cyrilzakka/clinical-trials huggingface dataset:
Effects and Costs of Respiratory Muscle Training in Institutionalized Elderly People

The global loss of muscle mass and strength associated with aging is a cause of functional impairment and disability, particularly in the older elderly (\>80 years). Respiratory function can be severely compromised if there is a decrease of respiratory (RM) strength complicated by the presence of comorbidities and physical immobility. In this context, the need for supportive services involves the need for long-term care and consequently the institutionalization.

Previous studies have shown that the increase of RM strength has positive healthy effects, such as the increase in functional capacity, the decrease in RM fatigue, the decrease of dyspnoea and the improvement of quality of life, both in healthy people and patients. Therefore, specific RM training may be regarded as a beneficial alternative to improve RM function, and thus prevent physical and clinical deterioration in this frail population.

Study hypothesis: The inspiratory muscle training (IMT) would improve respiratory muscle strength and endurance, exercise capacity and quality of life in an elderly population, who are unable to engage in general exercise conditioning.


Eligibility Criteria:
Inclusion Criteria:

* People aged \> 65 years
* Barthel Index \< 75 score
* Mini-mental state examination ≥ 20 score
* Inspiratory muscle weakness (MIP ≤ 30% predicted value)

Exclusion Criteria:

* Ability to independently walk more than 14 m
* Significant chronic cardiorespiratory diagnoses
* Acute cardiorespiratory episode during the 2 previous months
* Neurological, muscular, or neuromuscular problems interfering with the capacity to engage in the tests and training protocol
* Active smokers or former smokers (\< 5 years)
* A terminal disease
Effects of Physical Training and Isoflavone Supplementation On Pelvic Floor in Women in the Postmenopausal Period

This study evaluates the effect of Physical Training and Supplementation of Isoflavone About Pelvic Floor Musculature in Women in the Postmenopausal period, and it has two groups the intervetion.

The practice of physical exercise and isoflavone supplementation are ways of treating symptoms of climacteric, there is a lack of evidence as to whether these therapeutics when associated are useful for improving the strength, function, contraction pressure, electrical activity of the pelvic floor musculature of women in the Postmenopausal period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy postmenopausal woman
* to be able to practice exercises on treadmill and weight exercises
* without physical complications that prevent the execution of physical exercises
* have no history of cardiovascular disease, diabetes, renal pathologies or hypertension
* Present ability to contract the pelvic floor muscles

Exclusion Criteria:

* Smokers
* Use hormone therapy or isoflavone
* Use drugs that interfere with lipid and antihypertensive metabolism
* Presence of cognitive impairment or neurological condition that could affect muscle activation
* Present urinary tract infection at the time of data collection
* Training pelvic floor muscle
Awareness of Operating Room Staff About WHO OR Checklist

to understand and analyze awareness of proper timing of when to sing in, time out, and sign out for patients who will be operated in Hail multidisciplinary centers, Saudi Arabia. its role in improving communication in OR, and preventing errors. how frequent not comply and potentials of non compliance. how frequent dose WHO OR check list will cause anxiety in the staff, psychological insult ,potentials to be replaced or adjusted according to each specialty needs.


Eligibility Criteria:
Inclusion Criteria: operating room staff of hail region hospitals -

Exclusion Criteria: none

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fMRI Study of Early Brain Injury in Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease involving multiple organs and systems. The central nervous system is one of the most commonly involved parts, and the involvement of the nervous system is called neuropsychiatric lupus, which is one of the most common complications of SLE and the main cause of death. Cognitive impairment and emotional disorders are the most common neuropsychiatric symptoms, with a prevalence of up to 80%. Studies have shown that the prevalence of NPSLE is between 37% and 95%. Compared with SLE patients, the mortality rate increases by three times. Early diagnosis and treatment play an important role in improving the quality of life of patients. fMRI has the advantages of non-invasive, in vivo and high repeatability, and can detect the brain function changes of patients early before the structural changes. This study uses fMR to compare the differences in brain function changes between SLE patients and healthy controls, explore the neuroimaging mechanism of brain injury, and provide reference for the early clinical intervene.

The fMRI images of 40 SLE patients with neuropsychiatric symptoms, 40 SLE patients without neuropsychiatric symptoms and 40 healthy controls matched by sex, age and education level were collected. fMRI was selected as an evaluation method to compare the differences in brain functional changes among the three groups, and to explore the specific brain regions in the imaging of early brain injury in SLE. Neurocognitive assessment was performed on all subjects, clinical data and laboratory serum markers of SLE patients were collected, and the correlation between SLE patients and specific brain regions was analyzed, and multiple regression models were constructed to provide imaging references for early clinical diagnosis and intervention in the process of NPSLE.

