cyrilzakka/clinical-trials huggingface dataset:
Necessity for Repetitive Education of Behavioral Modification

Few studies have reported the efficacy of repetitive education for behavioral modification as the first-line therapy for patients with nocturnal polyuria (NPU). The aim of this study is to investigate the efficacy of repetitive education for behavioral modification as the first-line therapy in the patients with NPU and to show whether a single education for behavioral modification is sufficient for the patients.

Even though behavioral modification therapy seems to be effective, it is not usually recommended for patients with nocturia because much patience and understanding is required for the patients to follow the therapy. Few studies have reported the efficacy of repetitive education for behavioral modification as the first-line therapy for patients with nocturia and nocturnal polyuria (NPU). Furthermore, no report demonstrated the evidence about how many times or how long the education for behavioral therapy should be performed and how long will the education effect would continue. The aim of this study is to investigate the efficacy of repetitive education for behavioral modification as the first-line therapy in the patients with NPU and to show whether a single education for behavioral modification is sufficient for the patients.

Eligibility Criteria:
Inclusion Criteria:

* the urine volume at nighttime more than one third of total daily urine volume
* voided more than two times at nighttime

Exclusion Criteria:

* postvoid urine volume more than 100 ml
* sleep disturbance including sleep apnea
* diabetes mellitus
* diabetes insipidus
* neurogenic bladder
* congestive heart failure
* indwelling catheters
* urinary tract infection or urinary stones
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries- PreTerm

The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation.

Background: Prematurity is the leading cause of death in children younger than 5 years of age. Worldwide, 15 million infants are born premature, and India alone contributes to quarter of them. Approximately 1 million children die each year due to complications of prematurity.

Delayed cord clamping (DCC), one of the methods of transfer of placental blood to neonates (placental transfusion) immediately after birth reduce mortality by 30% in premature infants. But DCC is not recommended in neonates who require immediate resuscitation. Umbilical cord milking (UCM) is an option for placental transfusion in preterm infants who require immediate resuscitation but not currently recommended due to lack of randomized clinical trials.

HYPOTHESIS: UCM will reduce the in-hospital mortality in non-vigorous preterm infants born between 30 weeks to 34 weeks of gestation compared to early cord clamping.

METHODS: This multicenter cluster crossover randomized trial will enroll approximately 800 preterm infants to early cord clamping or milking the intact cord 4 times prior to clamping.

IMPACT: If investigators find that UCM is beneficial, this simple, low-tech, no cost intervention can be used in preventing deaths in preterm infants. This trial will potentially provide evidence to support a change in guidelines making UCM part of standard practice worldwide for preterm infants who require immediate resuscitation.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born between 30 0/7 weeks to 34 6/7 weeks of gestation
* Non-vigorous at birth

Exclusion Criteria:

* Infants with congenital malformation
* Major chromosomal abnormalities
* Complete placental abruption/cutting through the placenta at the time of delivery
* Cord conditions (umbilical knots, inadequate cord length, cord rupture, non-reducible nuchal cord)
* Mono-chorionic twins,
* Twins with no information on amnion/chorion
* Multiple gestation \>2
An Intervention to Promote Health Students' Well-being

The lack of well-being observed among health students underscores the urgent need of implementing interventions designed to meet their specific need and improving their quality of life.

This study aims to evaluate a well-being promotion intervention among paramedic students.

This is a before/after study using a quasi-experimental design. This study aims to compare well-being, resilience, and self-esteem before and after the intervention.

Students' satisfaction will be assessed through a questionnaire.

Health students' well-being is a big issue today. We need to increase the number of interventions designed to improve quality of life and well-being among this population of students.

The investigators aim to evaluate a well-being promotion intervention among paramedic students through a before/after study using a quasi-experimental design by comparing the scores of validated scales of well-being, resilience, and self-esteem of participating students before and after the intervention.

A satisfaction questionnaire will allow to assess the content and the organization of this intervention.

The first edition will be implemented in September 2022 in Le Havre. The questionnaires will be distributed before and eight months after the intervention.

The investigators will describe the study population, then they will compare the average scores.

The results of satisfaction questionnaire will allow to improve the intervention to best meet the needs of students.

The main benefit expected from this study is the improvement of paramedic students' well-being by adopting a healthy lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* paramedic students enrolled at IFP Mary Thieullent in september 2022

Exclusion Criteria:

* age \< 18 years
Burning Mouth Syndrome - New Diagnostic Criteria and Treatment

The first part of this study is to optimize diagnostic criteria for BMS, i.e. not a clinical trial, and will not be covered in this application.

