cyrilzakka/clinical-trials huggingface dataset:
Effect of Raw Milk on the Immune Response Upon Cholera Vaccination

Rationale: Infections are an important worldwide cause of death, both in elderly and young children. Therefore, support of immunity could help to reduce the incidence of infections. To screen the potential of specific foods or food ingredients to support immunity, oral vaccination can serve as a model. In this study, oral cholera vaccination will be applied in human adult volunteers, and used as a model to study the support of the immune response by raw milk.

Objective: To investigate whether raw milk is able to enhance the immune response as induced by oral cholera vaccination.

Study design: The study is designed as a single-blind randomized controlled trial of 4 weeks.

Study population: Healthy subjects of 18-50 years of age.

Intervention: Raw milk, obtained from farms that comply to the high quality requirements for production of raw milk, and that has been screened according to the safety criteria for raw milk.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 yr
* Signed informed consent
* Availability of internet connection
* Male or female
* Willing to stop blood donation at the blood bank during the study period

Exclusion Criteria:

* Currently participating in another clinical trial
* Previous Cholera, Salmonella, or E. coli vaccination
* Tonsillectomy
* Acute gastroenteritis in the past 2 months
* Use of antibiotics in the past 2 months
* Hypersensitivity to the vaccine, to formaldehyde or to any of the excipients (sodium salts)
* Pregnancy or lactating (pregnancy test will be performed on the vaccination days)
* Not willing to drink raw milk
* Allergic to milk or lactose-intolerant
* Disease of GI tract, liver, gall bladder, kidneys, thyroid gland
* Immune-compromised
* Use of immunosuppressive drugs
* Drug abuse, and not willing/able to stop this during the study
* Excessive alcohol usage (men: \>4 consumptions/day or \>20 consumptions/week; women: \>3 consumptions/day or \>15 consumptions/week)
Immature Plateletes in the Etiopathology of Deep Venous Thrombosis

The study is designed to evaluate the role of platelets and immature platelets in the ethiopathology of deep venous thrombosis and pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a newly diagnosed deep venous thrombosis and/or pulmonary embolism. The thrombembolism is idiopathic or caused by immobilisation.
* Control: Patients that present with a suspicion of deep venous thrombosis which is excluded by duplex sonography.

Exclusion Criteria:

* therapy with glycoprotein IIb/IIIa-antagonists within the last 10 days
* therapy with antiplatelet drugs (ASA, Clopidogrel, Ticagrelor, Prasugrel, Dipyridamol)
* preexisting anticoagulation
* number of platelets \< 100.000/µl
* anemia (hematocrit \< 35%, Hb \< 10 g/dl)
* age \> 80 y or \< 18 y
* renal insufficiency GFR \< 30 ml/min
* hepatic impairment with an increased risk for bleeding or coagulopathy, or liver cirrhosis (≥ Child Pugh B)
* intracranial or intracerebral bleeding within the last six months
* intraspinal or intracerebral vascular anomalies
* clinically relevant acute bleedings
* malign disease
* infections within the last 7 d
* hematological, rheumatologic and autoimmune diseases
* operations within the last six months
* transfusion of rec celll concentrates within the last six months
* transfusion of fresh frozen plasma or platelet concentrates within the last month
* preexisting medication with CYP 3A4 inhibitors and inductors, p-glycoprotein inhibitors (Azol-Antimycotis, HIV protease-inhibitors)
* hypersensitivity/contraindications for Rivaroxaban
* pregnancy or lactation
* thrombophilia
* thrombocytopathy
Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)

Lumbar arthrodesis is more and more common in general population. Patients need early reeducation after surgery but do not always have access to a physiotherapist.

The investigators aim to study the benefits of self-rehabilitation at home after lumbar arthrodesis, showing amelioration in lumbar pain and in quality of life for concerned patients. For this, the investigators designed a randomized-controlled study to test if self-rehabilitation at home right after surgery is superior than rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment for our patients).

Due to population aging, lumbar arthrodesis is becoming more frequent in general population. At the same time, those patients need early rehabilitation, even if they do not experiment any motor disability after surgery : it has been showed that early rehabilitation improves lumbar pain thanks to muscle strengthening.

The design of the study is prospective,monocentric, controlled and randomized. This study compares progressive self-rehabilitation at home after lumbar arthrodesis, explained to the patient by a physiotherapist during his or her stay at the hospital and started right after surgery, versus rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment).

The primary outcome is decrease of lumbar pain at 6 weeks and 3 months after surgery. The secondary outcomes are improvement of functional abilities and improvement of pelvis and limbs ranges of motion.