Eligibility Criteria:
Inclusion Criteria:

1. Age and gender matched the case group
2. Right-handed
3. No cerebrovascular, neurological or mental diseases
4. Can cooperate with MRI and neuropsychiatric examination

Exclusion Criteria:

1. Patients with serious diseases of other systems
2. Patients with diseases of central nervous system
3. Other rheumatic immune system diseases
4. Neuropsychiatric history
5. Smokers, drug users or alcoholics
6. Contraindicated MRI
Satisfaction Survey on PINS Stimulator System for Patients With Parkinson's Disease

This study will be done because the investigators would like to evaluate product satisfaction of two PINS products (product A, product B) that are to evaluate the effectiveness of rechargeable and non-rechargeable Deep Brain Stimulation (at baseline visit and at follow-up visit) and by evaluating their responses to the product satisfaction survey that will be given to them by a study coordinator.

Other: IPGs products Patients implanted with the rechargeable IPGs and non-rechargeable were followed before and 3 months after DBS surgery and completed a systematic survey of satisfaction with PINS Stimulator System.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 to 80 years of age.
2. Subject has been diagnosed, by a neurologist, with idiopathic Parkinson's disease.
3. The PD patients can recharge the neurostimulator independently, with favourable compliance and commit to cooperate with the clinical trial study,
4. Subjects are PINS neurostimulator users

Exclusion Criteria:

Subject were major depression with suicidal thoughts (a score of \>25 on the Beck Depression Inventory II,20 with scoresranging from 0 to 63 and higher scores indicating worse functioning), tumor, abnormality in routine liver and renal function, cerebral infarction, hydrocephalus, encephalatrophy, stroke sequela, heart disease, thrombocytopenia, hyperthermalgesia and any medical or psychological problem that would interfere with the conduction of the study protocol.Patients with symptoms of the midline at the state of off medication such as severe language barrier, dysphagia, disequilibrium, slipping-clutch gaitwere excluded. Patients who had undergone other implantation such as cardiac pacemaker, artificial cochlea because of the accompanied diseases such as were excluded. Patients with history of pallidotomy, stereotactic radiofrequency (Gamma Knife) and cell transplantation were also excluded.
Effects of Upper Extremity Immobilization and Use of a Steering Wheel Spinner Knob Following Distal Radius Fracture

The aims of the study are to better understand how upper extremity injury and immobilization influences a patient's steering ability. Patients with acute distal radius fractures treated with surgery will be recruited for study in a driving simulator. The results will hopefully assist physicians to better counsel patients with upper extremity injuries on when it is safe to return to driving.

The ability of an injured person to safely drive an automobile while immobilized in an upper extremity cast or splint is not well defined.

The aims of the study are to better understand how upper extremity injury and immobilization influences a patient's steering ability. The secondary aim is to further evaluate the effectiveness of a steering wheel spinner-knob to assist with one-handed driving. A steering wheel spinner knob may be a surrogate to assist with one handed driving while immobilized.

Eligibility Criteria:
Inclusion Criteria:

* • Acute distal radius fracture treated with surgery and initially immobilized in a cast or splint

  * Valid driver's license with 1 years of driving experience and actively driving during the last three months
  * English speaking
  * Ability to start testing within 10 days of surgery

Exclusion Criteria:

* • \<18 years of age

  * Current use of steering wheel spinner knob or hand controls while driving
  * Non-drivers
  * Multi-trauma
  * Open fractures
  * Surgical repair with external fixation
  * Concurrent distal radius/ulnar joint injury and repair
  * Any other joint besides the wrist immobilized following surgery
  * Contralateral upper extremity disability
  * Previous ipsilateral upper extremity functional deficit
  * Inability to participate for the full length of the study
Study of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido

This study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in naturally menopausal women who are taking estrogen or estrogen/progestin therapy.

Naturally menopausal women with hypoactive sexual desire disorder (HSDD) were randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients were stratified based on presence/absence of uterus and randomized to receive placebo or testosterone transdermal system. Patients had to maintain a stable dose of estrogen/progestin throughout the study. Patients who completed the first 52 weeks of the study were given the opportunity to participate in year 2-4 open-label (active treatment) study extension which was added to the protocol by amendment. Safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabois in evaluation, coagulation testing, and hermatology. Physical exam including clinical assessments of facial hair and acne were monitored.

