cyrilzakka/clinical-trials huggingface dataset:
Protocol of Self-Regulation in Early Learners: The Role of Recreational Programs

Protocol of Self Regulation in Early Learners: The Role of Recreational Activity Program (RAP) RAP, which included fun games and lasted 24 sessions, was applied to the students in the study group. Twenty-four sessions include games that help gain rhythm, balance, and patience. The program is planned according to the game theory model, which aims to have fun for children. The program, which aims to develop children's self-regulation skills based on the essential reflections of the model, will include fun games with simple rules. Before the program was implemented, the researchers informed the experimental group about the research and the program, and verbal consent was obtained from the participants.

The study titled "Protocol of Self-Regulation in Early Learners: The Role of Recreational Programs" focuses on the influence of structured recreational activities on the development of self-regulation skills among preschool children. Self-regulation is a crucial ability, facilitating children's academic performance, social behaviors, and emotional well-being.

RAP, which included fun games and lasted 24 sessions, was applied to the students in the study group. Twenty-four sessions include games that help gain rhythm, balance, and patience. The program is planned according to the game theory model, which aims to have fun for children. The program, which aims to develop children's self-regulation skills based on the essential reflections of the model, will include fun games with simple rules. Before the program was implemented, the researchers informed the experimental group about the research and the program, and verbal consent was obtained from the participants.

Eligibility Criteria:
Inclusion Criteria: Attending at least 22 sessions -

Exclusion Criteria:

-
Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure

Safety and Efficacy of Mesenchymal Stem Cell Transplantation for Acute-on-Chronic Liver Failure

Acute-on-chronic liver failure (ACLF) which occurs in patients with chronic liver disease, is a serious live-threatening disease. Currently, the clinical management, such as liver protection, anti-virus medicine, and artificial liver support, has not significantly improve the outcomes, the mortality still remains over 50%. Liver transplantation is the only effective treatment of ACLF, but this therapy is limited by the shortage of donor organs, potential surgical complications, immunological rejection and high medical costs. Mesenchymal stem cell (MSC) is one of adult stem cells, which has been suggested to play a role in amelioration of liver disease, such as: trans-differentiation of MSCs into hepatocytes, immunomodulation, inhibition of fibrosis development, protective effects on hepatic cell and restoration of hepatic cell proliferation capacity.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent
2. Meeting the definition of ACLF: patients with previously diagnosed or undiagnosed chronic liver disease acute decompensated within 4 weeks; significant GI symptom as such fatigue, jaundice; serum total bilirubin \[TBil\] ≥10 X the upper limit of normal; coagulopathy (international normalized ratio \[INR\] ≥1.5 or prothrombin activity \[PTA\] \<40%); complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination.
3. Model for End-Stage Liver Disease (MELD) scores ranging 17-30, (MELD(i) = 0.957 × ln(Cr) + 0.378 × ln(bilirubin) + 1.120 × ln(INR) + 0.643);
4. Chronic liver disease with definitive etiology such as viral hepatitis, alcohol liver disease, drug induced liver injury or autoimmune liver diseases
5. Body weight ≥50kg

Exclusion Criteria:

1. Serious complications in the previous 2 months (e.g., gastrointestinal bleeding: hemoglobin below 90g/L, serious infection such as sepsis, ascites ultrafiltration, and/or dialysis);
2. Malignant jaundice induced by obstructive jaundice or hemolytic jaundice;
3. Hepatocellular carcinoma (HCC) diagnosed by radiologic imaging and/or alpha fetoprotein (AFP);
4. Tumor diagnosed by ultrasound, CT, MR examination;
5. Moderate or severe chronic heart failure (NYHA III-IV), renal replacement therapy, severe chronic pulmonary disease (GOLD III-IV)
6. Extrahepatic cholestasis
7. Hepatic, portal and splenic vein thrombosis diagnosed by doppler ultrasound
8. Artificial liver support
9. Previous liver transplantation
10. Drug abuse in the past 5 years;
11. Mental disorders and/or has a family history of mental disorder.
12. HIV infection
13. Pregnant or breast-feeding females
14. Highly allergic
15. Patients can not cooperate or mobility
16. Enrolled in other clinical trials with 3 months
17. Patients who can not provide prior informed consent or refusal to participate
Cytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation

The purpose of the study is to determine if the use of activated T cells can effectively treat relapsed disease following allogeneic hematopoietic cell transplantation without causing GVHD.


