cyrilzakka/clinical-trials huggingface dataset:
Narrative Group Counseling and Psychological Resilience

This study aims to examine the effect of narrative group counseling applied to nursing students studying at a public university on psychological resilience. The research was used parallel group, randomized, controlled experimental design. According to the power analysis results, the sample size was determined to be at least 54 people. Due to possible losses, 25% more people were included in the study and 68 students who met the inclusion criteria were assigned to the intervention (n = 34) and control group (n = 34). In the study, the assignment of students to the intervention and control groups were made by stratified randomization(gender,class). Due to the fact that nursing department courses continued all day on weekdays, limited transportation and winter conditions, students from the intervention group (n = 7) and the control group (n = 5) did not want to continue the sessions. The implementation of the research was completed with a total of 56 students, with n=27 in the intervention group and n=29 in the control group. Personal information forms and Adult Resilience Scale were used to obtain research data. The data collection process was carried out in four stages: pre-test, post-test, 3-month follow-up test and 6-month follow-up test.

The intervention group received eight sessions of narrative group counseling. The control group also received four session of stress management training.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research
* Being 18 years of age or older

Exclusion Criteria:

* Having a neurological or psychiatric diagnosis based on self-report
* Having attended another similar program, individually or with a group.
* Having attended another similar program, individually or with a group, for at least 1 year ago.
* Being a foreign student.
Valvular Heart Disease Registry Study in Second Affiliated Hospital of ZheJiang University

We design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with valvular heart disease.

Valvular heart disease (VHD) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart disease are not so clear, especially in the developing countries such as China etc. Because of the slow and progressive nature of VHD, symptoms might not be too severe to be diagnosed on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe valvular diseases are very common in China. Hence, we design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with valvular heart disease.

Eligibility Criteria:
Inclusion Criteria:

Hospitalized patients over 18 years old meet one of the following conditions.

1. moderate or above valvular heart disease as defined by echocardiography: 1.1 Aortic stenosis, moderate or above, or valve area ≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient ≥20mmHg, 1.2 Aortic regurgitation, moderate or above, or jet width ≥25% of left ventricular outflow tract, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, 1.3 Mitral stenosis, moderate or above, or valve area ≤2.0cm2, 1.4 Mitral regurgitation, moderate or above, or effective regurgitant orifice ≥0.2cm2, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, 1.5 Tricuspid stenosis, moderate or above, or valve area ≤1.0cm2, 1.6 Tricuspid regurgitation, moderate or above, or central jet area ≥5.0cm2, 1.7 Pulmonic stenosis, moderate or above, or maximal jet velocity \>4m/sec, 1.8 Pulmonic regurgitation, moderate or above,
2. Patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
3. Diagnosis of endocarditis as assessed by Duke criteria.

Exclusion Criteria:

1. Patients cannot be followed up for any reasons.
2. Patients in critical condition may be die in one year.
3. Patients have been enrolled in this study.
Early Mobilization of Spiral Metacarpal Fractures Compared With Operative Treatment

Spiral metacarpal fractures (metacarpal II-V) can be treated conservatively or with operation. With minimal displacement this fracture is usually treated with immobilisation or early mobilisation. With appreciable displacement especially any malrotation the patient usually is treated with an operation. This usually includes an open reduction of the fracture and fixation with plates and screws or just screws. Even if this is an standard procedure both mild and severe complications have been reported. New studies have shown that even displaced fractures can be treated with early mobilization. In those cases the fractures may heal with some shortening but very good function. An advantage of early mobilization is that the patient avoids the risk of an operation and the costs for the treatment are decreased markedly. The study is designed to answer the question if early mobilization is not inferior to operative treatment but with lower costs and without any operation related risks.

The study is designed as an prospective, randomised controlled trial. The patients are divided into two groups (operative and conservative treatment with early mobilisation). The operative group is treated with internal fixation and 2 weeks in a cast. The conservative group is instructed to do a fist to correct any malrotation and to rehabilitate quickly. By this procedure shortening oft he metacarpalfractures is limited by the function of the deep transverse metacarpal ligament connecting the distal parts of the metacarpalbones II-V. Furthermore the participants in the conservative group are allowed to use their hands without any restrictions. A physiotherapist controls that early mobilisation is carried out.