Eligibility Criteria:
Inclusion Criteria:

Eligible women must:

1. Be 40-70 years old and in generally good health
2. Be post-menopausal with no spontaneous periods for 1 year
3. Be receiving a stable dose of hormone replacement therapy for at least 3 months prior to screening with the intention of maintaining that regimen.
4. Be, in her own judgment, in a stable, monogamous sexual relationship that is perceived to be secure and communicative, for at least one year prior to study entry
5. Meet the criteria for having hypoactive sexual desire disorder

Exclusion Criteria:

Eligible women must not:

1. Have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product)
2. Be experiencing any chronic or acute life stress relating to any major life change
3. Be experiencing depression and/or receiving medication for such illness or disorder
4. Have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages)
5. Have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months
6. Have a history of breast, endometrial, or other gynecological cancer at any time before study participation or other cancer within the last 5 years
7. Have diabetes, a history of cerebrovascular disease, thromboembolic disorders, heart attack, or angina at any time before study participation or thrombophlebitis within the last 5 years
8. Have abnormal laboratory test results upon initial screening for this study
9. Have previously participated in a clinical trial within 30 days or received an investigational medication within 30 days
Monitoring Effect Of Shock Wave On Microcirculation Changes In Type2 Diabetes Mellitus

The purpose of the study is to monitor the effect of low intensity extracorporeal shock wave therapy on impaired nitric oxide synthase and microcirculation changes in type 2 diabetes mellitus with peripheral neuropathy.

Low-intensity extracorporeal shockwave therapy (Li-ESWT) improved peripheral nerve repair and regeneration. Li-ESWT exerts its biological effects by increasing neuro¬trophic factors, Schwann cell activation, and cellular signaling activation. Li-ESWT could be a novel treatment for nerve injury-induced diabetic neuropathy and other conditions related to nerve in¬jury.

Eligibility Criteria:
Inclusion Criteria:

* Patients have to be symptomatically stable with type 2 diabetes mellitus complicated with peripheral neuropathy.
* Optimized pharmacological treatment that will be remained unchanged throughout the study.

Exclusion Criteria:

* Implanted cardiac pacemakers.
* Patients with known skin allergies.
* Presence of skin inflammations.
* Peripheral vascular disease.
* Patients with unstable angina pectoris.
* Progressive ventricular dysrhythmia.
* Intermittent claudication.
HIFU for Focal Ablation of Prostate Tissue: an Observational Study

The Sonablate HIFU device was approved by the U.S.FDA for prostate tissue ablation in October, 2015. The purpose of this observational research study is to investigate the localized treatment of prostate cancer using HIFU through clinical data and health-related quality of life (HRQOL) questionnaires.

This observational study will serve to collect data from medical record review and questionnaires before and after High Intensity Focused Ultrasound (HIFU) for focal ablation of prostate tissue. The subject will have already undergone or opted to receive the HIFU procedure as part of standard of care in order to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 40 years to 85 years
2. Subject has elected or already undergone HIFU therapy as their standard of care treatment methodand declined alternative treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
3. PSA ≤ 20
4. Prostate volume of ≤ 70 cc
5. Ability to complete informed consent form

Exclusion Criteria:

1. Prior treatment for prostate cancer (with the exception of androgen deprivation therapy)
2. Medical contraindication to follow-up mpMRI or prostate biopsy
3. Unable to tolerate general or regional anesthesia
4. Positive bone scan (only if bone scan has been done or clinically indicated. Bone scan does not need to be performed for study eligibility determination.)
Optimizing Physical Activity Outcomes After Total Knee Arthroplasty

Although total knee arthroplasty is an effective intervention for decreasing knee pain and improving physical function, physical activity levels remain low up to a year after surgery. This study will use mobile-health technology to deliver an intervention designed to improve physical activity behavior for Veterans recovering from total knee arthroplasty. The study will assess the effectiveness of using behavior-change intervention as a supplement to conventional rehabilitation to improve physical activity. The intervention will be delivered using home-based tablet computers for Veterans to have remote interaction with the researcher and real-time physical activity feedback from a wrist-worn activity sensor.

This randomized clinical trial will assess the efficacy of using physical activity behavior change intervention for Veterans recovering from total knee arthroplasty. Testing will occur at baseline (before surgery), at intervention midpoint (8 weeks after surgery), end of intervention (14 weeks after surgery), and 24 weeks after intervention. The primary outcome is accelerometer-assessed daily step count. Secondary outcomes include the percent time engaged in standing and walking activity and physical function (Six-Minute Walk, 30-Second Chair-Stand Test, Timed Up-and-Go, Western Ontario and McMaster Universities Osteoarthritis Index, and the Veterans RAND 12-Item Health Survey.

