cyrilzakka/clinical-trials huggingface dataset:
The Cognitive Neural Mechanisms and Neuroregulatory Interventions of Realistic Creative Problem-solving Under the Effects of Drug Addiction

Drug addiction persists as a significant global social concern with a negative impact on social harmony and stability that cannot be ignored. After returning to society, individuals with drug addiction often suffer from impaired creative problem-solving abilities and difficulties in interpersonal cooperation. The difficulties in survival stress and the sense of helplessness triggered by these factors are important reasons that lead them to seek drugs repeatedly and even to commit criminal behaviors. Therefore, enhancing creative realistic problem-solving abilities emerges as a pivotal pathway for drug addicts to facilitate rehabilitation from drug addiction and achieve societal adaptation. The project emphasizes both individual and collaborative creative solution generation for realistic problem solving. The abnormal cognitive neural mechanisms and interpersonal neural mechanisms will be systematically explored by using multiple cognitive and neuroimaging methods, such as functional near-infrared spectroscopy (fNIRS), electroencephalography (EEG), and eye-tracking. From the cognitive-behavioral-brain level, a comprehensive neurophysiological multimodal predictive model of how drug addiction affects creative realistic problem-solving will be constructed by multi-level data fitting modeling. Building upon this research foundation, The investigators will further implement single and repeated sessions of transcranial direct current stimulation (tDCS) targeting damaged brain regions for the intervention of individual and collaborative problem-solving ability under the effect of drug addiction. The indicators of brain, cognition, and behavior will be tracked at multiple time points.


Eligibility Criteria:
Inclusion Criteria:

* age between 30 and 60 years;
* fulfilling the diagnostic criteria for severe substance use disorder as specified in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders.
* a history of heroin use exceeding ten years, with a daily average intake of at least 0.1 grams.
* abstinence duration of eight months or less, with a positive result of a urine test before entering the rehabilitation center.
* no history of neuromodulation treatments such as tDCS within the past six months.

Exclusion Criteria:

* a history of alcohol dependence, neurological disorders, or other complex psychiatric conditions.
* the presence of intracranial metallic implants or elevated intracranial pressure.
* a history of epilepsy or recent electroencephalogram evidence of epileptiform activity.
* the use of implanted electronic devices, such as pacemakers;.
* scalp hyperalgesia or a tendency toward bleeding.
* severe cardiac conditions.
Comparing the Radial Extracorporeal Shock Waves and Botulinum Toxin Injection for Spasticity

Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity.

Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, the treatments of BoNT-A injection are associated with high cost and invasive treatment. Recent studies have showed that radial extracorporeal shock wave (rESWT) is a novel, effective and safety treatment method for the spasticity. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18-80 year-old
2. The onset of stroke must be at least 6 months previously
3. Spasticity measured as Modified Asthow Scale more(MAS) than 1+
4. Signed informed consent form

Exclusion Criteria:

1. Patients with marked contractures in the elbow and wrist (MAS\>4)
2. Resistant hypertension, coagulation disorders, malignant tumors, pregnancy, pacemakers, cognitive disorders
3. Prior or planned treatment with phenol or alcohol nerve blocks, intrathecal baclofen, or BoNT-A injection within the six months preceding the study
A Proof of Concept, Phase 2, Double-blind, Randomized Trial With d-Methadone Product Versus Placebo

Proof of concept, double-blind, randomized, placebo-controlled trial with d-methadone proposed for the first time for use in the treatment of patients diagnosed with primary, moderate to very severe Restless Legs Syndrome (RLS). Its glutamatergic mechanism of action might be effective on RLS arousal pattern and sleep disturbance which highly impair the quality of life of RLS's patients.

Patients will take the study drug/placebo once a day for 30 consecutive days.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary RLS.
* Moderate to very severe RLS defined as IRLS-RS score \> 10.
* Written informed consent.
* Willingness and ability to participate in the trial

Exclusion Criteria:

* Positive history of known causes of secondary RLS.
* Any other concomitant treatment for RLS (wash-out period: at least 7 days).
* Moderate-severe sleep apnea defined as Apnea Hypopnea Index ≥ 15.
* History or presence of clinically significant abnormality as assessed by neurological examination which in the opinion of the Investigator would jeopardize the safety of the patients or the validity of the study results.
* Evidence of clinically significant hepatic or renal impairment
* History or family history of sudden unexplained death or long QT syndrome.
* Any 12-lead ECG with demonstration of QTc ≥ 450 msec or a QRS interval ≥ 120 msec at Screening.
* Concomitant use of psycho-drugs dopamine agonists and opioids (wash-out period: at least 7 days).
* History or presence of any condition in which an opioid is contraindicated
* History of allergy or hypersensitivity to methadone or related drugs.
* Any clinically significant neurological, sleep, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, chronic pain, psychiatric or gastrointestinal disorder.
* Women who are pregnant or breast feeding.
* Inability to follow the procedures of the study, (e.g. due to language problems, psychological disorders, dementia, etc. of the participant).
* Previous enrolment into the current study.
* Enrolment of the investigator, his/her family members, employees and other dependent persons.
* Participation in another study with investigational drug within the 30 days preceding and during the present study.
Impact of a New Plant-based High-energy Oral Nutritional Supplement on Nutritional Outcomes in Malnourished Patients

