cyrilzakka/clinical-trials huggingface dataset:
Correction of Vitamin D Inadequacy in Nursing Home Residents

Vitamin D inadequacy continues to be neglected in nursing home residents. We hypothesized that part of this neglect is due to absence of data documenting safe and effective ways to replete this inadequacy.

Vitamin D inadequacy continues to be neglected in nursing home residents. We hypothesized that part of this neglect is due to absence of data documenting safe and effective ways to replete this inadequacy. Subjects with low vitamin D concentrations are dosed with 50.000 IU three times a week for 25 hydroxy vitamin D, parathyroid hormone and bone turnover status. .

Eligibility Criteria:
Inclusion Criteria:

* Able to walk
* Reside in nursing home for the 12 weeks of study

Exclusion Criteria:

* Non-ambulatory residents
Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple Sclerosis

The primary objective of the study was to evaluate the effect of Nerispirdine (50 mg or 400 mg) and placebo given orally as a single dose once a week in crossover design on latency of Visual Evoked Potentials (VEP) P100 in optic nerves.

Secondary objectives included evaluation of the effect of Nerispirdine on VEP amplitude and other visual parameters including visual acuity and contrast, as well as evaluation of the safety and tolerability of Nerispirdine in patients with Multiple Sclerosis (MS).

Contrast sensitivity and visual acuity examinations (in addition to Optical Coherence Tomography \[OCT\] and VEPs) were needed during the screening period for defining etiologic relationships (if non-MS related impairment) and for assessing the effect of treatment of age-related eye disease versus the MS-related vision impairment.

The crossover design included 3 treatment periods 1 week apart and 6 treatment sequences. Study participation were to be 5 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Clinically definite MS (McDonald criteria), which includes patients with remitting-relapsing, secondary progressive, progressive-relapsing, or primary progressive MS who have had a past history of Optic Neuritis.

Exclusion Criteria:

* Multiple sclerosis exacerbation within 60 days of the Screening Visit and the relapse involved the visual fields or visual acuity
* No eye with appropriate degree of lesions for this study as defined by criteria based on degree of visual acuity deficit, refractive error, VEP P100 latency and average retinal nerve fiber layer thickness of as measured by Optical Coherence Tomography (OCT)
* Any MS-unrelated prior ophthalmological impairment (eg, compressive, ischemic, toxic, or nutritional optic neuropathies, Leber's hereditary optic atrophy)
* Previously exposed to 3,4-diaminopyridine or 4-aminopyridine

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Effect of Progressive Relaxation Exercise on Nurses

This study aims to examine the effect of progressive relaxation exercise on nurses' life satisfaction, comfort and burnout levels. Data will be collected by using Descriptive Characteristics Information Form, Satisfaction with Life Scale, Nurse Comfort Scale and Burnout Scale. The nurses in the intervention group will be asked to perform relaxation exercises. The nurses in the control group will not receive any intervention.

This study aims to examine the effect of progressive relaxation exercise on nurses' life satisfaction, comfort and burnout levels. This study will be conducted as a randomized controlled experimental study. Data will be collected by using Descriptive Characteristics Information Form, Satisfaction with Life Scale, Nurse Comfort Scale and Burnout Scale. The nurses in the intervention group will be asked to perform relaxation exercises 3 days a week for 5 weeks, 20 minutes in each practice. The nurses in the control group will not receive any intervention.

Eligibility Criteria:
Inclusion Criteria:

Working as a nurse in a tertiary treatment center for at least 3 years Have not participated in any relaxation exercise Absence of neurological/psychiatric disorders Not having an obstacle to exercise Nurses who volunteered to participate in the study will be included in the study.

Exclusion Criteria:

Individuals who have any exercise program and use any relaxation method (yoga, acupuncture, massage, music therapy, etc.) will not be included in the study.
Intraoperative Goal-directed Fluid Management

The investigators propose to determine esophageal Doppler goal-directed fluid requirements in lean, overweight, obese, and morbidly obese patients with the goal of developing a body mass index (BMI)-specific fluid replacement strategy. Specifically, th investigators will test the hypothesis that perioperative fluid requirements on a per-kg basis varies as a function of BMI. Individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or genital prolapse repair will be eligible to participate

Recent evidence suggests that goal-directed fluid management using stroke volume (blood ejected by the heart) is the most physiologic approach for fluid replacement. We propose to develop a body mass index (BMI)-specific fluid replacement formula based on stroke volume guidance.

