cyrilzakka/clinical-trials huggingface dataset:
Eso-Sponge Registry

This international, prospective and multicenter registry was designed to collect clinical evidence for the endoscopic vacuum treatment using Eso-SPONGE® for anastomotic leakage after esophageal resection or iatrogenic or spontaneous esophageal perforation.

Anastomotic Leakages or other defects in the upper gastrointestinal tract can have serious consequences for the affected patients. Different parameters, like the size, location, time to diagnosis of the lesion, but also the general condition of the patient, have a significant influence on the clinical outcome of the patient. Often this situation is accompanied by symptoms of sepsis and a significant morbidity rate with corresponding substantial mortality rate. For this reason the treatment of this clinical situation is often a challenge for the clinician.

Besides surgical examination and the endoscopic stent system, good experiences have been obtained with the Endo-SPONGE® therapy for the lower gastrointestinal tract. In the future the endoluminal vacuum therapy for the upper gastrointestinal is available, too, with Eso-SPONGE®.

Eso-SPONGE® represent an innovative therapy concept for the treatment of this problem in the upper gastrointestinal tract, which can contribute significantly to the reduction of morbidity and mortality of the patients.

The overall success rate of endoscopic esophageal vacuum therapy in the literature ranges from 80-100%. Currently only cohort studies including a small number of patients have been performed and published. Therefore an international, prospective and multicenter registry was designed to collect clinical evidence for Eso-SPONGE treatment concept in a large population under daily clinical routine.

Eligibility Criteria:
Inclusion Criteria:

* Endoscopic vacuum therapy (EVT) of anastomotic leakage after esophageal resection or spontaneous or iatrogenic perforations
* age \> 18 years
* written informed consent

Exclusion Criteria:

* none
Study of a Self-Help Depression Skills Program for College-Aged Youth

We propose to conduct a pilot trial of an Internet-only depression skills training program for adolescents and young adults. The intervention, MoodHelper.org already exists and has been tested in two pilots. In this third pilot, we plan to use an enriched minority sampling frame to mail 3,000 to 6,000 invitational brochures to KPNW members aged 14 to 24, with a enrollment target of 150. Interested members will go to the study Internet site, and if they choose to participate, complete the online consent and assessment battery (used in the previous pilots). Participants will be randomly assigned by the site's software to one of two conditions: (1) the "Intervention" condition, with complete access to the SADhelper.org web site or (2) the "Usual Care" condition, with access to all Internet sites and KPNW health care, but with no access to the therapeutic portion of the SADhelper site. All participants (those with and without access to the research intervention) will be reminded by e-mail and, if necessary, by telephone to return to the web site and complete follow-up questionnaires four, eight, sixteen, and thirty-two weeks after enrolling in the study.

We propose to conduct a pilot trial of an Internet-only depression skills training program for adolescents and young adults. The intervention, MoodHelper.org already exists and has been tested in two pilots. In this third pilot, we plan to use an enriched minority sampling frame to mail 3,000 to 6,000 invitational brochures to KPNW members aged 14 to 24, with a enrollment target of 150. Interested members will go to the study Internet site, and if they choose to participate, complete the online consent and assessment battery (used in the previous pilots). Participants will be randomly assigned by the site's software to one of two conditions: (1) the "Intervention" condition, with complete access to the SADhelper.org web site or (2) the "Usual Care" condition, with access to all Internet sites and KPNW health care, but with no access to the therapeutic portion of the SADhelper site. All participants (those with and without access to the research intervention) will be reminded by e-mail and, if necessary, by telephone to return to the web site and complete follow-up questionnaires four, eight, sixteen, and thirty-two weeks after enrolling in the study.

Eligibility Criteria:
Inclusion Criteria:

current clinical diagnosis of depression Internet access

Exclusion Criteria:

none
Blackberry Intake and Biomarkers of Cancer Risk

Berry components have been shown to influence cancer processes in cell culture studies. The investigators will conduct a study to investigate if blackberries influence the same cancer processes in a human feeding study.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking men and women
* Aged 40-75
* BMI 19-38 kg/m2

Exclusion Criteria:

* Younger then 40 ears old or older than 75 years old
* BMI less than 19 or greater than 38
* Use of blood-thinning medications such as warfarin, dicumarol, or anisinidione
* Presence of kidney disease, liver disease, gout, certain cancers, untreated thyroid, gastrointestinal, other metabolic diseases or malabsorption syndromes
* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
* Fasting triglycerides greater than 300 mg/dL
* Fasting glucose greater than 126 mg/dL
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g. vegetarians, very low fat diets, high protein diets)
* Use of prescription of over-the-counter antiobesity medications or supplements during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity
* Active cardiovascular disease
* Use of any tobacco products in the past 6 months
* Use of oral or IV antibiotics during the month preceding the study or during the study
* Unwillingness to abstain from vitamin, mineral, and herbal supplements for two weeks prior to the start of the study
* Known (self-reported) allergy or adverse reaction to blackberries or gelatin
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Laryngoscope Prototype Tested Against the Traditional Macintosh Blade

The primary objective is to evaluate a knewly developed blade (for intubating patients about to undergo surgery) and compare it to the traditional Macintosh blade

Intubation of patiens can be difficult, even impossible. It can result in different complications as damage to the teeth, lacerations of the mucosa, bleeding, fractures/luxations, hypoxia, hypercapnia, reflex bradycardia and in worst case braindamage and death.

