cyrilzakka/clinical-trials huggingface dataset:
Mortality in Patients With Severe COVID-19 Pneumonia Who Underwent Tracheostomy

Background: Invasive mechanical ventilation (IMV) in COVID-19 patients has been associated with a high mortality rate. In this context, the utility of tracheostomy has been questioned in this group of ill patients. This study aims to compare in-hospital mortality in COVID-19 patients with and without tracheostomy due to prolonged IMV Methods: Cohort study of adult COVID-19 patients subjected to prolonged IMV. Since the first COVID-19 case (March 3, 2020) up to November 30, 2020, all adult critical patients supported with IMV by 10 days or more at the Hospital Clínico Universidad de Chile will be included in the cohort. Pregnant women and non-adult patients will be excluded. Baseline characteristics, comorbidities, laboratory data, disease severity, and ventilatory support will be retrospectively collected from clinical records. The indication of tracheostomy, as part of our standard of care, will be indicated by a team of specialists in intensive care medicine, following national guidelines, and consented to by the patient's family. The 90-days mortality rate will be the primary outcome, whereas IMV days, hospital/CU length of stay, and the frequency of healthcare-associated infections will be the secondary outcomes. Also, a follow-up interview will be performed one year after a hospital discharged in order to assess the vital status and quality of life.

The mortality of patients subjected to tracheostomy will be compared with the group of patients without tracheostomy by logistic regression models. Furthermore, propensity-score methods will be performed as a complementary analysis.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 confirmed case
* Invasive mechanical ventilation by 10 days or longer

Exclusion Criteria:

* Childhood
* Pregnant women
Intraperitoneal Irinotecan With Concomitant FOLFOX and Bevacizumab

The rationale of the current study is that the addition of intraperitoneal irinotecan (75 mg) to palliative systemic therapy is feasible and safe, and might result in an increased overall and progression free survival in patients with unresectable colorectal peritoneal metastases. The primary objectives are to explore the overall survival for the addition of intraperitoneal irinotecan (75 mg) to palliative systemic therapy in patients with unresectable colorectal peritoneal metastases. Secondary objectives are to assess the progression-free survival, toxicity profile, patient reported outcomes, costs, tumor response during trial treatment, and the systemic and intraperitoneal pharmacokinetics of irinotecan and SN-38. This is a single-arm, open-label, phase II study and patients will receive intraperitoneal irinotecan (75 mg) in combination with modified FOLFOX4 + bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed colorectal cancer;
* Radiologically and clinically or pathologically confirmed unresectable colorectal peritoneal metastases (e.g. PCI \>20, extensive small bowel involvement, unresectable disease due to anatomical location);
* WHO performance score of 0-1 with a life expectancy of \>3 months;
* Aged 18 years or older;
* Written informed consent;

Exclusion Criteria:

* Presence of extensive systemic metastases that are deemed to be the dominant factor determining prognosis in terms of life expectancy and performance status \[e.g. no imminent threat of impaired organ functioning due to the presence of systemic metastases\]);
* Prior cytoreductive surgery;
* Prior palliative systemic therapy for colorectal cancer;
* Prior neo-adjuvant/adjuvant systemic therapy for colorectal cancer within the last 6 months;
* Homozygous UGT1A1\*28 genotype;
* Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency
* Microsatellite instable (MSI) primary tumor
* Any contra-indication for the planned chemotherapy (e.g. active infection, serious concomitant disease, severe allergy), as determined by the medical oncologist;
* Inadequate organ functions, defined as an haemoglobin of \<5 mmol/L, an absolute neutrophil count of \<1.5 x 109/L, platelet count of \<100 x 109/L, serum creatinine of \>1.5 x ULN, creatinine clearance of \<30 ml/min, Bilirubin \> 2x ULN and liver transaminases of \>5 x ULN.
Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants

This study will examine the extent to which lower doses of a broccoli-derived beverage enhance the detoxication of air pollutants excreted in urine as compared to an maximal dose shown to be effective previously.

This is a 10-day placebo control Phase II broccoli sprout intervention to be conducted in Qidong, P.R. China. Up to twelve hundred people from the farming townships will be screened and one hundred seventy eligible individuals will be enrolled in the study. Participants will be randomized into 4 treatment groups: one will receive a juice beverage containing a standard dose of glucoraphanin- and sulforaphane-rich broccoli sprout powder mixed in pineapple juice, lime juice and water, the second will receive one-half dose, the third one-fifth dose and the fourth group will receive placebo beverage containing pineapple juice, lime juice and water. Participants will drink their assigned beverage every evening and provide consecutive 12-hour urine collections throughout the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* in good general health with no history of chronic illness
* normal liver function tests
* normal renal function tests

Exclusion Criteria:

* personal history of cancer except for non-melanoma skin cancer
* use of prescribed medicines
* for women, a positive pregnancy test
Bowel Preparation for Colonoscopy in the Elderly

The success of colonoscopy is closely related to the quality of colonic preparation. However, data regarding colonoscopy preparations in the elderly (65 years older) are scarce. Split-dosage cathartic bowel preparation are currently suggested, whereas supporting evidence is lacking in this particular group of patients. Moreover, patient tolerability is a key factor for success of bowel preparation in the aged people.

