cyrilzakka/clinical-trials huggingface dataset:
Lymph Node Ratio as a Predictor for Outcome in Rectal Cancer

This study aims to evaluate the value of the LNR as a prognostic indicator in patients with rectal cancer who offered total mesorectal excision.

Patients and methods Study design and setting This is a retrospective review of prospectively collected and maintained database of patients with CRC admitted in the Oncology Center of Mansoura University (OCMU), the Colorectal Surgery Unit of Mansoura University Hospitals, and the Department of General Surgery of Alexandria University.

Selection criteria Patients of either gender aged 18 years or above who presented with rectal cancer of any stage will be included in the study. We will exclude patients with patients younger than 18 years; patients with synchronous colon cancer; synchronous liver, pulmonary or bones metastasis; or synchronous gastrointestinal cancer; or patients who were lost to follow-up.

Study endpoints The primary endpoint of the study is to assess the value of lymph node ratio (LNR) on the oncological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* rectal cancer of TNM stage I-III
* underwent radical resection with curative intent

Exclusion Criteria:

* synchronous colon cancer
* synchronous gastrointestinal cancer
* underwent palliative resection
* presented with intestinal obstruction
* those lost to follow-up.
Weighted Blankets After Brain Injury

A non-blinded randomised controlled feasibility study of weighted blankets to help agitation and disturbed sleep after brain injury. This is a single centre study based in a community hospital in the UK. Outcomes centre on determining the feasibility and acceptability of the study taking place in an NHS setting.

A non-blinded randomised controlled feasibility study of weighted blankets to help agitation and disturbed sleep after brain injury. This is a single centre study based in a community hospital in the UK. Outcomes centre on determining the feasibility and acceptability of the study taking place in an NHS setting.

12 subjects will be randomised 1:1 to intervention or control; they will use the allocated linen for 7 consecutive days and nights. Sleep will be measured using observations and actigraphs; behaviour and behavioural interventions will be recorded.

Participants (where possible) and staff members will be interviewed about their experience and opinions.

Eligibility Criteria:
Inclusion Criteria

* Subjects capable of giving informed consent, or if appropriate, subjects having an acceptable individual capable of giving assent on the subject's behalf
* Aged over 18 years
* Admitted to King's Lodge Neurorehabilitation Unit for inpatient rehabilitation after a brain injury
* Within weight limits to be suitable for weighted blanket use

Exclusion Criteria

* On end of life pathway
* Pain which could be exacerbated by weighted blanket
* Unable to remove
* Presence of open wound / pressure sore
* Allergy to blanket material
* Participant or consultee unable or unwilling to give informed consent / assent
* Known respiratory disorder such as asthma, chronic obstructive pulmonary disease, obstructive sleep apnoea which could be exacerbated by use of heavy blanket over chest
* Claustrophobia
Visual Function Changes After Intraocular Pressure Reduction

During the glaucomatous disease process, subpopulations of cells may be dead, damaged or healthy. Visual function changes could be observed due to a recovering of the suffering ganglion cells after the intraocular pressure reduction. This study aims at evaluating the correlation between intraocular pressure reduction and visual function changes in glaucoma patients after using antiglaucoma medications.

Primary open angle glaucoma patients without use of antiglaucoma medications will be enrolled in this study. After inclusion, the patients will randomly receive one of three antiglaucoma medications (timolol maleate 0,5%, brimonidine tartrate 0,2% or travoprost 0,004%) in one randomly selected eye.

The patients will be evaluated with Goldmann applanation tonometry, visual acuity test, contrast sensitivity test, visual quality perception test (visual analogue scale) and standard automated perimetry before and after 4 weeks of glaucoma treatment onset.

Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma
* Intraocular pressure greater than 21 mmHg

Exclusion Criteria:

* Best corrected visual acuity (BCVA) worse than 20/80
* Significant media opacity
* History of steroid use
Muscular Training-induced Changes in COPD

The current protocol is developed in the context of a large Research and Innovation (R\&I) program aiming the promotion of daily life physical activity in chronic patients registered at clinicaltrials.gov (NCT02976064) and approved by the ethical committee of the Hospital Clinic de Barcelona (HCB/2016/0883). The project is partly supported by the Smart Innovation Strategies promoted by the EU Commission (COMRDI15-1-0016). Specifically, the protocol uses retrospective information collected between 2005-2008 as part of the EU project Biobridge (LSHG-CT-2006-037939).

The aims of the current analysis of the retrospective information are 1) to assess training-induced changes in muscle oxygen saturation (StO2) assessed by near-infrared spectroscopy (NIRS) during constant-work rate cycling exercise (CWRE) as a useful marker of the effects of training at limb muscle level in patients with chronic obstructive pulmonary disease (COPD), and 2) to further explore underlying mechanisms of skeletal muscle dysfunction as a characteristic systemic effect of COPD, potentially modifiable with preventive interventions as endurance muscle training.

Methods: Incremental exercise (VO2 peak) and CWRE at 70% baseline peak work rate, before and after 8-week of endurance exercise training, were done in healthy sedentary subjects and COPD patients. NIRS was used to assess StO2 in the left "vastus internus" during the CWRE (before an after training program) (objective 1); and blood samples and muscle biopsies of the quadriceps were obtained at rest (before an after training program) (objective 2).


Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis following GOLD criteria (FEV1/FVC post-broncodilator \<0,7)
* Clinical stability for at least 3 months

Exclusion Criteria:

* Age \<45 years
* Any active cancer
* Comorbidities which carry high-level of handicap
* Other respiratory disease than COPD
* No sign of informed consent
Study on Adhesion Properties of Three Different Adhesives

This clinical investigation is a single centre, double blinded, case control study in healthy adult females. This study will be conducted in private rooms at Gentofte Hospital (Hjerte-medicinsk Forskning, post 835, Kildegårdsvej 28, 2900 Hellerup).

The investigation centre will enroll 39 subjects including a 20% drop out within a four (4) months period. The subject will not be enrolled before approval of investigation protocol by the local ethics committee.

The subjects need to meet the inclusion and exclusion criteria to be included in this clinical investigation. Each volunteer enrolled in the investigation can only participate once in a procedure. The testing period for each subject will be minimum 72 hours.

The principal investigator's qualifications will be verified through his/her CV. The principal investigator is required to be a medical doctor with at least one year's experience in using similar medical adhesives (e.g. by being experienced in using electrodes where medical adhesives are included) and at least one year's experience with clinical research. In addition, the investigator must be trained in GCP before the study is initiated.

If any subject withdraws from the study, they will not be replaced as drop-out rate is included in the sample size.

Subjects must show up for two sessions, in the first session six adhesives will be placed below the subjects bra. The adhesives will be removed after minimum 72 hours at the second visit. While wearing the adhesives the subjects must keep the investigational area dry. 24, 48 and 72 hours after placement of the adhesives, the subject is asked to completed a questionnaire.

The eCRF must be completed for each subject that has signed the Informed consent form (ICF) and enrolled into this clinical investigation.


Eligibility Criteria:
Inclusion Criteria:

* Female Healthy Volunteers.
* Age 18 - 40 years old.
* Willing to attend two scheduled visits
* Able to assess itch and adherence at 24h, 48h and 72h.
* Provide written informed consent.

Exclusion Criteria:

* Non-intact skin barrier (e.g. eczema, rash, cut, scar tissue, wound, etc.).
* History of inflammatory skin diseases (e.g. atopic dermatitis or psoriasis).
* History of contact allergy
* Swimming or engaging in sport activities causing sweat during study peri-od. v. Use of medication (e.g. corticosteroids) which could affect skin reactions.
Non-invasive Biometric Monitoring in Nursing Homes to Fight COVID-19

Solving the problem of detecting asymptomatic carriers who can transmit infection is key to protecting vulnerable residents of nursing homes and assisted living facilities, to protecting frontline workers who care for them, and to facilitating return to work (including return of nurses and medical assistants).