The second part will compare topical treatment with clonazepam, capsaicin and placebo in a n-of-1 study design regarding effects of pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience in patients with primary BMS or other oral mucosal pain. The patients will be treated for two weeks with each drug, with a one-week wash-out period in between. After the last washed-out period, the patients will be able to chose the treatment that they prefer the most and continue with that treatment during 6 months.

The clinical trial in the present study will investigate treatment effects on pain, pain-related disability, jaw function and patients' experiences by topical treatment with clonazepam or capsaicin in comparison with placebo in patients with BMS or other oral mucosal pain.

Twenty patients with primary BMS and 20 patients with other oral mucosal pain will be included. The study will comprise a n-of-1-design where each participant will be it's own control.

The study will compare topical treatment with clonazepam, capsaicin and placebo regarding effects of pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience. primary outcome will be pain intensity and patient experience.

The patients will be treated for two weeks with each drug, with a one-week wash-out period in between. After the last washed-out period, the patients will be able to chose the treatment that they prefer the most and continue with that treatment during 6 months. After this 6 months, pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience will be assessed again.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary BMS according to International Classification of Orofacial Pain (ICOP) OR diagnosis of other oral mucosal pains according to ICOP

Exclusion Criteria:

* Fibromyalgia
* IBS
* Reflux
* Recent (\<3 months) intraoral surgical procedure
* Ongoing medication with Clonazepam or Capsaicin
Evaluation of Usefulness of Contrast Enhanced MRI in Evaluation of Spine Trauma: Prospective Study

Non-contrast MRI with T2 fat suppression has been a useful imaging modality in evaluation spinal trauma.

However, the role of contrast enhancement has not investigated in patients with spinal trauma.

Therefore, this prospective study aims to evaluate the usefulness of contrast enhanced MRI for spinal trauma W/U clinically.

The study hypothesis is that there is no additional gain in addition of contrast enhanced study to routine non-contrast MRI.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who provided the informed consent
2. Patients with spinal trauma
3. Patients with age of 19 years or more

Exclusion Criteria:

1. Relative contraindication of MR contrast

   * previous history of any adverse event after injection of magnetic resonance contrast
   * pregnant or breast-feeding state
   * within 2 weeks after liver transplantation
   * epileptic disorder
2. Patients impossible with follow-up period of at least 2 months clinically
3. Patients with severely impaired renal function of estimated glomerular filtration rate (GFR) \< 30 mL/min/1.73m2 and/or on dialysis
4. patients with age less than 19 years
Outcomes of Patients With Venoarterial Extracorporeal Membrane Oxygenation

Venoarterial extracorporeal membrane oxygenation (VA ECMO)-also referred to as extracorporeal life support-is a form of temporary mechanical circulatory support and simultaneous extracorporeal gas exchange. The objective of this observational, cohort study is to evaluate the short-term and long-term outcomes of patients with VA ECMO.


Eligibility Criteria:
Inclusion Criteria:

Patients receiving VA ECMO for cardiopulmonary support

Exclusion Criteria:

Refusal of consent
A Mindful Community for People With ALS and Their Primary Caregivers

The psychological impact of ALS on patients and caregivers is high, significantly affecting their quality of life (QOL). Despite this impact, there is not much research about psychological interventions that could reduce psychological distress and improve QOL.

The efficacy of mindfulness-based treatments for the improvement of QOL was previously demonstrated by the investigator's group. Despite preliminary positive results, treatment efficacy tends to weaken over time. The investigators believe that a robust solution to maintain efficacy is to maximize the utilization of technology and emerging social platforms, establishing a "mindful community" to promote and continuously reinforce mindfulness.

This project's primary aims are 1) to develop a "mindful" online community of people with ALS and their caregivers, and 2) to test its efficacy in QOL improvement. This two-part intervention consists of 1) optimizing the investigator's prior e-learning platform with a three-week program including cognitive exercises, videos and lectures to increase participants' mindfulness; and 2) involving participants in a "mindfulness community" within a social sharing forum. Assessments will be performed before and immediately post-treatment as well as 3- and 6-months post-program comparing subjects undergoing the intervention to a control group.


