cyrilzakka/clinical-trials huggingface dataset:
Kremezin Study Against Renal Disease Progression in Korea

1. To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD III-IV), on time to first occurrence of any event of the triple composite outcome of initiation of renal replacement therapy, decline of eGFR 50% or more or doubling of serum creatinine (sCr) when compared with standard-of-care group;
2. To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to GFR and proteinuria;
3. To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to health related quality of life;
4. To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD;
5. To evaluate the all-cause mortality and hospitalization apart from those planned for operation and intervention)


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age 18 years or older
* CKD stage 3,4 (estimated GFR by Cockcroft-Gault equation 15-59 mL/min/1.73m\^2)
* Followed up by responsible nephrologists more than 6 months
* eGFR checked 2 times or more during screening period
* eGFR declined or expected to decline \>= 5mL/min/year or \>=2.5mL/min/6 months
* Blood pressure \<= 160/100 mmHg
* Blood pressure checked 3 times or more during screening period
* No significant change of medication for CKD

Exclusion Criteria:

* Patients who took medicine AST-120 or ketosteril within 2 months
* Received any investigational agent or participated in a clinical study within the previous 2 months
* History of gastrointestinal disease (active gastric ulcer, inflammatory bowel disease, hiatal hernia, or severe GI dysmotility)
* obstructive urologic disease and other reversible kidney diseases
* chronic kidney disease due to autosomal dominant polycystic kidney disease, ADPKD
* severe nephrotic syndrome, 10g or more/day(or random urine pCR \>= 10.0)
* History of previous kidney transplant
* Heart failure (NYHA III-IV), uncontrolled arrhythmia, unstable angina
* Liver cirrhosis (Child-Pugh B,C)
* active infection, uncontrolled inflammatory disease
* progressive malignant disease
* cerebral infarction and intracranial hemorrhage within 6 months,except transient ischemic attack (TIA)
* uncontrolled blood sugar (HbA1c \>10%)
* severe anemia, Hb \<7g/dL
* Life expectancy less than 12 months at the point of randomization
* Pregnant and willing to bear child during study
* patients, inappropriate to study (researchers decided)
Effect of a Fermented Soy Product on Cognition, Immune Status and Vaccine

The research study will test the effects of Q CAN PLUS powder on the immune, inflammatory and cognitive functions.

The purpose of this study is to determine the effects of a fermented soy product (Q-CAN), compared to placebo, on the immune, inflammatory and cognitive functions of elderly individuals. The study intervention will be four months in length. sixty two participants , 65 years or older will be randomized to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Elderly men and women, 65 years of age or older
* Ambulatory
* Able to accommodate the intervention food products
* Live in or around Loma Linda to be able to commute to the Nutrition Research Center

Exclusion Criteria:

* Intolerance to soy products
* Immune system insufficiency or disease
* Insulin dependent diabetes mellitus
* Alzheimer's disease
* Dialysis
* Current cancer radiation or chemotherapy
* Prednisone or Prednisolone Therapy greater than 10mg/d
Effect of Activities and Exercise on Sleep in Elderly Persons With Dementia

The purpose of the study is to determine whether individualized social activities, physical resistance training and walking, and a combination of both are effective in improving nighttime sleep in elders with dementia.

Elders with cognitive impairment usually do not a get a good night's sleep and wake up often during their sleep at night. Increased daytime individualized social activity and physical resistance training with walking have the potential to increase nighttime sleep in elders. This can lead to a better quality of life, a decrease in caregiver burden and decrease in nighttime falls for this population and associated fiscal savings.

Consent forms for this RCT, were written in large print, followed all the guidelines of the Institutional Review Board of the University of Arkansas for Medical Sciences, and assured the participants that their participation in the study was voluntary.

