm3, platelets ≥ 150,000/mm3, Hgb ≥ 10 gm%, serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 65 cc/min; serum calcium ≤ 11gm/dl;
* Patients with prior malignancy are eligible if curable non-melanoma skin cancer or cervical cancer in situ or disease free ≥ 5 years;
* No prior chest or upper abdomen radiotherapy; no prior systemic chemotherapy within the past 5 years; no prior esophageal or gastric surgery;
* Written informed consent.

Exclusion Criteria:

* Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
* Prior systemic chemotherapy or radiation therapy for esophageal cancer
Xylitol for Otitis Media

This is a randomized, double-blind, placebo-controlled study of children, age 6 months to 3 years, with a diagnosis of Otis media with effusion (OME) based on examination by a provider at a Duke- affiliated otolaryngology clinic.

The primary purpose of this study is to evaluate the efficacy of intranasal xylitol in young children with otitis media with effusion as measured by the resolution of middle ear effusion based on physical examination and tympanometry at 6-, 12-, and 18 and 24-weeks post-treatment. Eligible subjects will be randomly assigned to receive either intranasal xylitol spray or a nasal saline spray placebo and will be observed for 24-weeks following initiation of daily xylitol spray or placebo. The primary efficacy endpoint, the time to middle ear effusion resolution with and without the xylitol nasal spray, will be analyzed using either a two-sample t-test or non-parametric Wilcoxon test, depending on whether the time is normal or non-normal. Risks include epistaxis, diarrhea, and allergic reaction. Serious adverse events are not anticipated.

Eligibility Criteria:
Inclusion Criteria:

* Between 6 months and 3 years of age.
* Clinical diagnosis of OME. Treated at Duke for the above condition.
* Ability of parent/guardian to be compliant with at-home nasal spray administration.

Exclusion Criteria:

* History of immunodeficiency or an immunologic disorder that predisposes to frequent infections.
* History of prior pressure-equalization (PE) tube placement and the tubes are still in place.
* Active or recent (\<1 month prior to screening) middle ear disease, including but not limited to: cholesteatoma, tympanic membrane perforation, congenital external or middle ear abnormalities or malformations.
* History of previous otologic surgery including tympanoplasty, and/or mastoidectomy.
* Previous use of intranasal sprays other than normal saline, including intranasal steroids, and/or xylitol within 1 month prior to screening.
* Any other clinically significant illness or medical condition, per PI discretion, that would prohibit the subject from participating in the study.
* Subject has previously been randomized to a trial of Xylitol.
* Parent/guardian is unable to administer the study nasal spray.
* Parent/guardian is unable to read, write, and understand English.
* Parent/guardian is unable to provide legally effective consent.
Evaluation of Cognitive Performance in 4 Dairy Beverages

The objective of the study is to evaluate the cognitive performance of 4 chocolate milk drinks.

Subjects will make a total of 4 visits. Four visits in which they will drink a chocolate milkshake at each visit.

At each visit the subjects will have to come fasting, and they will have to perform the cognitive test at the time when they have their peak glycemic level.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both sexes (10 men and 10 women).
* Subjects aged between 20 and 35 years.
* Subjects with a body mass index between 20 and 25 kg/m2.

Exclusion Criteria:

* Subjects suffering from diabetes mellitus or any chronic disease.
* Subjects with medical problems or a diagnosed psychiatric disorder.
* Subjects with alcohol abuse or excessive alcohol consumption (\>3 glasses of wine or beer/day).
* Subjects consuming any pharmacological medication that may affect memory.
* Participation in another clinical trial in the three months prior to the study.
* Unwillingness or inability to comply with clinical trial procedures.
* Subjects whose condition does not make them eligible for the study according to the investigator's criteria.
* Pregnant or lactating women.
Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging

Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. The investigators are testing whether statins improve endothelial function more in the arteries that have worse endothelium to begin with. One of the functions of the endothelium is to help control how blood vessels dilate (expand) or contract (narrow) in different situations. This affects how blood flows through those vessels. Magnetic resonance imaging (MRI) can be used to evaluate endothelial function in the arms and legs noninvasively.

