cyrilzakka/clinical-trials huggingface dataset:
Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma

This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adult patients aged 18-75 years with persistent asthma
* Patients with persistent asthma, diagnosed according to the Global Initiative for Asthma guidelines (GINA) and who additionally met the following criteria:

  1. Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to Visit 1.
  2. Patients with a forced expiratory volume in 1 second (FEV1) at Visit 1 of ≥ 50% of the predicted normal value. This criterion for FEV1 had to be demonstrated after a washout period of at least 6 hours during which no short acting β2-agonist had been inhaled, and a minimum of 48 hours for a long acting β2-agonist.
  3. Patients who demonstrated an increase of ≥12% and ≥200 mL in FEV1 over their pre-bronchodilator value 30 minutes after inhaling a total of 200 μg of salbutamol (or albuterol) via metered dose inhaler (MDI) (the reversibility test). Reversibility had to be demonstrated after an appropriate washout period of at least 6 hrs prior to the evaluation for a shortacting β2-agonist. The administration of salbutamol (or albuterol) for the reversibility test was to be within 30 minutes after pre-bronchodilator spirometry. Reversibility had to be demonstrated at Visit 1 or between Visits 1 and 2, in order for patients to be included in the trial.
  4. For each patient, the smaller value of the Visit 1 FEV1 or the Visit 2 FEV1 pre-dose value had to be at least 85% of the larger value.
* Body mass index (BMI) between 18 and 32 kg/m\^2 and weight \>50 kg.
* patients using local contraception

Exclusion Criteria:

* Pregnant or nursing women
* Recent use of tobacco or history of smoking \> 10 pack years
* Patients diagnosed with chronic obstructive pulmonary disease (COPD)
* Patients with recent experience of severe asthma attack/exacerbation within 6-months of study start
* Patients with frequent rescue medication (\>8 puffs/day for two consecutive days)
* Clinically relevant laboratory abnormality or a clinically significant condition
* Active cancer or a history of cancer with less than 5 years disease free survival time
* History of long QT syndrome or with long QTc interval prior to dosing
* History of hypersensitivity to the study drugs or to drugs with similar chemical structures
* Use of certain medications
* Use of other investigational drugs
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
* History of immunodeficiency diseases, including a positive human immumodeficiency virus (HIV) test result.
* History of drug or alcohol abuse or evidence of such abuse

Other protocol-defined inclusion/exclusion criteria may apply.
Venner a.p. Advance Video Laryngoscope

The purpose of this study was to compare the Venner a.p. advance video laryngoscope to Miller laryngoscope during resuscitation with and without chest compressions.

Endotracheal intubation (ETI) is a life-saving procedure performed daily in emergency medicine. The European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. However, ETI with uninterrupted chest compression in patients can be a very difficult skill to acquire.

Eligibility Criteria:
Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel (paramedics, nurses, physicians

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases
Double-S: a Wearable Device for Erectile Dysfunction

The purpose of this study is to use a minimally invasive erectile device for patients suffering from erectile dysfunction.

The purpose of the study is to use a minimally invasive erectile device support to provide to patients suffering from erectile dysfunction the possibility to achieve satisfactory penetrating intercourse.

The goal of this is to help men who have issues with erectile function (e.g.after radical prostatectomy for prostate cancer, vascular or metabolic erectile dysfunction non-responsive to phosphodiesterase-5 inhibitor medications, etc.) to have medication-free mechanical support for their penis in order to obtain sexual penetration satisfactorily.

Eligibility Criteria:
Inclusion Criteria:

* males \>18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy and/or radiation therapy for prostate cancer and or other pelvic malignancies affecting the sexual potency; emotional and psychological ED; organic vascular and/or metabolic ED etc.)
* having a female partner willing to participate in the study

Exclusion Criteria:

* not willing to attempt sexual vaginal intercourse with their partner
* inability to wear/operate the external penile device for any reason
Effectiveness of Internet-based Self-help Money Management Program Among Adult With Severe Mental Illness

This experimental study aims to develop an internet-based self-help money management program that improve financial self-efficacy and its associated adverse outcomes among adult population with severe mental illness. In particular, this study compares the efficacy of the internet-delivered self-help money management program with the wait-list control group.

