cyrilzakka/clinical-trials huggingface dataset:
New Fabric Attenuation Device in Endovascular Interventional Radiology II (PREFER II)

The PREFER II trial primary objective of the trial is to show how much radiation attenuation is provided by XPF thyroid collars in absolute and relative terms.

The PREFER II trial has three main objectives. The primary objective of the trial is to show how much radiation attenuation is provided by XPF thyroid collars in absolute and relative terms. The secondary objective of the study is to measure and compare the amount of radiation that interventional radiologists are exposed to per case in an interventional suite setting using FDA approved XPF thyroid collars or standard 0.5 mm Pb equivalent thyroid collars.

The third objective is to assess the operator comfort wearing the XPF protection devices. In order to achieve these objectives, measurements will be performed in 150 consecutive interventional procedures requiring C-arm fluoroscopy performed at BCVI. A prospective randomization will be performed, assigning participants to wear their own standard 0.5 mm Pb equivalent thyroid collar or to wear the FDA approved XPF thyroid collar. Radiation exposure will be monitored with 2 radiation detectors (TLDs, one inside and one outside the thyroid collar) which the participant is required to wear. After each procedure the participant will be asked to rate the comfort of wearing the devices on a scale from 1 to 100.

Eligibility Criteria:
Inclusion Criteria:

* Interventional Radiologists practicing in Baptist Cardiac \& Vascular Institute
* consecutive endovascular procedure requiring C-arm fluoroscopy

Exclusion Criteria:

* Interventional Neuroradiologists and Interventional Cardiologists will not be included in this study.
The Role of Clamping Before Removal of a Pneumothorax Drain Connected to a Digital Drainage System.

The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial. In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed. Primary outcome measure: recurrent pneumothorax after chest tube removal requiring chest tube reinsertion

Determining and timing of chest tube removal has been a continuous topic of debate amongst both surgeons and pulmonologist. It is plausible that provocative clamping tests are no longer necessary when a digital continuous recording drainage device is used that demonstrates the absence of (intermittent) air leak. However, clamping trials are still performed in clinical care, it is an expert opinion's policy prompted by fear of recurrent pneumothorax and no comparative studies exist. We hypothesize that chest tube removal exclusively based on digital drainage system data is as safe as adding a clamping test before removal in patients treated for pneumothorax or after lung surgery.

The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial. In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Digital chest tube drainage system
* Pneumothorax (primary, secondary, pulmonary surgery)

Exclusion Criteria:

* Pleural effusion as primary indication for chest tube placement.
* Empyema
* Suspected chest tube malfunction (e.g., leaking, occlusion, malposition)
* Intubated during chest tube removal
Effect of Preksha Meditation on Cognitive Abilities and Pulmonary Function in Students

The goal of this project is to assess impact of an 8 week course of Preksha Meditation (combination of Green color and buzzing sound meditation), in a group of college students to assess potential benefits to their pulmonary function, cognitive ability (immediate recall, attention), and happiness.

Preksha Meditation Research: The goal of this project is to assess impact of an 8 week course of Preksha Meditation (combination of Green color and buzzing sound meditation), in a group of college students to assess potential benefits to their pulmonary function, cognitive ability (immediate recall, attention), and happiness. The investigators will compare the data received from prior study to analyze their performance before and after. The investigators will also compare this data with control group data, to assess potential improvements as a benchmark. Analyse the EEG data to investigate its impact on brain. Further analyze their blood cells if they show any epigenetic changes. Data analysis team will be blinded for no identifiers are available.

METHOD AND PROCEDURES:

The data analysis will be undertaken by experts and will be blinded. The data currently is only de-identified.

The data which is already collected from the research "Effect of Preksha Meditation (Green color and Buzzing Meditation) on Cognitive Abilities and Pulmonary Function in Students with a Control Group" will be analyzed. The data is related to students having practiced minimum 3 guided 25 minute sessions per week in a controlled environment. The control group did not meditate for those weeks when they enrolled in the program.

The intervention the subjects received was as follows:

Experimental group 3 days per week Sessions: 5 minutes: Relaxation and Review of Meditation Practices 10 minutes: Mahapraan Meditation 10 minutes: Green color meditation Begin in stages

* 0 - 2 Weeks: Teach technique and carry out 15 minutes meditation sessions.
* 2 - 9 Weeks: Increment meditation sessions to a length of 25 minutes. 5 minutes: Review of meditation experience and collection of information

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* No prior experience in meditation

Exclusion Criteria:

* Prior experience with meditation.

