cyrilzakka/clinical-trials huggingface dataset:
Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain

A multi-center randomized controlled trial assessing the comparative effectiveness and cost-effectiveness of Chuna manual therapy for chronic neck pain

A multi-center randomized controlled, parallel, assessor-blinded trial will be conducted to evaluate the comparative clinical effectiveness and cost-effectiveness of Chuna manual therapy for chronic neck pain patients compared to usual care as assessed using pain, functional disability, health-related quality of life, economic evaluation, and safety measures.

Eligibility Criteria:
Inclusion Criteria:

* Chronic neck pain patients (with pain duration of 3 months or longer)
* Patients with numeric rating scale (NRS) of radicular pain ≤ neck pain in neck pain patients with or without radiculopathy
* Patients with NRS of neck pain ≥5 during the 3 days
* Patients who have agreed to trial participation and provided written informed consent

Exclusion Criteria:

* Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. spinal metastasis of tumor(s), acute fracture, spinal dislocation)
* Patients with history of neck surgery
* Patients with other chronic disease(s) which may interfere with treatment effect, safety, or interpretation of outcomes (e.g. chronic renal failure, vertebral artery complications, rheumatoid arthritis, Down syndrome)
* Patients with progressive neurologic deficit or severe neurologic symptoms such as spinal cord injury
* Patients with severe mental illness
* Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
* Patients who have received Chuna manual therapy or physical therapy, medicine such as nonsteroidal anti-inflammatory drugs (NSAIDs), or treatment(s) that may influence pain within the past week
* Pregnant patients or patients with plans of pregnancy
* Patients participating in other clinical studies or otherwise deemed unsuitable by the researchers
Binaural Sound for Remimazolam Induction

It is important to decrease the time-to-loss of consciousness and anesthetics dose of remimazolam for general anesthesia induction. We will evaluate the effect of binaural sound for general anestheia induction using remimazolam infusion.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for generla anesthesia
2. Patients aged 20-60
3. Patients with American Society of Anesthesiologist physical status classification 1-2
4. Patients with ideal body weight 50-80 kg

Exclusion Criteria:

1. Patients with hearing disability
2. Patients using opioids or sedatives in 1 week
3. Patients who are dependent for alcoholics or drugs
4. Patients with hypersensitivities to remimazolam
5. Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia
6. Patients with liver failure
A Study on Estimated Risks of Certain Adverse Events in Adults With Von Willebrand Disease (VWD) Treated With Veyvondi

The main aim of this study is to estimate the risks of certain adverse events in adults with Von Willebrand Disease treated with VEYVONDI. No study medicines will be provided to participants in this study.

Data from medical records of participants diagnosed with Von Willebrand Disease and treated with VEYVONDI will be evaluated during this study.


Eligibility Criteria:
Inclusion criteria:

1. Participants with 18 years of age or older
2. Participants with diagnosis of congenital VWD.
3. Participants received VEYVONDI with or without a FVIII concentrate.
4. Participants must have at least 7 days of observation time after the index dose.
5. Provides informed consent, if required, in accordance with local ethical and institutional requirements. All medical record data will be abstracted retrospectively; therefore, an exemption or waiver of informed consent will be sought from all associated independent ethics committees (IECs) and institutional review boards (IRBs).

Exclusion criteria:

1. History of any other coagulation or platelet disorder (including acquired VWD).
2. History of neutralizing antibodies / inhibitors to VWF or FVIII.
Combining Radiotherapy and Temozolomide With Dichloroacetate in Patients With Newly Diagnosed Glioblastoma

This is a study to see whether radiotherapy plus chemotherapy (Temozolomide) plus Dichloroacetate (DCA) improves overall survival and offers better control of the disease in patients with newly diagnosed Glioblastoma Multiforme Tumours.

