cyrilzakka/clinical-trials huggingface dataset:
Trial to Evaluate the Effects of the German eCHECKUP TO GO in Students

The purpose of this study is to evaluate the effects of the German eCHECKUP TO GO (eCHUG-D) in students. Compared to the control group subjects who conducted eCHUG-D should have less alcohol consumption and less alcohol associated problems after three and six months.

The effectivity of the eCHUG-D will be checked through a prospective randomized-controlled web-study.

All students at the participating universities will be informed about the PsSt-study. They have to agree to the informed consent to take part in the study. A missing agreement leads to exclusion. All subjects get an individual random login-code for study participation. After random assignment (intervention (eCHUG-D) vs. control group) all subjects have to answer the same web-questionnaires about their alcohol consumption (see outcome variables). Subjects of the intervention group are then requested to conduct eCHUG-D and to fill in their login-code at the end of the program.

The 3-month and 6-month follow-ups contain similar questions about alcohol consumption and alcohol related consequences. On 6-month follow-up additional questions ask about the acceptance of eCHUG-D (intervention group) and the acceptance of the study in general (control condition).

Earlier studies showed the effectiveness of eCHUG in US college samples. The primary endpoint of the study ist the amount of alcohol consumed. We hypothesize that the eCHUG group will show significantly lower levels of alcohol intake than the control group

Eligibility Criteria:
Inclusion Criteria:

* any student

Exclusion Criteria:

* ongoing recuperation
Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction

This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.


Eligibility Criteria:
Inclusion Criteria:

* Males 18 years-of-age or older
* Stable, heterosexual relationship for at least 6 months
* A history of erectile dysfunction (ED) for at least 6 months

Exclusion Criteria:

* Any underlying cardiovascular condition, including unstable angina pectoris
* History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1
* Uncontrolled atrial fibrillation / flutter at screening
* History of surgical prostatectomy for prostate cancer
* Hereditary degenerative retinal disorders
* History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision
* Presence of penile anatomical abnormalities
* Subjects who have been confirmed with phenylketonuria (PKU)
* Spinal cord injury
* Resting or postural hypotension or hypertension
* Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and erythromycin
* Use of any treatment for ED within 7 days of Visit 1
* History of congenital QT prolongation
* History of syncope within the last 6 months prior to entry into the study
Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma

Open-angle glaucoma is a degeneration of the optic nerve, highlighted by campimetric alterations, and wose only current therapeutic target is the lowering of the intra-ocular pressure (using eye drops, surgery or laser). MEMOPTIC is a tablet combining citicoline, magnesium and Gingko biloba, which have a neuroprotective effect already used in neurodegenerative diseases such as Alzheimer's disease for example. Citicoline has also shown several promising results in ophthalmological diseases (glaucoma, amblyopia or more recently in ischemic optic neuropathies). The citicoline used in eye drops (NEURODROP) has already shown results on the preservation of the vision of glaucomatous patients.

The purpose of this project is to determine if MEMOPTIC can have an effect, in addition to the conventional treatments, in the preservation of vision of patients treated for an open-angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of GCAO defined by OCT RNFL alterations and visual fields defects
* age between 20 and 80 years old
* Well controled intra-ocular pressure under treatment (PIO\<21mmHg or decreased by 20% compared to initial the PIO)

Exclusion Criteria:

* retinal or macular disease
* diagnosis of cataract or surgery of cataract during the follow-up
* allergy to citicolin
* ocular hypertonia due to a secondary cause (like corticosteroids)
* history of anterior, intermediate or posterior uveitis
* general treatment affecting PIO (beta blockers, corticosteroids)
* pregnancy or breastfeeding
Comparing Satisfaction With a Participatory Driven Web-application and a Standard Website

This project studies the effects of involving patients in the development of a web-application.

The point-prevalence of low back pain (LBP) has been estimated to 9.4 % and LBP is in many countries the most frequent reason to consult a general practitioner. However, general practitioners are under pressure with increasing workloads. The increasing number of patients and the typical 10-15 minutes of available time for each patient are challenging the provision of sufficient information and advice. According to international guidelines information and advice are recommended for every patient with LBP, therefore, new methods to support general practitioners (GPs) are very much needed. Online technologies give new opportunities to extend the treatment. Furthermore, involving patients with LBP in the development of online information material may produce more user friendly content and design and thereby increasing patients' acceptance and usage. Thus, optimizing clinical outcome. This project will study patients' satisfaction and clinical outcomes of a web-application for patients with LBP consulted in general practice compared to best existing technology (the Patient Handbook).