The online money management program course will consist of 4 weekly modules, incorporating the key components of money management and the Model of Human Occupation (MOHO). The program include the concept of money management, money management skill, and risk of financial exploitation. The main component of each module will be presented in video format, quiz, and homework. Materials will be presented interactively to facilitate engagement.

Money management is necessary for people with severe mental illness (SMI) to live safely in the community. Collective evidence has suggested that mental disorder leads to drift into poverty, is strong. Most of them struggle to meet basic needs with their existing income. Financial instability has been consistently linked to an increased risk of relapse. This experimental study aims to develop an internet-based self-help money management program that improve financial self-efficacy and its associated adverse outcomes among adult population with severe mental illness. Its efficacy will be compared with the wait-list control group. We hypothesized that (1) participants who received a money management program will improve financial self-efficacy after the intervention as compared with the wait-list controls; (2) participants from the money management program will have better financial well-being after the intervention as compared with the wait-list controls.

The online money management program course will consist of 4 weekly modules, incorporating the key components of money management and the Model of Human Occupation (MOHO), including the concept of money management, money management skill, and risk of financial exploitation. Each module will consist of the main component presented in video format, quiz, and homework. Materials will be presented interactively to facilitate engagement.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents
* Age ≥18 years
* Carrying a diagnosis of mental illness
* Being able to read Chinese
* Have a computer, tablet and/or smartphone device with Internet access
* Willing to give informed consent and comply with the trial protocol

Exclusion Criteria:

Nil
New Clinical Applications for Internet-based Cognitive Behavior Therapy for Insomnia and Depression

This study includes two sub-trials. Both are included in this singe registration since they have parallel inclusion of participants and have been approved by the Swedish ethics board together in one application.

Trial 1 includes patients with both insomnia and major or minor depression. Participants are randomized to either a combined therapist guided Internet-CBT for insomnia and depression, or to Internet-CBT for depression with an addition of a placebo intervention for insomnia. The primary purpose is to evaluate changes in insomnia and depression severity for the combination treatment compared to the depression treatment, after treatment and at 6 and 36 months follow up. A secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through mass media and the Internet psychiatry clinic's regular patient recruitment.

Trial 2 includes patients with insomnia who do not meet criteria for major or minor depression. All participants start therapist guided Internet-CBT for insomnia. After 4 weeks patients that are judged to be at risk of treatment failure are randomized to either continued treatment or treatment with added support intended to enhance outcome. The primary purpose is to evaluate change in insomnia severity for participants who get added support, compared to continued treatment with regular support level. A secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through mass media and the Internet psychiatry clinic's regular patient recruitment.

NOTE:

The first participants in trial 1 will be regarded as pilots, due to problems with the experimental treatment: technical issues as well as problems with the design of treatment modules. These problems were corrected when discovered. 12 participants in the experimental arm were affected by these errors. The pilot participants will not be included in the main analyses of data. This was decided upon on 31st of October 2014.


Eligibility Criteria:
Inclusion Criteria:

* Clinical level of Insomnia (more than 10 on ISI)
* Meets criteria for Insomnia according to DSM-IV-TR
* Enough language skills
* Only Trial 1: Meets criteria for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of \>19 is required).

Exclusion Criteria:

* Sleep disorders requiring other treatment
* Alcohol/drugs abuse
* Started to use or changed the dose of antidepressant drug during the last 2 months
* Somatic or psychiatric conditions requiring acute care
* Working night shifts
* Only Trial 2: Meets criteria for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of \>19 is required for exclusion).
Gut Hormones After Oral Versus Intravenous Amino Acids

The study hypothesis is that gut hormones are released after oral but not intravenous amino acids which result in stimulation of insulin secretion.

Amino acid mixture is given orally or intravenously to match total concentrations of amino acids in healthy subjects. Samples are taken regularly for 300 min after administrations. Plasma levels of the gut hormones glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1)and determined and related to plasma levels of insulin and glucagon.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Diabetes
* Liver disease
* Kidney disease
* Thyroid disease
The Effect of Physiotherapy Treatment Following Gynaecological Surgery

Optimal pelvic floor muscle function is known to assist bladder and bowel function and control, pelvic organ support, as well as other areas of health. It is also known that problems in some of tehse areas can be a consequence of pelvic surgery. By addressing the requirements for good bladder and bowel function/control, and organ support in the early post-surgery phase when tissue repair and scar formation are critical, it is proposed that there will be a rduction in the longterm prevalence of bladder problems, bowel difficulties and weakened pelvic floor and abdominal muscles in post-surgery patients. This study is a randomised controlled trial to compare patients undergoing a physiotherapy-supervised pelvic floor muscle training and behavioural therapy program with a control group. It is hypothesised that at the 12 month post-operative follow-up assessment, the treatment group will demonstrate better outcomes in bladder and bowel function and control, as well as stronger pelvic floor muscle contractile strength than the control group.