This study aims to compare nutritional outcomes in terms of percentage of weight gain between a new planted-based high-energy ONS and a standard high-energy ONS with animal protein (cow's mil protein) in patients at malnutrition according to Global Leadership Initiative on Malnutrition (GLIM) criteria.

Due to the increasingly pressing need to develop an oral nutritional supplement (ONS) that does not contain animal ingredients, Fortimel PlantBased, suitable for patients with Disease-Related Malnutrition or who wish to avoid or reduce the consumption of animal products for dietary or lifestyle reasons, is being promoted. At the same time, it is also a therapeutic option to be considered in the population with allergy or intolerance to cow's milk protein. Therefore, the aim is to offer an adapted therapeutic nutritional solution that guarantees nutritional results that are not inferior than ONS with animal protein (cow's milk protein).

This study was designed as an open-label randomized controlled non-inferiority trial with two arms: a new planted-based ONS (Fortimel PlantBased) as the intervention arm and standard ONS (Fortimel Energy) as the control arm, both high-energy formulas (1.5 kcal/m; 200ml).

The study will be carried out in patients at malnutrition according to Global Leadership Initiative on Malnutrition (GLIM) criteria, who need to supplement their diet by taking a high-energy ONS for at least 12 weeks. These patients will be treated and follow-up by the Endocrinology and Nutrition services of 6 public hospitals in Spain.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old

  * Malnourished patients according to GLIM criteria
  * Patients with a high energy requirement (1.5kcal/ml) requiring the intake of 2 bottles of ONS per day for at least 12 weeks
  * Patients presenting any of the following clinical situations:
* Elderly patients requiring oral nutritional support
* Patients with digestive pathology including but not restricted to inflammatory bowel disease, short bowel syndrome, pancreatitis, without active malabsorption and maldigestion.
* Chronic diseases such as COPD, mild to moderate renal disease, HIV
* Oncologic patients with Eastern Cooperative Oncology Group (ECOG) 0-1

  * Patients who have given their consent to participate
  * Patients who, in the opinion of the physician, have the capacity to answer the study questionnaires themselves or their caregivers

Exclusion Criteria:

* Patients who need ONS due to surgical or acute illness\*

  * Patients with known intolerance or allergy to cow's milk, soya or peas
  * Patients with hyperthyroidism. Patients with uncontrolled hypothyroidism
  * Uncontrolled diabetic patients (HbA1c \>8%)
  * Patients requiring enteral nutrition by tube or ostomy
  * Patients with moderate and serious renal insufficiency \< 30ml/min/1,73 m2
  * Patients who have value creatinine:

    * 1,70 mg/dl - 150,31umol/L Men
    * 1,50 mg/dl - 132,63umol/L Women
  * Patients with levels of haemoglobin \<10 g/dl, transferrin \<150 mg /dl
Prevention of Spinal Induced Shivering During CS

This study compares the efficacy of two different doses of intravenous (IV) granisetron on the prevention of postspinal shivering during cesarean section, in comparison with placebo.

The study will includes four groups as follows:

1. Granisetron1 group: women will receive 1mg IV granisetron
2. Granisetron 0.7 group: women will receive 0.7 mg IV granisetron and
3. Control group: women will receive 2 ml of 0.9% sodium chloride. Throughout the study period,shivering scores, core temperature, sensory level and motor block will be recorded, heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined. If heart rate decreases by more than 20% of the baseline atropin will be received and if blood pressure decreases 20% of the baseline ephedrine will be received.