Eligibility Criteria:
Inclusion Criteria:

* Contacting general practice with low back pain

Exclusion Criteria:

* Spinal stenosis
* Spine fractures
* Cauda equina syndrome
* Spinal malignancy
* Osteoporosis
* Spondyloarthritis
* Without Danish reading skills
* Without internet access
* Pregnant women
Montelukast With Status Asthmaticus, Ages 2-5

The purpose of this study is to determine if montelukast, in addition to standard treatment is helpful in treating patients ages 2-5 who are in the hospital because of status asthmaticus.

This is a prospective study of montelukast efficacy in addition to standard treatment of status asthmaticus in children from 2-5 years old who are in the PICU. Children who meet eligibility requirements will be randomized to receive a rapid-dissolving oral dose of montelukast or placebo. Once enrolled, a baseline modified Wood's-Downes clinical asthma severity score will be recorded pre and post completion of a standard nebulized albuterol treatment of 0.15 mg/kg/dose (min2.5mg/dose). Patients who are able will have FEV1 measurements obtained at predetermined intervals for determination of clinical asthma severity score. Blood samples for PK analysis will be collected prior to study drug administration and at predetermined time intervals to determine the plasma level of montelukast. In addition, a blood sample will be obtained for genetic study of polymorphisms of CYP3A4, CYP3A5, and CYP2C9.

Eligibility Criteria:
Inclusion Criteria:

* Participant's parent/legal guardian must give written informed consent prior to study participation. When appropriate, written assent from the child will also be obtained.
* Participant, male or female, must be 2 to 5 years of age.
* Participant must have a history of reactive airway disease (RAD) or asthma, and must currently be admitted for an acute exacerbation of RAD or asthma.
* Primary physician must believe that patient would benefit from improved bronchodilation and improvement in clinical asthma severity score.
* Participant must have received standard therapy for status asthmaticus: Oxygen as needed; 3 nebulized albuterol treatments of at least 2.5mg/dose; Methylprednisolone or prednisone loading dose of 2mg/kg; Ongoing methylprednisolone therapy @ 0.5mg/kg every 6

Exclusion Criteria:

* Known hypersensitivity to montelukast
* Chronic lung disease
* Cardiac or pulmonary congenital anomalies
* Known renal disease
* Known hepatic disease
* Known immunologic disorders other than allergy and atopy
* Other explanations for respiratory distress
* Use of leukotriene modifiers within 2 weeks of the acute presentation
* Intubated patients
Phase 4 Study - Mucinex D as Adjunct Therapy

The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection.


Eligibility Criteria:
Inclusion Criteria:

* Ages Eligible for Study: 18 to 75 years,
* Genders Eligible for Study: Both
* Adult patients presenting at the physician's office with symptoms diagnostic for acute respiratory infection, such as bronchitis or rhinosinusitis; with a clinical diagnosis of acute respiratory infection, meeting the physician's usual diagnostic criteria in practice for prescription of oral antibiotics.
* The investigator will evaluate patients on a total of seven criteria for inclusion.

Exclusion Criteria:

* Have chronic, recurring respiratory signs and symptoms, such as allergic rhinitis or chronic bronchitis, which, in the investigator's opinion, would confound interpretation of symptoms ratings for the acute respiratory infection;
* The Investigator will evaluate patients on twelve additional criteria for exclusion.
A Double-blind, Randomized, Controlled Trial of Quetiapine Versus Haloperidol for the Treatment of Delirium

The purpose of this study is to determine whether quetiapine, and haloperidol are effective and safe in the treatment psychiatric symptoms in patients with delirium.

A delirious state often founds in general hospitals and remains a significant cause of death. Existing methods of treatment includes identification and elimination of factors contributing to the delirium in addition to pharmacological and nonpharmacological treatment interventions (Trzepacz et al., 1999). Antipsychotics can play an important role in the management of the symptoms of delirium.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 -75 years
* Was admitted in Maharaj Nakhon Chiang Mai hospital
* Was diagnosed by the diagnostic criteria for DSM-IV-TR delirium due to a general medical condition or delirium due to multiple etiologies
* Delirious state (delirium) of the patients was confirmed by using name-assess confusion assessment method (CAM) and assessment of severity with delirium rating scale-revised-98 (DRS-R-98)
* Have a written consent from the legal representatives

Exclusion Criteria:

* Was diagnosed substance withdrawal delirium
* Having a history drug allergy either from quetiapine or haloperidol
* Female patients who are pregnant or breastfeeding
* No written consent from the legal representatives
* Received other anti-psychotic drug before attend the study
* Being ill with renal or hepatic failure
ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing (ACROBAT)

Evaluation of 24-hour antihypertensive effect of long-acting ARB-CCB tablet administrated to hypertensive patients with atrial fibrillation, and comparison of 24-hour antihypertensive effect of long-acting ARB-CCB tablet between morning administration and bedtime administration.


