cyrilzakka/clinical-trials huggingface dataset:
Valsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.

The purpose of this study is assess if treatment with valsartan and a diuretic, hydrochlorothiazide, has beneficial effects in people with high blood pressure, diabetes, and albuminuria (protein in the urine) compared with amlodipine. In particular, the study will assess whether the treatment will decrease the stiffness of the blood vessels.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* elevated blood pressure and pulse pressure
* albuminuria

Exclusion Criteria:

* Severe hypertension
* History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
* Liver, kidney (not caused by diabetes), or pancreas disease
* Type 1 diabetes or uncontrolled type 2 diabetes
* Allergy to certain medications used to treat high blood pressure

Other protocol-defined inclusion/exclusion criteria may apply.
New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System

This post-approval study is being implemented to monitor the use of Argus II System in a larger US population than available within pre-approval studies. An attempt will be made to include all eligible and willing subjects implanted with Argus II System in the United States.

Safety data will be monitored to ensure continued acceptability of risks to study subjects. The utility (i.e. visual function and functional vision) and reliability of Argus II System will also be evaluated.

There is no study hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Are adults, age 25 year or older;
* Have severe to profound retinitis pigmentosa;
* Bare light or no light perception in both eyes; if the patient has no residual light perception, then evidence of intact inner layer retina function must be confirmed;
* Have previous history of useful form vision.
* Aphakic or pseudophakic. (If the patient is phakic prior to implant, the natural lens will be removed during the implant procedure.)
* Patients who are willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation;
* Have consented to the implantation of an Argus II Retinal Prosthesis and subsequently consent to participate in this study;
* At the time of the Baseline Visit, do not suffer from non-ophthalmic serious adverse events (e.g. myocardial infarction, etc.) and

Exclusion Criteria:

* Ocular diseases or conditions that could prevent Argus II System from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus);
* Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva, axial length \<20.5 mm or \>26 mm, corneal ulcers, etc.);
* Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity, etc.);
* Inability to tolerate general anesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery;
* Metallic or active implantable device(s) (e.g. cochlear implant) in the head;
* Pre-disposition to eye rubbing;
* Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:

  * cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease,
  * psychiatric disease including diagnosed forms of depression;
  * does not speak a principal language associated with the region, and
  * deafness;
* Pregnant or wish to become pregnant during the course of the study;
* Participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study;
* Conditions likely to limit life to less than 1 year from the time of inclusion.
Central Venous Catheter Replacement Strategies in Patients With Acute Burn Injury

This project proposes to answer the following questions:

To determine the incidence of infection with three primary schedules of central venous catheter exchange in pediatric burn patients and to determine the regimen that will minimize infectious risk in children with burns.

The scientific knowledge to be acquired through this project is of likely benefit to the care of children with orthopaedic problems, spinal cord injuries or burns as follows:

The intention is to improve the outcomes in burned children by minimizing one of the most frequent causes of infection in the burn intensive care unit, those from central venous catheters. Decreasing infections will decrease morbidity, decrease length of stay, decrease costs, and decrease mortality in burned children

Aim: To determine the incidence of infection with three primary schedules of central venous catheter exchange in pediatric burn patients and to create a system that will minimize infectious risk in this patient population.

Hypothesis: A strategy of routine catheter changes without guidewire exchange will result in no more infections and a decreased risk of mechanical complications over frequent guidewire exchange or frequent new-site replacement.

Background: Reviews of burned children have implied that it is safe to change CVCs on a weekly basis, either by new site insertion or by wire exchange. In non-burn populations the routine use of wire exchange may increase infectious risk. Laboratory investigations have shown that the longer catheters are in place, the more often they are colonized with bacteria; this translates to an increase in catheter infection and patient sepsis. Centers for Disease Control recommendations note that catheters should not be routinely changed. The burn literature has disagreed with this concept, proffering that the change in microbial milieu from the burn wound increases infection risk, and national data indicates that burn units have three to four times higher rates of catheter related bloodstream infections than do other intensive care units. There is a trend in the existent retrospective data that using wires to change central venous catheters increases the risk of infection: CVCs changed to a new site have an infection rate of 16.6 per 1000 catheter days, whereas those changed by means of a wire have a rate of 25.2 per 1000 catheter days.