Also, Apgar score at one minute and five minutes will be recorded. At the end patient satisfaction will be assessed using Verbal Numeric Scoring system Side effects (bradycardia, hypotension, hypothermia, nausea and vomiting, pruritus etc ) will be recorded perioperatively in the operating room and postanesthetic care unit.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women at term,
* ASA status I or II (American Society of Anesthesiologists) physical status class I-II,
* low-risk cesarean section,
* Scheduled for the spinal anesthesia

Exclusion Criteria:

* Pregnant women in labor
* Patients who have the body temperature over 37.3 or less than 37 celsius degree
* Known allergies to the study drugs
* Contraindication to spinal anesthesia
Process Evaluation of the Effectiveness of Two Transdiagnostic Interventions on Emotion Regulation

Emotional regulation (ER) appears today as a fundamental skill for the adaptation of an individual to his environment. Indeed, functional and efficient ER is crucial for mental well-being, but also for physical health, for the maintenance of satisfying social relationships , and for work performance. Many research studies have shown that difficulties with ER are central to the development of many mental disorders. Consequently, this skill can be the target of psychological interventions , the effectiveness of which can be tested as well as the mechanisms underlying that effectiveness. Various "mechanisms of effectiveness" have been advanced in the literature. Of these, this project will specifically test cognitive flexibility and feelings of self-efficacy.

Although a growing number of interventions attempt to target emotional regulation, few are evaluated in subclinical populations and few are protocolized. Similarly, there is little research evaluating the effectiveness processes of these interventions. To date, two types of interventions show particular promise: emotion competence based interventions and compassion focused therapy. This research will therefore be based on the evaluation of two interventions in a randomized controlled trial: Emotion Competence Training Program and Compassion Focused Program that will take place over 12 two-hour sessions in a subclinical and clinical population.

This study is composed:

* a single case study in a subclinical population
* a randomized controlled study in a subclinical population
* a pilot study in a clinical population

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 inclusive
* Person who can understand, speak and read French
* Person who has been orally informed and has given informed consent to participate in the study
* Affiliated with a social security plan

Exclusion Criteria:

* Score greater than or equal to 14 on the DASS21 scale.
* Current participation in another study regarding emotional regulation
* Participation in positive psychology, mindfulness, or stress management groups for less than 3 months
* Change in psychotropic medication (taking, stopping, or changing dosage) within 2 months prior to study participation
* Substance use
* Person with an intellectual disability.
* Person deprived of liberty by judicial decision.
Upadacitinib for Refractory IBD in Asian Children and Elderly: Age-Stratified Analysis

This single-center, retrospective study aims to evaluate the effectiveness and safety of upadacitinib (UPA) in Asian pediatric patients with refractory Crohn's disease (CD) and elderly patients with refractory ulcerative colitis (UC). The study will analyze data from 21 patients (11 children aged 9-17 with CD and 10 adults aged 60 and older with UC) treated at the Sixth Affiliated Hospital of Sun Yat-sen University between January 2023 and December 2024. The primary objective is to assess the clinical remission rate and endoscopic response rate in both groups. Secondary objectives include comparing treatment outcomes between the two age groups, exploring the impact of immunosenescence on UPA efficacy in elderly UC patients, and analyzing the correlation between laboratory markers (CRP, albumin) and clinical outcomes. This study is the first in Asia to investigate the age-stratified efficacy of upadacitinib in pediatric CD and elderly UC patients. The findings will provide crucial real-world evidence to inform individualized treatment strategies for these specific populations. Patients included in this study will have previously failed at least two biological therapies. Data collected will include demographics, disease characteristics, prior treatment history, UPA dosage and duration, clinical and endoscopic scores (PCDAI/Mayo, SES-CD/UCEIS), imaging results, laboratory values, and adverse events. The study is registered on ClinicalTrials.gov (NCT06274996). Ethical considerations will be addressed through data anonymization and a waiver of informed consent due to the retrospective nature of the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IBD according to the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2023)"; Failure of at least two prior biological therapies (anti-TNF/anti-integrin/IL-12/23 inhibitors); Complete baseline and follow-up data (at least 12 weeks))

Exclusion Criteria:

* Active infection, malignancy, severe cardiovascular disease, or hepatic/renal insufficiency; Pregnancy or breastfeeding; Use of other JAK inhibitors within 30 days prior to baseline)
Coordinated Access to Care From Hospital Emergency Departments

The study will assess the effectiveness and cost-effectiveness of providing brief, intensive case management for frequent users of hospital Emergency Departments who have mental health and/or addictions problems. The goals of the intervention are to support patients' transition to community-based health and social services and supports - including primary and urgent psychiatric care, peer support and other community services and supports - so as to improve patient wellbeing and reduce avoidable ED visits and hospitalizations.


Eligibility Criteria:
Inclusion Criteria:

* legal adult status (age 18)
* able to give informed consent
* have made 5+ visits to participating hospital Emergency Department in the previous 12 months
* One of these visits will have been for a mental health and/or addiction problem.

