cyrilzakka/clinical-trials huggingface dataset:
Healthy Beat Accupunch (HBA) Exercise Program for Community Older Adults

This study aimed to test the effects of a 12-month Healthy Beat Accupunch (HBA) exercise program on the perceived health status and sleep quality of the community-dwelling older adults.

Phase I: A cluster randomized controlled trial was used to test the effects of a six-month, instructor-led Healthy Beat Accupunch (HBA) exercise program on the perceived health status and sleep quality of the community-dwelling older adults. Through the use of convenience sampling strategy, eight community care centers with 232 older adults in Kaohsiung were recruited and randomly assigned based on their community care centers to a HBA experimental group or a wait-list control group. Participants in the experimental group received the HBA exercise program led by trained and certified instructors, three times per week, 40 minutes per practice for six months; participants in the wait-list control group continued with their regular daily activities. One pre-test and two post-tests, three months apart, were conducted. Phase II: Using the same method as in the phase I, participants from the phase I continued practicing the HBA exercise program, but guided by a DVD, for another six months. The feasibility, compliance, and effectiveness of the DVD-led HBA exercise program on the community-dwelling older adults were tested, and another two post-tests, three months apart, were conducted on the same outcome measurements as in the phase I.

Eligibility Criteria:
Inclusion Criteria:

* community-dwelling older adults aged 65 and over
* Mandarin or Taiwanese speakers
* able to stand and walk without assistive devices
* cognitive alert and able to verbally state their name, address, and answer questions

Exclusion Criteria:

* participants with severe and acute cardiovascular, musculoskeletal, or pulmonary illnesses
Long-term Follow-up Study of Substance Abuse Screening and Intervention in Multi Primary Care Centers

The purpose of this research is to improve the ability of primary medical staffs in screening and intervention for alcohol, benzodiazepines, and other illicit drug use.

In order to reduce the social and personal harm caused by drugs, it is urgent to strengthen the ability of the primary health institutions in screening and intervention the addictive substances use. Firstly, the investigators will invite 10 primary medical staffs and 10 experts in addition to revise the manual of Alcohol, Smoking, and Substance Use Involvement Screening Test (ASSIST) and Brief Intervention (BI). Then, the investigators will recruit related medical staffs in five provinces to participate the training of ASSIST and BI. Secondly, the researcher will investigate the effects of BI technology in reducing the use of addictive substances, improve the addiction related knowledge of patients through randomized controlled study. Finally, the investigators will collect the research information, revise the manual, and promote the training.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-75 years;
* the patient to the community medical institutions;
* ASSIST score is in 12-27, in a moderate risk;
* voluntary to participate;
* to agree to complete baseline interviews and follow-up studies

Exclusion Criteria:

* unable to complete the questionnaire;
* serious physical illness, action inconvenience.
Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe RA.

This study will also assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.


Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥ 18 and ≤ 80 years old
* Subjects must be diagnosed with rheumatoid arthritis for at least 6 months before baseline
* Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline and at least one of the following at screening:

  * erythrocyte sedimentation rate (ESR) ≥ 28 mm/hr
  * serum C-reactive protein (CRP) \> 1.0 mg/dL
* Subjects must be taking methotrexate (MTX) for ≥ 12 consecutive weeks and on a stable dose of MTX 7.5 to 25 mg/week for ≥ 8 weeks prior to receiving the investigational product (IP), and be willing to remain on a stable dose throughout the study
* Subject has no known history of active tuberculosis

Exclusion Criteria:

* Class IV RA, Felty's syndrome or history of prosthetic or native joint infection
* Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome
* Use of commercially available or investigational biologic therapies for RA as follows:

  * anakinra, etanercept within 1 month prior to first dose of IP
  * infliximab, abatacept, tocilizumab, golimumab, certolizumab within 3 months prior to first dose of IP
  * other experimental or commercially available biologic therapies for RA within 3 months or 5 half-lives (whichever is longer) prior to first dose of IP
* Previous receipt of rituximab or a biosimilar of rituximab

Other Inclusion/Exclusion criteria may apply
A Phase III Study of NK105 in Patients With Breast Cancer

To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent breast cancer.

This study is a randomized, open-label, multi-national phase III study.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of the patient signed by herself.
* Histologically confirmed metastatic or recurrent adenocarcinoma of the breast.
* Aged 20 to 74 at the time of informed consent.

Exclusion Criteria:

* Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent breast cancer.
Clinical and Genetic Characterization of Individuals With Achromatopsia

The purpose of this study is to identify individuals with achromatopsia caused by mutations in the CNGB3 gene and characterize their clinical condition using several tests of visual function every 6 months for up to 1.5 years.

