cyrilzakka/clinical-trials huggingface dataset:
A Study of the Effect of Laughter Therapy on the Mental Health and Quality of Survival of Hematopoietic Stem Cell Transplant Patients

主要研究目的：

1)探讨笑疗法在造血干细胞移植患者移植心理健康及生存质量中的效果。 次要研究目的：

1. 了解造血干细胞移植患者移植后3个月、6个月、1年内的心理健康变化和生存质量水平；
2. 探讨笑疗法在造血干细胞移植患者预后等结局指标中的应用效果。

本研究将采用单中心、前瞻性的平行随机对照试验对2024年12月1日至2025年12月1日期间首次接受造血干细胞移植的患者进行招募。对照组实施常规护理措施和出院的常规延续护理措施，干预组从移植+1天开始进行笑治疗，住院期间为移植后+1天至出仓，按照笑的口令"hihihi（拼音拼读），哈哈哈，茄子茄子茄子，七喜七喜七喜，哈哈哈哈哈哈"，30遍口令为1次训练，1天进行1次。出仓及出院后，干预组患者集中线上笑疗法干预，1次/周，重复30遍口令，至移植后1年。分别于移植后3个月、6个月、1年对两组患者在预后、疲劳、焦虑及抑郁、幸福感以及创伤后成长、生存质量及结局指标上进行组间比较，明确笑疗法在造血干细胞移植患者心理健康及生存质量中的效果。

Eligibility Criteria:
Inclusion Criteria:

Patients with a pathologically confirmed diagnosis of hematologic malignancy; Patients undergoing their first hematopoietic stem cell transplant; Age ≥ 16 years; Those who have some reading and writing ability; Those who can cooperate in completing the questionnaires and assessments; Informed consent and voluntary participation in the study.

Exclusion Criteria:

Those with severe mental illness or personality disorders; Those who cannot operate a smartphone independently; Those with severe visual and hearing impairments; Those who are critically ill and cannot receive the intervention.
A Comparison of Tissue Adhesive Material and Suture as Wound-closure Techniques Following Carpal Tunnel Decompression

Participants will be randomly assigned to suture-based wound closure (n=50) or tissue adhesive-based wound closure (n=50) with two-component skin adhesive Glubran Tiss 2®. The outcomes will be assessed during the follow-up period at intervals of 2, 6, and 12 weeks postoperatively. A scar assessment will be using the POSAS (Patient and Observer Scar Assessment Scale) and cosmetic VAS (Visual Analog Scale). The VNRS (Verbal Number Rating Scale) will used to assess pain.


Eligibility Criteria:
Inclusion Criteria: (all of the above)

* age \>18 years
* carpal tunnel syndrome
* weakness of thumb abduction
* with atrophy of the thenar
* median nerve conduction impairment estimated by electromyography

Exclusion Criteria: (one or more)

* threatening haemorrhagic complications (patients with peroral anticoagulation and/or antithrombotic therapy)
* previous wrist trauma or surgery on the wrist region
* another aetiology of neuropathy
* previous allergic reactions (with lidocaine, cyanoacrylate, formaldehyde, tapes, or adhesives)
* personal or family history of keloids or hypertrophic scars
* severe general illness with cachexia
Acute Effects of Physical Activity On Memory, Cognitive Performance and Brain Activity

The overall aim of the study is to investigate the effects of an acute bout of physical activity on cognitive performance and long-term memory in elementary school children. Elaborating, the study seeks to investigate the effect of the intensity of the physical activity on cognitive performance and long-term memory in preadolescent children.

