cyrilzakka/clinical-trials huggingface dataset:
The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial- Stage I

Stage I of the Thoracic-POISE study will pilot-test a broad-based, multi-agent integrative care intervention delivered by naturopathic doctors in conjunction with standard surgical and oncologic care of people with thoracic cancer.

Despite enormous advances in thoracic surgery and oncology, two critical issues concern patients undergoing curative-intent surgery for lung, gastric and esophageal cancer: first, a majority (\~60%) of patients experience minor and major adverse events occurring during and in the days following surgery; second, patients worry about the significant risk of cancer recurrence and mortality months to years after surgery. These issues, combined with side effects of chemotherapy and radiation, have detrimental effects on health-related quality of life (HRQoL). On a deeper level, there is the problem of an ongoing failure to integrate and evaluate the best of what complementary medicine has to offer surgical oncology care.

The Thoracic-POISE Project has the overarching goal of improving care for thoracic cancer patients by impacting HRQoL, reducing surgical adverse events, prolonging overall survival and pioneering integrative care delivery. This multi-stage project aims to design, pilot-test and evaluate a broad-based, multi-agent, evidence-based integrative care program to be delivered by naturopathic doctors (ND) in conjunction with standard surgical and oncologic care. It is hypothesized that this integrative care program will improve HRQoL as well as reduce surgical adverse events and improve cancer survival. Stage I of the project will pilot-test the intervention and outcomes collection in a single-arm, feasibility study.

Eligibility Criteria:
Inclusion Criteria:

* Adults eligible and scheduled for major thoracic surgery for lung, gastric or esophageal cancer
* Candidate for complete resection
* Willingness to include an integrative component to their care
* Availability for follow-up visits over the course of one year
* Willingness to be interviewed regarding their experience of care
* Ability to answer self- and interviewer- administered questions in English or French
* Understand and sign a written informed consent form in English or French

Exclusion Criteria:

* Small cell, carcinoid, or gastrointestinal stromal (GIST) tumours
* History of cancer in the last 3 years
* Already seeing a ND or involved in an integrative program of care in the last 3 months that includes complementary medicine
the 95% Effective Dose of Ciprofol for Adjunctive Sedation Undergoing Knee Arthroplasty in Elderly People

Regional anesthesia is a common clinical anesthesia method, and regional anesthesia-assisted sedation play a central role in promoting patient comfort and relieving anxiety. With increasing age, elderly people experience changes in pharmacokinetics and pharmacodynamics and increased drug sensitivity. Ciprofol has advantages in adverse events such as hypotension and respiratory depression. There are fewer studies on the recommended dosage of ciprofol-assisted sedation for intrathecal anesthesia in elderly patients. The aim of study is to identify the 95% effective dose of ciprofol-assisted sedation in elderly patients undergoing spinal anesthesia using a biased coin design up-and-down sequential method(BCD-UDM)

Select the patients who will receive knee arthroplasty in the Second Hospital of Shanxi Medical University. The patients will receive a loading dosage of 0.05mg/kg of ciprofol to begin sedation following the completion of intravertebral anesthesia, and the maintenance dose is calculated using a biased coin design up-and-down sequential method. Based on the relevant literature and pilot study, 0.2 mg·kg-1·h-1 is selected as initial test dose with a dose gradient of 0.02 mg·kg-1·h-1. The Modified Alertness Sedation Score (MOAA/S ) scores and the bispectral index (BIS) were recorded for patients before administration (T0), 5 min after administration (T1), 10 min after administration (T2), 20 min after administration (T3), 30 min after administration (T4), 45 min after administration (T5), and 60min after administration (T6). If the first patient had ≥ 4 time points with MOAA/A score ≤3 from T0-T6, the sedation was regarded as satisfactory, the dose of next patient is randomly assigned to the next lower dose with 5% probability, or to the same dose with 95% probability; If the previous patient was not satisfactorily sedated, the next patient's infusion dose was increased by 0.02 mg·kg-1·h-1. When the number of satisfied cases of sedation reaches 45, the trial is terminated. At the same time, the change of vital signs and adverse reactions before and after administration were recorded

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* ASA grade I\~III
* BMI 18\~28 kg/m2

Exclusion Criteria:

* Contraindications to intrathecal anesthesia
* Suffering from severe psychiatric or neurologic disorders or taking sedative drugs within the last 3 months
* Difficult airway or having respiratory diseases such as upper airway obstruction
* Severe cardiovascular system diseases
* Severe hepatic or renal dysfunction
* Allergy or contraindication to propofol and its drug-related components
* Patient Prefusal
Interscanner Variation in Musculoskeletal Computed Tomography (CT) Measures