The participant will be seen for a follow-up at 1, 6 and 12 weeks and 1 year. Radiographs will be performed at 1v and 6v. The finger ranges of motion and pain will be evaluated with every follow-up, DASH score, range of motion, pain and grip-strength will be measured after 12v and 1 year. The investigators will measure return to driving, work and sport.

Complications will be registered continuously for all patients. The overall satisfaction of the patients and the costs for both treatments will be documented as well.

The study population is planned to be 21 patients in each group.

Eligibility Criteria:
Inclusion Criteria:

* single spiral fractures of metacarpal bone II-V
* fracture line at least twice the length of the diameter of the bone at the level of the fracture
* at least 1-2mm displacement of the fracture and/or malrotation
* normal hand function before the injury
* fracture less than 10 days old

Exclusion Criteria:

* multiple metacarpal fractures
* open fractures
* incompliance or dementia
* fracture line not twice the length of the diameter of the bone at the level of the fracture
* abnormal hand function before the injury
* fracture more than 10 days old
Pharmaco-economical Study in Kidney Transplantation

The prevalence of renal acute rejection in transplantation is reduced thanks to the optimized use of immunosuppressive drugs. However, graft survival at ten years has not improved since then; this may be explained in part by the toxicity of these drugs, viral infections, and other comorbidities (diabetes, cardiovascular diseases ...).

According to transplant center, strategies for the combination of immunosuppressive drugs are different, and probably involve a difference in the global cost of patient management. There is no recommendation in France to establish similar practices.

EPHEGREN is an observational, prospective, multicentric, pharmacoeconomic study for the renal transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients in the first month of renal graft, or patients already included in an other epidemiological French study (EPIGREN) in the 0-6 month period
* Men of women aged more than 18 years
* Patients able to exercise in writing their informed and free consent to participate to the biological collection
* Patients not opposing to collect their medical data
* Patients registered with a social security system
* Patients able to complete the questionnaires

Exclusion Criteria:

* Patients aged less than 18 years and patients under guardianship
* Patients with a follow-up at another center other than those part of the study
Analgesic Efficacy of Transversus Abdominis Plane Block Versus External Oblique Block in Patients Undergoing Elective Laparoscopic Cholecystectomy

Postoperative pain management is a critical aspect of recovery following laparoscopic cholecystectomy, a commonly performed procedure for symptomatic gallbladder disease. Effective analgesia not only enhances patient comfort but also facilitates early mobilization, reduces the incidence of complications, and improves overall outcomes.

Oblique subcostal transversus abdominis plane block (OSTAP), one of the regional anesthesia techniques, is used in middle and upper abdominal surgeries OSTAP blocks the T6-9 intercostal nerves between the rectus abdominis and transversus abdominis muscle. Many studies have shown that OSTAP block reduces the postoperative analgesic and opioid requirement and improves the quality of postoperative pain control.

the potential mechanism of the external oblique intercostal fascial plane block (EOIB) in a cadaver study in which both lateral and anterior branches of the intercostal nerves T7-T10 were stained. Patients to whom this block was applied exhibited consistent dermatomal sensory blockade between T6-T10 in the anterior axillary line and T6-T9 in the midline. It has been shown that this block can be used in the clinical setting for upper abdominal wall analgesia.

Various adjuvants have been used to improve the quality and increase the duration of the local anesthetic action in different peripheral nerves and regional block techniques. dexamethasone microspheres have increased the block duration in both human and animal studies. Furthermore, dexamethasone has been shown to possess antiinflamatory action.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients aged 18-60 years.
2. Gender: Both males and females.
3. BMI less than 35 kg/m2
4. Scheduled for laparoscopic cholecystectomy surgery
5. American Society of Anesthesiologists - ASA - I \& II

Exclusion Criteria:

1-ASA physical status more than II. 2-History of allergic response to local anaesthetics or any of the medications used in the study

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Post Market Clinical Follow-Up of the Zimmer Stafit Acetabular System

This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Zimmer Stafit Acetabular System.

The objective of this study is to obtain implant survival and outcome data on the Stafit Acetabular System by analysis of standard scoring systems, radiographs, and adverse event records.

Data will be used to monitor pain, mobility, dislocation rate and implant survival, and to confirm the long-term safety and performance of the Stafit Acetabular System in primary total hip arthroplasty.

The study design is a multi-center, prospective, non-controlled, consecutive cohort post market clinical follow-up study, involving orthopedic surgeons skilled in total hip arthroplasty procedures and experienced with the Stafit Acetabular System.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Patients suffering from severe hip pain and disability requiring a primary total hip arthroplasty.
* 18 years minimum
* Patients able to participate in a follow-up program based upon physical examination and medical history
* Patients who have provided written informed consent by signing the Patient Informed Consent Form.

