cyrilzakka/clinical-trials huggingface dataset:
Bone Demineralization Lesions in the Injured Marrow: Efficacy and Tolerability of Administration Early and Repeated the Zoledronic Acid. Comparative Study, Prospective, Double-blind Controlled (DBMZol)

Subjects with lesion bone marrow are at risk of fracture by fragility bone. The median time to onset of fracture was 8.5 years. Fracture increases costs of care, dependency.

Bone fragility is secondary to hormonal disorders and calcium phosphate, impaired excretion of neuropeptides, vasomotor symptoms associated with the asset that promote bone loss and architectural disorganization. These phenomena occur in the first weeks of development of spinal cord injury and predominate in the distal femur and proximal tibia. From the third year, the demineralization stabilizes, bone mass is estimated to be between 70 and 50% of the initial bone mass, the new equilibrium.

No clinical evidence is predictive of fracture risk. A criteria surrogate must be used to assess this risk. There is an association between bone mineral density and fracture risk. The fracture threshold knee was evaluated to 0.87 g/cm2. Evaluation of bone mineral density in the distal femur is a predictor of fracture risk. Measure reliable and reproducible, easy to perform, it is a good element for monitoring the efficacy of anti-resorptive therapy.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with a spinal cord injury less than 12 weeks of etiology stable,
* level of injury C5 L2,
* AIS grade A to D.
* Female or male between 18 and 45 years.
* No pregnancy.
* No osteoporosis.
* Good oral health.
* Good glomerular filtration.
* No cons-indication to Zoledronic Acid.
* No drugs affecting bone metabolism

Exclusion Criteria:

* pregnancy.
* osteoporosis.
* cons-indication to Zoledronic Acid.
* drugs affecting bone metabolism
Mindfulness-Based Ecological Momentary Intervention for Opioid Use Disorder and Chronic Pain

The goal of this clinical trial is to evaluate whether a smartphone app-based ecological momentary intervention called Mindful Journey, which teaches mindfulness skills, can support adults in recovery from both opioid use disorder and chronic pain. The primary objective of this pilot study is to assess the feasibility and acceptability of Mindful Journey in this population.

There is a paucity of interventions for co-occurring opioid use disorder and chronic pain. Difficulty with emotion regulation is a key shared vulnerability factor underlying both conditions. Mindfulness-Based Interventions (MBIs) are a promising intervention approach, as they target core skills that can improve emotion regulation. However, research on MBIs for co-morbid opioid use disorder and chronic pain is limited. Existing MBIs are also limited by not providing adequate support "in the moment" when individuals are in high-risk situations. A responsive, momentary MBI for co-occurring opioid use disorder and chronic pain may be highly promising, but has yet to be established. In the present study, we will be evaluating a smartphone app-based ecological momentary intervention, called Mindful Journey, for individuals with opioid use disorder and chronic pain. The core feature of the app is training in mindful acceptance and savoring skills via momentary "just-in-time" delivery of brief video-based exercises when individuals report elevations in challenging emotional states (e.g., craving, stress, and pain) and/or decreases in positive affect based upon ecological momentary assessments.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* fluent in English
* enrollment in medication-assisted treatment for opioid use disorder
* report at least bothersome chronic pain, as indicated by Graded Chronic Pain Scale-Revised
* has a smartphone.

Exclusion Criteria:

* self-reporting of chronic malignant pain (e.g., cancer) or systemic inflammatory disease (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus, and sarcoidosis)
* self-reporting of psychotic disorder symptoms
* participated in the previous phase of the study in which participants provided feedback to inform the development of the Mindful Journey app.
Implementing a Nurse-led Advance Care Planning (ACP) Intervention in Residential Care Homes

The goal of this cluster randomized controlled trial is to examine the effectiveness of a nurse-led advance care planning (ACP) intervention on improving ACP discussion uptake in residential care homes (RCHs). The main question it aims to answer is: The effectiveness of nurse-led advance care planning (ACP) interventions implemented on eligible residents in residential care homes on improving ACP discussion uptake in this population.

Compared to participants in the control group who will only receive usual care with no ACP intervention, residents and their family members in the intervention group will be invited to attend the ICP meeting with ACP discussion. The ACP discussion will be guided by the established protocol, which was developed by the expert panel and delivered by trained nurses.

Targeted issue: The lack of ACP discussion and poor dyadic congruence pose challenges to the provision of good EOL care in Hong Kong RCHs.

Population: RCHs in Hong Kong with nurse-to-resident ratios ≥1:3 will be targeted to ensure adequate staffing to carry out ACP. Eligible participants have to be age 65 or older and be able to communicate in Cantonese or Mandarin. Participants will also be invited to identify family members involved in making decisions about their care to participate in the intervention.