Eligibility Criteria:
Inclusion Criteria:

1. Hypertensive patients who meet the following conditions:

   Patients who meet any of the following standards of blood pressure after administration of 40 mg/day telmisartan or 5 mg/day amlodipine for 4 weeks:

   - Blood pressure at hospital visit: Systolic blood pressure is 140 mmHg or higher, and/or diastolic blood pressure is 90 mmHg or higher.

   (average of 3 measurements obtained at a scheduled visit)

   - Blood pressure at home: Systolic blood pressure is 135 mmHg or higher, and/or diastolic blood pressure is 85 mmHg or higher.

   (average of measurements for the 5 days prior to drug assignment \[4 measurements per day in total: 2 in the morning and 2 before bedtime\])
2. Patients with atrial fibrillation detected on an electrocardiogram within the last 2 years prior to obtaining informed consent.
3. Age: 20 years old or older (at time of informed consent)
4. Sex: male or female
5. Clinical classification: Outpatient
6. Patients who give written consent of agreement to voluntarily participate in the clinical study.

Exclusion Criteria:

1. Patients with serious liver and/or kidney disease
2. Patients with history of allergy to telmisartan or amlodipine
3. Patients receiving antihypertensives other than telmisartan or amlodipine during observation period
4. Patients diagnosed with persistent atrial fibrillation or chronic (permanent) atrial fibrillation.
5. Patients with atrial fibrillation caused by irreversible illness (e.g., heart surgery, pulmonary embolism, or hyperthyroidism)
6. Patients with average systolic blood pressure at hospital visit higher than 180 mmHg during observation period.
7. Patients with New York Heart Association (NYHA) class III-IV heart failure, patients with heart failure requiring hospitalization, or patients with poor left ventricular function.
8. Patients who have stroke or cardiac infarction within 6 months before giving consent.
9. Patients planning to undergo pulmonary artery ablation surgery or any surgical procedure (including PCI).
10. Patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant.
11. In addition, patients who are determined as not eligible by their study doctor.
Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002)

The purpose of this study is to assess the efficacy and safety of MK-1200 monotherapy in participants with advanced/metastatic gastric/gastroesophageal junction (GEJ) cancer, esophageal cancer, biliary tract cancer, and pancreatic ductal adenocarcinoma who have received, or been intolerant to, all treatments known to confer clinical benefit. Part 1 of the study will be a dose escalation to determine the maximum tolerated dose (MTD). Part 2 will evaluate safety and efficacy of MK-1200 at 2 different doses


Eligibility Criteria:
Inclusion Criteria:

* Confirmed advanced (unresectable and/or metastatic) solid tumor: gastric cancer (including gastroesophageal junction cancer), esophageal cancer, biliary tract cancer, or pancreatic ductal adenocarcinoma
* Participants who experienced Adverse Events (AEs) due to previous anticancer therapies must have recovered to \< Grade 1 or baseline
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
* Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
* Participants with a history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable
* Received and progressed on or after 1 or 2 prior lines of therapy

Exclusion Criteria:

* Active severe digestive disease
* History of acute myocardial infarction; unstable angina; stroke or transient ischemic attack within 6 months prior to the first dose of study intervention
* Diabetes or hypertension that cannot be controlled by medication
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before study intervention
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Known additional malignancy that is progressing or has required active treatment within the past 2 years
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Active infection requiring systemic therapy
* Have not adequately recovered from major surgery or have ongoing surgical complications
Vascular Markers During OGTT in Diabetics and First-degree Relatives

Arterial stiffness is associated with increased risk for cardiovascular disease. Moreover, the integrity of endothelial glycocalyx plays a vital role in vascular permeability, inflammation and elasticity. The association between damage of endothelial glycocalyx, impaired arterial elastic properties, and CFR in diabetics and first degree relatives has not been explored. The purpose of this study is to explore the association between damage of endothelial glycocalyx, impaired arterial elastic properties, and CFR in diabetics and first-degree relatives before and after during oral glucose tolerance test (OGTT).

The investigators plan to examine 90 subjects without known diabetes a standard 75-gr oral glucose tolerance test (OGTT) will be performed. \[30 first degree relatives of diabetics with normal OGTT (relatives), 30 with normal OGTT and no family history of diabetes (normals), and 30 with abnormal OGTT (diabetics) matched for age and sex\].

