cyrilzakka/clinical-trials huggingface dataset:
Optiflow in Sequential Non-Invasive Ventilation

Background : Patient with hypoxemic respiratory failure treated with NIV receive between NIV session oxygen therapy. Gaz exchange disorder with a decrease of the ratio between Partial Pressure of Arterial Oxygen (PaO2) and Inspired Fraction of Oxygen (FIO2) are noticed when NIV is stopped at the end of the session du to alveolar derecruitment Optiflow is a high flow oxygen delivery system used a heated humidifier and heated breathing circuit. In observational studies, Optiflow increase oxygenation of patients with hypoxemic respiratory failure. Oxygenation is better than under high-concentration mask and work of breathing is reduced.

The aim of the study is to compare in acute hypoxemic respiratory failure, optiflow to oxygen therapy under high-concentration mask, on patients oxygenation between NIV sessions (measured as the difference between PaO2/FiO2 ratio at the beginning and at the end of the session), during the first two NIV sessions

Study design : Prospective, randomized, controlled, multicentric, open clinical trial with two groups:

* control group with conventional clinical management, oxygen therapy and sequential used of NIV
* Optiflow group with high flow oxygen delivery system, conventional clinical management and sequential used of NIV for a period of 36 hours at least.

Number of subjects: 100 (50 patients per group) patients admitted in intensive Care Unit for hypoxemic respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* Patient at least 18 years old
* Patients affiliated to or benefiting of the French social welfare system
* Patients with ARDS on previously healthy lung. Acute respiratory insufficiency, defined as the PaO2/FIO2 ratio less than 200 mm Hg associated with the presence of lung infiltrates on chest radiograph
* Free and informed consent of patient
* Hospitalized in one of involved ICU

Exclusion Criteria:

* Existence of criteria for intubation.
* Refusal to participate in the study.
* Pregnancy
* Patient under guardianship or trusteeship
* Patients for whom a decision of non intubation has been decided.
* Patients who have received one or several NIV session for ARDS before hospital admission
* Home noninvasive ventilation
* Tracheostomy
* Hemodynamic instability
* Hypercapnia (PaCO2\>45 mm Hg).
* left ventricular failure (cardiogenic pulmonary acute edema).
* Ineffective coughing.
* Recent gastric or oesophageal surgery
* Severe ventricular rhythm disorder
* High digestive haemorrhage
* Lack of collaboration
* Pernicious vomiting
* Upper airway obstruction
* Severe sepsis.
* Undrained pneumothorax.
Radiologic Evaluation and Breast Density (READ)

The purpose of this study is to determine whether cessation of hormone replacement therapy for one or two months before a screening mammogram will improve its performance by decreasing breast density.

This randomized, controlled trial is designed to test whether short-term (1-2 months) HRT cessation will sufficiently lower breast density to decrease the proportion of women who receive a recommendation for additional evaluation following a screening mammogram, and to examine whether there is a trend by duration of cessation. The study is being conducted at Group Health Cooperative, a managed health care organization in western Washington State with an organized breast cancer screening program. We are recruiting 1,500 women and will randomize women to one of three HRT arms: 1) cessation two months before the screening mammogram; 2) cessation one month before; and 3) continued HRT use. We are using a computer-assisted method to measure mammographic breast density continuously. Mammography recall rates are being determined from an expert radiologist review of the mammograms, blinded to HRT status.

Eligibility Criteria:
Inclusion Criteria:

* 1 or more prior screening mammograms at Group Health Cooperative within the past 2 years
* Currently taking HRT
* Taking HRT at prior screening mammogram
* Due for a screening mammogram

Exclusion Criteria:

* BI-RADS breast density of 1 (entirely fat)
* Previous cardiovascular events (heart surgery, catheterization, stent bypass, angioplasty, stroke, DVT)
* Previous breast cancer
* History of breast implants
* Breast reduction since last mammogram
* Mastectomy
* History of using Tamoxifen or Raloxifene
* Declined contact or use of data for research
MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism

The purpose of this study is to investigate if androgen deprivation therapy in men with prostate cancer increases hepatic fat content and changes visceral/subcutaneous fat distribution.

This is a substudy of the ongoing randomized trial entitled: Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin (EudraCT number: 2013-002553-29). 20 consecutive patients are anticipated to participate regardless of assignment to either orchiectomy or triptorelin.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for inclusion are patients who are included in the already ongoing Randomised trial entitled: Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin (EudraCT number: 2013-002553-29)

Exclusion Criteria:

* Implanted devices or foreign metallic bodies incompatible with Magnetic Resonance Imaging.
* claustrophobia
* Severe Psychiatric disease
Evaluation of Aesthetic Surgical Wound Closure by a Single Layer in Comparison With Traditional Multi-layer Closure

the study is comparing the results of aesthetic surgery wound closure by a single layer versus the traditional multi-layer closure as regards the wound healing time, local wound complications, and the scar formed.