The wearable biometric technology, if widely disseminated among vulnerable populations and the community-at-large, will help avoid the ravages of seasonal flu and other contagious illnesses, and the society will be better prepared for future waves of COVID-19 or other pandemics. Even if a vaccine is developed, due to immune senescence and immunocompromise, elderly people and those with chronic medical conditions may not be well protected by it. Continuous biomonitoring provides another layer of protection for them.

1. Building the algorithm for early, pre-symptomatic DETECTION OF RESPIRATORY VIRAL INFECTION and for predicting eventual DETERIORATION.
2. Create an APP that AUTOMATES these algorithms and clearly REPORTS ACTIONABLE RESULTS to users, i.e., to medical professionals and citizens-at-large in near-real time. If alerted to a possible - and likely still asymptomatic - COVID-19 infection, they can self-isolate or be quarantined, get confirmatory COVID-19 testing done promptly, limit transmission to others, and stay safe knowing that if they are likely to deteriorate, the algorithm will alert the participants and their caregivers to the need to obtain medical attention promptly.

Eligibility Criteria:
Inclusion Criteria:

* Residents and staff members of U.S. LTCFs where COVID-19 transmission is actively occurring. The LTCF medical director must agree to enroll the LTCF, and each participant must have the capacity to agree and sign consent.

Exclusion Criteria:

* Current atrial fibrillation.

  * NB: Paroxysmal atrial fibrillation is permitted if the participant is in atrial fibrillation less than 50% of the day on most days.
* Pacemaker in place.
* Known active infection other than COVID-19.
* Dementia
Efficacy of an Encapsulated Probiotic Bifidobacterium Infantis 35624 in Irritable Bowel Syndrome

The purpose of this study was to determine the dose-ranging efficacy and safety profile of encapsulated Bifidobacterium infantis 35624 in female subjects with irritable bowel syndrome (IBS).

The pathogenesis of irritable bowel syndrome (IBS) may have a a post-infectious inflammatory component, suggesting that altered gut bacterial flora are of relevance and that probiotics may be beneficial. This clinical trial examined the efficacy of an encapsulated probiotic in subjects with Rome II IBS. After a 2 week baseline, 362 female subjects were randomized to placebo or one of three doses of B. infantis 35624 once daily for 4 weeks. IBS symptoms were monitored daily and scored according to a 6-point Likert scale; stool frequency and form were also monitored daily. The primary efficacy variable was the abdominal pain score; secondary efficacy variables included other IBS symptom relief and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Meet Rome II criteria for the diagnosis of IBS
* Refrain from using probiotic supplements during the trial

Exclusion Criteria:

* Organic diseases, including inflammatory bowel disease, and significant systemic diseases
* Subjects over 55 years of age that had not had a sigmoidoscopy or colonoscopy performed in the previous five years
* Use of anti-psychotic medications within the prior three months
* Had major psychiatric disorder (DSM-II-R or DSM-IV), including major depression, psychoses, alcohol or substance abuse, within the past two years
* Were pregnant or nursing
* Had known lactose intolerance or immunodeficiency
* Had undergone any abdominal surgery, with the exception of hernia repair or appendectomy
Longitudinal Study of Weight Change Following Lower Limb Amputation

The purpose of this study is to assess weight change in a population of Veterans with amputations. Little is known about the how weight changes following an amputation. It is widely believed that many patients experience weight gain following amputation. This study aims to identify magnitude of weight changes following amputation and determine characteristics associated with weight gain. Information on weight change trajectories would be useful to better understand long-term health consequences associated with amputation and to design and target interventions to encourage weight maintenance and general health promotion for groups at high risk of weight gain.