Methods: Patients will be randomized to three intervention groups: a frequent (6 days) moving of catheters to new sites; an alternating schedule of wire exchanges and new sites (every 6 and 12 days); and a less frequent moving of catheters to new sites (12 days) without wire exchange. This project requires enough patients to show a difference between three intervention groups. A significant decrease in infection rate would be from the current 20 infections per 1000 catheter days to approximately 15 per 1000 catheter days. This would require a minimum of 1000 catheter days per group.

Eligibility Criteria:
Inclusion Criteria:

* Burn patient with central venous catheter

Exclusion Criteria:

* none
Characteristics and the Future of the City Chilblains

Chilblains are cutaneous lesions affecting extremities (foot and fingers) with erythemic papules, evolving by painful relapse due to cold and sudden reheating.

This pathology is currently poorly understood while it's frequent.

The aim of the study is to evaluate all the characteristics of this pathology by reporting clinical and biological data of patient consulting for chilblains; and the other point is to assess the evolution of these patients.

Investigators are going to collect data on patient medical report to fill up a case report form. And in a second time they call patient by phone to ask him/her about the evolution of their pathology.

Eligibility Criteria:
Inclusion Criteria:

* patient consulting for chilblains
* diagnostic of chilblain during the consultation

Exclusion Criteria:

* patients consulting for other reason than chilblains
* patient who can't reply by telephonic call
Impact of Oral Dyglomera™ on Body Fat and Blood Lipids of Overweight and Obese Adults

The extract of Dichrostachys glomerata (DyglomeraTM), has been reported to be effective in weight reduction in obese patients with metabolic syndrome. This plant has been shown to have many biological properties and has been reported to have no toxic or adverse side effects in animals. The purpose of this human study was to prove that the effect of reducing body fat percentage (%) after 12 weeks of intake was superior to that of the control group.

This is a 12-weeks randomized double-blind placebo controlled trial. 120 number of subjects are planned. Each subject will be administered a single dose of the investigational product once daily, before lunch or dinner, consisting each time of 400 mg of the test product or placebo. Subjects will be assigned to the test group or placebo group in random order. Evaluations will be taken at baseline and at the beginning of each of the 5 study visits.

Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.

The following investigational products will be used:

* Test product: Dichrostachys glomerata extract (Dyglomera™) at a dose of 400 mg
* Control product: Placebo at a dose of 400 mg In this human study, starting with Visit 2, the duration of participation in the human study will be 12 weeks (84 days) in total. The study period will be planned to be 8 months from the date of approval of the human study. The screening visit of the first subject will be conducted at the MAX SPECIALTY HOSPITAL, and the first subject will be enrolled thereafter. The last subject will complete the study within about 5 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 19 to 65 years old,
* Patients with a BMI ranging between 25 and 34.9 kg/m2,
* Patients available for the entire period of study .

Exclusion Criteria:

* Patients that has an age below 19 years old and greater than 65 years old,
* Patients not available for the study period,
* Specific exclusion criteria included: morbid obesity (BMI \> 34.9 kg/m2); diabetes mellitus requiring daily insulin management; pregnancy/lactation; active infection; and systemic disease such as HIV/AIDS, active hepatitis or clinical signs of active malignancy within the past 5 years. Other exclusion criteria will include having taken any other medications or any natural health product within 1 month prior to the screening visit.
Renal Colic Fast Track Pathway in the Emergency Department.

Validation of a high-resolution, fast track pathway that combines the use of laboratory tests at the Point-of-Care Testing (POCT) and Point-of-Care ultrasound (POCUS) versus the classical pathway, in which blood samples are sent to the central laboratory and comprehensive radiological exams ordered, being equally effective, at a lower cost of care and time of stay in the emergency department.


Eligibility Criteria:
Inclusion Criteria:

* First renal colic episode
* Need of analgesia
* Oral tolerance

Exclusion Criteria:

* Hemodynamic instability
* Fever
* Anuria
* Abdominal trauma
* Chronic renal failure
* Active oncologic disease
* Kidney transplant or monorenal patient
Sleep Apnea in Lung Cancer: A Prospective Study

The study seeks to determine the prevalence of sleep disordered breathing in a population of patients diagnosed with lung cáncer.