The more difficult the intubation is the more frequent complicationrate. We believe to have developed a laryngoscopeblade that hopefully eases the intubationproces and thereby reduces the complicationrisk.

The patients included in this study is patients who are undergoing elective surgery requering intubation.

Eligibility Criteria:
Inclusion Criteria:

* age over 18
* ASA 1-III
* Patients undergoing elective surgery requering intubation at KAS Herlev

Exclusion Criteria:

* Prior difficult intubation indicating awake fiberoptic intubation
* pathology in the airways predicting difficult intubation
* columna cervicalis fractures
* pregnancy
* Requirement for Rapid sequence induction
Telemedicine for CPAP Therapy Control in OSA

Obstructive sleep apnea is a very frequent syndrome and Continuous Positive Airway Pressure (CPAP) is the gold standard treatment. Nevertheless, obtaining the sufficient compliance is complex. New communication technologies and the current health challenges, such as aging and high health care costs have encouraged the interest in new strategies.

As showed recently, telemedicine is an alternative (Isetta, Thorax 2015) in patients that use internet and mobile technologies usually. However, there is a significant percentage of patients that does not use Internet and mobile technologies, only the 58% of patients over 65 years uses them (Dorsey, NEJM 2016). Although evidence regarding telemedicine is conflicting, it suggest that it's applicability depends in patient's characteristics and it is necessary to personalize it to make it safe and effective (Takahashi, Arch Intern Med 2012). That's why the investigators believe that the next step should be to choose those patient's that doesn't use Internet or mobile technologies and to verify the applicability of a telematic system that could facilitate the extra hospital management of this patient's.

The aim of the study is to evaluate the telematic management of various outcomes that are emitted by CPAP machine, and by an app where the patient's will answer different questions regarding their treatment during the three months of study period.

We include OSA patient's that are not familiarized with the use of internet and mobile technologies and with CPAP prescription. They follow up an adaptation session where an automatic CPAP machine is delivered. Patient's are titrated with this automatic device in 5-7 days and are treated with the automatic device during 3 months.

The other part of the follow up consists on a voicemail where the patient can contact the sleep unit 24h a day and on a tablet, with an special app where the patient's answer a questionnaire once two weeks.

Eligibility Criteria:
Inclusion Criteria:

* OSA diagnosis and CPAP prescription
* No use of internet or mobile devices

Exclusion Criteria:

* Unstable diseases and severe comorbidities
* Previous CPAP treatment
Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

Tranexamic acid (TXA) reduces head injury deaths. The CRASH-4 trial aims to assess the effects of early intramuscular TXA on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury

TXA reduces bleeding by inhibiting the enzymatic breakdown of fibrin blood clots. Results from randomised trials (CRASH-3 and NCT01990768) show that early treatment with TXA (given intravenously) reduces head injury deaths (pooled RR 0.89, 95% CI 0.80-0.99). In the CRASH-3 trial, the reduction in head injury deaths with TXA was largest in patients with mild and moderate head injuries, particularly if patients were treated soon after injury. However, the CRASH-3 trial included mild TBI patients only if they had intracranial bleeding on CT scan. It is uncertain whether the results apply to mild TBI patients more generally. CRASH-4 is a randomised, double blind, placebo-controlled trial in symptomatic mild TBI in about 10,000 older adults. The pilot phase will include about 500 patients. The trial aims to provide reliable evidence about the effects of early intramuscular TXA on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury.

Eligibility Criteria:
Inclusion Criteria:

* 50 years or older (actual or estimated)
* History or evidence of head injury (e.g. laceration, bruise, swelling or pain in head or face)
* GCS ≥ 13
* Has one or more of the following:

  1. has or had any impaired consciousness (loss of consciousness, amnesia, or confusion)
  2. nausea or vomiting
* Within 3 hours of injury (do not include if interval cannot be estimated e.g. patient unable to confirm time of fall or patient found on floor after an unwitnessed fall and home alone)
* Not living in a nursing home, mental health institution or prison
* Patient will be conveyed to or is admitted to a participating hospital

Exclusion Criteria:

- TXA not clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspected stroke)
Folic Acid Supplementation in Women of Child Bearing Age

The objective of this study is to identify genes whose expression is potentially modifiable due to changes in folate intake and help delineate mechanisms accounting for the variability in individual response to folic acid supplementation. The study will be conducted in normal weight and obese women of childbearing age, supplemented for 8 weeks with 800 mcg/day folic acid.