Plasma glucose and serum insulin levels will be measured in venous blood collected at 0, 30, 60, 90 and 120min after glucose loading. At the same time intervals, the investigators will measure:

1. the carotid to femoral pulse wave velocity (PWVc) using the Complior apparatus
2. the aortic pulse wave velocity (PWVa), central systolic blood pressure (cSBP) and augmentation index (AI) using an oscillometric method (Arteriograph,TensioMed) as markers of arterial stiffness and wave reflections
3. the coronary flow reserve (CFR) at baseline and after adenosine infusion (140 μg × kg-1 × min-1) for 3 minutes to assess coronary vasomotor function
4. the perfusion boundary region (PBR- micrometers) of the sublingual arterial microvessels (ranged from 5-25 micrometers) using Sideview Darkfield imaging (Microscan, Glycocheck). Increased PBR is considered an accurate non invasive index of reduced endothelial glycocalyx thickness.

In addition, the investigators will measure free fatty acids, triglycerides, glycerol, C reactive protein (CRP), transforming growth factor-b (TGF-b), Lipoprotein-Associated Phospholipase A2, (LP-LPA2), tumor necrosis factor (TNF-a), interleukin 6 (IL6) and interleukin 10 (IL10) propeptide of type I procollagen, (PIP), propeptide of procollagen type III (PIIINP), matrix metallopeptidases 9 and 2 (MMP 9 and 2), macrophage-colony stimulating factor ( MCSF).

The investigators will measure insulin resistance a) after fasting, using homeostatic model assessment (HOMA) and hepatic insulin sensitivity (HIS) b) during oral glucose tolerance test (OGTT) using Matsuda index and insulin sensitivity index (ISI). The investigators will categorize patients in those with normal (\<140 mg/dl at 120 min) and those with abnormal OGTT (\>200mg/dl at 120min).

Eligibility Criteria:
Inclusion Criteria:

* subjects without known diabetes
* first degree relatives of diabetics

Exclusion Criteria:

* coronary or valvular heart disease
* congestive heart failure
* peripheral vascular disease
* liver or kidney failure
* history of alcohol or drug abuse
Influence of Sevoflurane and Desflurane on Postoperative Sore Throat

This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of sevoflurane or desflurane.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Patients scheduled for general anesthesia with endotracheal intubation

Exclusion Criteria:

* Difficult airway
* Friable teeth
* Rapid sequence induction
* Recent sore throat
* Recent upper respiratory infection
* Asthma
* Chronic obstructive pulmonary disease
* Chronic cough
* Arrhythmia
* Coronary disease
* Heart failure
* Pregnancy
* Allergy to sevoflurane
* Allergy to desflurane
* Fever after halogenated anesthetics
* Jaundice after halogenated anesthetics
* Malignant hyperthremia
* Allergy to remifentanil
* Friable teeth
* History of head and neck surgery
* Multiple intubation attempts
* Regional anesthetic agents
* Gastric tube
* Dexamethasone
* Severe hypovolemia
An Asthma Collaboration to Reduce Childhood Asthma Disparities on the Navajo Nation

National Jewish Health and The University of Arizona worked with Navajo Nation organizations to develop this program to improve the health of children with asthma. The Navajo Community Asthma Program will have two main parts. One will train doctors and health care professionals to improve the diagnosis and treatment of asthma. The second part will work with area schools to provide education to school nurses, teachers, and children to help them better understand asthma. The project also works with families to help them know how to best take care of their child's asthma. A major project aim is to make sure that doctors, teachers, and families work together to manage asthma.


Eligibility Criteria:
The project will involve three Navajo Nation Agencies: Tuba City, Chinle, and Fort Defiance. Project interventions will run for one year in each Agency. Interventions are population-level interventions. No intervention will be administered at the individual level.

Inclusion Criteria:

- The study will be conducted within three agencies on the Navajo Nation, each of which has its own IHS service unit. The three agencies are Chinle, Tuba City, and Fort Defiance.

Exclusion Criteria:

- This protocol pertains only to the three agencies listed above.

Community interviewees will be interested candidates who meet the following eligibility criteria:

Inclusion Criteria:

1. Able and willing to provide informed consent
2. Greater than or equal to 18 years of age
3. Guardianship of a child younger than 18 years of age who has been diagnosed with asthma
4. Able to read and/or understand English or Navajo

Exclusion Criteria:

1. Unable or unwilling to provide informed consent
2. Younger than 18 years of age, without presence of guardian
3. Unable to read and/or understand English or Navajo