Eligibility Criteria:
Inclusion Criteria:

"Exposed" cohort:

* incident lower limb amputation during the study period (1/1997-12/2008) in VISN 20
* \>= 1 plausible weight recoded in the medical record at baseline (defined as 8 weeks before amputation or 2-8 weeks post amputation)
* \>=1 weight measured post amputation (2 months to 42 months post amputation)

"Unexposed" (comparison) cohort:

* no lower limb amputation during the study period
* no prior history of amputation
* \>= 2 plausible recorded weights including at least one in the 2-6 weeks after their reference date ("baseline").
* Alive at least 18 months after "baseline"

Exclusion Criteria:

* female (due to small number of women with lower limb amputations)
* lack information on any of the characteristics used for matching (e.g., birth year/age and height to calculate body mass index)
Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junction Cancer

This study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer.

This randomized, open-label, Japan, Korea and Taiwan collaborative, phase 3 study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer. Approximately 400 subjects will be randomized in a 1:1 ratio to receive irinotecan (control group) or nimotuzumab and irinotecan (combination group). Nimotuzumab and/or irinotecan should be continued until disease progression or intolerable toxicity. Nimotuzumab is administered at 400 mg once weekly as an intravenous infusion and irinotecan is administered at 150 mg/m2 once every 2 weeks as an intravenous infusion.

Eligibility Criteria:
Inclusion Criteria:

1. Advanced or recurrent subjects with gastric or gastroesophageal junction adenocarcinoma.
2. Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent and platinum agent.
3. Subjects with EGFR overexpression (2+ or 3+ in IHC)

Exclusion Criteria:

1. Subjects who have received irinotecan
2. Subjects who have received EGFR-directed therapy
3. Other active malignancy within the last 5 years
Capacity to Consent in Acutely Intoxicated Emergency Department Patients

The ability to meaningfully consent intoxicated and chemically dependent patients for research has inhibited medical advances in this vulnerable population. A recent pilot supported use of the University of California, San Diego Brief Assessment of Capacity to Consent tool to assess the capacity of intoxicated emergency department patients to participate in research. The objective is to determine the number of intoxicated emergency department patients who could correctly complete the questionnaire, and evaluate alcohol concentration, sedation and ability to recall participation upon sobriety.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, intoxicated with alcohol

Exclusion Criteria:

* intoxication was due to a substance other than ethanol (negative breath alcohol concentration), refusal to participate, excessive agitation, or if the treating physician deemed the patient medically or psychologically unstable. Patients were also excluded if they had previously been enrolled in the study
Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain

There is an increasing trend on decreasing narcotic use and maximizing efficiency in the perioperative care. There are no studies that have compared a TAP block versus a TAP block plus gabapentin for laparoscopic procures.This study will investigate if taking gabapentin and receiving a TAP block decrease post-operative morphine consumption. It will be a randomized controlled, double blind study, with 130 patients between 18-60 years; that will undergo laparoscopic GYN procedures. Secondary outcomes will look at the incidence of nausea, vomiting, and VAS (verbal analog scale) scores. This combination may be helpful because gabapentin will be used to decrease visceral and central pain, and TAP block will decrease somatic pain. Performing a multimodal approach may decrease narcotic consumption, adverse effects and improve pain management.


Eligibility Criteria:
Inclusion Criteria:

* female
* receiving laparoscopic GYN procedure
* between 18-60

Exclusion Criteria:

* are already taking gabapentin
* have diabetic neuropathy
* have a chronic pain syndrome
* take opioids at home
* are pregnant
* have kidney disease
* have an allergy to morphine
Therapeutic Effect of New Biologics in Crohn's Disease

New types of biologics have brought advantages in therapy strategies for Crohn's disease. However, clinical data evaluating their efficacy and adverse in China is lacking. We aimed to evaluate the short-term and long-term therapeutic effect as well as drug adverse of Ustekinumab (UST) and Vedolizumab (VED). Besides, we aim to figure out the independent factors predicting the effectiveness of new biologics. Relations between drug exposure (trough concentration and antibody concentration) and therapeutic efficacy are study in-depth by this retrospective observational study.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult patients with confirmed diagnosis of Crohn's disease and administration of new type biologics.