Arterial pulse pressure variation (dPP) induced by mechanical ventilation is a proposed predictor of fluid responsiveness as well. We will therefore also investigate if stroke volume (measured by esophageal Doppler monitoring) and pulse pressure variation comparably predict fluid responsiveness by simultaneously measuring both parameters.

Adequate tissue oxygenation is essential to maintain normal physiologic functions. Fat tissue oxygenation is critically low in the obese surgical patient. It is likely that poor fat tissue oxygenation results in part from inadequate fluid replacement. We propose to determine if fat tissue oxygenation is comparable from lean to morbidly obese patients when fluid replacement is optimized.

Individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or genital prolapse repair will be assigned to six groups according to BMI, from lean to morbidly obese categories. The primary aim will be to develop a statistical equation for predicting fluid requirements as a function of BMI. A maximum of 100 patients will be able to detect an R-squared of 10% or more with 90% power at the 0.05 significance level, and will enable adequate estimation of the relationship of interest.

Eligibility Criteria:
Inclusion Criteria:

1. Women, aged \> 18 years old
2. Scheduled for elective, open abdominal or vaginal hysterectomies.

Patients will be recruited in the following body mass index categories:

1. 18.5-24.9 BMI \[kg/m2\]
2. 25.0-29.9 BMI \[kg/m2\]
3. 30.0-34.9 BMI \[kg/m2\]
4. 35.0-39.9 BMI \[kg/m2\]
5. 40.0-44.9 BMI \[kg/m2\]
6. \> 45 BMI \[kg/m2\]

Exclusion Criteria:

1. Hysterectomies due to gynecologic cancer diagnosis
2. Signs and/or symptoms of decompensate heart failure
3. End-stage renal disease
4. History of susceptibility to malignant hyperthermia or porphyria
5. Esophageal disease (excepting gastro-esophageal reflux without any other esophageal alteration)
Interest of Animal-assisted Therapy With Dogs in the Treatment of Depression

This study is a randomized controlled trial (comparing "occupational activities" versus "dog-assisted therapy" arms) investigating the effectiveness of animal-assisted therapy with dogs in small groups of participants with depression. Patients in the "dog-assisted therapy" arm will participate in two group sessions (groups of 3 to 7 participants) of canine-assisted therapy, supervised by a healthcare professional certified in animal-assisted therapy alongside a psychiatric caregiver, for 30 minutes each week over 6 weeks. Patients in the "occupational activities" arm will participate in two group sessions (groups of 3 to 7 participants) of occupational activities, supervised by a healthcare professional experienced in group occupational activities alongside a psychiatric caregiver, for 30 minutes each week over 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 to 65
* Patient affiliated with a social security scheme
* Patient hospitalized under voluntary psychiatric care
* Diagnosis of depression according to DSM-5-TR criteria
* QIDS-C16 score ≥11 at screening
* QIDS-SR16 score ≥11 at screening and inclusion

Exclusion Criteria:

* Severe comorbid psychiatric disorder
* Imminent risk of suicidal behavior
* Unstable comorbid somatic condition
* Vulnerable patients (under guardianship, curatorship, or judicial protection)
* Known fear of dogs
* Known allergy to dog fur
Independent Predictors Analysis and Model Construction of Cavitary Central Lung Cancer

This study is a retrospective, multicenter clinical study. The main goal is to identify the risk factors for cavity formation in central-type lung cancer lesions, and to construct a prediction model for cavity formation in central-type lung cancer lesions based on the above risk factors.