Obstructive sleep apnea hypopnea syndrome (OSAHS) is an important medical condition which causes significant morbidity and mortality. The prevalence of OSAHS in Spain is 4-6% in men and 2-4% in women and rises steadily with age. Snoring and smoking have been independently linked, and smoking may be a risk factor for developing OSAHS. This is particularly true of heavy smokers (\> 2 packs/day), those at greatest risk for LC. Associations between OSAHS and some forms of cancer have been described in humans, especially in those experiencing nocturnal hypoxemia, and intermittent hypoxia has been linked to the progression of cancer in animal models. LC is currently the leading cause of cancer deaths in developped nations. A link between OSAHS and LC, therefore, is plausible.

Sleep disordered breathing may be common among patients recently diagnosed of lung cancer and may contribute to tumor progression.

Objectives: a) To perform home sleep testing in patients recently diagnosed with lung cancer in order to determine the prevalence of sleep disordered breathing in this patient population. b) To include biological samples obtained from all participants, including surgically treated patients with stage I / IIp LC through the program in the CIBERES Pulmonary Biobank Platform. Biological samples will be preserved under different storage conditions for subsequent determination of molecular biomarkers. c) To follow-up lung cancer patients with and without sleep disordered breathing in order to determine the potential influence OSAHS might have on their prognosis.

Prospective screening for sleep disordered breathing will be performed by home sleep testing in 100 subjects diagnosed with lung cancer, irrespective of stage at diagnosis, who give their consent. A modified epidemiologic questionnaire for sleep disordered breathing will also be administered. Patients identified as suffering from OSAHS will be referred to sleep clinic. Biologic samples and lung function studies will be obtained in all participating patients.

All patients with lung cancer will undergo follow-up for at least three years or until their demise, and those identified with OSAHS will also be followed in sleep clinic. The prevalence of OSAHS in this patient population will be determined. A link between OSAHS, and especially intermittent nocturnal hypoxemia, and tumor progression will be sought.

Eligibility Criteria:
Inclusion Criteria:

* All patients with recently diagnosed lung cancer, inlcuding all stages of disease.

Exclusion Criteria:

* Patients unable to comply with home sleep testing.
Vasopressin for Septic Shock Pragmatic Trial

Life-threatening low blood pressure due to a serious infection is called "septic shock." Septic shock is treated with vasopressors, medications that raise blood pressure. Sometimes first-line vasopressors are inadequate, prompting addition of a second-line vasopressor called vasopressin. However, the threshold at which to start vasopressin remains unclear. This pragmatic, cluster-randomized, cluster-crossover trial will evaluate two different strategies for septic shock treatment commonly used in current practice, comparing a lower versus a higher threshold for adding vasopressin to first-line vasopressors.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Admitted to a study hospital emergency department (ED) or inpatient care unit
3. Administration of vasopressor(s) for septic shock

Exclusion Criteria: None
GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China

The purpose of this study is to assess the efficacy, safety, bleeding pattern of low dose LNG (12 mg/ 24 hrs), delivered locally by a new intrauterine contraceptive system suitable for use by women 18 to 40 years of age. In addition, pharmacokinetic assessments will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Has, in the opinion of the investigator, suitable general and uterine conditions for inserting the LCS.
* Normal cervical smear (normal cervical smear within the last six months prior to visit 1 presented in writing can be accepted. The cervical smear should be analyzed and reported according to the Bethesda System.)
* Has clinically normal safety laboratory results (i.e., inside the specified range for inclusion).
* Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).

Exclusion Criteria:

* Known or suspected pregnancy or is lactating.
* Vaginal delivery, cesarean delivery, or abortion within 6 weeks prior to visit 2.

Note: Postpartum insertions should be postponed until uterus is fully involuted, however not earlier than 6 weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum. In case of a difficult insertion and/or exceptional pain or bleeding during or after insertion, physical examination and ultrasound should be performed immediately to exclude perforation.