Exclusion Criteria:

* loss of follow-up, incomplete clinical data, without confirmed diagnosis
Functional and Morphologic MRI in the Detection of Prostate Cancer in Patients With Prior Negative Biopsy

Prostate specific antigen (PSA) and digital rectal exam (DRE) are used to screen for prostate cancer. Patients with abnormal DRE or elevated PSA undergo transrectal ultrasound guided biopsy (TRUS-Bx). There are some men who have a normal TRUS-Bx despite persistent elevated PSA and may harbor occult prostate cancer. The purpose of this study is to determine if MRI using an endorectal coil, and advanced MRI methods called H1 MR Spectroscopy (MRS) and Dynamic MR Perfusion Imaging (dMRI) can help identify and localize prostate cancer in these patients and direct repeat TRUS-Bx to the most suspicious location in the prostate gland. 100 men, currently under observation with elevated PSA but negative TRUS-Bx will be enrolled in the study.

Prostate specific antigen (PSA) and digital rectal exam (DRE) are used to screen for prostate cancer. Patients with abnormal DRE or elevated PSA undergo transrectal ultrasound guided biopsy (TRUS-Bx). There are some men who have a normal TRUS-Bx despite persistent elevated PSA and may harbor occult prostate cancer. The purpose of this study is to determine if MRI using an endorectal coil, and advanced MRI methods called H1 MR Spectroscopy (MRS) and Dynamic MR Perfusion Imaging (dMRI) can help identify and localize prostate cancer in these patients and direct repeat TRUS-Bx to the most suspicious location in the prostate gland. 100 men, currently under observation with elevated PSA but negative TRUS-Bx will be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* prior ultrasound biopsy of prostate showing no cancer or only single microfocus of cancer

Exclusion Criteria:

* contraindication to contrast enhanced endorectal coil MRI
Erythropoietin Effects After Traumatic Brain Injury

To determine if the early administration of erythropoietin to patients sustaining traumatic brain injury will reduce secondary brain injury.

Traumatic brain injury occurs with alarming frequency in the United States and is associated with significant morbidity, mortality and economic as well as emotional consequences. Since the initial traumatic event produces irreparable primary brain injury, the goal in care of the head injured patient focuses upon the prevention of secondary brain injury. Currently, the only clinical strategies available to prevent secondary brain injury relate to the maintenance of adequate cerebral blood flow and regulation of intracranial pressures.

Now, there is substantial laboratory evidence indicating that secondary neuronal cell death is reduced by the use of recombinant human erythropoietin (EPO) in a time-dependent fashion. These data suggest that strategies utilizing EPO during the resuscitative phase of head injured patients could improve neurologic outcome.

This is a randomized, double-blind, placebo-controlled single-center trial. All blunt trauma patients over 18 years of age with an admission GCS between 9 and 13 and evidence of traumatic brain injury (TBI) on CT will be eligible. After obtaining informed consent, patients will be randomized to receive EPO (40,000 Units IV) or placebo to be administered within 6 hours of injury.

Patients will have baseline (day of injury) and daily serum S-100B and NSE levels measured until 5 days after injury. Demographic and clinical data to be obtained will include age, gender, head AIS, ISS, admission and ICU GCS, daily mean ICP and CPP (when ICP is monitored), number and nature of ICP lowering interventions and daily mean PaCO2. The primary outcome measures are S-100B and NSE levels in patients receiving EPO compared to those receiving placebo. Secondary outcome measures will include ICU LOS, GCS at ICU discharge, 3-month and 6-month Glascow Outcome Score and in-hospital mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 17, Head CT shows intracranial hemorrhage \< 6 hours after injury, GCS\<13 consented

Exclusion Criteria:

* nonsurvivable injuries for more then 48 hours, CPR in the field, patients already on erythropoietin