Maintaining strong muscles is important for the independence and quality of life in our older population. Strong muscles provide mobility and reduce the chance of falls that lead to injury. Many researchers are carrying out studies to examine different types of exercise and drug treatments to prevent loss of muscle strength in older people. Often, these research studies use x-ray computed tomography (CT) scans to measure the size and the amount of fat in different muscles. These factors are known to reflect muscle health. Large studies can involve many research subjects recruited at many different clinics with different CT scanners. To ensure that these studies provide reliable results, the investigators must have procedures to make sure that different CT scanners measure the same results for the same amount of fat or muscle. The goal of our study is to develop these procedures. In this project, the investigators will study women because they have the highest risk of bone fractures resulting from falls. Thus, the subjects are being asked to volunteer for a study where the subjects will be scanned on different scanners.


Eligibility Criteria:
Inclusion Criteria:

* age 60-70 years old
* healthy

Exclusion Criteria:

* no history of spine surgery
* no history of hip implantation or replacement
* no scoliosis or other spine deformity
* not using walking canes or wheelchair
Effectiveness of Saline Water and Lidocaine Injections for the Treatment of Intractable Plantar Keratoma

An intractable plantar keratoma (IPK) is a conical thickening of the epidermis' stratum corneum and a common cause of foot pain which can have a significant, detrimental impact on the mobility, quality of life and independence of individuals. Conservative treatments are currently offered to patients with IPK, but they are unsatisfactory since they do not offer a sufficient or permanent reduction of symptoms. The purpose of this study was the evaluation of the feasibility, safety and effectiveness of innovative treatments for intractable plantar keratoma (IPK)


Eligibility Criteria:
Inclusion Criteria:

• Having a painful IPK for at least 3 months

Exclusion Criteria:

* Ongoing pregnancy or breastfeeding
* Severe cardiovascular or neurological disease
* Immunosuppressed status
* Presence of a plantar ulcer
* Allergy to lidocaine
* History of keloid or hypertrophic scar
* Simultaneous painful plantar syndrome unrelated to the presence of an IPK
A Study in Healthy Men to Test How BI 1291583 is Processed in the Body

The main objective of this trial is to

* Assess the mass balance and total recovery of \[14C\]-radioactivity in urine and faeces following a dose of BI 1291583 (C-14)
* Provide plasma and urine samples for pharmacokinetic investigations
* Provide plasma, urine, and faeces samples for metabolic profiling and structural identification of metabolites


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kilogram per square meter (kg/m2, inclusive)
* Signed and dated written informed consent in accordance with International Council for Harmonization - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
Efficacy and Safety of keepMED Positive Airway Pressure Device in Patients With Obstructive Sleep Apnea

A prospective, multi-centre, single-arm, open-label, interventional study with a non-marketed medical device.

The primary study objective is to assess the efficacy of the keepMED PAP device on modification of respiratory characteristics in patients with OSA at one therapy night in a sleep lab.

Secondarily, the safety of the use of the device in this setting is assessed.

The study includes a baseline visit, a habituation night, and a therapy night. Both nights will be undertaken in the sleep lab under identical conditions and will include the keepMED PAP therapy activated in parallel to polysomnography (PSG).

Baseline diagnostic PSG, performed within one month prior to enrollment to the study, will be used to assess the device efficacy.

An interim analysis to re-estimate the sample size will be performed after availability of data of 50% enrolled and treated study patients. The sample size will be re-estimated based on the observed changes of AHI in the interim analysis.

Eligibility Criteria:
Inclusion Criteria:

Age ≥18 years.

Newly diagnosed OSA with AHI ≥ 15 events/hours.

Indication for OSA PAP therapy in routine clinical care according to applicable medical guidelines within one month prior to study enrolment.

Naïve to PAP therapy, i.e. even no PAP therapy during a PSG night.

Weight \> 30kg.

Signed informed consent.

Exclusion Criteria:

Body Mass Index (BMI) of ≤20 kg/m² or ≥ 35 kg/m².

Pathologically low blood pressure (systolic ≤90mm Hg; diastolic ≤60 mm Hg).

Current unstable or serious medical conditions (such as angina pectoris, myocardial infarction, cancer, stroke, dementia, congestive heart failure) which based on the physician's judgment might put the patient at high risk.

Mixed and central apnea index ≥ 5 events/hour in PSG without PAP therapy.

Bullous lung disease.

Tracheostomy.

Pneumothorax.

Pneumocephalus.

Cerebrospinal fluid leak.

Current sinus or middle ear infection.

Persistent blockage of one or both nostrils (including nasal septum deviation and nasal polyps) or any other reason that leads to difficulty of breathing through the nose while awake.

