cyrilzakka/clinical-trials huggingface dataset:
C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy

When preparing an ICU patient for percutaneous dilational tracheostomy, correct positioning of the endotracheal tube is important. During the procedure, it is possible to puncture the cuff. Tracheal tube cuff puncture can lead to failure of ventilation, loss of positive end-expiratory pressure, and possible aspiration of gastric contents blood or secretions. To minimize the risk, in our ICU, we withdraw the endotracheal tube under direct laryngoscopic vision until the cuff is visible at the vocal cords. This maneuver would also facilitate insertion of the Seldinger needle and insertion of the tracheostomy tube below the endotracheal tube. However, this maneuver to remove the endotracheal tube under direct laryngoscopy can sometimes be difficult. ICU patients present frecuently difficult laryngoscopic vision due to airway edema or secretions. In ICU, the videolaryngopy has been shown to be superior to direct laryngoscopy in visualization the upper airway, allowing better laryngoscopic vision.

The investigators aim to compare C-MAC videolaryngoscopy versus conventional direct laryngoscopy for positioning the tracheal tube to facilitate insertion of the Seldinger needle and the tracheostomy tube below the endotracheal tube during percutaneous tracheostomy.

Eligibility Criteria:
Inclusion Criteria:

* ICU intubated patients that require a percutaneous dilational tracheostomy for clinical reasons (prolonged mechanical ventilation, airway protection or weaning failure).

Exclusion Criteria:

* Patients younger than 18 years and older than 85 years
* Trachea and neck abnormalities.
* Soft tissue infection in the neck.
* History of neck surgery.
* Coagulation disorders or changes in coagulation parameters (platelet count \< 50.000 mm3, an activated partial thromboplastin time 1.5-fold longer than the control value, and international normalized ratio \> 1.5).
* Consent refusal for participating in the trial.
Evaluation of the Positive Prevention PLUS Program

This study aims to determine if the Positive Prevention PLUS teen pregnancy prevention program has an impact on abstinence, birth control use, and likelihood of becoming pregnant.

A clustered randomized controlled trial (CRCT) was employed where participating high school sites were randomly assigned either to a treatment group that implemented the Positive Prevention PLUS program or a control group. Students completed a self-administered survey at baseline (prior to program implementation) and a 6 month follow-up survey (post program implementation). Eligible students in the sample included all male and female 9th-grade students from 21 high schools enrolled in mandatory 9th-grade health, science, or physical education classes, to which the district assigns students randomly. Of the 7,042 eligible students, 4,267 received parental consent and were enrolled in the study. Outcome variables include initiation of sexual activity, ever been pregnant, and birth control use.

Eligibility Criteria:
Inclusion Criteria:

* Must have parental consent and be in the eligible school sites.

Exclusion Criteria:

-
MEN STUDY (ESTUDIO MEN) Quality of Life in Patients With BPH and Nocturia Before and After Tamsulosin Ocas® Treatment

This is an exploratory study, to evaluate the improvement in terms of quality of life that can be reached by a group of outpatients with BPH ( Benign Prostatic Hyperplasia ) and nocturia when they are under treatment with Secotex Ocas.

This study will explore, the progress in terms of quality of life that can be reached by a group of outpatients with BPH ( Benign Prostatic Hyperplasia) and nocturia treated with Secotex OCAS®.

This is a not controlled study, " before and after type", which will consist of an assessment, of the quality of life for outpatients with BPH symptoms including nocturia, through the use of the Spanish version of the Nocturia Quality-of-life (NQoL) questionnaire, at three different moments:

1. Before to start Secotex OCAS® treatment.
2. Thirty (30) days after first visit and starting Secotex OCAS® treatment
3. Ninethy (90) days after first visit and starting Secotex Ocas® treatment

Study Design:

Eligibility Criteria:
Inclusion Criteria:

Men 40 years old with benign prostatic hyperplasia (BPH) which, according their doctor, requires medical treatment to improve quality of life. Patients may be new in the treatment or can be treated with other medicines but not having responded adequately to treatment (Not should be taking Tamsulosin OCAS).