Patients with newly diagnosed Glioblastoma Multiforme Tumours, once consented to the study, would undergo standard treatment of radiotherapy plus chemotherapy (TMZ) with DCA in pill form (twice a day) during the radiation phase of the study and then with TMZ for six months after. Other elements of the clinical trial include pharmacokinetics and MGMT genetic testing.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed GBM
* Diagnosis must be established by open biopsy or tumour resection
* Tumour must have a supratentorial component
* Over 18 years
* pre-treatment evaluations must be met
* study therapy to begin within 6 weeks of surgery
* KPS greater or equal to 70
* patients must sign informed consent
* If female, patients must not be pregnant or lactating
* Women of childbearing potential and male participants must practice adequate contraception

Exclusion Criteria:

* prior invasive malignancy )except for non-melanomatous skin cancer) unless disease free for greater than 3 years
* recurrent or multifocal malignant gliomas
* metastatic disease of leptomeningeal spread
* prior chemo or radiosensitizers for cancers of the head and neck region
* prior RT to head and neck region except for T1 glottic cancer, resulting in overlap of radiation fields.
* Severe active co-morbidity define in protocol
* Pregnant of lactating women
* Women of childbearing potential or men who are sexually active who are not willing or able to use medically acceptable forms of contraception; this exclusion is necessary due to the treatment involved potentially being teratogenic.
* prior allergic reaction to temozolomide and/or dichloroacetate
* History of HIV/AIDS
Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Liberia

To assess the efficacy of both first-line antimalarial medications used for the treatment of uncomplicated Plasmodium falciparum malaria infections in two geographic regions in Liberia.

Title: Efficacy of artesunate+amodiaquine (ASAQ) and artemether+lumefantrine (AL) for the treatment of uncomplicated Plasmodium falciparum malaria in Liberia

Objective: To assess the efficacy of both first-line ASAQ and AL for the treatment of uncomplicated P. falciparum malaria infections

Study Sites: Sacleapea Comprehensive Health Center, Saclepea-Mah District in Nimba County; and Sinje Health Center, Garwula District, Sinje, in Grand Cape Mount County

Study Period: August 2022 to August 2023

Study Design: Prospective study of two cohorts with simultaneous enrolment of each therapy

Patient population: Patients aged 6 to 59 months with confirmed uncomplicated P. falciparum infection

Sample Size: Total number of patients to be enrolled is 352 patients. This consists of 88 patients per arm per site. There are two arms in each of the two sites.

Treatment(s) and follow-up: Patients enrolled in the ASAQ arm will receive the treatment once daily dose for three days. Patients enrolled in the AL arm will receive treatment twice daily dose for three days. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy.

Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis.

Secondary endpoints: The frequency and nature of adverse events will be recorded.

Exploratory endpoints: Any polymorphisms of molecular markers for antimalarial drug resistance and prevalence of HRP2 deletions.

Eligibility Criteria:
Inclusion Criteria

1. Age between 6 to 59 months (5 years)
2. Weight ≥ 5 kg
3. Monoinfection with P. falciparum with a parasite density of 2,000 to 200,000 asexual forms per microliter of blood
4. Axillary temperature ≥37.5˚C or history of fever in the last 24 hours
5. Hemoglobin ≥ 8.0g/dl
6. Easy access to the health facility and ability to return to the health facility over the course of the four weeks of follow-up
7. Informed consent of parent or guardian

Exclusion Criteria on Day 0

1. Any danger signs or signs of severe malaria (see Appendix I)
2. Pneumonia or bronchopneumonia
3. Severe malnutrition (Z-score \< 3)
4. History of taking antimalarials (or antibiotics with antimalarial activity such as cotrimoxazole, tetracycline or doxycycline) in the last 14 days
5. Mixed malaria infection
6. History of hypersensitivity or allergy to the medication
Impact of Dedicated Hygienist Staff on the Occurrence of Intensive Care Unit -Aquired Bloodstream Infections

The purpose of this study is to evaluate in a multicentric cluster randomized study the effect of the presence of dedicated nurses for training of ICU staff in preventing nosocomial infections. The rate of bloodstream infections per 100 admitted patients is used as the main endpoint. A sample of 4000 included patients in the 6 participating ICU is included with the objective to show a reduction of one third of the rate of ICU-acquired bloodstream infections. The study is currently at the end of the recrutimeent phase.