Individuals with a clinical diagnosis of achromatopsia will be asked to provide informed consent and will then have a single 5 mL blood sample drawn for DNA sequence analysis of genes known to cause achromatopsia, including the CNGB3 gene. All participants will be informed of the results of testing for these mutations. Those with mutations in both alleles of the CNGB3 gene will be evaluated every 6 months for up to 1.5 years by using a variety of non-invasive visual function tests to more fully characterize their clinical condition. This testing will include routine ophthalmic examination and tests of visual acuity, color vision, reading speed, perimetry, nystagmus, light sensitivity, optical coherence tomography, adaptive optics retinal imaging, electroretinography, fundus photography and completion of a quality of life questionnaire.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of achromatopsia (screening portion of study);
2. Molecular confirmation of mutations in the CNGB3 gene (main portion of study);
3. At least 6 years of age;
4. Willing and able to perform study procedures;
5. Signed informed consent(s) obtained (and child assent where applicable).

Exclusion Criteria:

1. Not able to have a blood sample drawn;
2. Pre-existing eye conditions that would interfere with interpretation of study endpoints (e.g. glaucoma, corneal or lenticular opacities, diabetic retinopathy, history of retinal detachment);
3. Participating in an interventional research study of drugs or devices for treatment of achromatopsia or other retinal diseases;
4. Use of medications that may impair color vision (e.g. hydroxychloroquine);
5. Any condition which leads the investigator to believe that the participant cannot comply with the protocol requirements or that may place the participant at an unacceptable risk for participation.
Study to Evaluate Efficacy and Tolerance of R-GemOx in DLBCL and MCL

The purpose of this study is to determine efficacy of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.

The purpose of this study is to determine efficacy (overall response rate (ORR) and complete response) tolerance and toxicity of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. DLBCL and MCL diagnosed patients in primary resistance or relapsed not eligible for intensification chemotherapy followed by Autologous stem cell transplantation (ASCT) for age, comorbidity or previous ASCT.
3. Any IPI or ECOG, capable of understanding the nature of the trial.
4. Writtern Informed Consent.

Exclusion Criteria:

1. Nursing pregnant or lactation period women, or fertile age adults not using effective contraceptive method.
2. CNS lymphoma patients.
3. Patients with severa renal (creatinine\> 2,5 UNL) or hepatic (Bilirrubin or ALT/AST\> 2,5 UNL) impairement not provided by the same disease
4. HIV positive patients.
5. Serious psychiatric diseases patients that could interfere with their skill to understand the study (including alcoholism or drug addiction).
6. Murine proteins or any other component of the medicines of the study hypersensitivity patients.
7. Patients who have received more than 2 therapeutic previous lines. (for previous ASCT patients, induction and conditioning for the TAPH treatment is considered a single line therapy).
Support Pathway for ENT Cancer Patients in a Support Care Day Hospital

Cancers of the upper respiratory / digestive tract are a major public health problem, ranking 5th among the most common cancers. Surgery plays a central role in the recommended treatments for this type of pathology. The surgical procedure and its after-effects can be anxiety-provoking and have a major psychological, physical and social impact on patients over the long term.

Our institution's standard protocol is based on a pre-operative supportive care day hospital. The aim of this study is to compare our current care pathway with a more extensive interdisciplinary care pathway focused on patients' needs, in order to reduce anxiety and improve the quality of life of patients undergoing surgery for cancers of the upper respiratory / digestive tract.

Our aim is to use a prospective single-centre interventional study to assess the impact of adding three post-operative day hospitals to the existing care pathway in terms of reducing anxiety and improving the quality of life of patients undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

* patient undergoing surgery for VADS cancer requiring at least one night's post-operative hospitalisation
* Understanding of spoken and written French
* Patient covered by a social security scheme

Exclusion Criteria:

* Protected patient under a protective measure or legal safeguard
* Pregnant or breast-feeding patients
* Patients suffering from major cognitive disorders
* Patients with major anxiety disorders prior to the onset of cancer
Effect of Probiotics on Pre-diabetes and Diabetes in China

This study is aimed at verifying the effects of probiotics (KAWAI:dead S.thermophilus) on glucos management among T2DM and pre-diabetes Chinese adult. Additionally, the investigators intend to verify the effects of probiotics on modifying the structure and function of gut microbiome.

Methods: double-blind, randomized controlled trial. Number of participants: 160 patients with pre-diabetes and 60 diabetes. Intervention time: 3months. Data and Specimen collection time: at baseline and after the intervention.