Eligibility Criteria:
Inclusion Criteria:

* Age 55 years old or older
* Mini Mental State Examination (MMSE)of 4-26, indicating dementia or mild cognitive impairment
* Less than seven hours of nocturnal sleep and 30 minutes of daytime sleep
* At least two weeks residency in the nursing home
* Medical diagnosis of dementia; AND
* Ability to stand with assistance

Exclusion Criteria:

* Documented near-terminal or unstable medical conditions
* Unresolved malignancy
* Treatment with chemotherapy; AND
* Unstable cardiovascular disease
Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction

Study hypothesis :

The purpose of this study is to determine whether Intracoronary infusion of autologous bone marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior myocardial infarction will lead to an improvement in cardiac function greater than that seen by placebo alone.

Aims

* To demonstrate that it is safe and feasible to deliver autologous bone marrow derived stem cells within hours of the primary angioplasty procedure
* To demonstrate the effects of autologous bone marrow derived stem cells on cardiac function using cardiac MRI (or cardiac CT), echocardiography and left ventriculography.
* To demonstrate the effect of autologous bone marrow derived stem cells in addition to standard care leads to improvement in cardiac function compared to patients saline(placebo) and standard care.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the Heart Attack Centre with acute anterior myocardial infarction (ST elevation in at least 2 contiguous anterior leads ≥ 0.2 mV) and treated with acute PCI with stent implantation within 24 hours after symptom onset
* Acute PCI / stent implantation has been successful (residual stenosis visually \< 30% and TIMI flow ≥ 2).
* At the time of inclusion patient no longer requires i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
* Significant regional wall motion abnormality in LV angiogram at the time of acute PCI in the LAD territory
* Age 18 - 80 Years (primary angioplasty confers an adverse prognosis in those over the age of 80 years)
* Written informed consent in the recruiting centres native language

Exclusion Criteria:

* Regional wall motion abnormality outside the area involved in the index acute myocardial infarction
* Need to revascularise additional vessels, outside the infarct artery as a planned procedure (these vessels can be treated at baseline)
* Arteriovenous malformations or aneurysms
* Active infection, or fever or diarrhoea within last 4 weeks
* Chronic inflammatory disease
* Known HIV infection or active hepatitis
* Neoplastic disease without documented remission within the past 5 years
* Cerebrovascular insult within 3 months
* Impaired renal function (creatinine \> 200mmol) at the time of cell therapy
* Significant liver disease (GOT \> 2x upper limit) or spontaneous INR \> 1,5)
* Anemia (hemoglobin \< 8.5 mg/dl)
* Platelet count \< 100.000/µl
* Hypersplenism
* Known allergy or intolerance to clopidogrel, heparin or abciximab
* History of bleeding disorder
* Gastrointestinal bleeding within 3 months
* Major surgical procedure or trauma within 2 months
* Uncontrolled hypertension
* Pregnancy
* Mental retardation leading to inability to obtain informed consent
* Previously performed stem / progenitor cell therapy
* Participation in another clinical trial within the last 30 days
FOSAMAX PLUS and FOSAMAX PLUS D Re-examination Study (0217A-267)

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of FOSAMAX PLUS / FOSAMAX PLUS D through collecting the safety information according to the Re-examination Regulation for New Drugs.

Note: FOSAMAX PLUS D is known as FOSAMAX PLUS in several markets. FOSAMAX PLUS (70 mg/2800 IU) and FOSAMAX PLUS D (70 mg/5600 IU).


Eligibility Criteria:
Inclusion Criteria:

* Participants who are treated with FOSAMAX PLUS / FOSAMAX PLUS D within label for the first time

Exclusion Criteria:

* Participants who have a contraindication to FOSAMAX PLUS / FOSAMAX PLUS D according to the current local label
T-regulatory Cells in Diabetic Type Two Nephropathy

Diabetes mellitus is one of the most prevalent health problems worldwide. Diabetic nephropathy has become the leading cause of end-stage kidney disease worldwide and is associated with an increased cardiovascular risk.

Traditionally, metabolic and hemodynamic factors are the main causes of renal lesions in patients with type two diabetes mellitus and diabetic nephropathy , both considered non-immune diseases. Serial researches has demonstrated that diabetic nephropathy is a metabolic and hemodynamic disorder, with inflammation playing a vital role in the process.

