cyrilzakka/clinical-trials huggingface dataset:
Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia

This study is designed as cross-over double-blind placebo-controlled randomized clinical trial that 40 diabetic patients with sleep disorder with the inclusion criteria will enter into the study and randomly assign to first intervention and first placebo groups.The primary outcomes are change in sleep disorder and metabolic parameters that will be evaluated at the end of the study.

Considering the high prevalence of sleep disturbance in diabetic patients and the effectiveness of lavender in treatment of sleep disorders in this study the efficacy of Lavender aromatherapy in sleep disorder and metabolic parameters in diabetic patients will be investigated. This study is designed as cross-over double-blind placebo-controlled randomized clinical trial that 40 diabetic patients with sleep disorder with the inclusion criteria will enter into the study and randomly assign to first intervention and first placebo groups.The primary outcomes are change in sleep disorder and metabolic parameters that will be evaluated at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 2
* Age between 25-65 years old
* Fasting Blood Sugar between 70-130
* 2 hour post prandial glucose less than 180.
* HbA1C less than 7
* Sleep disorder according to pittsburgh Insomnia Rating Scale more than 5.

Exclusion Criteria:

* Any systemic illnesses
* Use of sedative or antidepressant drugs
* Pregnancy
* Lactation
* History of allergic reaction to Lavender
* History of allergic rhinitis, asthma and respiratory disorders
* Anosmia
* Headache that start with smell
* Cigarette smocking or substance abuse
* Hospitalization or surgery within 1 months ago.
* Work shift
A Nurse-led Individualized Educational Intervention

60 newly referred patients with psoriasis at the Department of Dermatology and Allergy, Herlev and Gentofte Hospital, Denmark will be consecutive included in the study. In the first phase of the study 30 patients will receive standard treatment (control group) and in the following phase 30 patients will receive the individualized conversational/educational intervention (intervention group).The rationale for using a historical control group instead of a randomised control group is that it in"real-life setting" is unpractical to realize a communicative intervention, because clinicians unintentional can intervene against the control group.

The first conversation will take place when the newly referred patient has initiated a new treatment. The rational for this is that the time of transition from private practice to the Department of Dermatology and Allergy is characterised by failed treatment, typically phototherapy or topical. This meaning that newly referred patients current needs is to get their psoriasis under control. When patients have initiated a medical treatment they will be more motivated and have better surplus to engage in the conversational/educational intervention.

Patients in the intervention group will receive an individual face-to-face conversation with a duration of 45 min. All patients will have access to telephone counselling by their primary nurse when needed and able to arrange a new face-to-face conversation. After 4-6 weeks the face-to-face the nurse will of conversation reach out to the patient by phone to follow up on the earlier conversation. Three months after the face-to-face conversation the nurse will offer the patient a closing face-to-face conversation of 15 min at the same time where the patient has a doctor appointment at the department. Those who are in the control group will continue standard care and not receive any conversation and be used as the control group.

The intervention will be provided by a team of specialized dermatological nurses who have received a formal training on patient-centred communication, Self-regulatory Model/Common Sense Model interviewing, the life with chronic disease and action plan support.


Eligibility Criteria:
Inclusion Criteria:

* Newly referred patients with psoriasis at the Department of Dermatology and Allergy, Herlev and Gentofte Hospital, 18 years or older and understand Danish.

Exclusion Criteria:

* Patients younger than 18 years
Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy

This will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four commercially available bowel preparations among patients undergoing colonoscopy for screening and surveillance in a single tertiary academic medical center.

We will randomize 300 consecutive patients undergoing colonoscopy for screening or surveillance purposes to receive one of four bowel purgatives. These purgatives include

1. Split dose 4 liter polyethylene glycol with electrolytes (PEG+E): Brand name GoLytely
2. Split dose 2 liter polyethylene glycol with ascorbic acid (PEG+Asc): Brand name: MoviPrep
3. Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid (P+MC): Brand name Prepopik
4. Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution (sulfate): Brand name Suprep

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or greater
2. Ability to understand and complete questionnaires
3. Ability to speak and read English
4. Willingness to participate in study
5. Colonoscopy is being performed for routine screening (i.e. no prior personal history of polyps or cancer) or surveillance (i.e. follow up for a personal history of polyps) purposes

Exclusion Criteria:

1. Previous bowel resection of any kind (small or large bowel)
2. End stage renal disease (ESRD)
3. Contraindication to bowel purgative
4. Necessity for inpatient admission to receive bowel preparation for any reason
5. Currently taking any narcotic/opiate pain or anticholinergic medication (since these may predispose to higher colon stool burden at baseline)
6. Currently taking stool softeners (e.g. Miralax, Amitiza, Linzess, lactulose) or stimulant laxatives (e.g. Dulcolax)
7. Subject did not follow appropriate dosing instructions for bowel purgative
8. Colonoscopy is being performed to evaluate a clinical symptom such as rectal bleeding, constipation, abdominal pain, or diarrhea
9. History of colon polyposis syndrome
10. Personal history of inflammatory bowel disease
11. History of inadequate colon preparation on any prior colonoscopies
12. Patient is pregnant
An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Depression