PSA \< 4.0 ng/ml or 4 ¿ 10ng/ml with prior negative Transrectal biopsy. IPSS \> 12 points. Two or more episodes of nocturia per night (score equal or exceed 2 in question 7 of IPSS).

IPSS QoL (Question 8) \> 3 points (score equal or superior to 3 in question 8 of Quality of Life (QoL) of IPSS).

Acceptance written of their participation in the study by the informed consent. The decision of treatment should be based on the best clinical practice accepted standard and according to the information for prescription for Secotex OCAS® 0.4 mg.

Exclusion Criteria:

Patients with clear indication to receive surgical treatment Hospitalized patients Patients with physical or mental disabilities that prevent, even with the help of doctor, completing the instruments of assessment of the survey Patients with a history of malignant disease Patients with known hypersensitivity to tamsulosin or to another component of the product Patients with a history of orthostatic hypotension or severe liver failure Positive digital rectal test for possible neoplasia or biochemical evidence of high PSA with figures \> 4.0 ng/ml Patients with diastolic blood pressure less than 60 mmHg or tachycardia greater to 120 beats per minute

Other reasons for the exclusion:

* Acute Urinary Retention (AUR)
* Urinary tract infection
* Renal failure
Prevention of Preeclampsia With Aspirin in Recipients of Donated Oocytes.

The main objective of this trial is to study the occurrence of preeclampsia in recipients of donated oocytes receiving aspirin at an early stage during pregnancy and to compare the results with those obtained in patients receiving placebo.

Various markers have been proposed for the early diagnosis of preeclampsia: determination of mean arterial pressure; presence of multiple risk factors of preeclampsia; biochemical, ultrasound, and angiogenic markers; uterine artery Doppler, etc. These are used to determinate which patients have an increased risk of developing preeclampsia during gestation, and therefore carry out closer monitoring of pregnancy in this population. In addition, these markers can also identify patients at increased risk of developing other problems such as IUGR or preterm labor.

For nearly 30 years, there have been multiple studies trying to demonstrate that aspirin prevents the onset of preeclampsia with inconclusive results. However, recent studies in which aspirin was administered at an early stage (before 16 weeks of gestation) in patients at high risk of complications, have demonstrated a decrease in the incidence of this entity. Thus, administration of aspirin to patients at high risk (patients classified with a high risk of complications during pregnancy, based on markers mentioned above) seems to be useful in preventing onset of preeclampsia, IUGR and other complications, whenever it is administered at an early stage, as shown by several studies carried out so far.

The incidence of preeclampsia, IUGR and other complications of pregnancy is increased in patients undergoing treatment for ovulation induction, being much higher in recipients of donated oocytes. It appears that this increase may be explained by immunological processes. The focus lies on the interaction between HLA-C fetal antigen with the maternal natural killer cells. We postulate, therefore, that the administration of aspirin in recipients of donated oocytes at an early stage of pregnancy, may also reduce the incidence of preeclampsia in this group of patients.

Moreover, it has been observed that patients with preeclampsia exhibit lower levels of VEGF, PlGF and PAPP-A (factors involved in placental angiogenesis) and that this is accompanied by an increase in the sFlt1 (a potent PIGF and VEGF antagonist).

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years.
* Recipients of donated oocytes.
* Pregnant women.
* Single or twin gestations.
* Patients who accept the conditions of the study by signing the appropriate informed consent.

Exclusion Criteria:

* Known allergy to acetylsalicylic acid .
* Personal history of peptic ulcer.
* Triplets.
* Use of prostaglandin inhibitors within 10 days prior to baseline.
* Personal history of chronic kidney, thyroid, liver or heart disease.
* Psychiatric or cognitive pathology that prevents understanding of the conditions of informed consent.
Changes in and Determinants of Movement Performance, Functional Status, and Health-Related Quality of Life After Stroke Rehabilitation

A total of 144 stroke patients 6 -24 months post onset who are between 45 and 75 years old will be recruited. A randomized-blocks pretest and posttest control group design will be applied. Four groups will be involved in this project and the subjects will be stratified on two variables: impairment level of the hand and side of lesion. Randomization will be done in blocks of six and each block randomization scheme is within each stratum. Treatment regimens will be designed to ensure that patients in 4 groups receive equivalent intensity of treatment (5 days/week for 1.5 hours/day for 4 consecutive weeks) directly supervised by senior occupational therapists.