Intervention: a nurse-led advance care planning (ACP) intervention

Main study aim: To implement a nurse-led ACP intervention for improving ACP uptake in RCH residents in Hong Kong to bridge the evidence-practice gap.

Study method: This implementation science study will use a mixed methods approach, including a pair-matched cluster-RCT and qualitative interviews, and relevant outcomes will be followed for up to 2 years. RCHs will be randomized into two groups: a nurse-led ACP intervention group and a control group with usual care only.The ACP documentation (i.e., new documentation related to ACP and EOL care) in medical records of all RCH residents in the intervention and control groups will be audited by the research team at baseline (T0), post-intervention (T1; after the ACP intervention), 1-year follow-up (T2; 1 year after the launch of the ACP intervention at the RCH), and 2-year follow-up (T3; 2 years after the launch of the ACP intervention at the RCH).

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants have to be age 65 or older and be able to communicate in Cantonese or Mandarin.
* Participants will also be invited to identify family members involved in making decisions about their care to participate in the intervention. For residents who have moderate or severe cognitive impairment (as determined by a score of less than 19 in the Hong Kong version of the Montreal Cognitive Assessment), the participation of family members is mandatory.

Exclusion Criteria:

* They have a moderate or severe significant cognitive impairment but do not have family members, or
* They have prior ACP experience (e.g., AD completed).
Selection of the Embryo to Transfer by Morphokinetics vs. Morphological Evaluation.

Our study intends to demonstrate that the selection of an embryo to transfer it at the sage of blastocyst through morphokinetics (analysis of embryos depending not only in their morphology -that is, the aspect of the embryo-, but also based on times of cell division) during the use of time-lapse (Embryoscope®) may have a better impact in clinical results, as selection is not performed in mere morphological evolution (visual aspect of the embryo) of the embryos.

Our study intends to demonstrate that the selection of an embryo to transfer it at the sage of blastocyst through morphokinetics (analysis of embryos depending not only in their morphology -that is, the aspect of the embryo-, but also based on times of cell division) during the use of time-lapse (Embryoscope®) may have a better impact in clinical results, as selection is not performed in mere morphological evolution (visual aspect of the embryo) of the embryos.

In order to obtain this objective, patients participating in the study will be randomly assigned to one of the following groups:

Group A: Patients who will perform an embryo transfer of a blastocyst using morphological criteria to evaluate que quality of the blastocyst (Gardner Classification), that is, based on the aspect or form of the embryo.

Group B: Patients who will perform an embryo transfer of a blastocyst using morphokinetics criteria to evaluate the quality of the blastocyst (Embryoscope®), that is, based not only in the aspect of the embryo but also in cell division times experimented by the embryos.

Eligibility Criteria:
Inclusion Criteria:

* Egg-donation IVF patients
* IVF patients if \< 38 years
* Sperm concentration \> 2 million/ml
* Frozen eggs for
* Single embryo transfer
* ICSI fertilization

Exclusion Criteria:

* Uterine pathologies that may interfere with implantation
* Endometriosis
* Frozen eggs
* Pre implantation genetic testing of the embryos
* Day 3 embryo transfer
* Conventional IVF treatments
OCS Lung System EXPAND II Trial

To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

Inclusion

At least one of the following:

* Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or
* Expected cross-clamp time \> 6 hours for the second lung; or
* Donor after Cardiac Death (DCD donor); or
* Donor age ≥ 55 years old

Eligibility Criteria:
Inclusion Criteria:

* Male or female primary double lung transplant candidate
* Age ≥ 18 years old
* Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

Exclusion Criteria:

* Prior solid organ or bone marrow transplant
* Single lung recipient
* Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis
* Participant in any other clinical or investigational trials/programs
PET-study on the Role of the Reward System in Weight Loss After Bariatric Surgery

Bariatric surgery (BS) is currently the most effective treatment in severe obesity. However, a considerable percentage of patients undergoing BS fail to lose sufficient weight or regain weight after initial weight loss during long-term follow-up, which may be attributed to personality traits and pathological eating behaviour. Previous positron emission tomography (PET) studies have shown reduced dopamine D2 receptor availability in obese patients and upregulation of this availability following successful BS in the brain's reward system. Dopamine D2 receptor availability in patients with unsuccessful BS has not been investigated to date.