The purpose of the study is to evaluate the efficacy and safety of SR58611A in elderly patients with depression.The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in elderly patients with depression. The secondary objectives are to evaluate the safety of SR58611A and to evaluate the efficacy of SR58611A on disability and quality of life in elderly patients with depression.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients or inpatients
* Major Depressive Disorder (MDD) with a recurrent Major Depressive Episode (MDE) according to DSM IV-TR criteria.
* MADRS score equal of above 22.

Exclusion Criteria:

* Patients with a current significant risk of suicide in the investigator's clinical judgment.
* The duration of the current depressive episode is greater than 2 years.
* Patients whose current depressive episode is secondary to a general medical condition
* Patients with a lifetime history according to MINI at screening of:bipolar disorder, psychotic disorder, antisocial personality disorder.
* Patients with a current history according to MINI at screening of anxiety disorders, alcohol dependence or abuse or substance dependence or abuse
* Patients with severe or unstable concomitant medical conditions.
* History of seizures other than a single childhood febrile seizure.
* Patients with abnormal thyroid functioning.
* Patients with clinically significant ECG findings at screening.
* Patients who have taken an investigational drug in the last 3 months prior to screening.
* Any subject who has previously participated in a SR58611A protocol.
* Patients with Mini-Mental State Examination (MMSE) score \< 25 at screening.
Fatigue Self-Management in Primary Care

This study will evaluate, in a primary care setting, the effectiveness of a brief self-management behavioral treatment in patients with medically unexplained chronic fatigue. The hypothesis will be tested that fatigue self-management will yield improvements in fatigue,functioning, and distress in comparison to the two control conditions: standard medical care alone or standard medical care plus an attention control symptom monitoring condition.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of unexplained chronic fatigue
* diagnosis of chronic fatigue syndrome

Exclusion Criteria:

* medically explained fatigue
* any psychosis or dementia
Evaluation of Vital Capacity

Respiratory failure is the most common cause of death in neuromuscular diseases. The aim of this research is to evaluate the thoracopulmonary recruitment by comparison of inspiratory vital capacity (VC ins)and inspiratory/expiratory vital capacity (VC ins-ex) with the vital capacity (VC) according to pathology and severity of pulmonary damage of patients with neuromuscular diseases. The methodology consists in realize VC by support of inspiratory/expiratory pressures, while the patient is passive and realizing a maximal inspiratory/expiratory effort simultaneously, with the aid of mechanical insufflation/exsufflation device (Cough Assist®). The evaluation will last for 30 minutes and the non-inclusion criteria are those for an insufflation. The study hypothesis is that long term insufflation/exsufflation device use could improve thoracopulmonary mobility.


Eligibility Criteria:
Inclusion Criteria:

* consent form signature
* Men and women aged over or equal to 18 years old
* Medical examination before the research
* Negative results of tests of pregnancy for the women at age to procreate or taking an effective contraceptive
* Patients with neuromuscular pathologies without tracheostmy - Vital Capacity \< 80% of theoretical value

Exclusion Criteria:

* Refuse to participate at the research
* Patient under guardianship or under trusteeship
* pregnant Women
* Patients unable to cooperate
* Patients without a security social scheme (as beneficiary or bearer of rights)
* Usual contra-indications for an insufflation (haemoptise, recent pneumothorax, pulmonary emphysema, pleuresy, nausea, chronic obstructive pulmonary diseasee or asthma, recent lobectomy, intracranial hypertension, troubles of consciousness, unable to talk)
VT ART Consortium: Radioablation for Ventricular Tachycardia

The overall objective of the study is to evaluate the efficacy and safety of stereotactic radiation therapy in the non invasive ablation of ventricular tachycardia refractory to any other type treatment.

By agreeing to participate in this study, the patient will undergo an initial evaluation to verify that his or her condition meets the inclusion criteria required for participation. At that visit,

* 12-lead ECG will be performed
* Echocardiography
* CT scan of the chest
* Laboratory tests: NT proBNP, HS Troponin I
* PMK device evaluation The study will have a duration of 60 months and will involve 52 patients with the same disease from which one is affected. Specifically, the total expected duration of individual subject participation in the study will be 60 months.

Participation in the study does not involve any expense for the patient or any compensation.

Participation in the study may involve some risks such as :: pericarditis, actinic pneumonia, worsening heart failure, exitus.

