cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Effect of AstraGin on Arginine Absorption and Nitric Oxide Production in Healthy Subjects

AstraGin increases the absorption of amino acids and peptides in Caco-2 cells and in normal and TNBS-induced rats. Given the potential beneficial applications of AstraGin for health, the effects on L-arginine uptake and nitric oxide production are investigated. The study is the L-arginine pharmacokinetic study: A randomized, double-blind, crossover trial. This study performed in healthy human subjects. The knowledge gained from this study will provide valuable information for the development of novel and effective natural food supplements.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults and age 20 years and above, subdivided into three groups, Early-life (younger than 45 years, midlife (45--65 years), and later-life (older than 65 years), respectively.
* Subject has provided written and dated informed consent to participate in the study.
* The subject is willing and able to comply with the study.

Exclusion Criteria:

* The subject is participating in another clinical trial thirty days prior to enroll-ment.
* Subject has diabetes, obesity, hypertension, cardiovascular disease, liver or kid-ney disease, current infections, and smoking were exclusion criteria.
* Subject has any medical condition or uses any medication, nutritional product, amino acids supplement or program which might interfere with the conduct of the study or place the subject at risk.
* Subjects lost to follow-up, non-compliance, concomitant medication.
Universal Preventive Resilience Intervention to Improve and Promote Mental Health for Teenagers

Adolescence is a period of many physical, mental, emotional, and social changes. It is also associated with risk behaviour conducts. Nonetheless, not all youths under disadvantage, adversity, or exposure to risk factors experience negative mental health outcomes. The concept of RESILIENCE provides one possible explanation for the ability of some individuals to maintain positive mental health. Resilience is thus the ability of an individual or community to adapt to life challenges or adversities while maintaining mental health and well-being. The increasing prevalence of mental disorders amongst children (around 10-20% of young people) makes positive mental health promotion in schools necessary through intervention programmes. UPRIGHT (Universal Preventive Resilience Intervention Globally implemented in schools to improve and promote mental Health for Teenagers) is a research and innovation project funded by the European Union´s Horizon 2020 programme (No. 754919). UPRIGHT general aim is to promote mental well-being and prevent mental disorders in youth by enhancing resilience capacities. It has been designed as a whole school approach addressing early adolescents, their families and the school community to finally create a real mental well-being culture at schools.

The operational objectives of UPRIGHT are:

* to co-create (involving adolescents, families, school staff, clinicians, policy makers) an innovative resilience holistic program in schools for the promotion of mental health in youth between 12 and 14 years;
* to deploy an intervention in five different pan-European regions;
* to better understand the natural history of mental disorders according to the resilience level and provide evidence of specific resilience factors promoting positive mental well-being longitudinally;
* to demonstrate the effectiveness and predict future impact of an intervention in terms of improvement of quality of life, mental well-being, and academic performance, and a reduction of absenteeism and bullying cases;
* to transfer the programme to Europe and beyond by disseminating the results and enabling innovative action plans for mental well-being in the youth.

The UPRIGHT programme´s conceptual framework is structured in four different domains including skills for coping, efficacy, social and emotional learning and mindfulness practice. The intervention was developed by an innovative co-creation process (co-design, co-production and co-customization) participating five European regions representative of the cultural and socioeconomic variability (Lower Silesian in Poland, Basque Country in Spain, Trento in Italy, Denmark and Reykjavik capitol area in Iceland).

Eligibility Criteria:
Inclusion Criteria:

* Adolescents from 1st grade (12-14 years of age) studying in the participating schools, their families and teachers of these adolescents.

Exclusion Criteria:

* None
Electro-acupuncture at Zusanli, Qihai, and Guanyuan Acupoints Regulate Immune Function in Patients With Sepsis

The purpose of this study was to investigate the biochemical and clinical effects of electro-acupuncture in patients with sepsis.

Patients were randomly divided into an electro-acupuncture (EA) group and a Western medicine group(WM group) using restricted block randomization (1:1 ratio).

Patients in the Western medicine group received conventional treatment with Western medicine. According to the International Guidelines for Management of Sepsis and Septic Shock: 2016, conventional treatment includes antibiotics and other anti-infection measures, fluid management, mechanical ventilation, and nutritional support, but did not include the use of immunosuppressants or immune enhancers including hormones, gamma globulin, and thymosin. Patients in the electro-acupuncture group were treated with Western medicine and electro-acupuncture. Electro-acupuncture was given at the Zusanli (ST36), Guanyuan (CV4), and Qihai (CV6) acupoints, twice a day for 30 minutes, and for 5 days in total.