It has been reported that glomerular basement membranes from diabetic rats induced significantly greater amounts of Tumor necrotic factor-alpha and Interleukin-1 than when these cells were incubated with basement membranes from non-diabetic rats.

These new findings were the first to suggest that inflammatory cytokines may participate in the pathogenesis of diabetic nephropathy .Cluster of differentiation 4 cells are believed to play central roles in modulating immune responses. Tumor necrotic factor-alpha and Interleukin-6, and induce inflammation in the pathogenesis of autoimmune diseases.

T- regulatory cells exert immunosuppressive effects which are important on the maintenance of immune homeostasis by producing anti-inflammatory cytokines, such as Interleukin-10 and transforming growth factor-b.

Aim of this work is to the role of T regulatory cells :( Cluster of differentiation 4, Cluster of differentiation 25,Cluster of differentiation 127 , forkhead box P3 cells) in the different stages of diabetic nephropathy before hemodialysis initiation.

Eligibility Criteria:
Inclusion Criteria:

Adult patients above 20 years diagnosed with type 2 diabetes mellitus and have microalbuminuria, macroalbuminuria or renal impairment

Exclusion Criteria:

Patients with ischemic heart disease, any other autoimmune diseases, and Hepatitis C or B positive patients.

b-Patients with diabetic nephropathy on dialysis therapy c- Patients with any other causes for renal diseases such as glomerulonephritis
Effects of High-Intensity Interval Training on Depressive Symptoms in Hong Kong Older Adults

Depression in later life is a common health problem in aging societies. It is associated with poor quality of life, and increased risks of morbidity and mortality. People with severe depression may develop serious psychotic symptoms (e.g., delusions) and have higher mortality and disability than those with mild and moderate depression.

Traditional moderate-intensity continuous training (MICT) (e.g., Baduanjin Qigong) has proved to be effective in preventing and alleviating depressive symptoms among older adults. However, older adults with mental illnesses have poorer engagement and compliance with MICT programs. In recent years, as a novel type of exercise, high-intensity interval training (HIIT), which includes repeated bouts of high-intensity effort followed by varied recovery times, appears to be a promising approach for overcoming limitations in traditional MICT programs.

Considering there is little evidence of HIIT benefits related to older adults with depression, the current study aims to evaluate the effectiveness of a 16-week HIIT intervention on depressive symptoms and other health-related outcomes among Hong Kong Chinese older adults.

The study will be a cluster randomized controlled trial (CRCT) with three groups and three times repeated measures. Data will be collected in a pretest, post-test, and three months after the intervention. The eligible community elderly centers will be randomly distributed into one of three groups in a ratio of 1:1:1. The participants recruited and meeting the screening criteria will receive a 16-week HIIT intervention or Baduanjin exercise or recreation workshop. The intervention effects will be evaluated on depressive symptoms, concentration of salivary cortisol, sleep quality, quality of life, and physical fitness.

Eligibility Criteria:
Inclusion Criteria:

* 60 to 74 years at the start date of the project
* Chinese version of Geriatric Depression Scale (GDS-C) scoring 5-11 (i.e., mild to moderate level of depressive symptoms)
* Passing the PAR-Q plus screening or with the physician's approval for readiness to participate in high-intensity exercise
* Above the average level of 2-mins stepping showing competent aerobic fitness
* No restriction on physical mobility
* No cognitive impairment, as determined by the Chinese version of the Mini-Mental Status Examination (i.e., score \< 24)
* No previous substantial experiences in practicing HIIT or Baduanjin Qigong. The written informed consent form will be collected from each participant

Exclusion Criteria:

* Severe chronic disease restricting high-intensity exercise
* Having cognition impairment regarded by specialists
Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry

The study is a clinical pilot study that examine the preliminary effect of cognitive-behavioral therapy for insomnia (CBT-I) in adolescents with comorbid psychiatric disorders. Participants (n=25) are recruited from three psychiatric clinics (n=19) and one pediatric pain clinic (n=6). After diagnostic assessment, participants that fulfil inclusion criteria are offered the CBT-I intervention. Pre-post and 3-months follow-up assessments include subjective measures of insomnia symptom severity, sleep parameters (collected through sleep-wake diaries), symptoms of depression and anxiety and daytime functioning.