Eligibility Criteria:
Inclusion Criteria:

* Veteran
* Planned unilateral total knee arthroplasty

Exclusion Criteria:

* Severe non-surgical limb pain (pain \>5/10 on non-surgical limb with walking)
* Unstable orthopedic, neurologic, or pulmonary condition that limits function
* Unstable cardiac condition
* Uncontrolled hypertension
* Uncontrolled diabetes
* Acute systemic infection
* Active cancer treatment
* Recent stroke (within 2 years)
Telephone Tinnitus Education for Patients With Traumatic Brain Injury (TBI)

This study continues the investigators' efforts to develop tinnitus management protocols for Veterans. More specifically, this study developed and evaluated an adaptation of Progressive Tinnitus Management (PTM) for use as a telephone-based program for Veterans and military personnel who have experienced TBI. This adaptation, called Tele-PTM, is a telephone-based program and has the potential of providing needed tinnitus services to Veterans with and without TBI for a relatively small cost and with minimal impact on individual VA hospitals.

Traumatic brain injury (TBI) is strongly associated with tinnitus. Tinnitus management for Veterans and military members with TBI has become a critical concern. The investigators' research has focused on developing effective, evidence-based methods of tinnitus management for Veterans. These efforts led to the development of Progressive Tinnitus Management (PTM). The investigators completed a pilot study to adapt PTM to meet the unique tinnitus management needs of Veterans and military members with TBI using a novel home-based telehealth program called Tele-PTM. Preliminary data analyses indicated that Tele-PTM is effective. The present study modified the PTM program in accordance with pilot study findings and evaluated Tele-PTM using a randomized clinical trial design.

The 4-year study was based at the VA National Center for Rehabilitative Auditory Research (NCRAR). Tele-PTM was implemented and evaluated in a randomized clinical trial. Qualified candidates were randomized to receive either Tele-PTM or Wait-List Control (WLC). All subjects completed questionnaires at baseline and at 3, 6, 9, and 12 months post-baseline. The WLC group received Tele-PTM after completing the 6-month questionnaires. The primary outcome measure was the Tinnitus Functional Index (TFI).

Tele-PTM involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.

Tele-PTM has the potential of providing needed tinnitus services to Veterans and active military personnel across the country for a relatively small cost and with minimal impact on individual VA hospitals.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria include:

* "clinically significant" tinnitus according to the initial score on the Tinnitus and Hearing Survey (THS) (minimum total score of 4 on section A; if score is 4-6, one item must be at least 3);
* demonstrates understanding of the requirements of the study (based on adequate responses to the questions by the RC that assess capacity-to-consent);
* has had a hearing test within the past 2 years (and was fitted with hearing aids if appropriate); and
* motivated and capable of participating (including ability to communicate over the telephone in English).

Exclusion Criteria:

* Callers who do not meet all of these criteria will be excluded from study participation.
Activation of Young Men - Population-Based Randomised Controlled Trial

The aim of the study is to investigate different novel IC technologies for promoting physical activity and health and preventing obesity in young men. The purpose is to provide new evidence-based knowledge on the effectiveness of an ICT-based physical activation and to identify factors predicting a positive response.

Specific objectives

* to identify the factors associated with physical activity and physical activity relationship in young men
* to develop an interactive method, based on peer networks, aimed at activating young men with use of their own skills, participation and modern ICT
* to assess the effectiveness of the chosen activation on the physical activity, weight, fitness, health, and relationship towards physical activity among young men

The study population consists of all conscription aged men in the Oulu area in 2011-2013 (n=4000). Conscription-aged men provide a large, population based representative sample of young men. In Finland military service is mandatory and annually all 18-year old men are called for military service. In the call-ups fitness for service is determined based on medical examination.

All those who are determined fit for service or who are granted postponement due to obesity will be invited for the activation intervention study. Those with severe obesity are exempted from service, but will also participate in the trial. After the call-up, the men will be randomised to an intervention group and a control group. The primary outcome variable is change in physical activity.

The study will be conducted during 2011-2015. The study includes technology development (ICT platform), collection of cross-sectional data at the call-ups, and a 6-month physical activity intervention (a randomized controlled trial) implemented between the call-up and start of military service. Game mechanics are integrated into the ICT platform to increase user engagement and participation.

Physical activity, fitness (aerobic and muscular), body composition,lifestyle and psychological and physical health will be followed. In addition, the subjects' entry into military service and its course will be followed.


Eligibility Criteria:
Inclusion Criteria:

* All men born 1995 liable for military service and attending call-ups in Oulu area at 2013

Exclusion Criteria:

* Severe physical or mental illness