Patients of both groups will be followed by surgeon and physiotherapist at 6 weeks and 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Lumbar pain and/or nerve root pain and/or limp without any motor deficiency of the limbs, before and/or after surgery (if any motor deficiency occurs after surgery, it will be a secondary exclusion criteria)
* Surgery for posterolateral lumbar arthrodesis, from a degenerative etiology, from 1 to 3 lumbar levels (one level means one inter-somatic space)
* Surgery indication after optimal medical treatment, including appropriate pain medicine, and fail of medical treatment for reducing lumbar pain and/or nerve root pain and/or limp
* Return home possible after surgery
* After signing consent during pre-operative visit with the surgeon

Exclusion Criteria:

* People under 18 years-old
* Pregnant or breast-feeding women
* Psychiatric and/or neurodegenerative comorbidity
* Motor deficiency of the limbs before and/or after surgery
* Iliac extension of arthrodesis
* Any postoperative complication lengthening stay at hospital
* Medical contraindication for early rehabilitation
Evaluating Alcohol Use in Alcoholic Liver Disease

This prospective, analytic observational study will investigate alcohol recidivism in patients with alcoholic liver disease. All adult subjects presenting with alcoholic liver disease are considered for inclusion. Subjects able to give consent are included.

This is a longitudinal observational study. Subjects with a diagnosis of alcoholic liver disease (acute alcoholic hepatitis or alcoholic cirrhosis) who present to Weill Cornell Medical Center or Columbia University Medical Center New York Presbyterian Hospital or the Gastroenterology and Hepatology Clinic will be invited to join this study, which entails a survey at baseline and follow-up at 3, 6, 9, 12, 15, and 18 months and then at 2, 5, and 10 years. Follow-up will consist of a chart review, a phone or in person interview, and most recent clinic visit interview for alcohol recidivism. The clinical providers will be blinded to the survey results.

Eligibility Criteria:
Inclusion Criteria:

* alcoholic liver disease able to consent

Exclusion Criteria:

* without alcoholic liver disease unable to consent
Biometric Factors Changes Caused by Myopia Orthokeratology (OK) Lens

Subjects fit with VST or CRT type lens are reviewed 1 day to 2 year after first wearing the lens. Ocular examinations were performed, including slit-lamp biomicroscope, uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), corneal topography (Medmont E300W, Medmont Pty Ltd, Melbourne, Australia), corneal refractive power (autorefractometer, KR880, Topcon, JAPAN), corneal epithelial thickness (Optical Coherence Tomography, RTVue-XR), axial length using IOL-Master 700 (Carl Zeiss Meditec AG). To investigate corneal and retina changes caused by overnight OK lens.


Eligibility Criteria:
Inclusion Criteria:

* Normal subjects without any history of ocular surgeries or diseases (except for refractive errors) or systemic diseases that might affect contact lens wearing. The spherical error between -1.0 and -5.0 D, cylindrical error of at most 2.0 D, and a corrected distance visual acuity of 20/20 or better.

Exclusion Criteria:

* Subjects who had previously worn contact lens, were also excluded
A Drug-Drug Interaction Study of ENV-101 (Taladegib) on Nintedanib Pharmacokinetics in Healthy Subjects

The goal of this clinical trial is to learn about the potential effect of ENV-101 (taladegib) on the pharmacokinetics of nintedanib (an approved treatment for idiopathic pulmonary fibrosis) when the two compounds are dosed together in healthy subjects. Participants in this study will receive ENV-101 and/or nintedanib on various days throughout a 10-day period during which they will reside at the clinical trial site.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥18 and ≤32 kg/m\^2
* Body weight ≤120kg
* Subjects must be willing to be sequestered for 10 consecutive days.

Exclusion Criteria:

* Chronic or current use of any prescription medications or acute use within the preceding 30 days or 5 half-lives, whichever is longer, with the exception of contraceptives, prior to study start
* Subject has an active infection of hepatitis B or C, or human immunodeficiency virus (HIV) at study start
* Subject has a history of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers, within 5 years before study start
* Participation in a clinical research trial that included the receipt of an investigational agent or any experimental procedure within 30 days or 5 half-lives, whichever is longer, prior to the screening visit, or planned participation in any such trial at time of study start
* Subject has a pulse \<45 or \>100 bpm; systolic blood pressure \>160 mmHg, or diastolic blood pressure \>95 mmHg at study start
* Subject has pacemaker; is not in sinus rhythm; has a corrected QT interval (QTc; using Fridericia's \[QTcF\] formula) of \>450 ms (for males) and \>470 ms (for females) during the Screening Period; or has a left bundle branch block or bifascicular block.
* Females and males of reproductive potential who are sexually active and unwilling to use birth control for the duration of the study and for 90 days after their final study dose
* Females that are pregnant or lactating
* Females and males that are unwilling to refrain from blood or blood product donation for the duration of the study and for 30 days after their final study dose
* Males who are unwilling to refrain from sperm donation for the duration of the study and for 90 days after their final study dose
* Females who are unwilling to refrain from egg donation for the duration of the study and for 90 days after their final study dose
* Subjects with a history of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of ENV-101 (taladegib) or nintedanib
* Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study investigative site or the study Sponsor
Using the Energy Gap to Prevent Weight Regain

The major challenge in obesity treatment is not producing weight loss but in preventing that weight from being regained. There are many different methods to lose weight, but there are no recommendations for how you can best achieve long-term weight loss maintenance. Despite the method used to reduce one's body weight, very few of these individuals are able to keep their weight off permanently. This project aims to identify how much activity is necessary to prevent weight regain after weight loss.