Eligibility Criteria:
Inclusion Criteria:

For the ALS patients

* a definite, probable, laboratory-supported, or possible ALS by revised El-Escorial criteria
* they must have the physical ability, with or without adaptive devices, to use a smartphone, a tablet, or a computer
* have access to the Internet.

For the caregivers

* be the person who resides with the ALS patient and is the major provider of unpaid care and assistance (typically, the spouse or another close relative)
* s/he must be able to use the application
* have access to the Internet.

Exclusion criteria

- Using shared devices. Patients and caregivers should have their own devices.
Autologous Bone Marrow Transplantation in Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission

Evaluate the role of high dose chemotherapy with autologous hematopoietic cell transplantation for AML.

To use high dose chemotherapy with autologous stem cell rescue to try to increase the chance of long term control and cure of the disease.

Eligibility Criteria:
Inclusion Criteria:- must be in remission

* adequate organ function Exclusion Criteria:- prior MDS
* active infection
* liver disease
Clinical Translation of a Novel Brain PET Insert for Simultaneous PET/MR

The primary goal of this project is to study the feasibility of a brain-dedicated PET insert for an MR scanner for simultaneous acquisition of PET/MR images of human brains. The study will also allow us to compare the imaging performance of the investigator's brain-dedicated PET insert against a commercial whole-body permanently integrated PET/MRI system using a common radiopharmaceutical.

This study will enroll up to 40 participants.

1. 20 participants at Stanford injected with an FDA-approved PET tracer (e.g. amyloid, FDG, etc.), and
2. 20 participants from Stanford who have been pre-injected with a radiopharmaceutical for a study on another PET imaging system

Eligibility Criteria:
Inclusion Criteria:

1. Whole body radiation dose within the last year of less than 5000 mrem
2. Subjects intended for injected tracer studies (not associated with another study) must be willing/able to undergo injection of 6-12 mCi of either FDG or Neuraceq radiotracer. Both tracers are FDA approved
3. Subjects will be at least 21 years of age
4. Subject provides written informed consent
5. Subject is deemed healthy by the PI by via self-reported questionnaire

Exclusion Criteria:

1. For patients who will be receiving a tracer injection, no known allergy to the imaging agents
2. Participant has a history of or current diagnosis of cancer
3. Participant is pregnant or nursing
4. Metallic implants (contraindicated for MRI)
Regorafenib Post-marketing Surveillance

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for colorectal cancer.

The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice.

A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.


Eligibility Criteria:
Inclusion Criteria:Patients

* who are determined to start Regorafenib/ STIVARGA treatment

Exclusion Criteria:

* Patients who have previously received Regorafenib/ STIVARGA
Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis

In patients who undergo shoulder manipulation for idiopathic adhesive capsulitis, a postoperative indwelling analgesic pain catheter will improve patient outcomes by decreasing shoulder pain and improving range of motion compared to a single-dose interscalene block.

Shoulder manipulation under anesthesia to treat idiopathic adhesive capsulitis is performed only when conservative treatment fails to remedy the condition.

It is common practice to use an interscalene nerve block as anesthesia for this surgical intervention. This randomized prospective study is designed to evaluate the effects of two different anesthesia methods on patient's post-surgical rehabilitation after manipulation. Forty patients scheduled for surgery will be entered into this study. Patients will be randomly assigned to receive a single-doseinterscalene block or a single-dose interscalene block and an indwelling nerve catheter which will provide a continuous infusion of local anesthetic. Patients with the continuous infusion of local anesthetic will receive the additional anesthesia for 24 hours. Patient's range of motion will be evaluated pre-op, intra-op and post-operatively at 10 days, 4,8,16 weeks and 6 months

Eligibility Criteria:
Inclusion Criteria:

* Males and Females over the age of 18 with a diagnosis of idiopathic adhesive capsulitis
* Failed conservative treatment for a minimum of 4 months
* Patient had 3 sequential office visits with no clinical improvement

Exclusion Criteria:

* Adhesive capsulitis following a surgical procedure and/or fracture
Preventing Medication-Related Problems in Care Transitions to Skilled Nursing Facilities

The Pharmacy Integrated Transitions (PIT) program, utilizes a crossover randomized control design to evaluate the impact of a clinical pharmacist in decreasing medication related problems during a patient's transition from hospital to skilled nursing facility (SNF).