  * health issues.
  * Alcohol
  * Smoking.
SHR-1701 in Combination With Chemotherapy and Radiotherapy in Locally Advanced Rectal Cancer

This study will evaluate the efficacy and safety of SHR-1701 combined with radiotherapy and chemotherapy as perioperative treatment for locally advanced rectal cancer. Eligible patients will receive standard chemoradiation with SHR-1701 followed by XELOX combined with SHR-1701. In all subjects, restaging pelvic MRI with chest and abdominal CT will be performed after completion of neoadjuvant treatment to determine resectability and to rule out any evidence of metastases. Subjects who have resectable disease will undergo surgery. Adjuvant XELOX combined with SHR-1701 will be given after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Be willing and able to provide written informed consent for the trial.
2. Locally advanced rectal adenocarcinoma and was evaluated as resectable ;
3. The inferior margin of the tumor ≤ 10 cm from the anal verge ;
4. No prior anti-cancer treatment for rectal cancer;
5. Estern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1;
6. Adequate hematologic and end-organ function;
7. Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug

Exclusion Criteria:

1. Unresectable disease determined by investigators
2. Recurrent rectal cancer
3. Evidence of metastatic disease or lateral lymph node metastases
4. Presence of synchronous colorectal cancer
5. Presence of obstruction or imminent obstruction
6. Not eligible for long-course radiotherapy
7. Severe cardiovascular and cerebrovascular diseases;Have clinical heart symptoms or diseases that are not well controlled
8. Prior malignancy within the prior 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical/breast cancer.
Evaluating Instrumentation for Dental Devices Used in Treating Sleep Apnea

Oral appliances are an accepted means to treat obstructive sleep apnea. We propose to develop monitoring sensors that could be inserted into commercially available oral appliances in order to monitor effectiveness of the oral appliances in treating sleep apnea.

Oral appliances are an accepted means to treat obstructive sleep apnea. In order to determine if they are effective, a polysomnogram needs to be conducted with the oral appliance in place. We propose to develop monitoring sensors that could be inserted into commercially available oral appliances in order to monitor effectiveness of the oral appliances in treating sleep apnea. We propose to look at heart rate variability as a marker for ongoing sleep apnea. We will use temperature as means of detecting how long the device is in the mouth as a means of assessing adherence.

The objective of the Phase I project is to validate this hypothesis by answering five questions:

* What is the optimal sensor suite? We will determine the optimal suite of sensors that provides adequate sensitivity and specificity to determine OA usage and effectiveness without compromising patient comfort.
* Can we develop designs that are compatible with the most popular OAs? We will design and develop prototype versions of the OAMS that are compatible with three of the most popular commercially available OAMS products (potential candidates include EMA, TAP, SomnoDent, Herbst, Suad).
* Do experienced dental care providers who specialize in OAs approve of the designs? We will collaborate with dental care clinicians to iteratively refine the OAMS design for maximum performance and patient comfort.
* Does the OAMS provide data that are consistent with PSG instrumentation? We will collaborate with the Dartmouth-Hitchcock Medical Center (DHMC) Sleep Disorders Laboratory to assess OAMS sensor accuracy for approximately five healthy volunteers by comparing OSA-related OAMS data with data from standard PSG instrumentation.
* Can we formulate a cogent Human Subject Testing plan for Phase II? We will develop a detailed HST study plan to be conducted in Phase II to demonstrate fully integrated and functional OAMS in a broad range of OSA patients who are candidates for an OA.

Eligibility Criteria:
Inclusion Criteria:

* Ages 21-65
* Diagnosed with obstructive sleep apnea actively treated with an oral appliance or interested in transitioning to an oral appliance
* Ability to give informed consent

Exclusion Criteria:

* Significant physical illness that might impair the ability to participate
* Pregnant women will be excluded
* Subjects presently taking medication such as beta blockers or alpha agonists know to alter the autonomic nervous system
The Effects of Intrauterine Interventions During Placenta Removal on Pain, Perception of Traumatic Birth, and Early Postpartum Health Indicators in Women

A prospective cohort study was conducted with 64 women who had vaginal deliveries at Adana City Training and Research Hospital between October 2023 and May 2024. Women who received intrauterine interventions during the third stage of labor formed the case group (n=32), and those who did not formed the control group (n=32). Data were collected using the Pregnant Information Form, Labor Observation Form, Early Postpartum Period Follow-up Form, Visual Analog Scale (VAS), and Traumatic Birth Perception Scale (TBPS). Findings were determined through regular monitoring and follow-ups during the first 24 hours postpartum.


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria required participants to be 18 years or older, to have delivered at term (38-40 weeks), to have had a vaginal delivery, and to have a singleton pregnancy. Additionally, participants must not have been using analgesic medications, must not have had hypertension or preeclampsia, and must not have experienced atony in a previous pregnancy. Participants also needed to be free from infections, placental anomalies, genital lesions, or coagulation disorders, and they had to agree to participate in the study

Exclusion Criteria:

Exclusion criteria included women who experienced a difficult labor or whose delivery involved the use of forceps or vacuum assistance.
Th Effects of Aubagio on Brain Pathology in Multiple Sclerosis Studied Over 12 Months

This study will evaluate the effects of Aubagio on changes in the brain using MRI.