Eligibility Criteria:
Inclusion Criteria:

1. All ethnic groups and both genders
2. Age: Lower age limit: 19 years; Upper age limit: 45 years
3. Body-mass Index: Lower BMI limit: 30 kg/m2; Upper BMI limit: 40 kg/m2 and weight stable within +/- 5 pounds in the last 6 months, and currently at maximum non pregnant body weight (+/- 5%)
4. A negative treadmill stress test or subsequent follow up cardiac testing for cardiac ischemia.

Exclusion Criteria:

1. History of cardiovascular disease, including coronary artery disease, congestive heart failure, \& unstable angina, or uncontrolled hypertension ( \> 140/90 mm Hg)
2. Currently smoking or stopped smoking in the last 12 months
3. Medications affecting weight, energy intake, or energy expenditure in the last 6 months
4. Use of oral steroids within the last 12 months
5. History of stroke or seizures, thyroid disease, type 1 or 2 diabetes, Cushings syndrome, cerebrovascular, renal disease, hepatic disease, arrhythmias
6. Cancer requiring treatment in the past 5 years, with the exception of skin cancers other than melanoma
7. Infectious diseases: Self-reported HIV positivity or Active tuberculosis
8. Weight loss or weight gain of \> 5% in past 6 months for any reason except post-partum weight loss
9. Likely to move away in next 1.5 years
10. Inability to adhere to the program such as inability to increase walking
11. Currently pregnant, lactating or less than 6 months post-partum
12. Major psychiatric disorder: Exclusions related to medications -Antipsychotic agents (these include, but are not limited to: Haldol, Loxitane, Mellaril, Navane, Prolixin, Stelazine, Thorazine, and Trilafon)
13. Current depression by history or Beck Depression Inventory (BDI)
14. Currently being treated for psychological condition
The Effect of Maintenance Fluids on Overall Fluid Balance in ICU Patients

The amount of fluids characterized as non-resuscitation fluids given to ICU patients are likely to be high and will probably have a substantial impact on the total amount of fluid administered to ICU patients daily. It will most likely also influence on the total fluid balance and the negative outcome of fluid overload.

The aim of our study is to investigate the amount of fluid given as maintenance fluids in the ICU and the impact of this fluid on total fluid balance.

Fluid therapy is an important part in both prevention and treatment of shock and multiple organ dysfunction in the ICU. However, the risks of giving patients too much fluids resulting in fluid has been gaining increased focus during recent years. Numerous studies regarding the amount of resuscitation fluid given to ICU patients have been performed, as well as investigations regarding factors that trigger the decision to deliver a fluid challenge to the patients. Likewise, multiple studies reveal that a more restrictive use of resuscitation fluids often lead to a better outcome for our patients.

However, data regarding the amount of maintenance fluids and the effect of maintenance fluids on fluid balance and consequently outcome remain sparse. One major difficulty is that there is no universal definition of the term maintenance fluid. Some researchers include all fluids that is not considered resuscitation fluids, i.e. fluids given to administer drugs, to keep peripheral and central venous catheters functioning, administration of basal fluid needs and nutrition, while others exclude fluids covering basal needs and nutrition from the definition.

Eligibility Criteria:
Inclusion Criteria: All ICU patients that spent one week or more in the ICU. -

Exclusion Criteria:

-
Study of Mitomycin-C Application in Laryngotracheal Stenosis

This is a randomized, prospective, double-blind, placebo-controlled clinical trial of the use of mitomycin-C topical application as an adjunctive treatment in the endoscopic surgical treatment of patients with laryngotracheal stenosis. We hypothesize that the use of mitomycin-C improves patient outcome in the endoscopic surgical treatment of laryngotracheal stenosis.