Any nasal, facial or head abnormalities that would not allow adequate placement of the device.

Previous diagnosis of insomnia, narcolepsy or periodic limb movement disorder that in the judgment of the clinician could affect sleep quality assessment.

Chronic respiratory disease (COPD, pulmonary fibrosis or asthma) or FEV/FVC ≤ 60% in history.

History of respiratory failure.

Supplemental oxygen is required.

Uvulopalatopharyngoplasty or other surgical procedure to correct apnea.

Acute respiratory infection.

Subject recovered from Covid-19 but suffers from on-going symptoms or when subject's Covid-19 illness history can affect the study outcome based on the physician's judgment.

Pregnancy.

Medication that may alter sleep architecture.
Creating Peace: Community-based Youth Violence Prevention to Address Racism and Discrimination

This cluster-randomized community-partnered study will examine the effectiveness of a trauma-sensitive, gender transformative youth violence prevention program called Creating Peace that integrates racism and discrimination prevention with youth ages 14-19.

This community-partnered cluster-randomized controlled trial will examine the effectiveness of a trauma-sensitive, gender-transformative youth violence prevention program that integrates racism and discrimination prevention.

Set in 24 neighborhoods in Pittsburgh, Pennsylvania with concentrated social and economic disadvantage, this study addresses gender and racial injustice through a series of group discussions, bringing together adolescents ages 14-19 with law enforcement officers in a process of social restoration.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be ages 14-19 (inclusive)
* Participants must speak English

Exclusion Criteria:

* Not ages 14-19 (inclusive)
* Do not speak English
Evaluation of AVANCE Fathers in Action/Padres Activos Fatherhood Program

The Child and Family Research Partnership (CFRP) will be conducting the "local" evaluation of AVANCE's Fathers in Action/Padres Activos (FA/PA) fatherhood program. AVANCE is a non-profit organization that has served low-income families and children since its founding in 1973. AVANCE sites have been providing fatherhood services for some time, but the programming offered has varied across sites and no rigorous evaluation of the programs has been completed. Through a federally-funded Responsible Fatherhood grant, AVANCE aims to create one fatherhood curriculum to be used across their sites: Fathers in Action/Padres Activos (FA/PA).

The purpose of the study is to advance the field of knowledge in the area of fatherhood programing by providing rigorous evidence on the impact of a comprehensive fatherhood program on enhancing a father's ability to be involved with and parent his child, in addition to providing more information on the selective characteristics of fathers who choose to participate in fatherhood programs. The study will seek to answer the following research questions: (1) What are the demographic and relationship characteristics of fathers who choose to participate in the Fathers in Action/Padres Actívos (FA/PA) program, and how do these characteristics compare to the fathers associated with mothers and children in other AVANCE programs?; (2) Does the FA/PA program positively impact parenting and co-parenting, father engagement and involvement, and healthy relationship?; (3) Are the program impacts similar for low-income fathers across regions (Houston v. the Rio Grande Valley), race/ethnicity (African American v. Hispanic), and coresidential status (nonresident v. resident)?; and (4) What are the factors that enhance or impede the successful implementation of the FA/PA program?


Eligibility Criteria:
Inclusion Criteria:

* Fathers (biological, adoptive, or social) over 18 years of age
* Able to travel to program location to attend classes

Exclusion Criteria:

* Under 18 years of age
* Female
Magnetic Resonance Imaging-guided Adaptive Radiotherapy for Large Brain Metastases

This study is an ambispective cohort study to evaluate the displacement and deformation of large brain metastases (BM) treated with magnetic resonance imaging-guided adaptive radiotherapy (MRIgART)

All patients had a pathologically confirmed malignant cancer and were diagnosed with brain metastases (BM) by enhanced magnetic resonance imaging (MRI) with BM volume of 2cm and above. All patients received Unity MR-linac adaptive radiotherapy. Gross tumor volume (GTV) and organs at risk (OARs) were re-delineated for every image set and analyzed for displacement and deformation.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years; KPS score ≥ 60.
2. pathologically confirmed lung cancer.
3. diagnosed with brain metastases by enhanced MRI.
4. BM volume ≥ 2cm.
5. Anticipated time to survival\>3 months.
6. Treated with Unity MR-linac.
7. Good compliance; Able to stay still in supine position for 45 minutes and above.

