cyrilzakka/clinical-trials huggingface dataset:
Prospective Randomized Trial Comparing the Effectiveness of Continuous Paravertebral Infusion of Local Anesthetics Versus Intravenous Patient-controlled Analgesia on Acute and Chronic Neuropathic Pain After VATS Lobectomy

Since mid-2000, thoracoscopic lobectomy has been replaced with conventional open lobectomy and it has reduced the operative morbidities and mortalities. However, thoracoscopic lobectomy also results in operative acute pain and the incidence of chronic pain after thoracoscopic lobectomy has been reported as up to 50%. Penetration of chest wall by trocar, torque at trocar and working window by operator, and compression of intercostal nerves have been suggested as a cause of pain after thoracoscopic lobectomy. The intravenous patient-controlled analgesia (IV PCA) that usually have used to control the operative pain, sometimes cause the side effects such as sedation, nausea and vomiting due to its systemic delivery of analgesics. Because of these side effects, IV PCA has to be discontinues and the effective dose of analgesics could not deliver to patients. In contrast to IV PCA, continuous paravertebral infusion of local anesthetics thorough catheter below the parietal pleura might reduce the side effects of IV PCA and control the operative pain effectively. In this study, we investigate the effectiveness of continuous paravertebral infusion of local anesthetics thorough catheter below the parietal pleura for 60 hours after operation competed to IV PCA.


Eligibility Criteria:
Inclusion Criteria:

* Age; 18≥, \<75
* Thoracoscopic lobectomy due to lung cancer or suspected lung cancer
* Tolerable cardiopulmonary and other systemic function tolerable to lobectomy
* Karnofsky performance status ≥ 80
* Agree with study

Exclusion Criteria:

* Intolerable to one-lung ventilation
* Bleeding risk due to Aspirin, coumadin and other drugs
* Past or current history of depression or other psychiatric disease
* Pain persisted before operation due to lung lesion
* History of rib fracture, trauma or lung surgery at the same side of operation
* Severe pleural adhesion or empyema
* Open thoracotomy conversion
* Reoperation due to postoperative bleeding or others
* Postoperative complications that need ICU care
* Chemical pleurodesis more than two times after operation
* Do not agree with study
Telephone-Delivered Exercise for Multiple Sclerosis Fatigue

Multiple sclerosis (MS) is a progressive demyelinating disorder that damages white matter in the central nervous system. Although individuals experience mobility (e.g., walking, balance) impairments that lower quality of life and limit participation in daily activities, one of the most prominent symptoms is fatigue. Up to 92% of individuals report fatigue that manifests as lack of energy, exhaustion or worsening of MS symptoms and ultimately contributes to increasing disability. The currently available pharmaceutical treatments fail to fully control fatigue in the majority of individuals with MS; non-pharmacologic therapies such as exercise and behavioral therapies offer the best hope for combating MS fatigue in the majority of individuals.

Exercise therapy is effective in reducing MS fatigue. However, access to exercise therapy is seriously limited for many individuals with MS due to geographical location, limited resources (e.g., financial, transportation), and/or disability. Thus, the development and evaluation of an alternative delivery method for exercise therapy to target MS-related fatigue that increases participation and reduces barriers is critical.

In this study, the investigators will compare traditional in-person delivered exercise therapy to telephone-delivered exercise therapy to target fatigue in persons with MS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RRMS, SPMS, or PPMS
* Ambulatory for at least 5 minutes at a time
* Self-reported fatigue on Fatigue Severity Scale
* Able to follow study-related commands
* Able to attend study appointments

Exclusion Criteria:

* MS exacerbation within the past 30 days
* Evidence of another neurological disorder or orthopedic disorder that would interfere with exercise participation
* Acute illness or injury that prevents participation in the intervention
* Pregnancy
Safety and Tolerability of Lu AG06474 in Healthy Young Men

The purpose of this study is to investigate the safety and tolerability of Lu AG06474 and what the body does to Lu AG06474 after swallowing single doses of the drug.

Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.