The study puts in comparison the surgical wound closure of aesthetic procedures by single layer sutures technique, involving part of the subcutaneous tissue and the subdermal layer, with the multi-layer traditional closure, which involves subcutaneous layer closure by one or two raws of sutures and skin closure with any type of suturing techniques, then to evaluate the wound healing time, local wound complications, and the scar formed.

Eligibility Criteria:
Inclusion Criteria:

* all cases presented for different aesthetic surgery procedures e.g different breast contouring procedures, surgical trunk contouring procedures, Brachioplasty, and thigh lifting. No gender discrimination, age between 16-60 years.

Exclusion Criteria:

* we excluded cases in age groups beyond that designed for the study, patients with co-morbid conditions that may affect the results of wound healing e.g Diabetics. Active smokers, trauma patients, or patients that will undergo primary or secondary reconstructive procedures.
CKD-828 (80/5mg) Pharmacokinetic Study

A randomized, open-label, single-dose, four-period, two-way, crossover study,

A randomized, open-label, single-dose, four-period, two-way, crossover study to compare the pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration telmisartan and s-amlodipine in health volunteers.

Eligibility Criteria:
Inclusion Criteria:

* A healthy volunteer over 20 years old
* More than 50kg and within 20% of ideal body weight
* No any congenital or chronic diseases and medical symptom
* Appropriate for the study from examination(laboratory test, ECG etc.) within 4weeks prior to the first IP administration
* Signed the informed consent form prior to the study participation.

Exclusion Criteria:

* History of relevant hypersensitivity against drug
* Clinical significant disease or medical history (ex. hepato/cholangio, cardio, endo, hemato, onco, CNS etc.)
* Active liver disease or abnormal laboratory result (AST or ALT or Total bilirubin \> 1.5\*ULN)
* SBP \<90mmHg or SBP \>150mmHg
* DBP \<50mmHg or DBP \>100mmHg
* Creatinine clearance \<80mL/min
* A Disease(ex.inflammatory intestinal disease, gastric or duodenal ulcer ,hepatic disease history , gastro-intestinal surgery except for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug
* The evidence of severe attack or acute disease or surgical intervention within 28 days prior to the first IP administration.
* A drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or regular alcohol consumer(more than 21 units/week) or a heavy smoker(more than 10 cigarettes per a day)
* Taking ETC medicine or oriental medicine within 14days or Taking OTC medicine within 7days prior to the first IP administration
* Abnormal diet(Especially, grapefruit juice within 7 days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug
Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients

The life span of adults with end-stage renal disease is reduced, and cardiovascular disease (CVD) accounts for approximately half the deaths among those undergoing hemodialysis (HD). Vascular calcification is a key process in the development of atherosclerotic and arteriosclerotic CVD, and contributes significantly to the greater mortality rates and CVD events in HD patients. Recently, there has been growing interest in the vitamin K-dependent matrix Gla protein (MGP) and its role in inhibiting vascular calcification. Animal studies have revealed that the vitamin K-dependent protein MGP may reduce the progression of vascular calcification, possibly by means of improving vascular function. The relationship between MGP and vitamin K lies in the fact that inactive matrix Gla protein requires vitamin K to carboxylate it for its activation. Currently, data in HD patients are scant and equivocal on the effects of vitamin K supplementation on CVD risk outcomes. Therefore, the purpose of this 8-week randomized, placebo-controlled, double-blind clinical trial is to determine whether daily vitamin K supplementation can favorably alter measurements of endothelial function and arterial stiffness in HD patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Kidney Disease Stages 3 to 5
* Receiving hemodialysis treatment for at least 3 months
* Subject understands the study protocol and agrees to comply with it
* Informed consent documents signed by subject

Exclusion Criteria:

* Using vitamin supplements containing vitamin K
* History of metabolic gastrointestinal diseases
* Subjects presenting chronic degenerative and/or inflammatory diseases
* Receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
* Subjects receiving corticosteroid
* Use of anticoagulants
* History of soy allergy
* Have an unstable medical condition, such as having a life expectancy of less than 6 months in the judgment of the investigator
* Known sensitivity, intolerance, or other adverse response to study drugs which would prevent compliance with study medication
* Subjects who have participated in a clinical study more recently than one month before the current study
Using Fludarabine and Melphalan Conditioning Regimen for CLL,Lymphoma,Multiple Myeloma

Allogeneic Non-Myeloablative Stem Cell Transplantation Using Fludarabine and Melphalan Conditioning Regimen for Chronic Lymphocytic Leukemia, Lymphoma, and Multiple Myeloma