Observation index

1. Physical measurement: gender, age, weight, BMI, waist circumference, hip circumference, waist-to-hip ratio, systolic pressure, diastolic blood pressure.
2. Lifestyle questionnaire: diet, drinking, exercise, sleep and other habits.
3. Blood test: blood glucose, OGTT, blood lipid, TNF-a, il-6, il-10, LPS, glp-1, gut microbiome metabolism products, T2DM related methylation.

4. Gut microbiome detection: gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis

Eligibility Criteria:
Inclusion Criteria:

1. Meet Diabetes/pre-diabetes diagnostic criteria
2. BMI 18-35kg/m2

Exclusion Criteria:

1. Patients with diabetes or hyperlipidemia, and need regular use of drugs.
2. Secondary obesity or diabetes
3. Digestive, tumor, heart, lung, kidney, rheumatic immunity and other systemic serious diseases
4. Pregnant women, women ready for pregnancy, and nursing mothers
5. Take antibiotics or bacterial agents within 1 month
6. Diarrhea or abscess in 1 month or blood or other abnormal feces
7. Diabetics have a history of more than 2 years
8. The OGTT experiment of diabetic patients FG≥9mmol/L or 2h≥14mmol/L
RCT to Evaluate STERN FIX Device As a Sternal Stabilization System in Patients After Sternotomy

The goal of this clinical trial is to compare the safety and performance of the sternal stabilization system STERN FIX with the standard of care (sternal closure with wires only) in normal conditions of use, in patients of risk undergoing median sternotomy during cardiothoracic surgery. The main question it aims to answer is:

• whether STERN FIX is a safe and efficient device to close the sternum after a sternotomy in patients of risk, achieving higher sternal stability than wires one month after surgery Participants will have their median sternotomy closed using STERN FIX in combination with wires or wires only at the end of their cardiothoracic surgery, according to the allocated treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing surgery that requires median sternotomy
* Patients with at least one of the following risk criteria: obesity (BMI\>30), diabetes, COPD, non serious osteoporosis (not associated with fractures), creatinine \> 200 µmol/L and/or under dialysis treatment, scheduled Bilateral Internal Mammary Artery (BIMA) grafting
* Patients willing and capable of granting informed consent to participate in clinical research and who have granted written consent
* Patient willing and capable of complying with the protocol requirements

Exclusion Criteria:

* Patient with suspected or known allergies or intolerance to the device material (PEEK - polyether-ether-ketone and carbon fibre)
* Patient with insufficient quality or quantity of bone or any other serious structural bone damage at the sternum
* Patient with serious osteoporosis (associated with fractures) or a degenerative bone disease affecting the sternum
* Patients with a latent or active infection or inflammation at the surgical area, that according to the surgeon criteria may interfere in the device implantation or proper function.
* Patient with sternal anomalies that, according to the surgeon criteria, prevent the use of the product, such as bone tumours in the implantation area.
* Pregnant patients or patients planning to become pregnant during the first 6 months after surgery.
* Patients with diagnosis of dementia with a mental status score (MMSE) \< 20.
* Patients with life expectancy lower than 6 months.
* Patients involved in other interventionist clinical trials or that have been involved in other interventionist clinical trials during the previous 4 weeks
* Parasternal sternotomy.
* Patients with intraoperative conditions that, according to the surgeon's opinion, require or exclude the use of a specific sternal closure system, or that cannot be closed following the study products instructions for use.

IMPORTANT: When the allocated closure method is wires only, the surgeon must assess whether the patient could have also had STERN FIX implanted in order to decide if the patient can continue in the study.
Sleep Survey for Medical Trainees

Background

This is a survey to understand sleep in the context of medical trainees (on call) and the participants knowledge about the relevance of sleep, shiftwork, and the impact that sleep may have on their working performance. The survey has been developed by sleep experts from America, Europe, and Africa, in collaboration with the World Sleep Society. It should take about 30-40 minutes to complete.

The survey will focus on three different aspects, complemented by two standard questionnaires:

1. Demographics and Place of Work
2. Basic Knowledge and Perception of Sleep
3. Sleep Routine
4. Epworth Sleepiness Scale, Insomnia Sleep Inventory


Eligibility Criteria:
Inclusion Criteria:

* medical staff
* student / intern / fellow / resident / consultant
* delivering on call work
* any gender

Exclusion Criteria:

* non-medical staff working in hospitals from the wider multidisciplinary team
* underage (less than 18 years)
SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access

SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care.

Patients are recruited in the platform for the research purpose of 4 downstream projects. For more information, please have a look at the "Groups and cohorts" section.