The following benefits can be expected from participation in this study: reduction of VT episodes compared to the pre-treatment period, reduction/total discontinuation of antiarrhythmic drugs compared to baseline (before radioablation), improvement of cardiac parameters compared to baseline : LVEF, left ventricular end-diastolic volume/diameter, end-systolic volume/diameter, RVEF and TAPSE for right ventricular function, improvement of patient's quality of life (SF-36) compared to baseline. No direct benefits may also emerge from the study, but still significant for research.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with refractory VT
2. age \> 18 years
3. Patients with ICDs for follow-up
4. Ineligible for heart transplantation.
5. Prognosis of not less than 1 year
6. Ability to express autonomous consent to therapies or (in case of inability due to clinical condition) deferred consent (first indicated by the referring clinician, later expressed by the patient once recovered to autonomous condition

Exclusion Criteria:

1. Evaluation of ICD demonstrating polymorphic VT;
2. Patients with INTERMACS class greater than 4;
3. Patients with LVAD;
4. Patients with active neoplastic disease undergoing oncological treatment.
Rehabilitation of Reconstructed Shoulder Rotator Cuff

The aim of this study to define the optimal rehabilitation for clients with full thickness rotator cuff reconstruction, with two goals: 1. Finding the optimal physical therapy dosage in enhancing post-operative outcomes of shoulder pain, shoulder joint range of motion, shoulder muscle strength, upper extremity function; and 2. Finding the effect of aquatic physical therapy in enhancing the post-operative outcomes.

Measurement devices:

Biodex: Biodex system is a muscle strength testing and rehabilitation instrument used in the testing and rehabilitation services for shoulder, elbow, wrist, hip, knee and ankle. Modes of operation for exercise and testing include isokinetic, passive, isometric, isotonic, and reactive eccentric. Patients are tested for their muscle performance for the required number of repetitions in the required mode. The muscle performance is measured by calculating the average peak torque (in Nm) and analyzed across the group of patients.

Goniometer: A manual devise used to measure joint range of motion. Visual Analogue Scale: A scale with 0 to 10, with 0 being no pain, and 10 being severe pain.

Measurement procedure:

All the subjects posted for surgery will be tested prior to and again 6 weeks following surgery for:

Shoulder Pain is measured using a visual analog scale. Shoulder Range of motion is measured using a standard goniometer. Shoulder Muscle performances are measured using Biodex.

Eligibility Criteria:
Inclusion Criteria:

* full thickness rotator cuff tear treated by arthroscopic or mini-open repair by a specialized upper extremity surgeons
* mentally competent
* able to read and write
* able to return for follow-up
* 18-65 years old

Exclusion Criteria:

* associated surgical procedures (Concomitant fractures, capsular releases surgical decompression)
* nerve injury
* neurological conditions
* irreparable massive rotator cuff tear, and
* comorbid health problems that limit rehabilitation potential (Rheumatoid arthritis, Diabetes).
Six Month Study of Gentamicin in Duchenne Muscular Dystrophy With Stop Codons

The purpose of this study is to determine the safety of giving intravenous (IV) gentamicin to boys with Duchenne muscular dystrophy who have stop codon mutations.

The primary purpose of this second cohort is to see if the IV Medication, gentamicin, is safe to give twice a week for six months to boys with Duchenne muscular dystrophy (DMD). Secondarily, we want to know if gentamicin can help strengthen the muscles of boys with DMD who have a particular type of genetic mutation known as a stop codon. The gentamicin is thought to allow for "read-through" of this type of mutation which would allow for the production of dystrophin, a protein which is lacking in boys with DMD.

Eligibility Criteria:
Inclusion Criteria:

* Age 5-20 years
* Duchenne muscular dystrophy documented by written report of stop codon mutation analysis of the dystrophin gene.
* Subject is capable of cooperating for efficacy and safety testing
* Absent dystrophin on muscle biopsy
* Subjects may be untreated, taking prednisone or comparable corticosteroids
* Subjects taking corticosteroids must be on the same dose for at least 3 months (90 days) prior to the start of the study.