Eligibility Criteria:
Inclusion Criteria:- Evidence of recurrent or persistent hematologic malignancy following HLA matched allogeneic hematopoietic cell transplant

* eligible for DLI
* no evidence of GVHD
* stable immunosuppressive regimen
* adequate renal and liver function Exclusion Criteria:- CML patients who have not received DLI, active infections
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

This is a randomized, multi-center, open-label, parallel group study with three arms:

* Rasburicase alone
* Rasburicase followed by Allopurinol
* Allopurinol alone

The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.

After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.

Eligibility Criteria:
Inclusion Criteria:

1. Meets high risk or at potential risk for tumor lysis syndrome (TLS):

   A patient is at high risk for TLS if he/she presents with:
   * Hyperuricemia of malignancy (plasma uric acid \> 7.5 mg/dL);
   * A diagnosis of very aggressive lymphoma/leukemia based on the Revised European-American Lymphoma (REAL) classification of lymphoma/leukemia;
   * Acute myeloid leukemia (AML);
   * Chronic myeloid leukemia (CML) in blast crisis; or
   * High grade myelodysplastic syndrome (refractory anemia with excess blast, chronic myelomonocytic leukemia, and refractory anemia with excess blast in transformation) only if they have \> 10% bone marrow blast involvement and are given aggressive treatment similar to AML.

   A patient is at potential risk for TLS if he/she presents with:
   * A diagnosis of aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria:

     * Lactate dehydrogenase (LDH) \>= 2 x upper limit of normal (ULN) (IU/L)
     * Stage III-IV disease
     * Stage I-II disease with at least 1 lymph node/tumor \> 5 cm in diameter

   In addition to the above-mentioned eligibility criteria, the patients should have the following criteria:
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
3. Age \>= 18 years
4. Life expectancy \> 3 months
5. Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).
6. Signed written informed consent
Cognitive Control Mechanisms in Older Adults

The prevalence of depressive symptoms in older adults is on the rise, affecting 13 to 37% of older adults globally. These symptoms significantly impact health, increasing the risk of dementia and cognitive decline, and impairing daily functioning and quality of life. Reduced cognitive control (CC) is a key factor contributing to depressive symptoms, affecting 40% of adults with such symptoms. Despite this, over half of affected adults do not respond well to available treatments. Computerized cognitive training (CCT) has shown efficacy in improving CC but its impact on daily functioning is limited. The Cognitive Orientation to Occupational Performance (CO-OP) approach has demonstrated promise in improving daily functioning, as measured by occupational performance (OP). We propose a novel intervention, GOLD-Cog+, combining CCT and CO-OP, to address CC and functional deficits in older adults with depressive symptoms.

The goal of this clinical trial is to investigate the relationship between mood and cognitive control in community-dwelling older adults (65+) with sub-clinical depression and to assess feasibility, efficacy, and sustainability of a proposed combined cognitive intervention, GOLD-Cog+, for this population group. Cognitive control is the mental abilities that underlie our goal-directed behavior. These mental abilities include: the ability to shift our attention, constantly monitoring and updating information provided by our environment and having the ability to inhibit unwanted reactions.

The main questions of this study are:

Question 1: What is the relationship between mood and cognitive control in daily life of older adults with depressive symptoms? Question 2: Can this proposed combined cognitive intervention, GOLD-Cog+ help improve daily functioning, cognitive control, mood, quality of life and subjective cognition in older adults with depressive symptoms? Question 3: Are the participants satisfied with this new proposed intervention?