* History of ectopic pregnancies. Note: For Korea only: History of ectopic pregnancies or high probability of ectopic gestation.
* Infected abortion within 3 months prior to visit 1. Note: For Korea only: Endometritis after delivery or infected abortion within 3 months prior to visit 1.
* Abnormal uterine bleeding of unknown origin.
* Any genital infection (until successfully treated).
* History of, or current, pelvic inflammatory disease
* Congenital or acquired uterine anomaly.
* Any distortion of the uterine cavity (by e.g., fibroids) likely to cause problems (in the opinion of the investigator) during insertion, retention or removal of the LCS.
* History of, diagnosed or suspected genital malignancy, and untreated cervical dysplasia.
* Current deep venous thrombosis or thrombophlebitis; history of deep venous thrombosis.
* Clinically significant endometrial polyp(s), which, in the opinion of the investigator, will interfere with the assessment of the bleeding profile during the study
* Clinically significant ovarian cyst(s)
* Use of any long-acting injectable sex-hormone preparations within 12 months prior to start of study medication, and if entering subset: any sex-hormone administration within one month prior to start of the study medication.
Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia

Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Able to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
* Meets criteria for chronic insomnia
* Body Mass Index (BMI) 18.5 kg/m2 and higher

Exclusion Criteria:

* Age \< 18
* Unable to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
* Unwilling to share email address/cell phone number to accept survey links.
* Life time diagnosis of psychotic or bipolar disorder
* Current use of supplemental oxygen for the treatment of sleep apnea
* History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, or was not treated with surgery or weight loss.
* Started new or changed treatment for sleep apnea in the past three months
* Does not meet criteria for chronic insomnia
* Meets criteria for narcolepsy or hypersomnia disorder
* Meets criteria for circadian rhythm disorder (including night shift work)
* Unstable medical conditions that would make participation unsafe or unfeasible
* Falls resulting in hospitalization, significant injury or fracture within past 12 months
* 2 hospitalizations or emergency room visits within past 12 months for chronic conditions
* Active chemotherapy or radiation therapy for cancer
* Lifetime diagnoses/treatment of chronic renal failure, hepatic insufficiency, chronic heart failure
* Does not agree to refrain from other treatments for insomnia beyond what is offered in this study
* BMI less than 18.5
* Substance abuse or dependence in the past 12 months
* Current use of prescription or over the counter medications taken for sleep greater than 2 times per week
* Current use of systemic corticosteroids or opiate medications
* Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth control for the length of the study
* Current use of medications contraindicated with trazodone
* Sleep apnea or periodic leg movement disorder as determined by sleep study
* Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg
* EKG corrected QT interval greater than or equal to 500 ms
TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study

The purpose of this investigation is to evaluate the safety and effectiveness of the TRIUMPH® Lumbar Artificial Disc for the treatment of patients who are suffering from Degenerative Disc Disease (DDD) at one level from L1 to S1.


Eligibility Criteria:
Inclusion Criteria:

* Degenerative Disc Disease in one vertebral level between L1 and S1
* Able to understand and sign informed consent
* Had at least 6 months of conservative treatment
* Oswestry Disability Index Score of at least 30 (one a 100 point scale)
* Other inclusion criteria as specified in approved IDE protocol

Exclusion Criteria:

* Bilateral leg pain
* Back or leg pain of unknown etiology
* Prior fusion surgery or another spinal device implanted at any other lumbar level
* Osteoporosis or osteopenia
* Other exclusion criteria as specified in approved IDE protocol
Low-Cost, Portable Flexible Nasopharyngoscope in Head & Neck Cancers in Low Resource Settings - Optimization Phase

This study aims to develop and evaluate a low-cost, portable, flexible nasopharyngeal scope (FNS) used to assess head and neck cancers (HNC) in low resource settings. The FNS will be compared to an endoscope that is used as standard of care (SOC) in terms of ease of use, image quality, and perceived pain. The ultimate goal is to compare the ease of use between the FNS to what is used in SOC.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Male or female, aged 18 or older
* Patients who clinical meet clinical criteria for SOC scope examination of the upper aerodigestive tract. This includes signs and symptoms such as dysphagia, nasal obstruction, neck mass, throat pain, and hoarseness.

Exclusion Criteria:

* Withdrawal of consent during the study duration
* Subjects who have complications from the SOC exam
* Anyone unable to under the SOC exam