Brain and movement reorganization will be evaluated with fMRI and kinematic instrument, respectively before and after the 4-week intervention period. Clinical measures on motor impairment, daily function and quality of life will be assessed before, immediately and six months after intervention. Two examiners blind to group allocation will collaborate to provide both fMRI and kinematic evaluations and one of them will administer clinical measures. Before being allowed to work with subjects, the examiner competence will be assessed by principle investigator and co-principle investigators. Multivariate analyses of covariance will be used to examine change in brain activation, kinematic variables and clinical measures as a function of intervention while controlling for pretest data, age and onset post stroke. Multiple regression models will be established to examine the possible predictor(s) for functional outcome of each rehabilitation approach. Canonical correlation analyses will be conducted to quantify the relationship between brain/motor reorganization and clinical measures.


Eligibility Criteria:
Inclusion Criteria:

1. able to reach Brunnstrom stage III or above for the proximal part of the affected upper limb(Brunnstrom, 1970);
2. considerable nonuse of the affected upper limb (amount-of-use \[AOU\] score \< 2.5 on the MAL) (Taub, Miller, Novack, et al. ,1993);
3. no serious cognitive deficits (score \> 24 on the Mini Mental-State Exam) (Folstein, Folstein, \& McHugh, 1975);
4. no balance problems compromising safety when wearing the constraint device; and,
5. no excessive spasticity (Modified Ashworth Scale ≤ 2 at any joint of the upper limb) (Bohannon, \& Smith, 1987).
Anderson Study 1 - Tart Cherry Study

The purpose of this study is to examine if tart cherry reduces food-induced elevations in serum uric acid.

Gout is a painful form of arthritis that is caused by hyperuricemia (high uric acid levels) that form crystals in the joints. Ingestion of food and/or beverages containing high purine levels (e.g., beef, game meats, liver, shellfish, herring, mackerel, anchovies, sardines, mushrooms, dried beans and peas, sweetbreads, excessive alcohol, etc.) increase uric acid levels and thereby can complicate the management of uric acid levels in individuals with hyeruricemia and/or gout. Prior research has shown that ingestion of a chrysanthemum flower oil containing a high level of polyphenols significantly reduced the uricemic response to ingesting a meal high in purines. Additionally, black cherry and grape juice extracts are purported to have uric acid lowering properties. We have previoulsy reported that tart cherry powder, another naturally occuriring source of phlyphenols, lessens exercise-induced inflammation. This study will examine if tart cherry can also reduce the uricemic response to ingesting a high purine containing meal. If so, this may provide another dietary approach to help individuals manage their uric acid levels.

Eligibility Criteria:
Inclusion Criteria:

* They are healthy males or females ages 30 to 60 years with fasting serum uric acid (UA) levels between 5.5 and 8.0 mg/dl obtained during the familiarization/screening visit;
* They have a willingness to provide voluntary, written, informed consent to participate in the study;

Exclusion Criteria:

* They take prescription (Rx) medications (i.e., Uloric, Krystexxa, etc.) or dietary supplements known to have UA-reducing activity (i.e., black cherry, devil's claw, grape seed extracts, etc.);
* They have regular diseases requiring regular prescription (Rx) medications (birth control is allowed);
* They have abnormal/out of range values in laboratory tests determined at the familiarization/screening visit;
* They have an allergy to tart cherry or immunoglobulin E;
* They are pregnant, trying to become pregnant or breastfeeding;
Long Term Safety Study of NVA237 vs QAB149 in COPD Patients

The purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients with COPD according to GOLD 2011 who have signed informed consent.
2. Patients with airflow limitation of 30-80% post-bronchodilator FEV1 at run-in.
3. Current or ex-smokers with a smoking history of at least 10 pack years
4. Patients with a mMRC score of at least 2 at run-in.