Participants will participate in a crossover randomized control trial in which they will participate in a 6-week experimental period and a 6-week waiting period. During the experimental period, they will take part in individual computerized cognitive training and functional-based, goal-oriented group sessions.

Eligibility Criteria:
Inclusion Criteria:

* Depressive Symptoms based on Patient Health Questionnaire (PHQ-8) ≥ 5
* Healthy Cognition based on Montreal Cognitive Assessment (MoCa) ≥ 20
* Capable of signing and agreeing to participate in the study
* Have the basic technological skills to use a tablet based on self-report
* Adequate sight and hearing abilities (with assistive technology) to be able to use a tablet and fully participate in a small group setting (6 people)
* Ability to fluently read, speak and understand Hebrew or English

Exclusion Criteria:

* Any neurodegenerative disorder (e.g., Mild Cognitive Impairment (MCI), Dementia, Parkinson's disease) via self-report
* Psychiatric disorders, not including depression or anxiety disorders (specifically: Schizophrenia, Bipolar or Psychotic disorders) via self-report
The Effect of Exercise in Postmenopausal Women with Low Bone Density

This clinical trial aims to evaluate the effects of a 12 month gym- and home-based exercise program on bone density and falls risk factors in postmenopausal women with low bone density. It is hypothesised that the exercise program will lead to improvements in bone density and falls risk factors such as balance and muscle strength compared with usual care.


Eligibility Criteria:
Inclusion Criteria:

* Be aged greater than 50 years
* Be at least 5 years post menopause (defined as the last normal menstrual bleed)
* Have osteopenia of the hip defined as a DXA T-score between -1 and -2.5 in one or more regions of the proximal femur (total hip, neck or trochanter regions).
* Have primary osteopenia
* Be community dwelling (not in residential care)
* Be able to attend an exercise program 3 times per week over the 12-month period
* Be able to read and write English

Exclusion Criteria:

* Secondary causes of bone loss such as osteomalacia, glucocorticoid medication
* Co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition
* Physical or orthopaedic disabilities that would place the subject at risk or limit their ability to perform exercise
* Spinal osteoporosis defined as DXA T-score \<-2.5
* A past vertebral fracture
* Body mass index \> 35 or \< 18.
* Currently on hormone replacement therapy (HRT)
* Current smoker
* Past use of HRT within the past 3 years and for more than 6 months duration
* Taking medication known to affect bone including oestrogen or steroid hormones
* Known clinically significant liver or renal disease
* Cancer within the past 5 years
* Doing regular strength training and/or weight-bearing exercise at least once per week in past 6 months
* Unlikely to comply with the intervention protocol
Food Literacy Intervention - is a "Train the Trainer" Approach Feasible and Effective?

Food literacy (FL) is the capability to make healthy food choices in different contexts, settings and situations. Although eating habits are shaped by different circumstances and skills, most nutrition programs focus on nutrition knowledge alone. Addressing factors such as competencies, self-efficacy and social norms enables sustainable positive change in nutrition behaviour. This study will assess a lay leader-led FL workshop to Arab and Jewish women from disadvantaged communities in the Jerusalem region, utilizing a train-the-trainer approach, and will compare the effectiveness and cost-effectiveness of a lay-led FL intervention to an expert-led intervention.

Food literacy (FL) is the capability to make healthy food choices in different contexts, settings and situations. Although eating habits are shaped by different circumstances and skills, most nutrition programs focus on nutrition knowledge alone. Addressing factors such as competencies, self-efficacy and social norms enables sustainable positive change in nutrition behaviour. This study will assess a lay leader-led FL workshop to Arab and Jewish women from disadvantaged communities in the Jerusalem region, utilizing a train-the-trainer approach, and will compare the effectiveness and cost-effectiveness of a manualized FL intervention given by trained lay-leaders vs. the same workshop given by experts.