The purpose of this study is to compare the bowel cleansing efficacy and patient compliance of following bowel preparation methods prior to elective outpatient colonoscopy in the elderly: (1) standard preparation of 4 liters (L) PEG-3350 solution on the night before colonoscopy, (2) split-dose of 4L PEG-3350 solution, and (3) split-dose of reduced volume \[2L\] PEG-3350 containing ascorbic acid solution.


Eligibility Criteria:
Inclusion Criteria:

* elderly people aged over 65 years
* elective outpatient colonoscopy
* informed consent

Exclusion Criteria:

* patients who had bowel movements of less than 3 per week during last one month
* patients who have a history of renal dysfunction (abnormal elevation of serum creatinine and electrolyte imbalance)
* patients who have a history of alimentary tract surgery
* patients who have other gastrointestinal diseases that are not suitable for undergoing colonoscopy (gastroparesis, gastric outlet obstruction, ileus, ischemic colitis, megacolon, and toxic colitis)
* patients classified as the American Society for Anesthesiology class III or higher
* Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study
Observational Study of CLL/SLL Treatment and Ibrutinib Treatment of CLL/SLL in Routine Clinical Practice

This is a non-interventional, Phase 4 study designed to improve understanding of current clinical practice in the treatment of CLL/SLL and to describe treatment pattern and evaluate outcomes of ibrutinib-treated CLL patients in China. This study will include both retrospective and prospective data collection.


Eligibility Criteria:
Inclusion Criteria:

* In the retrospective part:

  1. Male or female patients above 18 years old
  2. Patients underwent CLL treatment after Jan 1st, 2013
  3. Patient understand and voluntarily sign an ICF, if applicable.
* In the prospective part:

  1. Male or female patients above 18 years old
  2. Patients diagnosed with CLL，including treatment- naïve patients or patients who have received ≤3 prior therapies
  3. Patients treated with ibrutinib as monotherapy or a part of combination therapy
  4. Patient understand and voluntarily sign an ICF.

Exclusion Criteria:

* In the retrospective part:

  1. Patients with documented diagnosis of other cancers prior to the diagnosis of CLL
  2. Patients enrolled in interventional clinical trials of any drug for CLL treatment
* In the prospective part:

  1. Patients with documented diagnosis of other cancers prior to the diagnosis of CLL
  2. Patients with contraindication listed in the package insert of ibrutinib
  3. Patients enrolled in interventional clinical trials of ibrutinib or any other drug for CLL treatment
  4. Patient received Ibrutinib treatment as maintenance therapy.
Acute Effects of Herbal Dietary Supplements on Aerobic Performance

Positive effects of herbal supplements such as red berries, ginseng, ashwagandha on athletic performance have been reported. The aim of this study was to evaluate the acute effects of a herbal dietary supplement prepared from a mixture of red berries, ginseng and ashwagandha on aerobic performance of recreational athletes.

In the beginning of the study anthropometric measurements (weight (kg), height (cm), BMI, waist circumference (cm), body fat percentage, lean body mass, skeletal muscle mass) will be taken from the participants who accepted to participate in the study.

During the study, participants will be restricted from consuming alcohol, caffeine, red fruit, ginseng and ashwagandha.

First, Yoyo Intermittent Recovery Level 1 performance test (The Yo-Yo test is a maximal aerobic endurance fitness test, involving running between markers placed 20 meters apart, at increasing speeds, until exhaustion) will be done to all participants In this step, participants will not drink anything. Then there will be a 2-week break.

At the end of the 3-week break, the participants will be divided into two groups by block randomization method and one group will receive a herbal nutritional supplement mixture (100 ml 30 minutes before training). The other group will drink a placebo prepared with the same texture and consistency as our main mixture, containing an equal amount of carbohydrates (100 ml 30 minutes before training). Then the same performance test will be repeated. At the end of the test also 1 and 2 minutes after end of the test, the participants' heart rate measurement will be taken with a finger-type pulse oximeter and recorded . At the end of the test, perceived exertion levels will be questioned using the Borg scale.