Eligibility Criteria:
Inclusion Criteria:

* The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)/square meter (m\^2) at the Screening Visit and at the Safety Baseline/Baseline Visit.
* The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, a safety ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

* The participant has taken disallowed medication \<1 week prior to the first dose of study drug or \<5 half-lives prior to the Screening Visit for any medication taken.
* The participant has orthostatic hypotension, defined as a decrease in systolic blood pressure ≥20 millimeters of mercury (mmHg) and/or a decrease in diastolic blood pressure ≥10 mmHg from supine to standing, at the Screening Visit or at the Safety Baseline/Baseline Visit.
* The participant has a QTcF interval \>450 milliseconds (ms) at the Screening Visit or at the Safety Baseline/Baseline Visit, as calculated by the ECG equipment and evaluated by the investigator.
* The participant has taken any investigational medicinal product \<3 months prior to the first dose of study drug.
* The participant has received an injection of COVID-19 vaccination less than 30 days prior to the first dose of study drug.

Other inclusion and exclusion criteria may apply.
Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

The objective of the study is to clinically assess the safety and performance of the Dura Sealant Patch as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.


Eligibility Criteria:
Inclusion Criteria:

Preoperative Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.

Subjects who are ≥ 18 years old. Subjects who are able to comply with the follow-up or other study requirements. Subjects who are planned for an elective intracranial intradural surgery in whom a dural incision of at least 2 cm in length is necessary, which will be closed.

Female subjects of child bearing potential must agree to use any form of contraception from the time of signing the informed consent form through 90 days post-surgery.

Intraoperative Surgical wound classification Class I/Clean. Minimally 5 mm of dural space surrounding dural opening.

Exclusion Criteria:

Preoperative Female subjects who are pregnant or breastfeeding. Subjects with an assumed impaired coagulation due to medication or otherwise. Subjects suspected of an infection requiring antibiotics. Subjects with any type of dural diseases in planned dural closure area. Subjects requiring re-opening of planned surgical area within 90 days after surgery.

Subjects requiring local radiotherapy in planned surgical area. Subjects with a known allergy to any of the components of the Dura Sealant Patch.

Subject who previously participated in this study or any investigational drug or device study within 30 days of screening.

Subjects with a presence of hydrocephalus. Intraoperative Subjects in whom elevation of PEEP or pCO2 has a potential detrimental effect. Subjects who will require a CSF or wound drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery.

Primary closure of the dura mater with synthetic, non-autologous or autologous material other than galea.

A gap \> 3 mm after primary closure of the dura mater.
The Purpose of This Study Was to Determine Whether or Not Functional Training Has Similar Effects on Muscular Strength, Flexibility, Agility, Speed and Anthropometric Measures in Basketball Players as Traditional Resistance Training

Basketball has gained worldwide popularity and fascinated players and spectators with its dynamic characteristics as a team sport. This kind of sport is multifaceted that requires well-developed physical ﬁtness to be played successfully. Many authors have suggested that strength, power, agility, and speed are important performance related physical components for elite basketball players. The physical components require that fitness and conditioning attributes of basketball players are well developed to negate the limiting aspect of sport performance. Moreover, functional training is becoming increasingly popular within the fitness industry and has been considered to be a better alternative than traditional training methods for improving various measures of performance. The purpose of this study was to determine whether functional training has effects on performance and related various physical components of basketball players.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be professional basketball players
* Participants have not any upper or lower extremities injury during last 3 months
* Participants must implement age limits

Exclusion Criteria:

* If participants who has;

  1. Surgery
  2. Musculoskeletal injuries
* Participants who transfer to another professional basketball team
* If participants who has;

  1. Systematic inflammatory diseases
  2. Neurological diseases
  3. Vascular conditions
  4. Alcohol abuse
  5. Psychiatric disorders
Practicing Getting Up from the Floor to Reduce Fear of Falling and Improve Floor-Rise Ability in Community-Dwelling Older Adults: a Pilot Study

Goal:

This pilot study aims to determine whether practicing getting down to and standing up from the floor reduces fear of falling (FoF) and improves older adults' ability to complete this task. The study compares this to a control group that watches educational videos on the same topic. This practice is referred to as Floor-Rise Training (FRT).

Main Questions:

1. Can a short FRT intervention reduce fear of falling?
2. Can a short FRT intervention improve the ability to rise from kneeling, sitting, and lying positions?
3. Does watching an instructional video on FRT improve fear of falling or floor-rise ability?

Study Design:

Researchers will compare:

* A group receiving 20 minutes of FRT weekly for 5 weeks.
* A control group watching FRT videos followed by discussions over the same period. Changes in floor-rise ability and FoF will be assessed to determine the effectiveness of FRT.