Optimal pelvic floor muscle function is known to assist bladder and bowel function and control, pelvic organ support, as well as other areas of pelvic health. It is also known that problems in some of these areas can develop after pelvic surgery. By addressing the requirements for good bladder and bowel function/control, and organ support in the early post-surgical phase when tissue repair and scar formation are critical, it is proposed that there will be a reduction in the long-term prevalence of bladder and bowel dysfunction, and weak pelvic floor and abdominal muscles in post-surgical patients. There have been no previous studies investigating whether a physiotherapy intervention can assist pelvic function in this group of surgical patients.

This study aims to investigate the effect of a physiotherapy treatment program on pelvic function following gynaecological surgery.

Comparisons: Pre- and post-operative physiotherapy treatment vs no treatment following gynaecological surgery.

Outcome measures: Pelvic floor muscle strength, urine leakage, quality of life, sexual functioning, general fitness, measured at 3, 6 and 12 months post-operatively

Eligibility Criteria:
Inclusion Criteria:

* undergoing vaginal gynaecological surgery, for hysterectomy or prolapse repair

Exclusion Criteria:

* surgery for malignancy
* anti-incontinence surgery
* laparotomy
The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache

To develop a pragmatic migraine model the investigators will induce headache in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache responds to sumatriptan injection, the model can be used to test new drug candidates.

There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Cilostazol, a phosphodiesterase inhibitor induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO). To validate this model, the headache must respond to specific migraine treatment with sumatriptan.

Hypothesis: Cilostazol induces a migraine-like headache in MO-patients and the induced headache responds to sumatriptan injection Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.

Eligibility Criteria:
Inclusion Criteria:

* Migraine patients who meet IHS criteria for migraine with or without aura of both sexes
* 18-70 years
* 45-95 kg.

Exclusion Criteria:

* Any other type of headache then migraine without aura (except episodic tension-type headache \< 1 day per week)
* Serious somatic or psychiatric disease
* Pregnancy
* Intake of daily medication (except oral contraceptives)
* Triptan non-responders
Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla.(Group C ) A Randomized Controlled Clinical Trial

20 patients were selected requiring implant placement and divided randomly into two groups (10 in each group)

* for the study group, starter drill is used to locate the point of insertion as planned then pilot drill is also used to the full desired working length after that all other sequential drills are used at a low speed (50-70 rpm) without irrigation .
* In the study group: implant will be inserted in the low speed osteotomy site.
* In the control group: implants will be inserted in the conventional prepared osteotomy site.
* For both groups there is no surgical guide used.
* The flap will then be copiously irrigated with saline in preparation for closure.
* The flap will then be closed using interrupted 4/0 resorbable sutures.


Eligibility Criteria:
Inclusion Criteria:

* Patients restoring missing maxillary teeth with implant placement.
* Both sexes.
* Age: 25-45
* Mesio-distal dimensions: Not less than 6 mm
* Bone Height: Not less than 12 mm
* Bucco-lingual dimensions: Not less than 8mm
* All measures will be assessed using CBCT.

Exclusion Criteria:

* Sites needing bone grafting or augmentation.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
Effect of the Exoskeleton for Assisting Ambulatory Activities in People With Subacute Stroke

Background: Although rehabilitation activities, including physical therapy, are known to be beneficial for stroke patients, many patients still have poor walking function, especially after the acute phase of three months, where the recovery of lower limb walking ability through traditional rehabilitation therapy gradually decreases, requiring alternative approaches. Exoskeleton robots appear to provide benefits for stroke patients by providing exercise guidance, thus improving their independent gait endurance and stair climbing ability. For stroke patients who cannot continue to improve through general rehabilitation and have ongoing mobility difficulties, exoskeletons may be a potential solution. However, previous literature on the use of exoskeletons to assist gait training has had mixed results, with one major reason being that the frequency of use is too low or the duration of use is too short, due to the high cost and inconvenience of travel to medical institutions. Therefore, it is necessary to find ways to enable patients to use them frequently and for a long period.