Exclusion Criteria:

-
A Biomarker Study for Immunotherapy in Advanced or Locally Advanced dMMR/MSI-H Colorectal Patients

dMMR/MSI-H colorectal cancer patients are the dominant population of immunotherapy/neoadjuvant immunotherapy, but imaging evaluation of immunotherapy efficacy is insufficient. There are some cases, although no disease remission was found on imaging,pathological complete response (pCR) was confirmed after surgery. Meanwhile,previous studies have shown that dynamic changes in ctDNA can help assess immunotherapy efficacy. Therefore, we propose to conduct a multicenter, prospective, observational clinical study to explore the efficacy prediction and monitoring value of ctDNA in immunotherapy for advanced or locally advanced dMMR/MSI-H colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

- advanced or locally advanced dMMR/MSI-H colorectal cancer Expected to receive/be receiving immune checkpoint inhibitor therapy ECOG performance score is 0-1, life expectancy ≥12 weeks

Exclusion Criteria:

- The presence of other uncured malignancies Patients with one or more serious concomitant systemic diseases that, in the investigator's opinion, impair the patient's ability to complete the study Patients with autoimmune disease are not suitable for PD1 monoclonal antibody therapy
Effects of Fermented Red Clover on Muscle Strength and Muscle Mass

The project is designed as a randomized controlled, double-blinded, cross-over trial, including 10 healthy postmenopausal women consuming fermented red clover extract or placebo twice daily over a two-week period. After the first trial (two weeks), participants will undergo a two-week washout period, after which they will receive the opposite trial drink for two weeks. The trial period runs over six weeks. Before each of the two trial rounds, participants will meet in the laboratory and perform muscle strength tests (trial days 1 and 3). After each trial round (trial days 2 and 4), participants will meet fasting in the laboratory, and a blood test and a muscle biopsy will be taken initially. Next, the subject consumes the test drink (placebo or red clover extract) before the subject performs a strength training session with one leg. Right after the training session, the subject consumes a protein drink. Three hours after the protein drink, another muscle biopsy is taken. During the period from the protein drink to the final biopsy, the subject performs two muscle strength tests (respectively grip strength and maximum upper arm muscle strength (biceps)). The primary target parameter is muscle protein signaling measured in the muscle tissue samples using the western blotting method.


Eligibility Criteria:
Inclusion Criteria:

* maximum of 5 years since last menstrual bleeding
* Minimum of 6 months since last menstrual bleeding

Exclusion Criteria:

* Performed systematic resistance training within the last 6 months
* Smoker
* Using any form of medicine influencing the effects of resistance training
The Efficacy of Proper Breakfast Times on Cognitive Function

The goal of this cluster randomized controlled trial is to learn if a proper breakfast time may increase cognitive function. It will also learn about the effectiveness of proper breakfast time on health outcomes. The main questions it aims to answer are:

Does a proper breakfast time increase cognitive function and health outcomes?

Participants will:

* wake up in the morning at 6 o'clock
* Having breakfast at 6.30 - 7.30 am or 7.31-8.31 am, or having breakfast time according to their wishes.
* Having lunch started at 12.00 pm.

This experimental study uses a Cluster Randomized Controlled Trial non-blinding parallel method design. The objective of this study is to assess the effectiveness of proper breakfast time on cognitive function including the focus on learning and mood among university students. Additionally, the study determines health outcomes such as heart rate, systolic blood pressure, diastolic blood pressure, and macro and micronutrient intake. There are a total of 60 participants from three different faculties. All faculties will be randomly selected and assigned to intervention group 1, intervention group 2, and the control group. Each group consists of 20 participants from each faculty in the university. Intervention Group 1 will have breakfast from 6:30 to 7:30 am, and Intervention Group 2 from 7:31 to 8:31 am. Meanwhile, the control group will continue their preferred breakfast routine. The intervention groups are required to wake up at 6:00 am and have lunch at 12:00 pm.

Eligibility Criteria:
Inclusion Criteria:

* Active student in the year 2024
* Not in medication
* Do not have gastritis or any diseases that require to have breakfast earlier in the morning
* Willing to sign an informed consent
* Have health insurance

Exclusion Criteria:

* Abstain in the education session
* Having emotional and mental health problems
* Students in the final class who are undergoing the thesis writing
Safety and Efficacy of Lumiracoxib in Patients With Osteoarthritis and With Controlled Hypertension

This study will investigate the effect on ambulatory blood pressure of lumiracoxib 100 mg once daily versus ibuprofen 600 mg three times a day in osteoarthritis patients with controlled hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the hand, hip, knee or spine
* High blood pressure (\<140/ 90 mmHg) which is controlled by antihypertensive medication(s).

Exclusion criteria

• Evidence or history of any cardiac and cerebral thrombotic/ ischemic diseases and/ or events

Other protocol-defined inclusion/exclusion criteria may apply