Based on a power analysis a total population of 100 children (four school classes) will be invited to participate in a 10-day protocol. The children will be randomly allocated, within their cluster (classes) and stratified for gender and soccer level, to one of 3 intervention groups. The groups consist of: A small-sides soccer game group (SSG), a walking soccer group (WSG) and a rest group watching soccer on TV (RES). At day 1 the children will complete a screening of their physical characteristics (height, weight, fat percentages, lean muscle mass and fitness status). On day 2 the children will complete a screening and a familiarization to the cognitive tasks used (cognitive performance and long-term memory) and the brain activity measuring devices (transportable EEG systems). On day 3 the children will complete the interventions, which first consist a long-term memory task, where the children will be asked to remember forty different pictures. Immediately after exposure to the forty pictures, the children will participate in 2 x 10 minutes of their respective interventions with 5 minutes break in between. During the break, the children will complete a short questionnaire to address their flow. Furthermore, during the intervention they will be equipped with heart rate monitors to quantify the physical demands of the intervention. Immediately after completing the 2 x 10 minutes interventions the children will be equipped with a transportable EEG system, and undergo a cognitive test (the Flanker task) to address their cognitive performance. The EEG recordings are used to measure the P3 amplitude and latency, biomarkers for cognitive performance. While equipping the children with the EEG system, the children will complete questionnaires about their participation. At day 10 the children will try to remember as many pictures of the forty pictures as possible to address the effect of the interventions on their long-term memory.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent from the childrens´ legal guardians.
* Physical, linguistic and mental competencies to complete the intervention and testing.

Exclusion Criteria:

* Use of prescription-only drugs that kan affect learning ability.
* Smoking.
* Neurological diseases inclusive damages to the spinal cord.
* Children who is not evaluated to being cable of completing the protocol among these psychological diseases or psychological unstable children.
A Phase I/II Study of Diffuse Large B-cell Lymphoma

For continuous variables, mean, median, minimum, and maximum will be used for the descriptive purpose. For categorical variables, frequency and percentage will be used for descriptive statistics. The variables of OS will be estimated by the Kaplan-Meier method. Differences between groups will be calculated using the log-rank test for univariate analysis. Cox's proportional hazards model will be employed to test independent prognostic factors. All calculations will be performed using the Statistical Package of Social Sciences software, version 17.0 (SPSS, Inc., Chicago, IL, USA). The level of statistical significance will be set at 0.05 for all tests.

This is an open-label, single arm, prospective, multiple-center phase Ib/II study.

In phase Ib, a maximum of 18 patients will be enrolled in the dose-finding period to determine the RP2D, dependent on the toxicity of the study drugs. The response rates of salvage chemotherapy regimen in R/R DLBCL were reported to be within the range of 35-65%.3 Assuming that the response rate of traditional salvage therapy has an overall response rate of 35% (H0=0.35) and that our experimental regimen would increase it to 50% (H1=0.50), the estimated sample size according to the Simon's two-stage minimal design will be 49 in the second phase.1 Briefly, among the 31 patients recruited during the first stage, the response should be seen in at least 10 of the cases, the lowest threshold for the trial to be moved into the second stage of the phase II part. Furthermore, for the RPR regimen to be deemed effective, a response must be demonstrated in at least 21 of the whole 49 patients enrolled in the phase II period. This would achieve a power of 80%, with a two-sided type I error rate of 10%. An additional 7 patients will be recruited, for an estimated dropout rate of 10%.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with relapsed/refractory CD20+ diffuse large B-cell lymphoma.
2. Age greater than 20 years and younger than 75 years old.
3. Measurable disease
4. Patients must have an ECOG performance status of less than or equal to 2.
5. Patients must have recovered from toxic effects of all prior therapy before entering onto study.
6. A treatment of drug-free interval of at least 3 weeks since the last dose of chemotherapy is required.
7. More than 4 weeks since prior radiotherapy is required.
8. Adequate bone marrow function
9. Adequate renal function with calculated glomerular filtration rate \> 15 mL/min
10. Patients must have adequate liver function
11. All patients must sign a document of informed consent indicating their awareness of the investigational nature and the risks of the study.