Eligibility Criteria:
Inclusion Criteria:

1. Age：older than 18 years；
2. Clinical or pathologically confirmed central lung cancer;
3. Lesions without cavities at first diagnosis of central lung cancer;
4. Performed complete laboratory and imaging research at the first diagnosis of the central lung cancer;
5. Patients with cavities formation during follow up, and the cavities were independently confirmed by at least 3 imaging experts;
6. Patients with complete medical records;

Exclusion Criteria:

1. Patients suffering other malignant tumors;
2. Patients missing the imaging data;
3. Patients missing the clinical data.
Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of ME-401 in the treatment of Japanese participants with Relapsed or Refractory indolent B-Cell Non-Hodgkin's Lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 years or older at the submission of the written informed consent form
* Patients that have undergone therapy after at least 2 prior systemic therapies (anti-CD20 Ab, chemo, and so on) for relapsed or refractory B-cell NHL
* Patients who have not undergone phosphatidylinositol 3-kinase (PI3K) inhibitors to date
* Patients who have not undergone Bruton's tyrosine kinase (BTK) inhibitors to date
* Patients with Eastern Cooperative Oncology Group Performance status (ECOG PS) "0 or 1"

Exclusion Criteria:

* Patients with relapsed or refractory B-cell NHL who is categorized into Small lymphocytic lymphoma (SLL), Waldenström's macroglobulinemia (WM), Lymphoplasmacytic lymphoma (LPL) by WHO classification
* Patients who have been histologically confirmed FL Grade 3b transformation from Follicular lymphoma (FL) to an aggressive lymphoma at least once
* Patients with lymphomatous involvement of the central nervous system
* Patients with uncontrolled clinically significant illness
* Patients with active interstitial lung disease or a history thereof
Metabolomics of Children With SMA

The aim of the proposed project is to evaluate whether the metabolome of patients with spinal muscular atrophy (SMA) before the initiation of treatment with nusinersen differs from the metabolome of healthy individuals and whether it changes 14 months after treatment with nusinersen.

Spinal muscular atrophy (SMA) is a severe, debilitating disease and is an important source of morbidity and mortality of children. Novel disease modifying therapies can alter the natural course of the disease. However, many aspects of their action remain unknown. Metabolomics is the large-scale study of metabolites, within cells, biofluids, tissues or organisms. Collectively, these small molecules and their interactions within a biological system are known as the metabolome.

The aim of this study is to evaluate whether the metabolome of patients with SMA before the initiation of disease modifying therapy with nusinersen differs from the metabolome of healthy individuals. Next, we would like to asses whether tretament with nusinersen alters the metabolome of patients with SMA. Utilizing metabolomics, we would like to assess whether we can identify parameters reflecting the state of the disease in a particular patient, and parameters with diagnostic and/or prognostic value. Using metabolomics, we will aim to identify SMA patients that will positively respond to gene therapy.

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed SMA
* Age up to 21 years

Exclusion Criteria:

* None
OPtical Frequency Domain Imaging Versus INtravascular Ultrasound in Percutaneous Coronary InterventiON - OPINION Imaging

This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to evaluate how Optical frequency domain imaging (OFDI) or Intravascular Ultrasound (IVUS) imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.

Optical frequency domain imaging (OFDI) is a novel, high resolution intravascular imaging modality. Intravascular ultrasound (IVUS) is a widely used conventional imaging modality for achieving optimal stent deployment.

This study is the sub-study of OPINION Trial. (UMIN000010580) The aim of this study is to evaluate how OFDI or IVUS imaging technology influence to the Percutaneous Coronary Intervention (PCI) strategy.

We will enroll the first 100 patients who have enrolled in the main-study of OPINION trial.(UMIN000010580). We will assess lesions by the other device in addition to the assigned device in the main study at the time of post-PCI.

We will then assess lesions by OFDI at a 8-month follo-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients participating in the OPINION Trial
* Patients who has provided written informed consent

Exclusion Criteria:

* Ineligible patients according to the investigator's judgment
* Inability or unwillingness to perform required follow up procedures
First in Human Study of SakuraBead for Genicular Artery Embolization to Treat Pain Secondary to Knee Osteoarthritis

A prospective, single-centre, single-arm, unmasked, First in Human study that aims to evaluate the safety and efficacy of SakuraBead resorbable microspheres in adult patients suffering from pain secondary to knee osteoarthritis.