Obstruction of the upper airway caused by laryngotracheal stenosis (LTS) often results in severe morbidity and even mortality. Treatment of LTS continues to present a challenge and a wide array of surgical techniques have been employed. Despite multiple endoscopic and/or open reconstructive procedures, patients often experience restenosis as a result of the abnormal wound-healing process that initially instigated the airway obstruction. The high rate of stenosis relapse has therefore motivated researchers to find new methods to modulate and control the wound-healing process of the airway. Although other adjuvant treatments such as steroids and antibiotics have been investigated in LTS, much attention in recent years has turned to the use of topical mitomycin-C (MMC). As a topical application, MMC has been shown to inhibit fibroblast proliferation in wound-healing processes. The use of MMC in the treatment of airway stenosis was first reported in 1998 and is now routinely used in the endoscopic management of LTS. However, despite numerous animal and human studies, the benefit of MMC in LTS patients remains questionable. While previously published retrospective data suggest that the addition of MMC improves outcome, there have been no prospective studies to directly address the efficacy of MMC in endoscopic LTS surgery. This study will be the first randomized, prospective, double-blind, placebo controlled clinical trial designed to investigate the efficacy of MMC as an adjunctive therapy to endoscopic surgical treatment in patients with LTS. In addition, the study will investigate the relationship between patient symptoms and objective pulmonary function measurements. Ultimately, the results of this study may influence the treatment and evaluation of patients with laryngotracheal stenosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with laryngotracheal stenosis, including subglottic stenosis or tracheal stenosis
* Patients with disease amenable to treatment with endoscopic CO2 laser radial incisions and balloon dilation
* Age greater than or equal to 18 years

Exclusion Criteria:

* Age less than 18 years
* Pregnancy
* Patients with glottic and supraglottic stenosis
* Patients with disease not amenable to treatment with endoscopic CO2 laser radial incisions and balloon dilation
* Patients with cartilaginous subglottic or tracheal stenosis
Feasibility Assessment of Implementing a Care System to PREVENT Iatrogenic Dependency (ID)

To assess the feasibility of a care system to prevent iatrogenic dependency during hospitalisation in people 70 years old and over. 2 cares units participate : one with routine care and the other with a care system to prevent ID. The caregivers of this unit receive training about iatrogenic dependency and how prevent it. They set up this prevention and the research compare evolution of dependence hospitalized patients.


Eligibility Criteria:
inclusion criteria:

* Patient hospitalized for at least 48 hours in the participating center
* Persons affiliated to a social security system,
* The patient, his trusted person or a relative present during his hospitalization have not expressed opposition to his participation in the research..

exclusion criteria:

* End of life situation,
* ADL at 0/6 for 15 days before hospitalization.
* Refusal to participate,
* Patient under judicial protection
Continuous Negative Abdominal Pressure in ARDS (CNAP in ARDS)

The aim is to test a device for applying continuous negative abdominal pressure in patients with ARDS

Adult respiratory distress syndrome (ARDS) is a serious pulmonary disease affecting adults and children. It has a high mortality and there is no specific therapy. The mortality is high (approx. 40% in severe cases) and this has not changed in the last 20 years.

Mechanical ventilation is the mainstay of management, and this assists the patient by increasing oxygenation and removal of carbon dioxide. Despite optimizing tidal volume, driving pressure and positive end-expiratory pressure (PEEP), patients with ARDS develop large areas of atelectasis and poor oxygenation. There are few additional ventilator approaches that have proven to be useful in preventing this type of injury.

A major aim of ventilator support is recruitment of atelectatic (i.e. de-airated) lung, but while this is supported by excellent rational and laboratory data, the conventional clinical approaches have not been associated with a demonstrable improvement in patient outcome. Most atelectasis in ARDS occurs in the dorsal (dependant, lower-most) lung regions, and these are near the diaphragm.

The main ways to recruit lung are to increase the airway distending pressure (but this over-expands and damages the already-aerated lung regions); or, to turn the patient into the prone position (but clinicians are reluctant to utilize this approach - despite evidence that it may increase survival).

Continuous Negative Abdominal Pressure (CNAP) aims to selectively recruit basal atelectatic areas of lung, while enabling the patient to remain in the supine (usual) position.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≧ 18 years old
2. Patients with moderate to severe ARDS as per the Berlin definition (PaO2/FiO2 ≤200mmHg)
3. Patients with absence of any significant cardiopulmonary disease

Exclusion Criteria:

1. Contraindication to CNAP

   a. open abdominal wounds or drainage tubes; b. Acute brain Injury with intracranial pressure \>30 mm Hg or cerebral perfusion pressure \<60 mmHg; c. Decompensated heart insufficiency or acute coronary syndrome; d. Major hemodynamic instability: Mean arterial pressure lower than 60 mm Hg despite adequate fluid resuscitation and two vasopressors or increase of vasopressor dose by 30% in the next 6 hours; f. Unstable spine, femur, or pelvic fractures; g. Pregnancy; h. Pneumothorax;
2. Contraindication to EIT electrode placement: Burns, chest wall bandaging limiting electrode placement
3. Severe liver insufficiency (Child-Pugh score \> 7) or fulminant hepatic failure
4. Major respiratory acidosis or PaCO2 \> 60 mmHg
5. Severe COPD (according to the GOLD criteria defined as severe = FEV1: 30-50% or very severe = FEV1 \< 30%)
6. Clinical judgement of the attending physician