Exclusion Criteria:

* Patients who are unwilling or unable to give informed consent, or to comply with the follow-up program
* Known pregnancy
* Revision hip arthroplasty
Anticipated Patient and Caregiver Burden

Amyotrophic lateral sclerosis (ALS) is a degenerative neurological disease that causes progressive motor disability and is life threatening within a few years. The severity of the disease, the progressive loss of autonomy that leads to dependence on family and caregivers, and the lack of effective treatment sometimes leads patients to a loss of hope and to dark thoughts. The prevalence of suicidal ideation is high, with more than one third of people with ALS experiencing it. The psychological suffering of patients is often associated with that of their caregivers. The evaluation of the patients' feeling of being a burden has rarely been addressed in previous studies in ALS on the notion of burden. In this work, the investigators wish to evaluate the patient's ideas of death by also taking into account the caregiver's burden and the patient's feeling of being a burden. They wish to better understand this difficult experience by refocusing the study on the patient himself, which has rarely been addressed in studies on ALS and the notion of burden. By working on the caregiver's burden, both from the caregiver's point of view and as perceived by the patient, the investigators hope to find avenues of intervention and define actions that could help patients and their families and improve the quality of life of the patient-caregiver couple.


Eligibility Criteria:
Inclusion Criteria (patient) :

* Patient is at least 18 years of age.
* Patient having given informed consent
* Patient with ALS who has already had at least two multidisciplinary assessments in the ALS center in Marseille with an evaluation by the clinical psychologist.
* Patient with a motor handicap of grade 3 to 5 on the Rankin score
* Patient with a primary family caregiver at home (spouse, child) willing to participate in the study
* Patient who is a beneficiary of or affiliated with a social security plan

Inclusion Criteria (caregiver) :

* Adult subject at least 18 years of age.
* Subject who has given informed consent.
* Primary family caregiver of a patient with ALS who agrees to participate in the study
* Caregiver present during hospital visits.

Exclusion Criteria (patient):

* Patients with a serious and unstable associated disease, cardiac, oncological, hepatic or renal, psychiatric (schizophrenia, bipolar)
* Autonomous patient, who does not need the help of a third party for the basic gestures of daily life (Rankin 0 to 2)
* Patient living in an institution or alone at home
* Patient with cognitive impairment that interferes with activities of daily living
* Patients with marked emotional lability (spasmodic crying) due to ALS
* Patients who have had a recent diagnosis of their disease (less than 6 months)
* Patients who are unaware of the severity of their condition
* Any condition that in the opinion of the investigator or psychologist would not be compatible with the study.

Exclusion Criteria (caregiver):

* Subjects with severe and unstable cardiac, oncological, hepatic, renal or other illnesses.
* Subject with a history of psychiatric illness
Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

To evaluate the efficacy and dose-response relationship of HRS9531 injection compared with placebo in reducing body weight in obese subjects without diabetes after 24 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent;
2. Male or female subjects, 18-65 years of age at the time of signing informed consent;
3. At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;
4. Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.

Exclusion Criteria:

1. Presence of - clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit;
2. Uncontrollable hypertension;
3. PHQ-9 score ≥15;
4. Medical history or illness that affects your weight;
5. History of diabetes;
6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
7. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
8. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;
9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
10. History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening;
11. Use of any medication or treatment that may have caused significant weight change within 3 months;
12. History of bariatric surgery;
13. Known or suspected hypersensitivity to trial product(s) or related products;
14. Participation in other clinical trials for any weight-loss indication within 3 months prior to screening, or participation in other clinical trials for any drug or medical device within 1 month prior to screening;
15. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
16. Surgery is planned during the trial;
17. Mentally incapacitated or speech-impaired;
18. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
19. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.
Study of NMB (Company's Name) Drug Ejecting Balloon for Arteriovenous Fistulae

The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) Balloon.