To evaluate safety and efficacy of SakuraBead for the treatment of pain secondary to knee osteoarthritis. Treatment will be performed on up to 15 patients who will be followed up for a period of 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is able and willing to provide written informed consent, and
2. Clinical diagnosis of knee OA, and
3. Moderate to severe knee pain (VAS ≥ 5), and
4. Pain refractory to at least 3 months\* of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections), and
5. Kellgren-Lawrence grade 1, 2 or 3 on radiograph of the knee, and
6. Age 40 years or older.
7. Subject has confirmed evidence of knee OA, defined as an angiographic 'blush' pattern (radiographic) in one or more of the target genicular artery(ies).

Exclusion Criteria:

1. Severe knee OA (Kellgren-Lawrence grade 4)
2. Current infection of target joint, or
3. Life expectancy less than 24 months, or
4. Known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or
5. Rheumatoid or known serologic diagnosis of autoimmune arthritis, or
6. Prior knee replacement surgery in the target knee, or
7. Complete meniscal or cruciate tear that requires surgery, or
8. History of uncorrectable coagulopathy, or
9. Prior iodinated contrast reaction resulting in anaphylaxis, or
10. Pregnant and/or lactating female, or
11. At the discretion of the Principal Investigator
12. Subject has evidence of arterial occlusion precluding catheterization.
13. Subject has occlusion of the genicular arteries.
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study

This research study is being done to determine whether the repetition and resistance from the daily use of the myofunctional therapy (MT) nozzle will improve obstructive sleep apnea and primary snoring.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild-moderate Obstructive Sleep Apnea and snoring.
* Diagnosis of mild to moderate obstructive sleep apnea with Apnea Hypopnea Index 5-29 events/hour confirmed within last 2 years with an in-lab diagnostic polysomnography or home sleep apnea test.
* Ownership of a smartphone and willingness to use a smartphone application to automatic log daily water intake.
* Willingness and ability to discontinue the currently prescribed OSA treatment for at least 3 days prior to testing.
* Age greater than or equal to 18 years

Exclusion Criteria:

* Individuals not diagnosed with Obstructive Sleep Apnea and snoring.
* Significant weight change (10% change in body weight in Kg) from the time of the OSA diagnosis until the study initiation.
* Persistent excessive daytime sleepiness (Epworth Sleepiness scale \> 10), despite treatment of OSA
* Significant medical comorbidities requiring restricted oral fluid intake - decompensated heart failure, end stage renal disease, end stage liver disease, hyponatremia (S. Na \<130 mg/dl), nocturia \> times/night.
* Unable or unwilling to participate in study procedures.
* Previous upper airway surgeries significantly modifying upper airway anatomy such as UPPP, apnea surgeries, oral and throat cancer surgeries or radiation.
* Known congenital or acquired diseases significantly affecting upper airway anatomy such as Down's Syndrome, oral and throat cancer.
* BMI \>40 kg/m\^2.
* Currently treating OSA with hypoglossal nerve stimulator.
Exploratory Study of Volatile Organic Compounds in Alveolar Breath

The purpose of this secondary analysis is to identify breath signatures associated with idiopathic malodor conditions.

Individuals with metabolic disorders may sporadically produce malodors despite good hygiene. Analysis of volatile organic compounds (VOCs) helps to gain insights into medical conditions arising due to metabolic dysfunction as different metabolic pathways emit and or consume various VOCs. These VOCs can be detected via the exhaled breath collected and analyzed with a portable breath collection apparatus. VOC profiles will be compared with self-reported symptoms and other observations of participating subjects.

Eligibility Criteria:
Inclusion Criteria:

* good general health
* willing and able to travel to one of the participating sites

Exclusion Criteria:

* medical conditions that, in the opinion of the investigator, would prevent participation
* elect not to participate in the study
Measurement of Respiratory Admittance for Pediatric Asthma Diagnosis

The purpose is to characterize the change of respiratory admittance induced by salbutamol inhalation in children and young adults. A variation threshold will be fixed to distinguish asthmatic and healthy subjects.