Eligibility Criteria:
Inclusion Criteria:

* Being a student in the Exercise and Sports sciences department
* Not using any supplement
* Not being in a period that will affect sleep patterns (midterm/finals week, holiday, etc.)
* Doing regular exercise

Exclusion Criteria:

* Having a known food allergy
* Using any supplement
* Being a professional athlete
* Drinking alcohol regularly
Healthy Volunteer Solid Oral Dose and Multiple Ascending Dose Evaluation of CTP-656

Two-part study to assess CTP-656 dosed as a solid oral dosage form versus Kalydeco and multiple-ascending doses of CTP-656 dosed for 7 days.

This two-part study will assess in healthy male and female subjects a solid oral dose formulation of CTP-656 vs. Kalydeco® and the safety, tolerability and pharmacokinetic profiles of escalating CTP-656 solid oral doses following 7 days of dosing. In Part B, three doses of CTP-656 ranging from 75 mg up to 300 mg per day will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between 18 and 50 years of age, inclusive
* Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive, at screening

Exclusion Criteria:

* History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal (including nephrolithiasis), hepatic, including history of Gilbert's syndrome or gastrointestinal (GI) conditions
* PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcF interval \> 450 msec obtained at screening visit or prior to the first dose of study drug
* Liver function tests greater than the upper limit of normal.
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening
* Urinalysis positive for greater than trace blood, protein or glucose
* A positive screen for alcohol, drugs of abuse, or tobacco use.
* Inability to comply with food and beverage restrictions during study participation.
* Donation or blood collection or acute loss of blood prior to screening.
Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease

This study is a post-marketing surveillance in Japan, and it is a local prospective, company sponsored and observational study of patient who have been treated by Adalat CR for hypertension with diabetes and/or chronic kidney disease. The objective of this study is to assess safety and efficacy profile of using Adalat CR in real clinical practice. A total 2,000 patients will be recruited and be observed for 6 months. Then, patient of whom microalbumin urea and serum creatinine are continuously monitored are additionally followed for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Patient who are administered with Adalat CR for hypertension with diabetes and/or chronic kidney disease (CKD)

Exclusion Criteria:

* CKD with stage 5
* CDK with dialysis
Lead Migration in Spinal Cord Stimulation Trials: Comparing Non-suture vs Suture and Lead Anchor

To assess lead migration rates using different methods of securing leads during Spinal Cord Stimulation trial period.

Spinal cord stimulation has two phases. Trial, which is a precursor for a permanent implantation. Trial lasts less than a week, which gives the patient an opportunity to assess the effectiveness of the treatment.

Lead migration has been a known issue/complication with spinal cord stimulation. Lead migration during the trial period can alter the success of a trial. There is no one way of securing the leads to the skin.

Our endeavor was to look at different modes of securing the leads to the skin during the trial period and present their respective lead migration rates. The three methods are

1. suturing the leads using 2.0 mono-filament nylon to the skin,
2. suture (2.0 mono-filament nylon)over the lead anchor(St.Jude Med Co. long, model # 1106) attaching them to the skin,
3. non- suture.

In all three groups copious amounts of benzoin and steri-strips will be used.

Fluoroscopy pictures were taken after the leads were inserted and the level of the leads will be marked. After the trial period, before the leads were removed, an AP/lateral plain X-ray was taken and compared to the fluoroscopy pictures taken at the time of lead placement.

Eligibility Criteria:
Inclusion Criteria:

* All the patients undergoing Spinal Cord Stimulation (age \> 18yrs)

Exclusion Criteria:

* patients whose trial period lasts less than 3 days or more than 5 days will be excluded from the study.
* patients that may require revision of leads or any complication that requires to take the leads out before the end of trial period.
Effect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome

This study aims to investigate the effect of pentoxifylline administration on the status of endothelial function and oxidative stress biomarkers in patients with Acute Coronary Syndrome (ACS).

The study will be carried out at Ain Shams University Hospitals. Patients with ACS who meet the eligibility criteria and consent to participate in the study will be randomly allocated to either the intervention group or the control group.

All participants will receive the standard pharmacologic treatment for ACS according to the applied guidelines offered by the facility. In addition, patients in the intervention group will receive Pentoxifylline tablets 400mg orally three times daily.

Patient follow-up will be scheduled every 2 weeks for each patient to check the tolerability, the development of side effects, any medication change and medication adherence. Physical examination at each visit will be done by physician in attendance for all patients in both groups.

A blood sample will be taken at baseline and at the end of the study after 2 months. for measurement of basic laboratory parameters (Complete Blood Count, Liver Function Tests, Kidney Function Tests ,..etc), the level of Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1) as a marker for endothelial dysfunction, the level of Malondialdehyde (MDA) as a marker for oxidative stress.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years old.
* Recent ACS diagnosed-patients within the past 2 weeks.