Patients who take Aubagio will have an MRI, eye test, have blood taken, and complete a questionnaire on environmental risk factors to evaluate changes in the brain and on disease progression. A healthy control group will also complete the same testing regimen.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18-65
* Clinically definite MS according to the Polman criteria, 52
* Relapsing MS or Healthy Control (no neurological disorders)
* Expanded Disability Status Scale (EDSS) scores ≤5.5
* Disease duration \<30 years
* Normal kidney function (creatinine clearance \>59 mL/min) (patients only)
* Signed informed consent
* None of the exclusion criteria

Exclusion Criteria:

* MS patients with hepatic impairment
* Nursing mothers or pregnant women who will need to undergo 12 months follow-up
* Women of childbearing potential not using reliable contraception
* Patients currently treated with leflunomide
* Serum alanine aminotransferase (ALT) \>1.5 times the upper limit of normal
* A clinically significant infectious or neurological (for HC only) illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to treatment assignment
* Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol
* Any other reasons that, in the opinion of the Investigator, indicate that the subject is unsuitable for enrollment into this study
* Other pathology related to MRI abnormalities
Efficacy of Atorvastatin in Chronic Subdural Haematoma

This prospective, double-blind, randomized, placebo-controlled study aims to evaluate the efficacy and safety of atorvastatin in patients with chronic subdural haematoma. The degree of disability or dependence in daily activities, as well as surgical intervention or recurrence, of the treatment and control groups will be compared.

Objectives: Chronic subdural haematoma (CSDH) is a common neurosurgical condition in the elderly population associated with mild head injury. Surgical drainage has been regarded as safe and effective. However, surgical complications including recurrences can result in poor functional outcome and fatality, particularly in the elderly patients. Atorvastatin, an HMGCoA reductase inhibitor and a widely prescribed lipid lowering medication has properties of inflammation modulation and neovasculature promotion.

Hypothesis: Atorvastatin can improve functional outcome in patients with CSDH for both initially non-operatively treated group (estimated to be 10%) and the operative group (90%) by reducing the rate of surgical intervention and recurrence rate.

Design: A prospective multicentre study of 690 consented patients with symptomatic CSDH will be randomised on the day of admission to receive atorvastatin 20 mg or a placebo daily for 8 weeks. All seven regional neurosurgical units in Hong Kong and two units outside Hong Kong, each treating 80-200 patients per annum, have been invited to participate.

Main Outcome Measures: Primary outcome: Modified Rankin Scale (mRS). Secondary outcome: surgical recurrence.

Sample Size: Assuming an absolute 10% improvement in favourable outcome in the Modified Rankin Scale score (mRS 0-3) at 6 months from the control group of 70% to the treatment group 80%, allowing a 10% loss to follow up, a sample size of 690 is required.

Expected Results: A successful study for improving clinical outcome of CSDH, an important illness of the elderly with an annual incidence of 58/100,000 will change clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years old;
2. Evidence of supratentorial chronic subdural haematoma (unilateral or bilateral) by Computed Tomography (CT);
3. Patients are joining the trial voluntarily with consent form signed.

Exclusion Criteria:

1. Allergy to atorvastatin or other statins;
2. Deranged liver function;
3. Patients who are already on long term steroid for other condition(s);
4. Patients who are already on statin for other condition(s);
5. Presence of cerebrospinal fluid diversion device (e.g. ventriculo-peritoneal shunt);
6. Pregnant or on breast feeding;
7. Hematoma is secondary to tumour or haematological disorders;
8. Patients taking angiotensin converting enzyme (ACE) inhibitor.
Brain Slice Explants to Predict Drug Response in Brain Tumors

This biospecimen collection study will evaluate the feasibility of engrafting and testing resected Central nervous system (CNS) tumors tumor tissue ex vivo to estimate drug response, in pediatric and adult subjects. CNS tumors display remarkable heterogeneity and unfortunately there are no reliable precision oncology platforms that can identify the most effective therapy for each patient. Recent work has demonstrated the success of functional precision oncology platforms using patient-derived explant (PDE) at predicting drug response in various cancers. Since PDEs maintain important aspects of tumor heterogeneity they may prove effective as functional models for CNS tumors. The purpose of this study is to explore the feasibility of using a novel PDE platform to generate drug sensitivity scores from patients with central nervous system tumors in Pediatric and adult subjects having low- or high-grade CNS tumors resected. The secondary objective is to estimate the proportion of successfully scaled PDEs generated per given tumor size.