This project could allow a better identification of asthmatic individuals needing a treatment, a reduction of morbidity of asthma, a reduction of unnecessary treatments administered in individuals with respiratory but not asthmatic symptoms, a better comprehension of bronchial hyperreactivity and its role in asthmatic disease.


Eligibility Criteria:
Inclusion Criteria:

Asthmatic children group:

* Several episodes of paroxysmal wheezes, spontaneous or after exercise, without bronchial-pulmonary infection
* Absence of bronchodilator taking during last 12 hours
* Absence of reported intolerance to adrenergic substances
* Parental authorization and consent of child to participate to the study

Control children group:

- Parental authorization and consent of child to participate to the study

Control adult group:

- Consent to participate to the study

Exclusion Criteria:

Control children and adult groups:

* At least 2 episodes of wheezes during breathing
* Several wheezes, abnormal breathlessness, cough during physical exercise
* Asthma diagnosed by family doctor
* Administration of drugs to treat asthma
* Eczema or food allergy at inclusion
* Episode of cough for longer than 6 weeks, without bronchial infection
* Bronchitis, throat infection, rhino-pharyngitis during last 15 days
* Paleness or cyanosis with loss of consciousness when the child was a baby or during an exercise
Treatment Management and Factors Affecting Mortality in Retroperitoneal Hemorrhage Due to Cardiac Catheterization; Single Center Experience

Bleeding complications after cardiac catheterization have been reviewed previously, but there are very few studies on retroperitoneal hematoma and appropriate treatment of patients is not well defined. For this reason, the investigators aimed to analyze the clinical manifestations of retroperitoneal hematomas in a single center using a case-control study design, to analyze the treatment procedure determinants and consequently to provide an updated and usable treatment algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Retroperitoneal hematoma following cardiac catheterization

Exclusion Criteria:

* Patients with retroperitoneal hematomas other than cardiac catheterization and patients with missing file records.
The Use of DXA in Scoliosis

This is a pilot study to look at image quality of iDXA AP supine spinal images to see if the investigators can accurately measure the size of the curve from iDXA images and to see how patients with scoliosis feel about iDXA imaging compared to normal x-rays. With normal x-rays being taken standing (or sitting if patients are in a wheelchair), it is important that the investigators understand how the lying down images compare to the standing images. Where there may be some clinical benefit, images will be taken standing (normal x-rays) and lying down (iDXA images). The investigators will see if the addition of iDXA images can help in brace design and brace monitoring.

This pilot study is an interventional study where patients having routine standing or sitting spinal x-rays for scoliosis monitoring or as part of a treatment protocol will be approached to see if they would have an additional supine AP DXA image. Participants will only have one additional DXA image during the pilot study. The consent will be obtained by one of the spinal surgeons or a specialist spinal nurse. The DXA scan will be performed by one of the radiographers. This study may be performed by a medical student or junior doctor (either would be part of the care team) and supervised by the PI.

The pilot study is expected to last 9 months and consist of 25 patients. The DXA images will be reviewed by 2 consultant spinal surgeons and a consultant radiologist who will make a collective decision every month as to whether the study, or that part of the study, should continue.

Two scoliosis patients have read the study protocol and given their input. The Sheffield Children's Hospital Scoliosis PPI group will feedback on key aspects during the study and help define future studies suggested by this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Adolescent Idiopathic Scoliosis (AIS, aged 10-16 years) or Juvenile Idiopathic Scoliosis (JIS, aged 4-9 years) having an x-ray to look for curve progression OR to guide design of a new brace.
* Patients with quadriplegic Cerebral Palsy (CP) having an x-ray to look for curve progression. Within the age range for inclusion for patients with CP, the recruiting clinician will make a clinical judgement on whether the patient is able to lie still long enough to undertake the iDXA, before inviting the patient to take part.

Exclusion Criteria:

* Parents unable to understand the study procedures.
* Patients unable to lie still for 1-2 minutes