Eligibility Criteria:
Inclusion Criteria:

* be between 13-17 years old
* meet criteria for insomnia disorder (primary or secondary insomnia) according to DSM-IV-TR
* have insomnia symptoms at a clinical level, as defined as more than 10 points on the ISI-a
* adequate Swedish language skills

Exclusion Criteria:

* severe psychiatric disorder that is contraindicative of the treatment (i.e., bipolar disorder, psychotic disorder)
* autistic disorder
* severe suicidality (defined as ≥17 points on MINI-kid suicide subscale)
* alcohol or drug dependence
* psychotropic medication
* previous (\> 5 sessions) or ongoing CBT-treatment for insomnia
The Impact of Serial Remote Ischemic Conditioning on Dynamic Cerebral Autoregulation in Healthy Adults

The purpose of this study is to determine the impact of serial remote ischemic conditioning on dynamic cerebral autoregulation and related hematology indexes in healthy adults.

Remote ischemic conditioning(RIC) is the phenomenon whereby brief cycles of ischemia and reperfusion, applied to a distant organ, provide protection to the target organ. Dynamic cerebral autoregulation(dCA), a mechanism to maintain the cerebral blood flow, has been proved to be critical for the occurrence,development and prognosis of ischemic neurovascular disease. In this study, we hypothesis that RIC provides neuro-protection by means of improving dCA.

Eligibility Criteria:
Inclusion Criteria:

* age from 18 to 50,both genders
* willing to participate in follow-up visits

Exclusion Criteria:

* current or having a history of chronic physical diseases or mental diseases
* suffering from infectious diseases in late one month
* pregnant and lactating women#
* smoking or drinking#
* inability to cooperate sufficiently to complete the dCA examination
Pilot Study: Investigating Mood Changes After Slow-wave Enhancement

The aim of this pilot project proposal is to test the hypothesis that decreased sleep slow-wave activity (SWA) observed in individuals with major depressive disorder (MDD) is related to mood dysfunction, and that manipulating SWA may serve to improve mood by normalizing SWA regulation. The investigators propose to enhance SWA during nighttime sleep in a group of 20 antidepressant-free males and females age 25-50 with varying degrees of impairment in mood. Each participant will undergo one baseline night of sleep in the laboratory and then will sleep with the SmartSleep Headband nightly for two weeks in their own home. For one week, slow-wave sleep will be enhanced. On the alternate week, sleep will not be changed. Following the two weeks of sleeping with the device, participants will then spend another night in the sleep laboratory to assess changes in sleep. Mood will be assessed by self-report and clinician-administered scales following the baseline night of sleep, virtually after the first experimental week, and at the conclusion of the study.


Eligibility Criteria:
Inclusion Criteria:

1. Age 25-50 years.
2. Primary language is English.
3. Normal cognition.
4. Normal (or corrected-to-normal) vision and hearing.
5. Current depression.
6. Stable, normally-timed sleep-wake cycle as determined by interview, 1-week daily sleep log, and 1-week wrist actigraphic evidence, and defined by:

   1. Habitual nocturnal sleep duration between 6h and 9h.
   2. Habitual bedtime between 9pm-12am.
   3. No evidence of habitual napping.