Method: investigators designed a non-blinded, randomized crossover trial to observe the potential benefits of using the device at home for one month. Patients were randomly divided into two groups, one receiving traditional rehabilitation first and the other using the exoskeleton first. There were four time points for testing: before, after the first stage of treatment, after the second stage of treatment, and one month after completing the second stage, to observe the sustained effects.

The testing involved executing a 6-minute walk test, timed up and go test, and a 10-step stair test (up and down) both with and without the device. An electronic software app was used to record daily usage time to determine the quantity and degree of home use.

Analysis: Repeated measures ANOVA models were used to analyze the effects and correlations of the experiment. The effects of the duration/frequency of use on dosage were also analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with first-time stroke, with onset time within 1 month to 2 years from the time of recruitment, and all participants must sign an informed consent form.
2. Patients must have independent walking ability, with or without cane.
3. Lower limb muscle tone Modified Ashworth Scale \<3.
4. Able to perform a 25-meter walking test and a 10-step stair test without assistance from others.
5. Cognitive function Mini-Mental State Examination \> 23 points.

Exclusion Criteria:

1. Combined with other central nervous system problems, such as brain tumors or spinal cord injuries.
2. Clearly, lower limb joint diseases that cannot achieve complete hip, knee, and ankle joint activity are not excluded, but mild joint activity limitations caused by stroke are not excluded.
3. Skin diseases that are not suitable for contact with exoskeleton devices.
4. Unable to cooperate with the two-month research plan.
Long-term Study of The Press Fit Condylar (P.F.C.) Sigma Total Knee Replacement System

The main purpose of this study is to record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals to assess the functioning and symptomology of each knee following surgery.

In addition, any adverse events or complications are to be recorded, and any device failures or early revisions are to be recorded and reported directly to the Sponsor. The data are to be used in an evaluation of the performance of the P.F.C. Sigma knee implants over a minimum of 5 years.

The primary outcome measures are detailed above in the brief summary. Secondary outcomes are any adverse events or complications and any device failures or early revisions to be recorded and reported.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have given voluntary written informed consent to participate in this study.
* Patients for whom primary Total Knee Replacement is indicated due to degenerative joint disease, including rheumatoid arthritis, osteoarthritis, avascular necrosis, and post-traumatic arthritis, which is causing pain, deformity, or limitation of function uncontrolled by medical treatment.
* Patients who, in the opinion of the Investigator, are able to understand this study, co-operate with the investigational procedures and are willing to return to the hospital for all the scheduled post-operative follow-ups.
* Male or female patients who are skeletally mature and for whom an appropriate size of device is available.

Exclusion Criteria:

* Patients scheduled for Revision Total Knee Arthroplasty, or who have had previous surgery to their knee except menisectomy, arthroscopy or synovectomy.
* Patients experiencing any condition that may, in the opinion of the Investigator, interfere with the Total Knee Replacement's survival or outcome (e.g. Paget's disease, Charcot's disease, severe osteoporosis, etc.)
* Patients who have evidence of active infections which may spread to other areas of the body (e.g. osteomyelitis, pyrogenic infection of the knee joint, overt infection, etc.).
* Patients who are currently participating in any other clinical investigation of a device or pharmaceutical.
* Patients having non-contained defects in the tibia or femur necessitating bone graft.
* Patients with psychosocial disorders that would limit rehabilitation or follow-up.
* Subjects with a known history of poor compliance to medical treatment.
* Subjects who are known drug or alcohol abusers.
* Other contraindications for the use of the P.F.C. ® S Knee System as listed in the package insert.
Transrectal Photoacoustic Imaging of the Prostate

The purpose of this study is to image human prostate tissue using a new transrectal photoacoustic imaging probe and correlate this with ultrasound and MRI imaging performed once the specimen has been surgically removed. We hope to see what we can visualize with our device as this has never been done before. Eventually, we hope to use a similar device to image the prostate in men being seen by their doctor for prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with clinically-localized prostate cancer
* Participant desires prostatectomy
* Male
* Patient receiving treatment at Palo Alto Veterans Administration (VA) Hospital
* Age 18 to 80 years old
* English-speaking

Exclusion Criteria:

* Cannot tolerate a surgical prostatectomy due to medical comorbidities
* Cannot give informed consent