Exclusion Criteria:

1. Patients contraindicated for muscarinic antagonist agents and beta-2 agonists
2. Patients with a history of malignancy of any organ system, treated or untreated, within the last five years
3. Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention
4. Patients who had a COPD exacerbation within 6 weeks prior to screening.
5. Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
6. Patients with a history of asthma.
7. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to 40 years of age.
8. Patients with a blood eosinophil count of greater than 600 mm/3 during run-in
9. Patients with concomitant pulmonary disease
10. Patients with a history of certain cardiovascular co-morbid conditions
11. Patients with a diagnosis of alpha-1 anti-trypsin deficiency
12. Patients with active pulmonary tuberculosis
13. Patients in the active phase of a pulmonary rehabilitation programme
14. Other protocol-defined inclusion / exclusion criteria may apply
Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy

Ultrasound guided percutaneous ethanol injection (PEI) is an established method in the treatment of hepatocellular carcinoma (HCC) and considered a safe procedure with severe complications occurring rarely. Previous studies revealed, that the occurrence of bradycardia and sinuatrial blockage is quite frequent during ethanol instillation sometimes accompanied by clinical complications such as unconsciousness, respiratory arrest or seizure like symptoms. Study purpose is to evaluate whether the use of i.v. Atropine before starting ethanol instillation can prevent dysrhythmias during instillation. Study design: randomized, placebo controlled, double blinded study. Atropine or saline solution will be administered intravenously to 40 patients immediately before starting percutaneous ethanol instillation. A 6 line ECG with limb leads will be recorded at rest and during ethanol instillation to reveal possibly occurring dysrhythmias.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hepatoma scheduled for treatment with percutaneous ethanol instillation

Exclusion Criteria:

* contraindication for the administration of atropine like
* narrow angle glaucoma
* mechanic stenoses of the GI-tract
* clinically relevant prostatic hypertrophy
* paralytic ileus
* myasthenia gravis
* severe cerebral sclerosis
* acute lung edema
* acute myocardial infarction
* cardiac insufficiency
* hyperthyroidism
* patients with contraindication to undergo percutaneous ethanol instillation
A Trial of a Preventive Intervention Program for Chilean Families With Depressed Parents

The overall aim of this pilot study is to evaluate the acceptability and feasibility of an adaptation of Beardslee's 'Preventive Intervention Program (PIP) for Depression' in Chilean families.

The PIP is a family intervention directed towards strengthening family functioning and enhancing resilience in children of depressed parents. It comprises several modules that work on psycho-education and skill development within the family nucleus.

A single-blind randomized controlled trial will be conducted with two arms, the intervention arm (n=32) which will receive a home-based PIP for depression, and the TAU arm (n=32).

Being a child with depressed parents is associated with poor health and academic outcomes as well as having four times the likelihood of developing a mood disorder compared to children of non-depressed parents.

Objectives: To evaluate acceptability and feasibility of an adaptation of Beardslee's 'Preventive Intervention Program (PIP) for Depression' in Chilean families, and to measure the clinical effects of this intervention.

Participants: Parents with an episode of Depression in the past 3 months with at least one non-depressed child between the ages of 6-12.

Design: single-blind randomized controlled trial with two groups; the intervention group (n=32), which will receive a home-based PIP for depression, and the treatment-as-usual control group (n=32).

Results: Acceptability and feasibility will be measured by determining whether the trial was successfully conducted and well received by the families and preventionists. Recruitment and delivery of the intervention will be assessed as well as whether there was appropriate response and follow-up, and whether the objectives of the study were reached. Secondary outcomes will look at depressive symptoms, family function, psycho-education, parental competence, adaptive behavior and resilience in children.

Follow-up times: T = 0 baseline, T= 2 months (post-intervention), T=5 months, T=8 months, T=11 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are currently undergoing a depressive episode or have done so in the past 3 months.

Exclusion Criteria:

For parents:

* Alcohol or drug dependence or abuse as assessed by the MINI or being in treatment for substance use.
* Psychosis, personality disorder, bipolar disorder or suicide ideation as assessed by the MINI.
* Having a relationship crisis with current partner. Assessed by self-report or by having attended couple's therapy in the past month.
* Attending family therapy.