Exclusion Criteria:

1. Patients who have prior treatment with ruxolitinib or taxane for DLBCL.
2. Pregnant or breast-feeding females.
3. Active or uncontrolled infection.
4. Life expectancy \< 6 months
5. Patients with brain or leptomeningeal metastases.
6. Known hypersensitivity to ruxolitinib or paclitaxel
7. Grade III peripheral neuropathy secondary to prior to therapy
8. Second malignancy, except indolent cancers not on active anti-cancer therapy.
Effectiveness of a Team-based Follow-up Program in General Practice Among People With Chronic Conditions

The study will develop and evaluate the effectiveness of a team-based follow-up program in general practice (GP) among people with chronic conditions.

The epidemic proportion of lifestyle related non-communicable diseases is a worldwide challenge and public health problem resulting in significant hospitalization rates, mortality and morbidity, and huge personal and societal costs. This project involves research for better public health and health outcomes acknowledging the need for improvements in the health-care services in the prevention of risks and harm and better risk-factor management. We will conduct a randomized control study in four GP practices with ≥3 GPs and ≥one nurse among 154 people at risk for developing Type 2 Diabetes Mellitus (T2DM) or manifest disease, and 154 people in the control group. Inclusion criteria are Diabetes Risc Calculator (FINDRISC) ≥ 15 or HbA1c ≥6,5 % or specific need for individualized follow up such as Body Mass Index (BMI) ≥ 30. In addition, we will conduct a feasibility study among 30 people with risk for Chronic Pulmonary disease (COPD) or manifest disease. The study has the following two objectives: 1) to evaluate the effectiveness of a team-based follow-up program among people with risk for T2DM or manifest T2DM with the use of Guided Self-Determination (GSD) as an empowerment approach for patients in general practice, 2) to test the feasibility and pilot a team-based follow-up program among people with risk for COPD or manifest COPD with the use of GSD as an empowerment approach for patients in general practice.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 20-80 years with FINDRISC score ≥15
* Body Mass Index ≥ 30
* Manifest T2DM (HbA1c ≥48 mmol/mol (6,5%))
* Positive smoking status (risk for COPD)
* Manifest COPD (spirometry value: FEV1/FVC \< 0,7).

Exclusion Criteria:

* Severe somatic disease (cancer, end stage renal disease)
* Severe psychiatric diagnosis or dementia
* Patients who do not understand nor speak Norwegian.
Investigating Geographic Atrophy Insights (i-GAIN) Natural History Study

An observational study to investigate the natural history and evaluate biomarkers of participants with geographic atrophy secondary to age-related macular degeneration

Prospective, observational study to assess the relationships between circulating levels of complement proteins measured using the Complement Precision Medicine (CPM) Platform, genetic profile and lesion progression in subjects with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD) up to a 24-month period

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of bilateral GA due to AMD as confirmed by fundoscopy and imaging at Screening
2. GA lesion sizes of ≥ 1.25 mm2 to ≤ 17 mm2 (approximately 1-7 disc diameters) in at least one eye as per Central Reading Center
3. Willing and able to provide written informed consent
4. Male or female aged 65 years and over

Exclusion Criteria:

1. History of neovascular (wet) AMD or presence of neovascular (wet) AMD in either eye confirmed by fundoscopy at screening and/or any pre-existing retinal imaging
2. History of intravitreal (IVT) injection in the study eye. Note: Intravitreal treatment with pegcetacoplan (Syfovre®) and avacincaptad pegol (IzervayTM) if approved within the participant's country of origin AND if deemed necessary by the Principal Investigator (PI) is allowed in the fellow eye only. IVT injections in the study eye are prohibited.
3. History of uveitis or endophthalmitis
4. High myopia (more than 6 diopter) in the study eye
5. Any ocular pathology which would impede clear imaging of the macula, e.g. intra-ocular opacities
6. Macular changes from causes other than AMD
7. Diabetic retinopathy in either eye. Note: Presence of systemic diabetes with no retinopathy is not exclusionary
8. Any other physical condition which would prevent the participant from undertaking imaging procedures
9. Any cell or gene therapy in either eye
Study of Oral ABBV-932 Capsules to Evaluate Dopamine D2 and D3 Receptor Occupancy in Brain in Adult Healthy Volunteers

The main objective of this study is to evaluate the dopamine D2 and D3 receptor occupancy in the brain as measured by PET with radiotracer \[11C\]-(+)-PHNO up to 14 days of once-daily oral doses of ABBV-932 in healthy subjects.