Treatment plan

* Conditioning chemotherapy before infusion of allogeneic stem cells will include fludarabine 30 mg/m2/day for 5 consecutive days (days -6 to -2) and melphalan 100 mg/m2 at day -2.
* Fludarabine and Melphalan will be infused intravenously over 30 minutes in D5W 100 mL.
* Melphalan will be administered following the completion of Fludarabine infusion at day -2.
* In case of unrelated donor HCT, thymoglobuline 3 mg/kg in N/S 500 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500 mL (less than 2 mg/mL) IV qd on days -4, -3 and -2. Infuse over 4 hrs. Premedicate with Avil 45.5 mg IVP and Tylenol 600 mg po. Methylprednisolone 2 mg/kg in D5W 100 ml will be given IV over 30 minutes before thymoglobulin (or lymphoglobuline) on days -4 to -2.
* Before the administration of melphalan, prehydration will be done intravenously with 0.9% NS 1L over 3 hours.
* 30 minutes before melphalan infusion, premedication with dexamethasone 10 mg and ativan 1 mg i.v. push will be given. Appropriate antiemetics such as ondansetron 8 mg i.v. push every 4-6 hours and ativan 1-2 mg i.v. push every 4-6 hours will be administered.
* Hydration with 0.9% NS at 80 mL/hour will be administered for at least 7 days. Appropriate amount of KCl should be mixed.
* GVHD prophylaxis will include cyclosporine A (CSA) and methotrexate.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 15 years of age or older and 65 years of age or younger
* Patients with CLL, lymphoma, or multiple myeloma will be included in this study
* No prior anti-cancer treatment should be done within 30 days.
* Informed consent should be given.
* Patients should have an HLA-identical or single HLA-locus mismatched donor.
* Karnofsky performance scale should be 50 or over (see Appendix I).

Exclusion Criteria:

* Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the stem cell transplant treatment unlike, and making informed consent impossible.
* Patients with high serum creatinine level will be excluded.
* Patients should have uncontrolled infection.
* No major anticipated illness or organ failure incompatible with survival from stem cell transplant.
* Serum bilirubin less than or equal to 4.0 mg/dL.
Correlation Between Circulating Tumour Markers Early Variations and Clinical Response in First Line Treatment of Metastatic Colorectal Cancer

The chemotherapy monitoring is currently based on radiological (RECIST 1.1 guideline) and clinical evaluation every 3 months. Circulating markers as Carcino Embryonic Antigen (CEA), circulating tumour DNA and total cell free DNA represent an alternative approach to evaluate the response. In the field of metastatic colorectal cancer (mCRC) recent studies suggest that early evaluation could be clinically relevant. Indeed, early tumoral response seems to be correlated to overall survival. Moreover, post-operative morbidity increases with the number of prior chemotherapy treatments. Early evaluation could allow to modify chemotherapy regimens when response appears to be insufficient.

The aim of the present study is to evaluate, in a prospective cohort of patients treated with systemic IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy as first line treatment for a mCRC, the correlation between early variations of circulating tumour markers including CEA, circulating tumour DNA and total cell free DNA, and the 3 months objective response as defined in the RECIST 1.1 guideline.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age superior to 18 years.
* Histologically confirmed metastatic colorectal adenocarcinoma.
* Measurable disease according to the RECIST 1.1 guideline
* ECOG performance status \<3.
* Disease requiring IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab) every 14 days
* No prior chemotherapy for this adenocarcinoma with the exception of adjuvant chemotherapy
* Signed and dated informed consent document.

Exclusion Criteria:

* Medical history of cancer within 5 years
* Medical contraindication for a treatment consisted of IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab)
* Patient with known psychiatric or substance abuse disorders that could interfere with cooperation with the requirements of the study
Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa

The purpose of this study to evaluate the long term safety, tolerability and efficacy of adalimumab in subjects with moderate to severe hidradenitis suppurativa (HS).

HS is a painful, chronic skin disease characterized by recurrent inflamed nodules and abscesses, which may rupture to form fistulas and subsequent scarring. This study is an open-label extension study available to subjects who participated in a prior adalimumab study who meet all the inclusion and none of the exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who previously participated in a prior Phase 3 AbbVie hidradenitis suppurativa (HS) study (M11-313 or M11-810) and:

  1. Completed the study; or
  2. Experienced a loss of response (LOR); or
  3. Experienced worsening or absence of improvement

     Exclusion Criteria:
* Prior treatment with any other anti-tumour necrosis factor (anti-TNF) therapy (e.g., infliximab, etanercept), or participation in an adalimumab trial other than a prior Phase 3 AbbVie HS study.
* Subject received any oral antibiotic treatment for HS within 28 days prior to the Baseline visit, except for antibiotics permitted in a prior Phase 3 AbbVie HS study.
* Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline visit of Study M12-555.
Automate Detection of Sleep Apnea by ApneascanTM

The purpose of the study is to compare, three months after implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D), the apnea-hypopnea index (AHI) obtained from conventional in-lab NPSG/NPG (AHIPSG) with similar indices obtained from autoscoring algorithms of the ApneaScan™, an implantable impedance-based respiration sensor (AHIAS).