The indicators of immune dysfunction including the percentage of T lymphocyte subsets, percentage of natural killer (NK) cells, and serum soluble programed cell death protein (sPD-1) level, and clinical effect including APACHE-II and SOFA score, whole blood analysis, levels of tumor necrosis factor-α (TNF-α) and C-reactive protein (CRP), were determined before treatment and after treatment for 5 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sepsis;
* Signed the informed consent form.

Exclusion Criteria:

* Pregnancy or psychiatric disorder;
* Immune deficiency or using immunosuppressants or immune enhancers;
* History of malignancy;
* HIV positive;
* Unwilling to participate in the study or cooperate with the treatment. Patients who cannot tolerate electroacupuncture treatment or loss of follow-up for complicating with other diseases during the study would be dropped off.
CARATKids: Italian Validation of Asthma and Allergic Rhinitis Control Test in Children

This project is an observational study for the Italian language validation of the CARATKids questionnaire investigating the asthma and coexisting allergic rhinitis control in children. 113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months will be enrolled for the validation process at outpatient clinic of Pediatric Allergology \& Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy.

The study will be completed in two medical examination, within 3-6 weeks of each other.

CARATKids questionnaire, VAS (Visual Analogic Scale) and C-ACT (Children Asthma Control Test) will be filled by each patient.

The main outcome is the Italian language validation of the CARATKids questionnaire investigating the coexisting asthma and allergic rhinitis control in children.


Eligibility Criteria:
Inclusion Criteria:

* 113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months
* 12 \< years old \> 6

Exclusion Criteria:

* Patients with asthma only or allergic rhinitis only, or younger or older than the targeted age group
Testing the Validity of the "Modified Confusion Assessment Method for the Emergency Department" (mCAM-ED)"

The proposed Study validates the accuracy of the modified Confusion Assessment Method for the Emergency Department

Delirium is a complex neuropsychiatric syndrome with sudden change in cognition such as disturbance in orientation or memory particularly in elderly patients in the context of acute illness. Multiple complications such as falls or increased duration of hospitalisation may result in delirium. Long-term consequences may result in increased mortality rates and higher admissions rates to nursing homes. In 2012, delirium prevalence in the Emergency Department (ED) of the University Hospital Basel was 9.5% in patients with 65 years and over. Although a systematic delirium management was introduced in 2012, without systematic screening delirium detection rates varies between 20 and 40% only. The risk of non-detection over the complete hospitalisation is high when early delirium detection did not occur in the ED. In a preliminary evaluation we could show the usefulness of the mCAM-ED

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 65 years

Exclusion Criteria:

* patients under resuscitation or fatal illness
* not speaking German
* being aphasic
* being deaf
Software as a Medical Device for the Treatment of Patients With PTSD

To evaluate the efficacy and safety of Software as a Medical Device in patients with Post-Traumatic Stress Disorder (PTSD)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PTSD according to the DSM-5
* Subjects who are within 1 to 20 years since index trauma

Exclusion Criteria:

* Subjects diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, bipolar I disorder, autism spectrum disorder, or intellectual disability based on DSM-5.
* Subjects diagnosed with any mood disorder and anxiety disorder according to DSM-5 that is the primary focus of treatment in the last 6 months prior to screening, as per the clinical judgement of the investigator
* Subjects who have completed two or more full courses of trauma-focused therapy in the past
A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis

The main aim of this study is to assess the effects of switching from another biologic to tildrakizumab on patient-reported outcomes and to assess psoriasis intensity, patient's quality of life prior and after switching and the individual rationales for switching biologics.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent.
2. \>=18 years of age.
3. Moderate-to-severe plaque psoriasis currently treated with a biologic therapy (TNFα antagonist, IL12/23 antagonist, IL17 antagonist).
4. Switch to tildrakizumab due to:

   1. primary or secondary treatment failure (PASI \>= 3 or ΔPASI \< 75 and/or DLQI \> 5)
   2. adverse events, contraindication, intolerance
   3. patient wish (dosing regimen), lack of adherence, or other, including nonmedical reason
5. Treatment with tildrakizumab planned in the frame of clinical practice.