Exclusion Criteria:

* Known allergy to any aminoglycoside or sulfate compounds
* Current use of potential nephrotoxic or ototoxic drug
* Current use of corticosteroids has not been stable for 3 months (90) days
* Known mutation at nucleotide 1555 in 12S rRNA gene of mitochondrial DNA (predisposes to aminoglycoside hearing loss and commercially available via Athena Diagnostics Lab). This DNA testing (Hearing susceptibility test) will be made available through funding from this grant.
* Inability to hear within the range of 0 to 25 dB in any hearing frequency by pure tone audiometry
* Cystatin C equal to or \> 1.4mg/L
* Other medical condition that would impede the conduct of study (e.g., congestive heart failure)
The Adaptation and Evaluation of the WHO's ASSIST-linked Brief Intervention to Khat-Using Ethiopian University Students

The leaves of the khat tree (catha edulis) are traditionally chewed in the countries around the Horn of Africa. They contain the amphetamine-like alkaloid cathinone and their use can produce a Substance Use Disorder. The researchers intent to validate an Amharic and an Oromo version of the WHO's ASSIST-linked Brief Intervention among khat-using Ethiopian university students. In an RCT, khat using students of Jimma University with initial motivation to stop or cut down khat use will be randomised to either an intervention or a control group. In the intervention group, the WHO's ASSIST-linked BI will be delivered in a single session by trained local counsellors. In the control group, participants will receive a neuropsychological assessment (Raven's Standard Progressive Matrices, SPM; Raven, 1972). Khat use, the neuropsychological variables and psychiatric symptoms will be assessed before the intervention and two weeks after it. Additionally, the researchers will measure the participants resistance during the session. The control group will receive the intervention after the post test. In order to study state variables that influence brief intervention effectivity, e.g. by increasing or reducing resistance, the researchers randomise subjects in each study arm to several short pre-interventions that are based on Gollwitzer's empirically well established Mindset Theory of Action Phases (for summary: Gollwitzer \& Keller, 2016). This means, before delivering the ASSIST-linked BI (intervention group) or before the SPM assessment (controlgroup) a specific psychological state will be induced by a brief writing task that theoretically should affect the openness to the intervention: (1) implemental mindset, (2) deliberative mindset, (3) no mindset induction. The researchers expect that khat use will be reduced more in the intervention condition compared to the control condition and that induced states influence the effectiveness of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* second year student or higher year student at Jimma University
* khat use in the month prior to baseline
* participant's wish to reduce or stop khat use

Exclusion Criteria:

* severe substance use, except khat
* inability to read and write Amharic or Oromo languages
* ongoing acute episode of severe mental disorder
* current suicidal ideation
A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2)

A study to compare the bronchodilatory effect of a single dose of Mometasone Furoate/Formoterol Fumarate (MF/F) pressurized metered dose inhaler (MDI) delivered with and without an AeroChamber Plus® with Flow-Vu® Anti-Static Valved Holding Chamber (spacer) versus Placebo MDI (combined with and without spacer) and formoterol fumarate (F) dry powder inhaler (DPI). Participants were randomly assigned to 1 of 6 treatment sequences and each participant was to receive a single dose of each of 4 treatments in each period. Each treatment period was separated by a 5 to 7 day washout period. It assumed that a single dose MF/F MDI 100/10 microgram (mcg) delivered with a spacer would produce bronchodilation, defined as a significant increase in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours (AUC\[0-12 hr\]) when compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of asthma of at least 6 months duration
* Must have taken an Inhaled Corticosteroid (\[ICS\]; alone or in combination with a long-acting beta-2 Agonist \[LABA\]) for at least 3 months prior to the Screening Visit and must have been on a stable daily dose for at least 2 weeks prior to the Screening Visit
* FEV1 must be at least 70% predicted after all restricted medications have been withheld for the appropriate intervals
* Must demonstrate an increase in absolute FEV1 of at least 12% within 30 minutes after administration of 360 mcg albuterol (4 inhalations x 90 mcg, ex-actuator) or of nebulized albuterol (2.5 mg), if confirmed as standard office practice

Exclusion Criteria:

* Has been treated in the emergency room for a severe asthma exacerbation requiring systemic glucocorticosteroid treatment, or hospitalized for management of airway obstruction within 3 months prior to the Screening Visit
* Has required ventilator support for respiratory failure secondary to asthma
* Demonstrates a decrease in absolute FEV1 of \>20% at any time from the Screening Visit up to and including the Baseline Visit
* Requires the use of greater than 8 inhalations per day of short-acting beta-2 agonists (SABA) MDI, or 2 or more nebulized treatments per day of 2.5 mg SABA on any 2 consecutive days from the Screening Visit up to and including the Baseline Visit
* Experiences a clinical deterioration in asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids, but allowing SABA) as judged by the investigator, at any time from the Screening Visit up to and including the Baseline Visit
PMS Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention

The objective of this study is to collect data on the use of the WIRION system in Patients undergoing Percutaneous Intervention of Saphenous Vein Graft (SVG).

WIRION system is used as protection device in patients undergoing SVG stenting procedure. This retrospective study collects data on the usability of the WIRION during the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent percutaneous intervention (PI) of SVG stenting in which the WIRIONTM system was used.
* Patient is greater than or equal to 18 years of age.

Exclusion Criteria:

* Undergone cardiac surgery in the past 60 days before the procedure.