Eligibility Criteria:
Inclusion Criteria:

* Bariatric surgery 24-36 months prior to the study
* Adult (over 18y old)
* Mentally capable to understand the consequences of the procedure and make his or her own choice without coercion
* Able to undergo PET and MRI, according to the investigator's assessment
* Native speaking
* Able to participate in follow-up
* Written informed consent

Exclusion Criteria:

* Presence of a DSM-IV axis 1 disorder
* The use of drugs that bind to dopamine D2/3 receptors, including various classes of antipsychotics and antidepressants
* History of stroke, brain tumor, Parkinson's Disease or dementia
* History of head trauma with loss of consciousness
* Alcohol or substance abuse in the last 6 months
* Alcohol consumption 24h prior to PET scanning
* Smoking or other forms of nicotine intake 12 hours prior to PET scanning
* Use of anorectic drugs in the last 6 months
* Current pregnancy
* Medication for Diabetes Mellitus
* Claustrophobia
* The presence of implanted metal objects of the type which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field (such as certain implanted devices, shrapnel, ocular metal shavings)
* Patients with a bodyweight \> 200kg will be excluded to ensure the maximum load of the camera bed of the PET-scanner (227 kg) is not exceeded.
Prospective Longitudinal 1-year Study of the Correlation Between Cognitive Functioning in Patients With Clinically Isolated Syndrome Suggestive of Multiple Sclerosis and Disconnection in the Brain Assessed by MRI

Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS). Cognitive deficiencies could occur at this early stage and concern mainly information processing speed (IPS) and their mechanisms are not fully understood. Diffusion Tensor Imaging (DTI) can help in the understanding of these mechanisms.

This is a prospective cohort, observational, longitudinal, monocentric study. This study will include 60 patients with CIS followed for 1 year and 60 healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Patients:

  * Men and Women
  * ≥16 years
  * Fluent French speaker
  * Clinically isolated neurological syndrome (CIS) compatible with a demyelinating inflammatory episode within the central nervous system, potentially beginning multiple sclerosis (MS) whatever the mode of presentation
  * Between 60 and 180 days from the onset
  * At least two clinically silent lesions on their T2-weighted brain or spinal MRI scan with a size of at least 3 mm, at least one of which being cerebral, ovoid, or periventricular
  * Having a medical insurance
  * Free and informed consent signed
* Controls:

  * Men and Women
  * ≥18 years
  * Fluent French speaker
  * Having a medical insurance
  * Free and informed consent signed

Exclusion Criteria:

* Patients:

  * Prior documented neurological episode suggestive of MS.
  * Other ongoing neurological diseases.
  * Known chronic systemic diseases as judged by the investigator (for instance: lupus, Gougerot-Sjögren, sarcoidosis, sclerodermia, Crohn disease,...).
  * Other causes (trauma, tumor, radiotherapy, infections, vascular diseases, neuromyelitis optica).
  * Current dependence on alcohol or drugs.
  * Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 15 days
  * MRI contra-indications.
  * Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.
* Controls:

  * Known chronic psychiatric or neurologic diseases which could interfere with neuropsychological testing, not taking into account stable and mild depressive syndrome
  * Known chronic systemic diseases as judged by the investigator (for instance: lupus, Gougerot-Sjögren, sarcoidosis, scleroderma, Crohn disease...).
  * MS familial history
  * Current dependence on alcohol or drugs
  * Known cognitive impairment
  * Prior neuropsychological testing with the same tests less than one year
  * Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 2 months
  * Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.
  * MRI contra-indications
  * Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily.
Engaging Tribal Policy Makers to Improve the Food and Physical Activity Environments in American Indian Communities

The overall objective of the study is to reduce adult obesity in participating American Indian (AI) communities and to improve understanding of the behavioral and environmental factors affecting obesity in these settings.

The investigators plan to accomplish this objective by developing, implementing, and evaluating a randomized controlled trial of an intervention to improve diet and physical activity-related risk factors of obesity. A previous iteration of the intervention trial, called Obesity Prevention Research and Evaluation of InterVention Effectiveness in NaTive North Americans (OPREVENT) was implemented in five American Indian communities in Michigan and New Mexico. OPREVENT was a multi-level, multi-component intervention functioning at the community, institution, household, and individual levels and was implemented in schools, food stores, and worksites. Prior to OPREVENT, the research team has run multi-level interventions by working with schools and food stores in Native North American (NNA) communities1-6. For this new trial, named OPREVENT2, the research team will expand on the collective experience working on obesity prevention interventions in American Indian (AI) settings by developing complementary policy and social media components to support long-term sustainability of the OPREVENT intervention. OPREVENT2 will be implemented in six new AI communities.

Eligibility Criteria:
Inclusion Criteria:

* With the exception of the school intervention, which will only include teachers of grades 2-6 and students in grades 2-6 (ages 6-13), all community members will be included in the intervention.

Gender, Age and Locale

* The investigators will work with male and female schoolchildren and adults, aged 6-13 and 18-75 years who live in one of the participating tribal communities.