Eligibility Criteria:
In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

1. Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information or written assent and parental consent for pediatric subjects or surrogate consent provided by the subject's legally authorized guardians.
2. A diagnosis of a tumor residing in the central nervous system with surgery plan to have surgical resection.
3. The subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designer.

Exclusion Criteria:

1. All subjects must not meet any of the following exclusion criteria prior to enrollment to participate in this study:

   Any serious medical or psychiatric disorder that would interfere with the subject's ability to give informed consent.
2. Incarcerated individuals.
Effect of TEE-guided Non-fluid Limited Combined With Dobutamine on Hepatic Venous Blood Flow Spectrum

Patients meeting enrollment criteria will be randomized 1:1 to either the dobutamine or the control group. In the dobutamine group, 3\~6μg/kg/min dobutamine will be injected intravenously after anesthesia induction until hemostasis is completed. To ensure preload, transesophageal echocardiography (TEE) will be used to monitor left ventricular end-diastolic volume (LVEDV) and stroke volume (SV). In the control group, 3mL/h normal saline will be injected intravenously after anesthesia induction until hemostasis is completed, and the liquid will be restricted according to the currently commonly used principle of low central venous pressure(LCVP), nitroglycerin can be used if necessary.

Patients meeting enrollment criteria will be randomized 1:1 to either the dobutamine or the control group.

Dobutamine group: 3\~6μg/kg/min dobutamine will be injected intravenously after anesthesia induction until hemostasis is completed. The dose of dobutamine will be increased if the operating field grade exceeds Grade II. Monitoring LVEDV and SV with TEE to ensure preload: after admission, the patient will be given 3-4 mL /kg/h equilibrium fluid as background infusion. LVEDV and SV will be monitored using TEE every 30 minutes after anesthesia induction. If LVEDV\<75mL or SV\<45mL, 200mL colloidal fluid will be given within 5min.

Control group: 3mL/h normal saline will be injected intravenously after anesthesia induction until hemostasis is completed. According to the currently commonly used principle of LCVP, the fluid will be limited to 3-4 mL/kg/h after anesthesia induction. If the operating field grade exceeds Grade II, nitroglycerin will be injected intravenously for remedial purposes at a rate of 0.3-0.8μg/kg/min.

Dobutamine and nitroglycerin will be stopped after hemostasis, and the anesthesiologist will supplement the infusion according to his/her experience.

Eligibility Criteria:
Inclusion Criteria:

* undergo laparoscopic partial liver resection at West China Hospital from February 2024 to April 2024
* aged 18 to 65 years
* BMI\<30kg/m2
* liver function Child-pugh grade A to B
* American Society of Anesthesiologists（ASA）grade Ⅰto Ⅲ.

Exclusion Criteria:

* coronary heart disease
* heart valvular disease
* arrhythmia
* stroke history
* cirrhosis
* esophageal varices
* esophageal disease, stomach disease, previous esophageal or gastric surgery history
* chronic kidney disease
* coagulation dysfunction.
Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction

Hemiplegic shoulder pain (HSP) is a common and disabling complication following a stroke, and it may affect the quality of life. It often occurs following two to three months of stroke. Upper limb impairment is seen in 90% of patients affected by stroke.

Numerous causes have been implicated in developing HSP in stroke. This includes muscle flaccidity around the shoulder joint, shoulder subluxation, shoulder-hand syndrome, increased muscle tone, impingement syndrome, frozen shoulder, brachial plexus injury, and the thalamic syndrome.

Muscle paresis, abnormal muscle tone and loss of proprioception following stroke may render the shoulder complex unstable and therefore prone to misalignment.

In recent years, high-intensity laser therapy (HILT) has been considered as a treatment option for shoulder pain.

HILT increases microcirculation and tissue regeneration and lowers edema, inflammation, and pain with its photomechanical, thermal, electrical, and bio stimulating effects in deep tissues that cannot be reached with LILT.

It has some advantages over LILT, i.e., having higher power, greater tissue penetration capacity to deep tissues, the short emission time, and long rest periods preventing heat accumulation.

In recent studies, effectiveness of HILT has been shown in the treatment of subacromial impingement syndrome, rotator cuff tendinopathy, and frozen shoulder.


Eligibility Criteria:
Inclusion Criteria:

* DISORDER MORE THAN 6 MONTHS
* UNILATERAL
* FIRST TIME

Exclusion Criteria:

* Iinflammatory rheumatic disease,
* cervical radiculopathy,
* diabetes mellitus,
* thyroid disease,
* coronary heart disease,
* cardiac pacemaker,
* neurological disease,
* shoulder surgery, and
* shoulder injection in the last 3 months