This is a prospective, multi center, phase-IV with blinded analysis and central reading of polysomnography trial.

The study is performed in patients with a standard CRT-D or Implantable Cardioverter Defibrillator (ICD) devices indication. A total of 160 subjects will be recruited in France. The study duration is 03 months for each subject.

Eligibility Criteria:
Inclusion Criteria:

* Male and female aged \> 18 years old
* Current ICD or CRT-D device-based guidelines indication (for primo-implantation)
* patients with optimal recommended medical therapy
* Patient willing and able of undergoing the device implant procedure
* Patient willing and able of undergoing the LATITUDE® NXT Patient Management system procedure
* Patient willing and able to complete the requirements of the study including the signature of the Informed Consent after full explanation of the study by the investigator prior to participation.

Exclusion Criteria:

* Obstructive lung disease as defined by a FEV1/FVC less than 70%
* Obesity hypoventilation syndrome
* Treated sleep disorders breathing
* Cardiac surgery scheduled or strong likelihood of cardiac surgery 4 months after enrollment
* Life expectancy less than 1 year
* Inability to complete overnight PSG as defined by the protocol
* Patient who are or suspected to be pregnant and or plan to become pregnant
* Patient protected by the Law, under guardianship or curators
* Concomitant participation in an interventional biomedical research trial
H. Pylori Testing for Patients With Non-specific Upper Abdominal Pain in the Emergency Department

This pilot study aims to estimate the prevalence of Helicobacter pylori (H. pylori) colonization in patients presenting with non-specific abdominal pain (NSAP) in an urban academic emergency department (ED) located in Washington, DC.

The major goal is to study the prevalence of H. pylori using the 13C Urea Breath Test (UBT) in emergency department (ED) patients with non-specific abdominal pain. The investigators plan to enroll 250 patients during the pilot stage of this study. This T2 translational trial aims to apply recommended guidelines for the investigation and management of NSAP and dyspepsia into the practical arena of ED clinical care. The "test-and-treat" approach to symptomatic H. pylori infection has been endorsed by the American Gastroenterological Association (AGA). Patients who test positive for H. pylori by UBT will be treated with clarithromycin-based triple medication therapy as recommended by the American College of Gastroenterology (ACG) at the discretion of the treating physician. The rationale is that successful identification of H. pylori in the ED and initiation of treatment may reduce future risk of gastritis, gastric lymphoma, and gastric cancer, and is cost-effective through reduction of future healthcare costs and symptom severity. Study subjects will be followed for medication compliance, resolution of symptoms, and ability to obtain outpatient follow-up. As part of this study, the investigators will be collecting important information on the ED evaluation of abdominal pain.

Eligibility Criteria:
Inclusion Criteria:

For any patient with chief complaint of "ABD", "STOM", "EPIG", "CHEST", "NAUS" "Do you have pain or discomfort or burning in your upper abdomen as the main reason for coming to ER today?"

Exclusion Criteria:

* The patient LESS than 18 years old.
* Patient does NOT speak English NOR has reliable adult translator.
* Patient does NOT have capacity to give consent? (confused/intoxicated/etc.)
* The patient currently is on antibiotics.
* The patient currently is on a PPI. (eg. Prilosec \[omeprazole\]), protonix \[pantoprazole\], prevacid \[lansoprazole\], aciphex \[rabeprazole\], nexium \[esomeprazole\]
* The patient has taken bismuth or pepto-bismol today.
* The patient is known to be or suspected to be pregnant.
* The patient UNABLE to walk to H.pylori Breath test.
* The patient had "recent" negative H.pylori test for same symptoms.
* There an "obvious alternative cause" for pain (per attending).
Clinical Outcomes of Single Stage Versus Two-stage Treatment of Severe Obesity

Laparoscopic Roux-en-Y gastric bypass (LRYGB) in super obese patients (BMI≥50kg/m2) is a challenging operation. Weight reduction with intragastric balloon (IGB) prior to LRYGB may improve operative outcomes and improves weight loss. We assessed 155 patients, with a BMI≥50 kg/m2 who underwent either intra-gastric balloon (IGB) insertion followed by LRYGB (two-stage group), or LRYGB as the definitive bariatric procedure (single-stage group) in our institution. Two stage procedure was adopted for high-risk individuals.


Eligibility Criteria:
Inclusion Criteria:

* patients, with a BMI≥50 kg/m2, underwent either intra-gastric balloon (IGB) insertion followed by LRYGB (two-stage group), or LRYGB as the definitive bariatric procedure (single-stage group)

Exclusion Criteria:

* NA