Exclusion Criteria:

* No adult community members will be excluded from the intervention as they are "passive" media and environmental changes, and available to everyone.
Effects of Probiotics (P. Pentosaceus, L. Lactis or L. Helveticus) in NASH

A study for evaluating the improvement effect of non-alcoholic steatohepatitis (NASH) of probiotics

Non-alcoholic fatty liver disease progresses to fatty liver, hepatitis, cirrhosis, and liver cancer, resulting in a high mortality rate. The prevalence of non-alcoholic fatty liver disease at home and abroad is a major social and economic burden. However, there is no cure for non-alcoholic fatty liver disease. Recently, intestinal axis theory related to the development of chronic liver disease and microbial community has emerged. Intake of probiotics is known to play a role in regulating gut microflora. Improvement of non-alcoholic fatty liver disease can be expected through administration of probiotics.

Eligibility Criteria:
Inclusion Criteria:

1. Those who agreed to participate in this study and signed a written consent
2. Adult men and women over 20
3. Patients diagnosed with non-alcoholic fatty liver

   ※ Exclusion criteria for alcoholic liver disease
   * Those who have an alcoholic drinking ability of at least 60g per day for at least one year before visiting (30g for women)
   * 1 bottle of shochu 360 ml \* 20% = 72 g, 1 bottle of beer 500 ml (330 ml for commercial use) \* 5% = 25 (16.5 g)
4. Patients with higher liver numbers than normal ※ Adult normal liver level range by enzyme

   * AST, ALT: 40 or less
   * ALP: 20-130
   * GOT: 0-30, GPT: 0-38
   * GGT: 10-62 (male), 7-35 (female)

Exclusion Criteria:

1. Those who have consumed probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligosaccharide, etc.), new biotics, fermented milk, etc. within the past month.
2. Those who have continuously taken antibiotics within the last 2 months or who are likely to take them during the study period
3. Those who have continuously consumed medicines or health functional foods that affect liver function within the past month.
4. Those who have participated in other clinical trials within the past 1 month (but not applicable to medical device clinical trials)
5. If you have any of the following

   * Alcoholic liver disease, hereditary metabolic disease, autoimmune hepatitis
   * systemic inflammatory disease or immune disease
   * Hepatocellular carcinoma
   * Uncontrolled cardiopulmonary disease
   * Other serious systemic disorders in the heart, lungs, blood, and endocrine system
6. A person with a history of malignancy diagnosis within the last 5 years
7. Pregnant or lactating women
8. Persons who have hypersensitivity to the test drug / placebo or components contained in the test drug / placebo or have severe allergic reactions
9. Those who are not suitable for the clinical trial because the investigator judges
Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis

The purpose of this study is to evaluate the efficacy of the combination of tacrolimus + methotrexate compared to methotrexate alone in the treatment of the signs and symptoms of rheumatoid arthritis over 6 months in patients with partial response to methotrexate.

This is a Phase III, 6 month randomized, double-blind, placebo controlled multi-center study with a 6 month open-label extension. Patients will be randomized to the tacrolimus + methotrexate arm or the placebo + methotrexate arm in a ratio of 2:1. Patients who complete the 6-month double-blind phase will be eligible to enroll in the open-label phase of the study.

Eligibility Criteria:
Inclusion Criteria

* Willing to discontinue DMARDs, other than methotrexate
* Has a diagnosis of Rheumatoid Arthritis using American College of Rheumatology Criteria, of at least 6 months duration
* Have been receiving oral or parenteral methotrexate for at least 3 months

Exclusion Criteria

* Has received tacrolimus for any indication
* Has moderate or severe liver disease
* Has a known history of HIV infection
* Has serum creatinine outside the normal range
Medical Management of Caries in the Primary Dentition Using Silver Nitrate

This pilot trial compares conventional restorations with a new strategy based on the medical management of caries using silver nitrate and fluoride varnish with no restorations.

This is a two-arm, parallel group, patient-randomized controlled pilot trial. Children with at least one primary tooth where caries extends into dentine. Children will be randomized and treated according to one of two treatment approaches;(1) conventional caries management with best practice prevention, or (2) medical management of caries using silver nitrate with best practice prevention.

Baseline measures and outcome data (at treatment/review during two year follow-up) are assessed through direct reporting, clinical examination including blinded radiographic assessment, and child/parent questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Presense of one or more cavitated carious lesions in the primary dentition, extending into dentin but not encroaching on the pulp.
* Absense of any spontaneous or elicited pain due to caries, or signs of pulpal infection in response to any of the carious lesions in the primary dentition to be included in the study

Exclusion Criteria:

* Hereditary developmental defects of the teeth such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
* Medical conditions that prevent treatment of the child in the outpatient clinic. These conditions include severe bleeding disorders, cardiac problems and mental disabilities that prevent child from communication with the research team.
* Known allergy/sensitivity to any of the dental materials.