ABBV-932 is a dopamine D3 receptor-preferring D3/D2 receptor partial agonist. Approximately 12 adult healthy volunteers will be enrolled in the United Kingdom.

Participants will receive ABBV-932 oral capsules once daily for 2 weeks and followed for 60 days.

Participants will be confined for approximately 15 days. Participants will receive 3 \[11C\]-(+)-PHNO PET scans during the study. Adverse Events and blood tests will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) is \>= 18.0 to \<= 35.0 kg/m2.
* Supine pulse rate \>= 50 bpm and \<= 100 bpm obtained after a 5-minute rest at Screening.
* Supine systolic blood pressure (SBP) \<= 160 mm Hg and \>= 90 mm Hg and supine diastolic blood pressure (DBP) \<= 90 mm Hg and obtained after a 5-minute rest at Screening.

Exclusion Criteria:

* Orthostatic (SBP decrease of \>= 30 mmHg, DBP decrease of \>= 20 mmHg, or pulse increase of \>= 30 bpm) as determined after standing for 5 minutes.
* Current or history of suicidal ideation as indicated by answering "Yes" answer to Suicidal Ideation Questions #4 or #5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening in the past 3 months or any "Yes" answer to Suicidal Behavior Questions #1-5 in the past year. Non-suicidal self-injurious behavior is not exclusionary.
* History of suicide attempt(s) within 1 year prior to study drug administration as evidenced by answering "Yes" to any Suicidal Behavior Questions (a "Yes" to Non-Suicidal Self-Injurious Behavior is not exclusionary).
* Contraindications to MRIs (metal implants, paramagnetic objects contained within the body, claustrophobia, etc.)
* Clinically significant findings as determined from screening brain MRI.
* History of previous radiation exposure for research purposes such that participation in this study will result in cumulative ionizing radiation exposure \>10 mSv in the past 12 months, in additional to normal background exposure.
Acapella With Nebulization in Normal Subjects

Background:

Devices used to facilitate mucus mobilization have been target of several controversies and mainly a few scientific studies that endorse the use of those equipments. According to the principle of acapella® device, it should be used concomitant with nebulization aiming to optimize its performance in bronchial hygiene.

Aims: To assess the effect of acapella® device application in the radioaerosol regional pulmonary deposition through pulmonary scintigraphy in normal subjects.

Materials and method: 10 health individuals, males and mean age of 24,4 ± 2,2 years participated in this study during the three phases of this research: 1st phase were done with nebulization through acapella® device, attached in the final branch according to manufacturer recommendation; in 2nd phase a ¨T¨tube connector were adapted, being nebulizer attached to the mouthpiece and in 3rd phase nebulization were performance through the mouthpiece as routinely used in aerosoltherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Performed spirometry
* According to the criteria of the Guidelines for Pulmonary Function-2002 published by the official organ of the Brazilian Society of Thoracic

Exclusion Criteria:

* Presence of pulmonary pathology;
* Neurological diseases and body temperature greater than 37 º C during the initial evaluation and during intervention
* Respiratory rate (RR) greater than 35ipm.
Resiliency Training for Adolescents With Craniofacial Conditions and Their Caregivers

This is a prospective study that will examine psychosocial improvements among CF adolescents and caregivers going through the Stress Management and Resiliency Training - Relaxation Response Resiliency Program (SMART-3RP).