It is hypothesized that (1) a change in folate status, induced by the supplementation, will influence the DNA methylation of specific genes and (2) the DNA methylation response to folic acid supplementation may differ between the normal weight and the obese women of childbearing age.

This study will be conducted in two phases. An initial screening study will be performed to determine folate status, MTHFR677 genotype and body composition of potential participants of the intervention study. Both folate status and MTHFR677 genotype are known independent predictors of response to folic acid supplementation. Blood samples will be collected, after an overnight fast, for determination of serum folate concentration and for MTHFR677 genotyping. Body composition and 24-hr dietary recalls will also be conducted during the screening visit.

The second phase is an eight week supplementation trial with 800 mcg/day folic acid. Screened individuals determined to have a serum folate \< 30 nmol/L (\< 50th percentile of NHANES 1999-2004) and of the CC or CT genotype (for MTHFR677) will be eligible for inclusion in the supplementation trial. Participants will be instructed to avoid dietary supplements, fortified ready-to-eat cereals, and other high folate content foods during intervention. Blood samples will be collected, after an overnight fast, at baseline and after 4 and 8 weeks of supplementation for determination of primary (DNA methylation profile) and secondary (nutritional, metabolic and health status biomarkers) outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Screening Phase:
* Female 18-40 yr
* Body Mass index 18.5 to 24.9 or \> 30 kg/m2
* Intervention Study:
* Serum folate \< 30 nmol/L
* MTHFR677CC or MTHFR677CT genotype

Exclusion Criteria:

* Currently pregnant, pregnancy within past 12 months
* Greater than 2 previous pregnancies
* Use of prescription drugs other than oral contraceptives
* Chronic disease (diabetes, hypertension,epilepsy,cancer, kidney disease, CVD)
* Acute illness (pneumonia, urinary tract infection, mononucleosis)
* Use of antibiotics in past 30 days
* Current smoker
* Use of dietary supplements including multivitamins in past 30 days
* Habitual consumption of fortified ready-to-eat cereals
* Significant weight change in past 12 months
* Typical alcohol consumption of 2 or more drinks per day
* INTERVENTION: all above plus serum folate \> 30 nmol/L; MTHFR677TT genotype
Improving Diet Protein Intake in Middle-aged Women

The study sought to examine the effectiveness of nutrition education with and without diet coaching on dietary protein intake and muscle mass, strength and function among a group of middle-aged women.

The study sought to examine the effectiveness of nutrition education alone and with 10 weeks of diet coaching on dietary protein intake and muscle mass, strength and function among a group of middle-aged women.

Eligibility Criteria:
Inclusion Criteria:

* able to understand and respond to questions or instructions in English
* working telephone
* willingness to consume protein-containing animal products,
* willingness to make changes to the diet

Exclusion Criteria:

* self-reported information that they have been told by a medical doctor that they have kidney (renal) disease
* current or past history of a diagnosed eating disorder
* have an internal cardiac pacemaker/defibrillator or other metal-type implant present
* vegan dietary practices
* refusal to make changes to usual dietary protein intake
* usual dietary protein intake greater than 1.2 g per kg body weight
Intraocular Pressure (IOP) Lowering Efficacy of Transdermal Brimonidine Therapy

The purpose of this study is to evaluate the safety and effectiveness in lowering intraocular pressure (IOP) utilizing an experimental lotion containing 0.1% Brimonidine that is applied to the outside of one eyelid.

Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma the most common form of glaucoma. Vision loss is caused by damage to the optic nerve. The modern goals of glaucoma management are to avoid glaucomatous damage, nerve damage, preserve visual field and total quality of life for patients with minimal side effects.

Although intraocular pressure is only one of the major risk factors for glaucoma, lowering it via various pharmaceuticals and/or surgical techniques is currently the mainstay of glaucoma treatment. Intraocular pressure can be lowered with medication, usually eye drops. There are several different classes of medications to treat glaucoma with several different medications in each class. In order to prevent blindness from glaucoma, it is critical that patients take their glaucoma eye drops accurately and faithfully for the rest of their lives. Poor compliance with medications and follow-up visits is a major reason for vision loss in glaucoma patients. In addition, coordination involved in placing an eye drop in the eye is considerably more difficult and unpleasant to patients than many other therapies. Thus, localized transdermal eyelid lotion would create a leap in safety of drug delivery while at the same time rendering ocular drugs easy and non traumatic to use.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of stable Chronic Open Angle Glaucoma and stable Vital signs who are controlled on a stable dose of a single IOP lowering agent and who have demonstrated stable target intraocular pressure for a minimum of 3 months.
* Male or Female patients aged at least 18 years of age.
* Females of childbearing potential must use a reliable form of contraception throughout the study period such as celibacy, birth control pills, or condoms.
* A negative urine pregnancy test result at Screening and Baseline (Day 1) for women of childbearing potential
* Best-Corrected Visual Acuity of 20/800 or better in both eyes
* Written informed consent.
* Ability to follow instructions and likely to complete all study visits based upon patient factors such as cognition, reliability, motivation, and ability to obtain reliable transportation to study site.