Eligibility Criteria:
Inclusion Criteria:

* patients 18 years and older
* Patients with arteriovenous fistula with obstructive lesion
* Patient who is willing and able to sign a written informed consent

Exclusion Criteria:

* age \< 18
* female with child bearing potential
* Previous participation in another study with any investigational drug or device within the past 30 days
* Life expectancy of less than 12 months
Clinical Study of GKT in Diabetes Related Dementia

Recently a new clinical dementia subgroup based on brain imaging, called "diabetes related dementia (DrD)". DrD, unlike Alzheimer's disease and vascular dementia, is considered a "controllable" or "modifiable" form of dementia. However, there is currently a lack of corresponding treatment measures. Ginkgo biloba ketone ester tablets are extracts of Ginkgo biloba leaves. Previous studies have shown that they can increase cerebral blood flow, reduce cerebrovascular resistance, improve cerebral circulation, and are beneficial for the treatment of cognitive impairment. This project intends to explore the role of ginkgo ketoester tablets in diabetes related dementia through a multicenter randomized double-blind controlled clinical study.

This study was divided into two treatment groups: the experimental group and the control group. 370 type 2 diabetes patients with mild cognitive impairmentpatients were randomly selected and assigned to the experimental group of 185 patients and the control group of 185 patients in a 1:1 equal amount. Experimental group: Ginkgo biloba ketone ester tablets combined with conventional hypoglycemic treatment group, the usage is Ginkgo biloba ketone ester tablets (Styron), taken orally, 3 times a day, 0.5g each time, and continuously administered for 6 months. Control group: conventional hypoglycemic treatment group. The Montreal Cognitive Assessment Basic (MoCA-B) was used for the detection of cognitive dysfunction. Neuropsychological testing of cognitive function was conducted using Alzheimer's Disease Assessment Scale - Cognitive Scale (ADAS-cog), Auditory Word Learning Test (AVLT-H);Assessment of Daily Living Ability - Functional Activity Questionnaire (FAQ);Shape Connection Test A and B and Symbolic Digital Form Test (SDMT).Collect patients' blood, and detect C-reactive protein, interleukin-6, oxidative stress, ApoE4 genotype, phosphorylated tau protein, irisin, β- Amyloid protein before and after the experiment.Detect changes in ankle brachial pulse wave conduction velocity (baPWV)/and ankle brachial blood pressure index (ABI) of patients before and after the experiment.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes with mild cognitive impairment patients aged 65 years or above;
2. Able to cooperate in completing cognitive function testing;
3. Patients who can swallow pills
4. No previous history of stroke，cerebral thrombosis, etc

Exclusion Criteria:

1. Type 1 diabetes;
2. Acute cerebral infarction and myocardial infarction within 3 months;
3. Severe liver and kidney dysfunction;
4. Late stage malignant tumors;
5. Thyroid dysfunction；
6. Brain injury and cerebral hemorrhage within 3 months；
7. Folic acid and/or vitamin B12 deficiency
8. Patients who are currently using thrombin inhibitors, defibrillators (with unclear efficacy in ischemic stroke and increased risk of bleeding), antiplatelet drugs, blood activating and stasis resolving agents, and other ginkgo biloba leaf preparations (as they may affect the evaluation of the therapeutic effect of ginkgo biloba ester tablets in this trial), as well as other trial medications.
This Study Will Evaluate the Persistence of Hepatitis A Antibodies, 8 Years and 10 Years Later, in Children Who Had Received Havrix at Selected Health Centres of Panama

The purpose of this study is to evaluate the persistence of hepatitis A antibodies, approximately 8 years and 10 years post vaccination with the complete series of Havrix (2 doses) and the partial series completion (1 dose).

The study comprises of two independent cross-sectional surveys (Year 8 and Year 10). The first cross-sectional serosurvey will evaluate the long term persistence of immunity approximately 8 years post vaccine administration and the second cross-sectional study will evaluate long term persistence, approximately 10 years post vaccine administration.

Eligibility Criteria:
Inclusion Criteria:

* Subjects whose parent(s)/ LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written informed assent/consent obtained from the subject or subject's parent(s)/ LAR(s) of the subject.
* Available HAV vaccination records.
* Children who have received either 1 or two doses of Havrix at selected health centres of Panama.
* Children with ≥ 7 years and \< 10 years between last dose and Persistence Visit 1 (Year 8) and children ≥ 10 years and \< 13 years between last dose and Persistence Visit 1' (Year 10).

Exclusion Criteria:

* Child in care.
* Subjects with history of vaccination with other hepatitis A vaccines other than Havrix.
* Subjects with known past history of hepatitis A infection, both without vaccination and after they received the last dose of Havrix (1 dose or the complete 2 dose schedule).