Correct

Eligibility Criteria:
Inclusion Criteria:

* Age 40-90
* Male or female
* Type 2 diabetes

Exclusion Criteria:

* Known pregnancy or nursing.
* Females of child bearing potential must have been surgically sterilized or be post menopausal.
* Smoking
* Known vascular disease
* Inability to complete MRI scan
* Symptoms of claudication
* Use of a nitrate medicine
* Use of any cholesterol-lowering agent
* LDL \< 70
* Acute illness
* Liver disease
* Contraindication to getting an MRI scan (i.e. electronic implant, shrapnel, cerebral aneurysm clip, welding history).
Tailored Implementation Intervention for Managing Depressed Elderly Patients in Primary Care

Background The prevalence of depression is high and the elderly have an increased risk of developing a chronic course. International data suggest that depression in the elderly is under-recognised, the latency before clinicians provide a treatment plan is longer, and elderly patients with depression are not offered psychotherapy to the same degree as younger patients. Although recommendations for the treatment of elderly patients with depression exist, health care professionals adhere to these recommendations to a limited degree only. Investigators conducted a systematic review to identify recommendations for managing depression in the elderly and prioritised six recommendations. Investigators identified and prioritised determinants of practice related to implementation of these recommendations in primary care, and subsequently discussed and prioritised interventions to address the identified determinants. The objective of this study is to evaluate the effectiveness of these tailored implementation interventions to implement six recommendations for the management of elderly patients with depression in primary care.

Methods/design Investigators will conduct a pragmatic cluster randomised trial comparing implementation of the six recommendations using tailored interventions with usual care. Investigators will randomize 80 municipalities into one of two groups: an intervention group, to which investigators will deliver tailored interventions to implement the six recommendations, and a control group, to which investigators will not deliver any intervention. Investigators will randomise municipalities rather than patients, individual clinicians or practices because we will deliver the intervention for the first three recommendations at the municipal level and investigators want to minimise the risk of contamination across practices for the other three recommendations. The primary outcome is the proportion of general practitioners' behaviours which are consistent with the recommendations.

Discussion This trial will investigate whether a tailored implementation approach is an effective strategy to improve collaborative care in the municipalities and health care professionals' practice towards elderly patients with depression in primary care. The effectiveness evaluation described in this protocol will be accompanied with a process evaluation exploring why and how the interventions were effective or ineffective.


Eligibility Criteria:
Inclusion Criteria:

Home-dwelling patients aged 65 or higher, who have a diagnosis of depression, according to International Statistical Classification of Diseases and Related Health Problems, Tenth Revision

Exclusion Criteria:

Patients will be excluded if they have a diagnosis of dementia, bipolar disorder or reside in nursing homes or is assessed by their practitioner to have low life expectancy.
Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy in HIV Patients With Viral Suppression

This is a prospective, open controlled trial in which HIV-1 with viral suppression patients will be randomized to continue with their current treatment (lopinavir/ritonavir plus emtricitabine or lamivudine plus any nucleoside analogue reverse transcriptase inhibitor) or to simplify to lopinavir/ritonavir plus lamivudine.

Randomization will be stratified according to the values of nadir CD4 and time of viral suppression.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex (female or male) and 18 years or older.
* Patients seropositive for HIV-1 using standard diagnostic criteria.
* There is confirmation of viral load to be lower than 50 cop/ml during the 6 previous months to inclusion. The requirement is to have at least two viral loads lower than 50 cop/mL separated by 6 months and no one \>50cop/mL during the 6 months before inclusion.
* Patients on continuous HAART consisting of LPV/r, emtricitabine (FTC) or 3TC (lamivudine) and an NRTI for at least 2 months before being randomized in this study.
* Patients who are clinically stable, in the opinion of the investigator, at entry into the study (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization). Patients receiving therapy for an active opportunistic infection are eligible for enrollment if the above criteria are met. Standard prophylaxis of opportunistic infections is permitted.

Exclusion Criteria:

* Pregnancy, nursing, or planned pregnancy during the study period.
* Previous failure with regimens including a protease inhibitor (PI) or 3TC/FTC.
* Known resistance mutations to PIs or 3TC/FTC.
* Patients with an active opportunistic infection or malignancy. Patients with a stable chronic opportunistic infection may be included in the study.
* Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.
* Patients diagnosed with visceral Kaposi's sarcoma (KS), patients with lymphoedema secondary to cutaneous KS or cutaneous or palatine KS who have been treated with systemic immunosuppressive therapy must also be excluded.
* Patients with chronic hepatitis B on treatment with tenofovir + 3TC/FTC
Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration

The purpose of this study is to determine whether oxygen therapy during sleep improves quality of life, exercise capacity and heart function among patients with chronic heart failure and central sleep apnea.

Oxygen therapy reduces the number of central apneas among patients with congestive heart failure but it is unknown whether quality of life and heart function also improve. We aim to test whether the quality of life, exercise capacity and heart function are improved with nocturnal oxygen therapy during 6 weeks with nocturnal oxygen from oxygen concentrator or nocturnal air from placebo concentrator.

Eligibility Criteria:
Inclusion Criteria:

* Stable heart failure with left ventricular dysfunction
* Cheyne-Stokes respiration with central AHI\>15 and obstructive AHI\<5

Exclusion Criteria:

* Heart infarction within 3 months.
* Dementia
* Chronic obstructive pulmonary disease and daytime hypoxemia.