Exclusion Criteria:

* Known allergy to pentoxifylline
* Heart failure New York Heart Association (NYHA) class III or IV
* Severe Left Ventricular Dysfunction (left ventricular ejection fraction \<30%)
* High Serum creatinine level ≥ 2 mg/dl
* Liver disease (baseline alanine transaminase \>2.5 times the upper limit of normal)
* Active bleeding or bleeding diathesis
* Major surgery or trauma within 1 month
* Recent cerebral and/or retinal hemorrhage within 3 months
Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With TM-Ardis

To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability. Assess whether the appropriate procedural modification facilitates clearer images when implanted with a trabecular metal spinal implant

To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability, and assess whether the appropriate procedural modification facilitates clearer images when implanted with a trabecular metal spinal implant.

Eligibility Criteria:
Inclusion Criteria:

* A signed informed consent.
* Male or non-pregnant female scheduled for Trabecular Metal (TM - Ardis) implant, single level lumbar.
* Participant must be at least 18 years of age.

Exclusion Criteria:

* Patient is pregnant Patient is unable to comprehend the requirements of the study.
* Patient is unable to undergo scanning (due to body habitus, inability to comply with positioning requirements, etc.).
Nadolol Versus Propranolol in Children With Infantile Hemangiomas

The purpose of this study is to assess the efficacy and safety of oral propranolol versus nadolol in patients with Infantile Hemangiomas (IH) in a randomized, controlled, double-blinded study.

The study objective is to compare the efficacy and safety of oral propranolol in comparison with oral nadolol in patients with IH. Patients will be randomly assigned to either propranolol or dose equivalent nadolol. The duration of the study will be 24 weeks, however, patient will be monitored for up to 1 year post study enrolment. Both efficacy and safety will be closely monitored and captured.

Eligibility Criteria:
Inclusion Criteria:

* 1-6 months corrected age
* Written parental informed consent
* At least one of the following:

  * Size: hemangioma \>1.5 cm on the face or \>3 cm on other body parts
  * Causing or with potential for functional impairment (e.g. amblyogenic IH, ulcerated hemangioma)
  * Causing or with potential for cosmetic disfigurement (e.g. nasal tip, glabella location)

Exclusion Criteria:

* Contraindications to beta-blockers

  * Hypotension
  * Bradycardia
  * Hypoglycemia
  * Cardiac disease associated with decreased ejection fraction and/or \> second degree heart block
  * Bronchospasm (including bronchial asthma)
  * Allergic rhinitis
* Corrected gestational age less than 1 month at screening
* Patients with PHACES cerebral arteriopathy at risk of stroke
* Patients and/or breastfeeding mothers receiving treatment with anti-arrhythmic agents, calcium channel blockers, ACE inhibitors, inotropic agents, vasodilators, hypoglycemic agents, neuroleptics, antiacids, benzodiazepines, thyroxine, warfarin
* Patients treated with an oral beta-blocker or other agent (e.g. systemic steroids, vincristine) within 2 weeks from randomization
* Patients treated with topical timolol within 1 week from randomization
* Vascular tumors other than infantile hemangioma (e.g. pyogenic granuloma, hemangioendothelioma)
Accuracy of VABB Elite 10G Versus BARD 14G CNB

In this study, patients whose breast ultrasound showed a space-occupying lesion and needed biopsy to clarify the pathology were selected as the research subjects. This study aims to determine whether Vacuum-assisted biopsy device Elite is superior to the traditional BARD ejection type air core needle in the diagnosis of breast cancer through a prospective randomized study.

The main purpose of the study was to analyze the difference in the accuracy of two biopsy devices in the diagnosis of breast cancer puncture. The purpose of the secondary study was to analyze the difference between the underestimation rate, false negative rate, sensitivity, and negative predictive value of the two devices, the consistency of the immunohistochemistry between the puncture pathology and surgical pathology of the two groups of patients, the number and time-consuming of the puncture acquisition specimens, and the two biopsies Differences in the incidence of complications (safety).

If the biopsy device is a vacuum-assisted Elite 10G needle, insert the needle groove into the mass and rotate to cut the biopsy tissue one circle; If the biopsy device is a BARD 14G hollow core needle, insert the needle to the edge of the mass and pull the trigger in different directions to eject the needle to retrieve the material.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old (including 18 years old)
* Ultrasound examination indicates the presence of space-occupying lesions in the breast. The size, location, and BI-RADS classification are not limited.
* Agree to undergo surgery after puncture
* Ability and willingness to sign informed consent

Exclusion Criteria:

* A biopsy has been performed in the external hospital
* Contraindications for puncture or surgery such as severe coagulation dysfunction
* Refuse breast surgery
* Axillary lymph node puncture