Exclusion Criteria:

1. Fail to complete radiotherapy as planned; Anticipated time to survival less than 3 months.
2. Suffer from severe back pain in supine position, unable to receive Unity MR-linac.
3. Suffer from severe claustrophobia.
4. Incomplete pre-Unity image data.
Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

Eligibility Criteria:
Identify inclusion criteria

1. Histologically confirmed invasive and/or in situ carcinoma of the breast
2. Any race and ethnicity
3. Females 18-70 years of age
4. Willing and able to provide informed consent
5. Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment or procedure between the CEDM and CE-MRI

Identify exclusion criteria

1. Unwilling or unable to undergo informed consent
2. Planned to undergo neoadjuvant chemotherapy
3. Breast implants
4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be performed for confirmation.)
5. Breast-feeding
6. Surgical excision of the biopsy proven malignancy
7. Known allergy to gadolinium contrast agents
8. Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other ferromagnetic surgical implant or severe claustrophobia)
9. Suspected to be at risk to complications from the contrast agent. These include the standard iodinated contrast agent contraindications:

   1. Subject has renal insufficiency as determined by an elevated serum creatinine and is not being treated with dialysis.
   2. Documentation of a normal eGFR (MDRD) within the previous 2 months will be required for any subject with any of the following risk factors for renal insufficiency:

   i. Age \> 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c. Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or severe asthma regularly treated with medication f. Subject has had an episode of serious allergic reaction (anaphylaxis) to any substance
Clinical Assessment of Chitosan Nanoparticles on Periodontal Problems Post Steroidal Inhalation in Asthmatic Patients: Phase I Trial

Periodontal problems management is the most important goals of chronic asthmatic patients that adapted to use steroid inhalation for long time. Gram negative anaerobic bacteria are generally suggested as the primary cause of Periodontal problems and mechanical procedure is the treatment approach, which is performed nonsurgical or surgically. The understanding of the role of bacteria in the initiation and progression of periodontal disease has led to great interest in the use of antibiotics to suppress or eradicate pathogenic macrobiotic. Systemic antibiotics have been used in different forms of periodontal disease treatment. Systemic antibiotics can penetrate soft tissues and may target invasive organisms, can be used to treat multiple sites simultaneously, and may also affect reservoirs of bacterial reinfection such as saliva, the tonsils, and the oral mucosa. However, there may be problems associated with the use of systemic antibiotics such as the development of resistant bacteria, and potential side effects (hypersensitivity reactions, gastrointestinal discomfort, etc.). so in this study we aimed at To evaluate the effect of chitosan nanoparticle spray in management of dental problems in asthmatic patients receiving corticosteroids inhaler that support the growth of bacteria in periodontal area.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18-50 years old
* Both sex male and female
* Patients diagnosed as Asthmatic
* Patients treated with corticosteroids inhaler or ( beta2-adrenergic agonist inhaler or nebulizer for their symptoms)

Exclusion Criteria:

* Patients treated with other medication
* Patients not diagnosed as asthmatic
* Comorbidity
rTMS Pilot for Anxiety

The purpose of this study is to evaluate the safety and tolerability of 1 Hz parietal stimulation in anxiety. Our approach will be to administer 1 week of open-label accelerated 1 Hz parietal rTMS (5 days, 8 sessions/day, 600 pulses/session) and measure the effect of this neuromodulation on APS, and short term memory in a cohort of anxiety GAD patients.

Aims 1 and 2 of this project will be tested using a within-subjects design where anxiety patients will receive a 5-day course of accelerated 1 Hz rTMS (8x session x 600 pulses/session) to the right IPS. In Aim 1, we will test the effects of this stimulation on arousal during the NPU threat task (NPU section). In Aim 2 below, we will test the effects of this stimulation on arousal-related attention control deficits using the VSTM task (VSTM section).

Subjects will undergo 7 study visits spaced over a roughly 3-week period depending upon availability. First, subjects will have a pre-stimulation test visit. On this visit they will undergo the following procedures: 1) motor threshold testing, 2) noise habituation, 3) shock workup 4) NPU task, 5) VSTM task. Then they will have 5 rTMS visits. On these visits, subjects will receive 8 trains of 1 Hz rTMS (600 pulses per train, each separated by \~50 min). Finally, they will have a post-stimulation test visit, which will included the noise habituation, shock workup, NPU task, and VSTM task.

Eligibility Criteria:
Inclusion Criteria

* Meet the DSM-V criteria for an anxiety disorder (i.e. generalized anxiety disorder, social anxiety disorder, panic disorder, etc.)
* Subjects must be 18-50 years old
* Able to give their consent
* Right-handed

Exclusion Criteria

* Non-english speaking
* Any significant medical or neurological problems
* Current or past (non-anxiety) Axis I psychiatric disorder(s), active or history of active suicidal ideation
* Alcohol/drug problems in the past year or lifetime alcohol or drug dependence
* Any medical condition that increases risk for TMS
* History of seizure
* History of epilepsy
* Increased risk of seizure for any reason
* Pregnancy, or positive pregnancy test
* Hearing loss