Exclusion Criteria:

1. Current or prior medical condition that could interfere with collection or interpretation of data, based on medical history.
2. History of stroke, epilepsy, brain scarring, or head injury causing unconsciousness.
3. Independent/Intrinsic sleep disorder other than insomnia based on history or polysomnogram.
4. Recent use of psychoactive medications or medication thought to impact sleep or CNS function, as determined by investigators (e.g. SSRIs, benzodiazepines, glutamate modulators, gabapentin).
5. History of or current psychiatric conditions that increase study risk or grossly impair CNS function (e.g., current anorexia or bulimia, history of substance dependence or current substance abuse, lifetime history of psychosis).
6. Lifetime history of electroconvulsive therapy.
7. Pregnancy as determined by self-report.
8. Travel beyond 2 time zones in the 2 months before study.
9. Unwillingness to refrain from using alcohol or caffeine during the study.
Effect of a High Protein Diet on the 24-hour Profile of Ghrelin, GH (Growth Hormone) and IGF-1 (Insulin-like Growth Factor-1)

In this study we tested the hypothesis that an increase in protein content of the diet will result in an increase in the 24-hour integrated circulating growth hormone (GH) and insulin-like growth factor-1 (IGF-1) concentrations and an increase in lean body mass in people with untreated type 2 diabetes.

Subjects with untreated type 2 diabetes were studied using a randomized crossover design. The study began with an initial two-week observation period. Subjects then were randomly assigned to one arm of the study for 5 weeks. The carbohydrate:protein:fat ratio for the control diet is 55:15:30 whereas for the test diet it is 40:30:30. Following a five-week washout period, subjects were assigned to the other arm of the study. All meals were provided by the SDTU. A six-day rotating meal plan has been devised. At the beginning and end of the 5-week diet period, the subject was admitted to the SDTU (Special Diagnostic and Treatment Unit), was provided with the meals appropriate for the test or control arm of the study, and had blood drawn at various times during a 24-hour period. In addition to measurement of GH and IGF-1, IGF-binding proteins 1 and 3, ghrelin, and body composition were determined.

Eligibility Criteria:
Inclusion Criteria:

* People ages 55 - 75 years old with type 2 diabetes, not receiving oral hypoglycemic agents or insulin.
* Fasting plasma glucose \< 250 mg/dl (\<14 mM) (tGHb \< 14%).

Exclusion Criteria:

* Subjects will be screened for hematological abnormalities, liver disease, kidney disease, macroalbuminuria (\>300 mg/24 hours), untreated thyroid disease, congestive heart failure, angina, life-threatening malignancies, proliferative retinopathy, diabetic neuropathy, peripheral vascular disease, serious psychological disorders, a body mass index \> 35, and a fasting triglyceride of \> 400 mg/dl.
* Presence of any of the above will be considered exclusion criteria.
Prospective Comparative Multicenter Study of the Care Pathway After Shoulder Surgery

Post-operative management of shoulder surgery patients, particularly in terms of pain management and follow-up, can vary from one center to another, influencing clinical outcomes and patient satisfaction. The aim of this study is to compare two approaches to post-operative follow-up in two distinct centers: structured follow-up using the Vivalto-Dom protocol in Paris, and autonomous follow-up through contact with a nurse in Saint-Grégoire. The hypothesis is that these differences in the care pathway will affect pain management, comfort and patient satisfaction. By controlling for operative variability (a single surgeon operating in both centers), the study will identify the most effective follow-up practices for improving post-operative management, with the ultimate aim of optimizing quality of care and reducing post-operative complications.


Eligibility Criteria:
Inclusion Criteria:

* Patient eligible for one of the following 4 types of surgery: Simple non-repair arthroscopic surgery (acromion, calcification), arthroscopic repair surgery (cuff, DAS, bankart), open surgery without prosthesis (ligamentoplasty, bone block), open surgery with prosthesis (inverted prosthesis, anatomic prosthesis, etc.).

Exclusion Criteria:

* Patients with one or more communication disorders.
* Pregnant or breast-feeding patients
* Patients not covered by a social security scheme
* Refusal to participate in research
* Patients unable to understand or give informed consent
* Patients under guardianship, deprived of liberty or under court protection
* Patients with past or present drug addiction
* Patients with neuropathy
* Patients with cognitive disorders
* Patients with chronic illnesses or inflammatory pathologies leading to chronic pain.