15% of patients admitted to intensive care have an infection acquired in the service, including bacteremia is a serious form. Compliance with hygiene measures and recommendations in the use of invasive devices can reduce the incidence. The advantage of simple recommendations type "bundle" could, however, be insufficient because not associated with training and monitoring compliance with the recommendations. The aim of this study is to show that the daily intervention of a public health nurse on the basis of a half full-time equivalent, allows these actions and therefore a reduction in the bloodstream of the attack rate acquired in the ICU compared dissemination of simple recommendations.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to reanimation department

Exclusion Criteria:

* no exclusion criteria
Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.


Eligibility Criteria:
Inclusion Criteria:

* Men \& women ≥20 years of age
* Histologically confirmed unresectable advanced or recurrent esophageal cancer
* Refractory to or intolerant of standard therapy
* ECOG Performance Status score 0 or 1
* A life expectancy of at least 3 months

Exclusion Criteria:

* Current or past history of severe hypersensitivity to any other antibody products
* Patients with multiple primary cancers
* Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment
* Patients with active, known or suspected autoimmune disease
Feasibility of Utilising Brushing Cytology and Dermoscopy for Diagnosing Penile Lesions

In an attempt to reduce patient flow into the hospital we are going to assess the use of penile cytological brushings and dermoscopy in diagnosing cancer or non-cancer conditions of the penis.

Currently the standard of care pathway for all patients suspected of having penile cancer involves the need for a penile biopsy under local (LA) or general anaesthetic (GA). We hope to assess the feasibility of cytololgical brushings and the patient experience of the use of such a technique. Additionally, we will make initial comparison on the concordance between cytological brushing and dermoscope photo vs actual biopsy only.

Importantly for this study, all patients will be offered standard of care: a biopsy under LA or GA. The additional procedures of the cytological brushing and dermoscope photo will be done in an out-patient clinic setting (with no anaesthetic).

If it can be shown that the inclusion of the cytological brushing and dermoscope photo have comparative results over current standard of care histological biopsy, this will provide sufficient evidence to expand this study to acquire more data.

Eligibility Criteria:
Inclusion Criteria:

1. All patients requiring either diagnostic biopsy or WLE (wide local excision) of a lesion of the penis
2. Age \> 18 years
3. Written informed consent provided by the patient
4. Subject has been scheduled for surgical intervention, with a biopsy procedure being a part of the surgical plan

Exclusion Criteria:

1. Subject is unfit for surgery upon surgeon's assessment.
2. Unable to provide consent
3. Those with terminal disease
4. Those with palpable lymph nodes
5. Other coincident cancers
6. Previous radiotherapy treatment to the penis, bladder, prostate, anus
7. Subject is deprived of liberty or under guardianship
8. Subject is not able to follow and understand the procedures of the study due to mental state or other reasons
Chewing Gum and Cognitive Function

This study is to investigate whether the improvement or maintenance of cognitive function is superior to the control group when gum chewing is performed in elderly people with subjective cognitive decline or mild cognitive impairment.

The intervention group chew one unscented gum provided by the study for 12 weeks. Using KakaoTalk, the coordinator sends a chewing gum alarm.

The participants are instructed to masticate a gum for 20 minutes every day, alternately for 10 minutes on the right side and 10 minutes on the left side.

After chewing gum, they perform masticatory muscle stretching and tongue exercises. After they finish chewing the gum, he or she reports completion by posting an authentication photo in the KakaoTalk chat room.

The research coordinator checks the certification on a weekly basis and sends a separate phone call to encourage participants who do not chew gum more than twice a week.