Eligibility Criteria:
Inclusion Criteria:

* Hebrew or Arabic literate women who are over 25 years old

Exclusion Criteria:

* Women who do not meet inclusion criteria.
The Effects of Sacral Neuromodulation for Urinary Urgency, Frequency, and Urge Incontinence

This prospective one group cohort study seeks to investigate the effects of sacral neuromodulation on urinary urgency, frequency and urge incontinence are maintained after the simulator device is temporarily turned off for a period of four weeks.

Urinary urgency, frequency, and urge incontinence are very common symptoms, affecting up to one in three adults in the United States. The total economic cost of these disorders was estimated to be above $12 billion in the year 2000, with the vast majority being for women.

Sacral neuromodulation (SNM) has become a popular and successful treatment option for people who suffer from these conditions. Sacral neuromodulation device delivers electrical pulses to an area near the sacral nerve.

There has been some data published which showed that for patients with fecal incontinence, symptom relief can persist for significant time periods despite having the stimulator device turned off. Based on their findings, potential exists to prolong battery life if patients can cycle the on and off periods for their device while keeping their symptoms stable.

The typical battery life of the implantable pulse generator (IPG) is approximately 5 years depending on the system settings. When the IPG is at the end of its battery life, a new IPG must be implanted. The cost of replacing the IPG ranges from $13,952 to $16,470. IPG replacement must be done in the operating room and requires the patient to undergo anesthesia and its associated risks.

This study will investigate whether the symptoms of urinary urgency, frequency, and urge incontinence remain stable in patients with SNM with the device turned off for a period of four weeks.

Current Cincinnati Urogynecology Associates (CUA) patients who are currently being successfully treated with sacral neuromodulation for the primary diagnosis of urinary urge incontinence or urgency and frequency who elect participate in the study will have the device turned off for four consecutive weeks. Their symptoms will be monitored during this time period.

Eligibility Criteria:
Inclusion Criteria:

* Women, aged 18-85 with who have previously had the InterStim device implanted and have experienced good control of their symptoms for at least one year.

Exclusion Criteria:

* Patients with less than 6 months of expected battery life on their device established at office testing.
* Patients with poor control of their symptoms within the last one year.
* Patients with degenerative neurological disorders or spinal cord injuries.
* Patients with cognitive disabilities or those lacking the mental capacity to understand and answer questionnaires.
* Patients who are pregnant or may become pregnant.
Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma

P) patients with acute obstructive colon cancer I) resection or bridge to surgery with stent or stoma C) emergency procedure O ) morbidity and mortality within 30 days, 90 day mortality and 3 \& 5 years overall survival

The aim of this prospective observational study is to evaluate primary resection for malignant obstruction of the colon compared to only decompression as first intervention regarding postoperative outcomes. We hypothesize that patients with malignant obstruction benefit from avoidance of emergency cancer resection, by a two-stage procedure, with decompression by a stoma or stent as first intervention, leading to decreased short-term morbidity and mortality and improved long-term oncological outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Symptomatic large bowel obstruction requiring acute intervention
* CT-verified colon obstruction due to colon cancer independent of presence of metastases
* Informed consent

Exclusion Criteria:

* Colonic perforation or bleeding
* Colonic obstruction of other origin than colon cancer
* Palliative situation
Beauty as a State of Wellness Beauty as a State of Wellbeing in Women 40 to 64 Years of Age

The sociocultural pressure towards women's body image is one of the problems that today afflicts much of the female population. It is a reality that society exerts a strong pressure on body image, particularly on women.

The main objective of this study is to analyze the self-perception and self-esteem of people who apply a facial cosmetic. A convenience sample of 150 participants is estimated, who can be randomly included in one of the three groups with different interventions.

The aging process is something inherent in all people, causing biological and structural changes in our organism, being the skin the one that shows the first signs of this aging. Being healthy is no longer a desire and a natural aspiration of every person, but a kind of tyranny that has turned health into a duty that, according to the wellness industry, can only be satisfied through the consumption of certain commercial products and services. The cosmetic industry feeds us with false beliefs where perfection is something achievable, but many women do not want false promises from the cosmetic industry when they are aware that they have wrinkles. Such practices jeopardize physical health and impact mental health.