Standard hospital discharge processes (e.g. as recommended by the Joint Commission Center for Transforming Healthcare), include hospital staff completing a paper-based discharge summary and medication reconciliation form. To reduce the likelihood of medication-related problems during care transitions, the Pharmacy Integrated Transitions (PIT) program aims to improve the standard transition process by adding a coordinating transitional pharmacist to provide a structured synchronous "warm-handoff" between clinical teams at the hospital and the Skilled Nursing Facility, in addition to reconciling, adjusting, and monitoring medications during and after discharge from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* patients receiving inpatient care at University of Washington Mountlake, University of Washington Northwest, Harborview, and Valley Medical Center hospitals to one of 14 collaborating SNF's on a day when the PIT program pharmacist is conducting the intervention

Exclusion Criteria:

* Under 18 years of age
* patients with a discharge on hospice care
* patients discharged on days that the pharmacist is not conducting the intervention
The Frequency of Central Sensitization in Patients With Chronic Musculoskeletal Pain

Central sensitization is as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with in many musculoskeletal diseases with chronic pain has been demonstrated in several studies. However, the effect of central sensitization on disability in these patients is not fully known. In this study, it was aimed to investigate the frequency of central sensitization and its effect on patients with chronic musculoskeletal pain who were admitted to physical medicine and rehabilitation outpatient clinics.

The term central sensitization (CS) was first used in 1988 and was explained as the increase in pain sensitivity with the amplification of neuron-derived signals in the central nervous system. With the development of CS, a decrease in the pain threshold and an increase in generalized sensitivity occur. There is no method for the diagnosis of CS is accepted as a gold standard. Clinical scales and quantitative sensory testing (QST) is used for this purpose widely. In addition, the well-known scale used for the evaluation of CS is the Central Sensitization Inventory (CSI), developed for detect CS in chronic pain patients. The use of CSI, which is more practical to use, is becoming widespread because QST takes time, is costly and requires experienced practitioners. The prevalence of chronic pain is reported as 30% in Europe and has an important place among diseases that cause disability worldwide. Until this time, the relationship between CS and many diseases that cause chronic pain has been revealed, and an increase in pain intensity, duration and prevalence has been detected in patients accompanied by CS. In addition to all these changes, the decrease in the treatment response of these patients makes the clinical management of individuals with pain sensitization even more difficult. Although the increase in the frequency of CS in patients with chronic pain is known, data on the incidence of this condition in various diseases with chronic pain is limited.The frequency of CS was mostly reported in patients with low back (37.8%) and neck pain (32.4%) and the authors reported that the higher rates of disability is seen in patients with high CSI scores. Similarly, in this study, it was planned to show the relationship between CS and disability in patients with chronic musculoskeletal pain.

Eligibility Criteria:
Inclusion Criteria:

* Have musculoskeletal pain that lasts for at least 3 months
* Accepting to participate in the study

Exclusion Criteria:

* Have rheumatic disease
A Study to Evaluate and Compare Injections of Autologous Dermal Cells Into the Balding Scalp of Subjects With Hair Loss

Evaluate the ability of Ji Gami(TM) DO to induce hair growth in male and female subjects with hair loss.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers 18 to 65 years old, inclusive
* Hair loss consistent with ≥ Grade III-Vertex, IV, VA, V, and VI, based on Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the vertex circle.
* Have no clinically significant disease or abnormal laboratory results taken at the screening visit.

Exclusion Criteria:

* Known sensitivity to DMEM/F-12 or any component of the study material.
* Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin sulfate.
* Subjects who have used minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening.
* A history of drug or alcohol abuse within 1 year of study enrollment.
* Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
* Any clinically significant abnormal laboratory parameters.
* A positive result at screening for human immunodeficiency virus (HIV 1 or 2), Hepatitis B or C, HTLV I/II.
* Dermatologic condition in donation and/or study areas.
* Prior surgery in the treatment area.
* Insufficient hair or scarring in the donor area that might impact cell growth.
* Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.
Mind-Body Skills Groups for the Treatment of War-Related Trauma in Children in Gaza

The objective of this study is to determine whether participation in a mind-body skills program by war-traumatized children in Gaza will result in improvement of posttraumatic stress symptoms, depression, and decreased hopelessness compared to a control group.


Eligibility Criteria:
Inclusion Criteria:

* having experienced a political violence or war-related criterion A stressor
* meeting the American Psychiatric Association (DSM-IV-TR) criteria for PTSD according to screening scores on the Child PTSD Symptom Scale

Exclusion Criteria:

* former psychosocial or medical treatment for mental health conditions
* significant cognitive impairment