Eligibility Criteria:
Inclusion Criteria:

* 60 to 79 years of age
* All posterior teeth are evenly occluded on both sides, and those who have lost 4 or less teeth in the posterior teeth
* Those who scored 50 points or less on the periodontal disease self-checklist
* Meet the diagnostic criteria for subjective cognitive decline or mild cognitive impairment
* Provide written informed consent

Exclusion Criteria:

* Those who have difficulty in chewing due to toothache, periodontal disease, temporomandibular joint disease, severe malocclusion, shaking teeth, etc.
* Those who wear dentures on the upper or lower teeth
* Dementia
* Major psychiatric illness such as major depressive disorders
* Other neurodegenerative disease (e.g., Parkinson's disease)
* Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease, or any medical conditions preventing to complete the study as judged by the study physician
* Severe loss of vision, hearing, or communicative disability
* Significant laboratory abnormality that may result in cognitive impairment
* Any conditions preventing cooperation as judged by the study physician
* Coincident participation in any other intervention trial
* Those who are planning dental treatment such as preservation, prosthetics, and implants during the research period
Virtual Temporal Bone Surgery: Defining and Translating Metrics

The goal of this project is to improve the efficiency of training and assessment of technical skill in surgical treatment of otologic disease. Through previous funding, we have developed an intuitive virtual simulation environment to be used as an adjuvant for teaching temporal bone surgery. Using direct-volume visualization techniques with integrated stereoscopic display, haptic (force) feedback, and aural simulation, we have achieved a straightforward, low-cost learning environment ready for translation into a practical training and assessment tool. This application challenges and seeks to shift current practice in clinical training by translating the simulation environment into a vehicle for curriculum development, technical skills assessment, and dissemination. The intent is to provide more accessible, inexpensive, safe, and deliberate practice with objective and continuous quantitative, objective assessment in the early stages of training.

The aims of this research include: 1) definition of standardized metrics for otological surgical techniques, 2) the translation of those standards into objective criteria for use in a computer synthesized surgical environment, and 3) the correlation between expert evaluation and computer automated assessment of resident proficiency.

The interactions will be computer-based and include:

Experts will learn to use the system so that they can evaluate the quality of translation of metrics to the simulation environment.

Evaluations will be in the form of anonymous web-based surveys. Experts serve as a focus group.

Residents will use the simulation environment to perform surgical procedures on virtual specimens. Residents will then evaluate the quality of the simulation environment via anonymous web-based surveys.

Experts will use the simulation environment to evaluate and rate the residents performance.

The computer environment will be used to automatically assess and rate the residents performance.

Expert and computer assessment will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Specific knowledge of otologic surgery.

Exclusion Criteria:

* request not to participate
A Comprehensive Longitudinal Cohort Study in Type 2 Diabetes With High Risk of Cardiovascular Diseases in China

In 2010, the sponsor conducted an observational study, entitled as "Nationwide Assessment of Cardiovascular Risk Factors: Blood Pressure, Blood Lipid, and Blood Glucose, in Chinese Patients with Type 2 Diabetes - 3B Study " which was to evaluate the level of cardiovascular diseases (CVD) risk factor control and its regional difference in China. As a continuation, this extension of the 3B Study is designed to assess the incidence of cardiovascular events, cardio-renal events, and other microvascular complications, in 1, 2 and 3 years in patients with type 2 diabetes and with high risk of (CVD) with or without existing or history of coronary artery diseases.

Limited by its cross sectional design, 3B study was not be able to provide any information on how various patterns of treatment and prescribing behaviors would impact the outcomes of prevention of cardiovascular and cardio-renal diseases in type 2 diabetes longitudinally. This information, however, would be crucial in better guiding the real world medical practice and maximizing the effectiveness of medical treatment for better controlling cardiovascular risk factors.