Participants:

Participants will be recruited from five Otago exercise classes (a falls prevention program without FRT) in Renfrewshire. Each class will be randomly assigned to either:

* The FRT intervention group (3 classes).
* The control group (2 classes) watching videos that include an FRT demonstration. Participants will complete questionnaires (to assess FoF) and timed floor-rise tests before and after the intervention. Some may also be invited to focus groups to share their experiences with the intervention, videos and with our recruitment procedures.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 or older
* Able to provide written informed consent
* Currently engaged with ROAR and attending the Otago exercise classes

Exclusion Criteria:

* Requiring a walking frame indoors to mobilise
* Have any medical condition that renders it inadvisable to descend to the floor (e.g. such as awaiting knee replacement surgery)
* Any uncontrolled medical condition requiring medical input
* BM I≥ 30 kg/m2
* Lacking capacity to consent to participate
* Unable to comprehend FRT instructions
Ultrasound as a Diagnostic Tool for Occult Hip Fractures

The purpose of this study is to measure the sensitivity and specificity of ultrasound exam of the hip in diagnosing occult hip fractures.

Introduction: Most hip fractures are diagnosed by history, physical examination and confirmed by plain radiographs. When initial X-rays are negative or equivocal, and there is a clinical suspicion of occult hip fracture, additional diagnostic tests are necessary such as MRI which is expensive and in many hospitals less available, or bone scan which needs to be delayed 48-72 hours from injury to be indicative. Ultrasound examination has been shown to be an accurate measurement to diagnose occult fractures in the ankle and is a relatively easy, available, non-expansive examination. We propose the use of bedside ultrasound examination of the hip as a screening tool for occult hip fractures.

Objective: To measure the sensitivity and specificity of ultrasound exam of the hip in diagnosing or ruling out occult hip fractures.

Materials and methods: We will include all patients 40 years and older with a painful hip after an injury, and with "normal" hip X-rays. Each patient will undergo two hip ultrasounds by two different examiners. Afterwards, the patients will undergo MRI of the hip. The MRI will serve as the gold standard for treatment decisions. The results of the ultrasound will be compared to the MRI to evaluate its sensitivity and specificity.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40 years or older, with suspected hip fracture but normal plain X-rays

Exclusion Criteria:

* Patients younger than 40 years and with contra-indications for MRI scan
Advance Care Planning in Palliative Care

The question of the end of life is a major public health issue. In the field of palliative care, the notion of anticipation is central for people with a serious and progressive illness. Indeed, an important consideration for general practitioners is the need to anticipate the disease's evolution and the uncomfortable symptoms (physical or psychological) the patient is likely to experience. This approach aims to relieve the patient without delay and thus improve comfort to ensure an acceptable quality of life for patients and their families. Even if the usefulness of anticipatory prescribing seems obvious, their use is not generalized to all palliative care patients. Caregivers are confronted with obstacles to the implementation of these prescriptions, particularly with regard to the relationship with the patient. It can then be assumed that patients' experiences and perceptions may influence symptom management and the use of anticipatory prescriptions. It seems essential to explore this subject. For this purpose, the investigator will carry out a qualitative study based on individual semi-structured interviews with palliative care patients.


Eligibility Criteria:
Inclusion Criteria:

* Persons of all genders
* Persons 18 years of age and older
* In a palliative care situation of any serious illness
* Persons hospitalized in palliative care unit at the Givors hospital or followed at home by the Mobile Palliative Care Team
* Patients who have received full information about the study and signed a written consent.

Exclusion Criteria:

* Persons under legal protection
* Persons unable to express their consent, making it impossible to conduct interviews: dysarthria, cognitive disorders, mental confusion, altered state of consciousness
* Pregnant or breastfeeding persons
Photo-medicine-Guided Dual Approach for Reoperation of Sentinel Lymph Nodes in Locally Recurrent Breast Cancer Patients

Sentinel lymph node biopsy (SLNB) is essential for staging and treatment planning in early breast cancer patients. As a less invasive procedure, it has replaced axillary lymph node dissection (ALND) by reducing complications and improving patient outcomes. However, the 10-year local recurrence rate for breast cancer is approximately 2-10%, and the role of SLNB in the surgical management of recurrent breast cancer remains unclear.