Eligibility Criteria:
Inclusion Criteria for Adolescent Patients:

1. Adolescents aged 14 to 22
2. English fluency and literacy
3. Diagnosis of a craniofacial condition by self report

Inclusion Criteria for Parents or Other Caregivers:

1. Must be 18 years of age and older
2. English fluency and literacy
3. Parent or caregiver of a child or young adult with a craniofacial condition

Exclusion Criteria:

1. Unable to benefit from the program due to cognitive, psychiatric or other reasons based on the opinion of the group leader
2. Unable or unwilling to sign the informed consent documents
Outcome of Endodontic Retreatment in One or Two Visits

This study is a prospective randomized controlled study of patients who come to the University and non-surgical root canal retreatment is considered as the election of choice in presence of periapical disease. The aim is to evaluate the success rate of non-surgical retreatment performed in one compared to two visit treatment up to 10 years of follow-up. The null hypothesis is that there will be no statistically significant differences in rates of success, when performing root canal non-surgical retreatment in one or two visits.


Eligibility Criteria:
Inclusion Criteria:

* Patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form.
* Understands and is willing to comply with all study procedures and restrictions.
* Not presence of clinically significant and relevant abnormalities of clinical history or oral examination.
* Retreatment cases due to an endodontic failure.
* Diagnosis of apical periodontitis.
* Single or bi-radicular teeth.

Exclusion Criteria:

* General: Patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities.
* Specific: root resorption, root fractures, impossibility of restoration and cases were secondary root canal treatment is not the treatment of choice.
Single Rising Dose Study of BI 135585 XX in Health Asian Male Volunteers.

The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male volunteers,
2. Chinese or Japanese ethnicity

Exclusion criteria:

1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance according to the investigators medical judgement
2. Any evidence of a clinically relevant concomitant disease
3. Intake of drugs with long half life (\>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration
Comparing a Sensor for Movement Assessment With Traditional Clinical Assessment Methods in Patients After Knee Surgery.

Eight parameters measurable by the sensor "Orthelligent Pro" are compared with traditional measurements based on a goniometer or video taping. The aim is to inform potential users about the distribution of the differences they have to expect when moving from traditional measurement methods to the new sensor.

Patients will perform eight corresponding movement exercises at a single study visit.

In patients suffering from musculo-skeletal disorders, the restoration of full functioning is an important goal of many interventions. Assessment of functioning is often based on corresponding tests. If functioning is related to specific movement patterns, accelerometers and similar sensors are promising to allow a simple and objective assessment, and may replace traditional assessment methods, e.g. based on measurements with the goniometer. Corresponding products tend to enter the market and face clinicians and patients with the question, to which degree they are reliable and comparable with the traditional assessment methods.

Recently, a sensor named "Orthelligent Pro" has been released by the medical device company OPED and is today commercially available. The sensor - to be attached to the knee of a subject - offers the opportunity to assess several parameters related to movement patterns in the lower extremities that are of relevance in the rehabilitation process of orthopedic patients.

The aim of the current project is to inform potential users of this sensor about the difference they have to expect when compared to traditional assessment techniques of the same parameters and about the reproducibility of the measurements both based on the sensor and based on traditional assessments.

Patients of a single clinic will be offered participation. The patients will perform the eight exercises at a single study visit arranged as an addition to a routine follow up visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients after knee surgery (ACL reconstruction, total or partial knee arthroplasty, knee arthroscopy etc.) who are scheduled to a clinical follow up assessment by the surgeon between 4 months and 15 months after surgery.
* Informed consent

Exclusion Criteria:

* Age below 18 years
* Patients who underwent surgery in the lower extremities within the last 4 months
* Patients with severe acute pain
* Patients with contraindications to perform the movements/exercises
* Patients who underwent surgery also at the contralateral leg since the surgery related to the current follow up visit
* Patients who cannot follow the instructions due to language or cognitive problems
A Study on Nutrition Support in Adult Patients With Severe Burns

To delineate nutritional support in adults patients with severe burns to investigate associations between nutritional practice and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients were at least 18 years of age
* Patients were expected to survive more than 48 hours.

Exclusion Criteria:

* irreversible disease