For children:

* Being outside the age range of 6-12 years at the time of recruitment.
* Intellectual disability
* Having depression as assessed by the MINI Kid
* Being in treatment for a psychiatric disorder or having taken psychotropic medication in the last month.
Intraductal Secretin Stimulation Test: What Is the Proper Collection Time?

The aim is to evaluate the peak secretory flow rates and bicarbonate concentrations as determined by a 30 minute intraductal secretin stimulation test in patients with a low likelihood of pancreatic pathology and to compare these data to those obtained from our historical patients with suspected chronic pancreatitis. These will be patients in which inadvertent pancreatic cannulation occurs during therapeutic endoscopic retrograde cholangiopancreatography (ERCP) for biliary indications . All study subjects will receive a 5 day follow-up phone call. Enrollment goal is 36 subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥ 18 years of age referred to Indiana University Health, University Hospital for ERCP for a biliary indication, at the discretion of the treating MD (e.g. suspected common bile duct stone, initial post-liver transplant evaluation, suspected or confirmed cholangiocarcinoma, suspected primary sclerosing cholangitis -- see exclusion criterion #12)

Exclusion Criteria:

1. Pregnant woman or breast feeding
2. Age \<18 years
3. Patient unable to give informed consent
4. Patient with a history of pancreatic surgery
5. Patient with a history of pancreatic cancer
6. Patient with a history of acute or chronic pancreatitis
7. Patient with radiographic evidence of acute or chronic pancreatitis on CT, MRCP, or EUS
8. Patient with a current or prior history of average daily alcohol consumption of greater than 60 g per day for more than 2 years
9. Patient with a history of cigarette smoking greater that 20 pack-years
10. Patient with a history of pancreas divisum
11. Evidence of chronic pancreatitis on pancreatogram during ERCP
12. ERCP for an isolated biliary indication with previous biliary sphincterotomy or for biliary stent exchange, when pancreatic entry should easily be avoided by the endoscopist.
13. History of allergy or adverse reactions to secretin
Prospective Clinical Trial of Three Apical Sealing Materials

This prospective comparative randomized clinical trial compares healing and bony regeneration in patients who received 1 of 3 different retrograde filling materials following microsurgical apicoectomies for the treatment of periapical lesions of endodontic origin.

A prospective comparative randomized clinical trial was designed to evaluate the healing and bony regeneration in patients who received 1 of 3 different retrograde filling materials (EndoSequence®, ProRoot® MTA, or Biodentine®) following microsurgical apicoectomies for the treatment of periapical lesions of endodontic origin.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, American Society of Anesthesiologists (ASA) classification I and II
* Any tooth with a single chronic periapical lesion requiring apical microsurgery
* Informed consent signed prior to surgery

Exclusion Criteria:

* Background of drug/alcohol abuse
* Adjacent periapical lesion
* Periodontal disease
Act Healthy! A Controlled Trial of Worksite Health Promotion

The purpose of this project is to determine if a worksite wellness intervention using a theoretically-based self-management model increases confidence for carrying out healthy behaviors and improves health practices of participating employees. The research questions are: 1) does the intervention produce between group differences in behavior self-efficacy and actual health behaviors, 2) are self-efficacy and performance of health behaviors related, and 3) do changes in self-efficacy result in changes in behavior.

The purpose of this project is to see if a six-week education program called Act Healthy! led by trained volunteers from the UM T.E. Atkins Wellness Program is able to help people who take the classes improve their confidence in their ability to choose good health behaviors and carry out new behaviors. The project will use the Stanford University Self-management education model and train volunteers to be teachers. People who work on the MU campus will be recruited to take a 50-minute class once a week for six weeks. Class members will complete questionnaires before and after the class and again three months later that ask about their health behaviors and confidence to perform health behaviors. This information will be analyzed to determine if the classes were effective in helping people act in healthier ways.

Eligibility Criteria:
Inclusion Criteria:

* full-time employee of the University of Missouri

Exclusion Criteria:

* inability to read and speak in English