According to the NCCN guidelines and Korean Breast Cancer Treatment Recommendations, surgical management for recurrent breast cancer includes mastectomy and axillary lymph node surgery for patients who have previously undergone breast-conserving surgery and radiotherapy. For axillary recurrence, surgery is recommended if feasible, followed by radiotherapy. Conversely, the ASCO guidelines recommend SLNB for surgically resectable recurrent breast cancer, and recent studies have reported promising outcomes for repeat sentinel lymph node biopsy (reSLNB). Vugts G et al. demonstrated an 80.1% tumor-negative rate with reSLNB, suggesting that ALND could be avoided in many cases.

Although reSLNB offers the advantage of reducing unnecessary invasive procedures and associated complications, challenges remain due to disrupted lymphatic pathways in patients who have previously undergone surgery and radiotherapy. Additionally, research on the long-term prognosis of these patients is still limited.

This study aims to evaluate the detection rate of sentinel lymph nodes using a photo-medicine-based dual localization technique that combines traditional radiotracer methods with indocyanine green-fluorescence (ICG-F) in patients undergoing reSLNB for locally recurrent breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ipsilateral locally recurrent breast cancer who previously underwent ipsilateral axillary surgery.
* Female patients aged 18 years or older.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Patients who voluntarily decide to participate in the study and provide written informed consent.

Exclusion Criteria:

* Patients with distant metastases.
* Patients who previously underwent ipsilateral mastectomy.
* Pregnant or breastfeeding women.
* Patients with a general condition that impairs the ability to understand or provide informed consent.
Secondary Ear Reconstructions Based on Nagata Method

The goal of this observational study is to provide a feasible surgical strategy based on Nagata method for patients who require secondary revision surgeries and to verify its long-term aesthetic outcomes. The main question it aims to answer is:

• Whether ear reconstruction surgery based on Nagata method can improve the unsatisfactory outcomes of primary reconstruction surgery? Participants who had accepted secondary ear reconstruction based on Nagata method in our department will be required to received questionnaires in the follow-up and their photographs will be collected for reconstructed ear evaluation of its realness through convolutional neural network (CNN) models we previously developed.


Eligibility Criteria:
Inclusion Criteria:

* Chest circumference larger than 60cm at the lowest sternum level;
* Willingness to participate long-term follow-ups;
* Ability to correctly understand the questionnaire(\>8 years old).

Exclusion Criteria:

* Patients with damaged superficial temporal artery (STA);
* Patients with poor condition of rib cartilage;
* Patients with active inflammation in auricular area;
* Patients who refuses surgical approach.
HemoSonics - UTMB Cardiac Surgery Study

This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra QPlus Cartridge in patients undergoing cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, and ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra QPlus Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system.

This single-center, prospective, observational study will evaluate the performance of the Quantra System as compared to and comparable measures determined using the TEG 5000.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years
* Subject is scheduled for cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.
* Subject is willing to participate, and he/she has signed a consent form.

Exclusion Criteria:

* Subject is younger than 18 years
* Subject is unable to provide written informed consent
* Subject is incarcerated at the time of the study
* Subject is pregnant
* Subject is currently enrolled in a distinct study that might confound the results of the proposed study
* Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks
Adjuvant Acupuncture Care for Breast Cancer Patients Experiencing Side Effects From Chemotherapy

Breast cancer patients report many symptoms while undergoing conventional care, including nausea/vomiting, fatigue, pain, depression and anxiety. Existing interventions to address these common side effects of treatment are limited. Patients diagnosed with cancer frequently seek complementary medicine (CAM), and there is a need to investigate potential effects of CAM therapies. This phased pilot and feasibility study has two aims:

1. Develop an acupuncture treatment protocol for adjuvant acupuncture care for breast cancer patients undergoing chemotherapy using structured interviews with established acupuncture teams in Norway.
2. Implement the treatment protocol in a pilot study to evaluate outcome measures, effect sizes and acceptability of acupuncture care delivered alongside conventional care.

Study results will support the design of future research; including a Phase III randomised controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Females, 18 years or older with early stage breast cancer, no previous chemotherapy and no metastatic disease

Exclusion Criteria:

* Needle phobia, use of anticoagulant drugs, inability to comply with study regimen