The 3B Extension study is thus designed to extend the 3B study by continuing to follow up on enrolled patients for 3 years. The 3B Extension study is expected to demonstrate the clinical outcomes of nationally representative type 2 diabetes patients who are treated by endocrinologists, cardiologists and nephrologists separately in all tiers of hospitals, as measured by diabetes progression, incidence of cardiovascular complications, and incidence of microvascular complications. It will be the first study of this scale in China based on its exclusivity, extensiveness, and the level of government and national thought leaders' support. It will be conducted in collaboration with the advisory board of China Cardiometabolic Registries (CCMR).

Eligibility Criteria:
Inclusion Criteria:

* Age 40 years or older
* Outpatients who meet the inclusion and exclusion criteria of 3B study
* With hypertension,dyslipidemia and one of the following:
* History of acute coronary artery disease or ischemic stroke
* Age \> 65 years old
* Overweight or obesity (BMI \> 24 kg/m2)
* Microalbuminuria or albuminuria
* Current smoker

Exclusion Criteria:

* Patients with type 1 DM
* Pregnant or breast feeding women
* Patients who are unable to or not willing to return for follow up visits every 6 months for 3 years;
* Patients have severe heart failure (NYHA Class III-IV)
* Patients with severe renal deficiency (creatinine clearance \< 30 ml/min)
* Patients who are not willing to sing the informed consent form;
* Patients who are participating in any other interventional clinical studies,
Decitabine and Plerixafor in Elderly Acute Myeloid Leukemia (AML)

The hypothesis of this proposal is that combining plerixafor, an inhibitor of stromal cell derived factor - 1α (SDF-1α), with decitabine, a DNA methyltransferase inhibitor, as induction and postremission therapy for older patients with Acute Myeloid Leukemia (AML) will improve treatment outcomes via mobilization of leukemia stem cells and alteration of the pharmacodynamics of decitabine. The protocol will establish the safety and feasibility of combining two different doses of plerixafor with a fixed dose and schedule of decitabine.


Eligibility Criteria:
Inclusion Criteria:

* Unequivocal pathologic diagnosis of AML (≥ 20% blasts in the bone marrow based on WHO criteria) excluding: i) acute promyelocytic leukemia t(15;17)(q22;q12); PML-RARA; ii)acute myeloid leukemia with t(8;21)(q22;q22); RUNX1-RUNXT1; iii) acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16)(p13.1;q22); CBFB-MYH11.
* AML patients with an antecedent hematologic disorder or myelodysplastic syndrome (MDS)are eligible for treatment on this trial provided that they have not received prior treatment with decitabine or prior cytotoxic treatment for AML.
* AML patients with therapy-related myeloid neoplasms (t-MN) are eligible if they have not received chemotherapy (not including hormonal therapy) for their primary malignancy or disorder for \>6 months.
* Age ≥ 60 years.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* Prior treatment with decitabine
* Prior treatment with plerixafor
* Ongoing treatment for another malignancy.
* Patients with good-risk molecular or cytogenetics features
* Patient has a medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational drug treatment.
* Patient has a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies.
* Patient has an inability or unwillingness, in the opinion of the investigator, to comply with the protocol requirements.
Cardiovascular Disease Risk Factors and Healthy Lifestyle Behaviours in Patients with Ankylosing Spondylitis

A review of the literature did not identify any studies that assessed knowledge of cardiovascular disease risk factors and healthy lifestyle behaviours in patients with ankylosing spondylitis. The aim of this study is to assess knowledge of cardiovascular disease risk factors, healthy lifestyle behaviours and physical activity levels in patients with ankylosing spondylitis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ankylosing spondylitis according to ASAS diagnostic criteria
* Being aged 18-65
* Stable medication use for at least 3 months
* Voluntary participation in the study

Exclusion Criteria:

* Having uncontrolled cardiopulmonary disease
* Being pregnant
* Having undergone recent surgery
* Presence of malignancy