Exclusion Criteria:

1. Patient appears to be unwilling or unable to comply with the requirements of the study or who, in the opinion of the Investigator, should not participate in the study.
2. \>=3 previous biologic treatments in the last 3 years.
3. Participation in a clinical trial simultaneous to participation in SW-ATCH.
4. Any condition preventing prescription of Tildrakizumab according to the SmPC, including but not restricted to any contraindication or history of hypersensitivity or intolerance.
5. Patient dependent on the Investigator.
6. Previous treatment with Tildrakizumab.
Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI, and total body vitiligo area (facial and nonfacial) not exceeding 10% BSA.
* Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
* Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.

Key Exclusion Criteria:

* No pigmented hair within any of the vitiligo areas on the face.
* Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
* Have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
* Use of protocol-defined treatments within the indicated washout period before baseline.
Current Exercise Approaches in Patients With Multiple Sclerosis

This study was conducted to examine the effects of exercises performed with mechanical hippotherapy device and Cawthorne-Cooksey exercises on balance, dizziness, fatigue and quality of life in patients with Multiple Sclerosis.

The research is a quantitative study, and it is in the form of randomized controlled type research, one of the experimental research types. In order to provide a homogeneous distribution, the patients were divided into two different exercise groups using the double-blind method from the minimization method.

The sample of the study consisted of definitively diagnosed multiple sclerosis (MS) patients who volunteered to participate in the study. Patients who voluntarily agreed to participate in the study; While they were informed about the aims of the study, the duration of the study, the evaluation methods and the applications to be made, the informed consent form was signed by these patients and their consent was obtained. The study sample was divided into two groups by randomization method. The first group was given 35 minutes of traditional physical therapy program and 15 minutes of exercises with a mechanical hippotherapy device, while the second group was given 15 minutes of Cawthorne-Cooksey exercises in addition to the 35-minute traditional physical therapy program. Both exercise groups were given a 50-minute physical therapy program. Patients diagnosed with Multiple Sclerosis in the study; It was classified according to the Expanded Disability Status Scale Score. Tinetti Balance Rating Scale was used to assess balance. The Dizziness Disability Inventory was used to assess dizziness, the Fatigue Severity Scale and the Fatigue Impact Scale to assess fatigue, and the Ferrans \& Powers Quality of Life Index MS Adaptation to assess quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Being cooperative and oriented,
* Being 25 - 64 years
* Having a definite diagnosis of MS,
* Being able to sit dependent/independently and stand supported/unsupported,
* Not having an attack in the last 1 month or not currently in the attack period,
* Volunteering to participate in the study.

Exclusion Criteria:

* Having another neurological disease or musculoskeletal system problems in addition to the diagnosis of MS,
* Being on cortisone treatment in the last 1 month or still ongoing,
* Having a mental, cardiovascular, pulmonary or orthopedic disease that will prevent exercise.
A Multicenter Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery

The purpose of this study is to verify the 5-year disease free survival (DFS) of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery.

Study type：Interventional Study phase：Phase III Objectives of Study：to verify the 5-year DFS of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery.

Study design：Randomized parallel control

Eligibility Criteria:
Inclusion Criteria:

1. informed consent
2. single colorectal adenocarcinoma, located at any segment of the colorectum with lower margin 5cm or more to the dental line
3. cTNM：colon cancer T1-4N1-2M0，rectal cancer T1-3N1-2M0，longest diameter no more than 6cm
4. age less than 80 years old
5. normal blood routine test and hepatic or renal function test
6. no gastrointestinal surgery history or chemotherapy, radiation, No complete obstruction.

Exclusion Criteria:

1. severe comorbidity such as heart attack or stroke, malignance in 5 years
2. can not tolerate to general anesthesia, pneumoperitoneum or surgery
3. pregnant or during breast-feeding period
4. attending other clinical trial involving therapy
5. cannot or disagree to attending the clinical trial
Spirituality and Will to Live in Patients With HIV/AIDS

This study is assessing the extent of spirituality in patients with HIV/AIDS and will determine the relationship between spirituality, health status, and the will to live.

Approximately 1,000,000 Americans have HIV/AIDS. Although advances in treatment have made HIV/AIDS a relatively manageable chronic disease, the disease can cause significant morbidity and mortality. Surprisingly, research has found that some HIV/AIDS patients feel that their life is better than it was before they had HIV/AIDS. Many of these patients show a strong will to live and often express a preference for longevity over quality of life. Patients who prefer longevity often ascribe their feeling to spiritual growth, or finding a meaning to life. This study is examining the spiritual beliefs of HIV/AIDS patients and will determine the relationship between spirituality, health status, and the will to live.