IIn line with this evolution, the researchers propose this study that suggests a relationship between the use of cosmetics, psychological well-being, stress and self-esteem of the people who consume them.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 40 and 65 years old
* Who use a facial cosmetic at least once a week.

Exclusion Criteria:

* Receiving oncological treatment at the time of participation in the study.
* Suffering acute infectious disease processes in the 3 months prior to the study or during the study period.
* Being diagnosed with some type of mental illness.
* Failure to sign the informed consent form.
Continuous Blood Purification for Regulation of Early Inflammatory Response In Severe Acute Pancreatitis

Systemic Inflammatory response syndrome(SIRS) is common in patients with severe acute pancreatitis (SAP) in early stage. Continuous Blood Purification (CBP), especially Continuous Veno-Venous Hemofiltration(CVVH) is proved to have an important role in SAP patients to control SIRS. But the detail treatment for this is controversial. In this study, the investigators aim to evaluate the different effects of three kinds of treatment protocols which is CVVH 6h,continuous venovenous hemodiafiltration(CVVHDF) 6h,CVVH 10h for first three days in SAP patients. Compare the vital sign, SIRS parameters, and others between these three groups. This study will try to find a better way for CBP in patients with SAP

Condition Severe Acute Pancreatitis

Intervention CVVH 6 hours for first three days CVVH 10 hours for first three days CVVHDF 6 hours for first three days

All therapeutic volume is 45ml/kg.h, Device: Braxter HF 1200

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

1. Diagnosis of pancreatitis:

   * Typical pain
   * Increase in serum lipase or amylase
   * Onset of abdominal pain within \<=72h before admission
2. The diagnosis criteria of Severe Acute Pancreatitis is according to Atlanta criteria revisited in 2012
3. no chronic diseases such as Chronic Obstructive Pulmonary Disease, Diabetes Mellitus and so on
4. Age from 18 to 65 years old

Besides criteria above, the patient should also satisfied one of these CBP criteria:

1. Have Acute Kidney Injury satisfied RIFLE classification (risk above): increased Serum Creatinine \> 1.5 times baseline，26.5umol/L increase, or urine output \< 0.5ml/kg.h for 6 hours
2. Systemic Inflammatory Response Syndrome: temperature \>38℃ or\<36℃；heart rate respiratory rate White blood cell count \>12\*10\^9/L，or\< 4\*10\^9/L
3. Refractory acid-base and electrocyte balance disorder, metabolic acidosis conservative treatment is not effective.

Exclusion Criteria:

1. Pregnancy
2. Chronic pancreatitis
3. Immunosuppression condition such as HIV, Corticosteroid for 3 weeks in 60 days; White Blood Cell \< 0.5\*10\^9/L for 10 days
The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery

Antibiotics are sometimes prescribed to patients who have had reconstructive surgery of wounds on their face using skin grafts. But, it is not yet known whether antibiotics improve the healing of skin grafts and reduce the risk of infections after surgery in these patients. It is known that antibiotics, like all medications, have side-effects although these are rare. This research study is designed to show us whether antibiotics improve wound healing or not, so that we may determine if we should continue using antibiotics even if they have side-effects in some patients.

Our hypothesis is that patients treated with post-operative, systemic antibiotics will demonstrate a statistically significant improvement in the survival of their facial full thickness skin grafts compared to patients who are not treated with systemic antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* all adult patients with a nasal or facial skin/soft tissue defect requiring reconstruction limited to or including a full-thickness skin graft

Exclusion Criteria:

* current or recent (within one week of surgery) systemic antibiotic use, intolerance to both clindamycin and cephalexin, discovery of a persistent cutaneous malignancy at the site of the defect following the reconstructive procedure and previous reconstruction at the site of the skin/soft-tissue defect.