Eligibility Criteria:
* Patients with pathologically confirmed selected tumor types (at site or centrally);
* Mandatory availability of adequate human biological material (HBM);
* Centrally performed confirmation of HBM adequacy in terms of quality and quantity for SPECTA downstream project requirements;
* Age ≥ 12 years;
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
* Written informed consent according to applicable legal and ethical requirements;
SLAP Lesions; a Comparison of Conservative and Operative Treatment. A Prospective, Randomized Study

The purpose of this study is to evaluate whether there is a difference between conservative and operative treatment of Superior Labral Lesions(SLAP)of the shoulder.

Treatment of superior labral lesions is controversial. Some authors advocate labral repair, some advocate biceps tenodesis,and others again questions whether these lesions should be repaired at all. There are no randomized studies comparing operative treatment and conservative treatment(i.e. physical rehabilitation), and likewise no randomized studies comparing labral repair and biceps tenodesis.

In this study;all patients who have a patient history, clinical signs of a SLAP lesion,a MRI study revealing an isolated superior labral lesion and have agreed to participate in the study, will have a diagnostic arthroscopy performed.

If a SLAP lesion is diagnosed, the patients are randomized to three different groups:1) SLAP repair with suture anchors 2) Biceps tenodesis 3) Physical therapy

Eligibility Criteria:
Inclusion Criteria:

* Clinical history and signs of superior labral lesion
* MRI study revealing an isolated superior labral lesion

Exclusion Criteria:earlier shoulder procedures,

* Other accompanying shoulderpathologies(such as cufflesions, instability, ac-joint pain, arthritis)
Predictive Role of KLK10 and Other Neuroinflammatory Molecules on Clinical Outcomes of AIS

This study aims to investigate the dynamic changes and differential expression characteristics of neuroinflammatory molecules such as kallikrein-related peptidase 10 (KLK10), soluble triggering receptor expressed on myeloid cells 2 (sTREM2), and glial fibrillary acidic protein (GFAP) in the plasma of patients with first-ever anterior circulation acute ischemic stroke (AIS). It will analyze the correlation between these molecules and the severity of neurological deficits, infarct volume, brain edema, hemorrhagic transformation, progressive stroke, and clinical outcomes at three months. The goal is to assess the predictive value of these molecules for AIS prognosis, guiding early treatment and new molecular targets for prevention and treatment.

1. Informed Consent and Recruitment: Participants will be recruited based on inclusion and exclusion criteria.
2. divided two groups: the case group(ischemic stroke group) and the control group(healthy individuals).
3. First survey(At the time of admission): baseline Assessment- Survey on gender, age, medical history, smoking, drinking habits, and current medication; NIHSS score at admission; measurement of plasma levels of KLK10, sTREM2, and GFAP; a collection of blood glucose, creatinine, high-sensitivity C-reactive protein, blood cell analysis report, and brain MRI or CT imaging reports.
4. Second survey(24 hours after onset): NIHSS Score and Plasma Levels of KLK10, sTREM2, and GFAP Detection.
5. Third survey(Within 7 days of onset): Obtain brain CT or MRI reports to extract information on infarct volume, brain edema, and hemorrhagic transformation; perform NIHSS scoring to assess the occurrence of progressive stroke.
6. Forth survey( 3 months after onset): Final Assessment\<if Good Functional Outcome or Mortality\>:Record the Modified Rankin Scale (mRS) score at 3 months after stroke.

Eligibility Criteria:
Inclusion Criteria:

for AIS patients:

* Selection of 182 patients with first-ever acute ischemic stroke (AIS) who are hospitalized at our hospital, aged ≥18 years, with no restriction on gender;
* Patients must be admitted within 24 hours of the onset of AIS;
* Diagnosis must be confirmed by cranial magnetic resonance imaging (MRI) or computed tomography (CT);
* All enrolled patients must provide written informed consent.

for healthy controls:

* Age and gender-matched;
* No organic diseases;
* Written informed consent must be signed

Exclusion Criteria:

* Intracranial hemorrhage;
* Pregnancy;
* Stroke with unknown onset time;
* Malignant tumors;
* Hematologic disorders;
* Severe liver or kidney dysfunction;
* Recent myocardial infarction (less than 3 months);
* Ongoing anti-inflammatory drug treatment.
Peripheral Venous Pressure as an Indicator of Central Venous Pressure in Post Operative Surgical Patients: A Randomised Controlled Trial

The study is aimed at comparing peripherial venous pressure as an indicator of central venous pressure in post operative surgical patients.


Eligibility Criteria:
Inclusion Criteria:

* ASA I/II/III surgical patients who require central venous access as part of their surgical treatment plan with no organ support in post operative period.
* Age between 18 and 75 years
* Who have atleast 1 x 18 gauge peripherial venous cannula in the upper limb from elbow below to the hand
* Who have given consent

Exclusion Criteria:

* Not meeting the inclusion criteria