The study consists of interviews with HIV/AIDS patients from Cincinnati and Washington, D.C. who have been interviewed twice over 12 to 18 months. During the interviews, participants completed self-report scales to assess their quality of life, life satisfaction, concerns about medication, trust in their health care providers, depressive symptoms, self-esteem, optimism, and various clinical and demographic variables. Participants were also asked about their spiritual well-being; spiritual beliefs; spiritual, religious, and social support; and overall functioning.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HIV or AIDS

Exclusion Criteria:

* None
3D Rotational CT Angiogram With Embolization Guidance and CBCT in Prostatic Artery Embolization

The purpose of this research study is to learn about how cone-beam Computerized Tomography scans (X-ray images taken from different angles) work together with an embolization guidance software (helps the doctor see the arteries that feed the prostate)to find and see arteries in the prostate.


Eligibility Criteria:
Inclusion Criteria:

* Patient is age 50 to 79, inclusive
* Patients undergoing Prostate artery embolization for BPH or urinary retention -Patient has signed informed consent.

Exclusion Criteria:

* Patients with biopsy proven prostate cancer
* Patient weight of \>300 lbs
A Pharmacokinetic Study of JKB-122 Tablets Compared to Capsule

The purpose of this study is to compare the pharmacokinetics of JKB-122 tablets with JKB-122 capsules in healthy male subjects subjects.

This clinical study will be a randomized, open-label, multiple-dose, two-period, crossover study in healthy male subjects. After screening, subjects will be randomized to receive either JKB-122 tablet or JKB-122 capsule in a 1:1 ratio. There will be two dosing periods (Period 1 and Period 2). Subjects who receive JKB-122 capsule during Period 1 will receive JKB-122 tablet during Period 2 and vice versa. The 2 dosing periods will be separated by a washout period.

Eligibility Criteria:
Inclusion Criteria:

1. The subject has a body mass index (BMI) range of 18.5 and \< 25.0 kg/m2 and weighs at least 50 kg.
2. Agreement for subject and female partner of childbearing potential to use acceptable method of contraception
3. The subject provided written informed consent.

Exclusion Criteria:

1. Any history or evidence of any clinically significant major disease or malignancy, as judged by the Investigator.
2. Any clinically significant abnormality following the Investigator's review of the physical examination, ECG and clinical study protocol-defined clinical laboratory tests.
3. Use of prescribed or non-prescribed drugs (including vitamins, natural and herbal remedies, e.g. St. John's Wort) in the 2 weeks prior to study drug administration.
4. Consumption of grapefruit, pomelo, citrus fruits, starfruit, pomegranate, papaya, mango, rambutan, kiwi fruit, dragon fruit or passion fruit and products containing these fruits in the 2 weeks prior to study drug administration.
5. Current smoker or history of smoking within 3 months before the Screening Visit.
6. History of drinking more than 21 units of alcohol per week within 3 months prior to the Screening Visit.
7. Any use of drugs-of-abuse within 3 months before the Screening Visit.
8. Any significant blood loss or donation of blood (250 ml within 2 months or 500 ml within 3 months) prior to study drug administration.
9. Positive serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus.
10. Participation in any clinical study or administration of any investigational product within 1 month of study drug administration.
11. The subject has any other condition, which in the opinion of the Investigator precludes the subject's participation in the clinical study.
RFN-Advanced Retrograde Femoral Nailing System

This study is a retrospective chart review of the safety and performance Standard of Care data on individuals that have previously been implanted with the femur nail of the RFNA System for the internal fixation of the femur. Demographics, medical history, primary diagnosis, mechanism of injury, type of injury, clinical and radiographic evaluation of bone consolidation, and device-related adverse events were collected. Descriptive statistics were applied to the data collected.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects 18 years or older at the time of index procedure
2. Subjects who received the Depuy Synthes Advanced Retrograde Nail in accordance with the indications for use.
3. Subjects who have at least 6 months of follow-up.

Exclusion Criteria:

* Subject with less than 6 months of follow up, pathologic fractures, and patients \< 18 years of age will be excluded from the study.