Exclusion Criteria:

* Uncontrolled glaucoma
* Glaucoma requiring more than a single agent for IOP control
* Patients with a corneal thickness greater then 620 micrometers
* Female patients who are pregnant, nursing, or planning a pregnancy during the study
* Patient who has any situation or condition, which in the investigator's opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the participation in the study
* Uncontrolled or labile hypertension
* At the conclusion of the washout period any study participant with an IOP lower than 22 or greater than 35 mmHg.
Impact of Cocoa Flavanols on Pulmonary Oxygen Uptake Kinetics and Exercise Tolerance in Sedentary Middle-aged Adults

In recent years, there has been significant interest in dietary flavonoids (biologically active plant-derived compounds) as potential therapeutics. This is due to the capacity of flavonoids to enhance processes related to energy metabolism and cardiovascular health. We are interested in implementing a short-term supplementation regime (daily cocoa-flavanoid ingestion), in order to explore the possible beneficial effects of flavonoid-based interventions on responses to exercise. Hence, the objective of our study is to examine the impact of short term cocoa-flavanoid supplementation on processes related to energy use (oxygen utilisation). Our aim is to develop a novel intervention which improves cardiovascular health and enhances exercise tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Aged 35-55 years
* Healthy (no known cardiovascular or metabolic disorders e.g. diabetes)
* Do not engage in regular structured physical training (i.e. less than two sessions for 60 minutes per week, for at least 1 year

Exclusion Criteria:

* Smokers
* Medical history of cardiovascular and/or metabolic disease, including diabetes and abnormal blood pressure
* Family history of cardiovascular disease
* Currently taking any medication
* Asthmatic
* Currently suffering from musculoskeletal injury
* Younger than 35 or older than 55 years old
* Known food allergies or special dietary requirements
* Currently taking any dietary supplements
* Currently engaging in \>2 hours structured training per week
FAST-A Study to Evaluate the Efficacy and Safety of Quetiapin IR in Patients With Acute Psychosis

The purpose of this study is to compare the efficacy of quetiapine IR, following rapid titration versus conventional titration in patients with acute psychosis


Eligibility Criteria:
Inclusion Criteria:

* provision of written informed consent
* male or female, aged 18-65 years
* requirement of hospitalization and in need for antipsychotic treatment for an acute psychotic episode
* able to swallow tablets from Day 1

Exclusion Criteria:

* In-patients who are anticipated to be discharged before evaluation of the primary outcome variable at Day 5
* patients with known relevant clinical disease
* history of syncope, or orthostatic hypotension
* patients with known neutropenia
Dextromethorphan and Silymarin in Chronic Kidney Disease (CKD) Patients

The investigators test the renal and cardiovascular protective effects dextromethorphan and silymarin on patients with the proteinuric chronic kidney diseases, who enrolled in our clinical trial, had progressing kidney diseases and merit aggressive anti-inflammatory therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with Stage 3 or 4 chronic kidney disease as measured by a Modification in Diet in Renal Disease Study (MDRD) estimate of between 15 ml/min and 59 ml/min and and 0.5 g/day\<proteinuria\<3g/day.
2. Age between 18 and 75 years old.
3. Patients without hospitalization for cardiac or infection related morbidity over the previous 2 months(due to the potential confounding effects on baseline study variables).
4. Patients who are able to provide consent to participate in the study.-

Exclusion Criteria:

1. patients will significant mental illness, pregnant women, and other vulnerable populations.
2. Patients with active hepatic disease and/or ALT \> 2.5 times upper limit of normal.
3. Patients with history of congestive heart failure and NYHA Class III-IV symptoms at any time.
4. Patients for whom living donor renal transplantation is already scheduled or in the process of being evaluated, as these patients will be unlikely to complete study protocols before transplantation.
5. Patients with severe co-morbid conditions (eg, symptomatic hepatic cirrhosis, metastatic cancer, HIV infection with AIDS).
6. Patient with active inflammatory process (eg., SLE, rheumatoid arthritis, gout) for which they are currently receiving immune modulating medications.
7. Patients who are on corticosteroid therapy.
8. Patients who do not consent to participate in the study.