cyrilzakka/clinical-trials huggingface dataset:
A Retrospective Multicenter Review to Evaluate the Performance of the Ion Endoluminal System in Sampling Pulmonary Lesions

This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system.

This study is a retrospective multi-center chart review of patients who underwent an attempted biopsy of one or more pulmonary lesion(s) with the Ion Endoluminal System with the aim of assessing the overall performance of the system. The primary objectives of the study will be performance (evaluated by diagnostic yield and sensitivity for malignancy) and safety (assessed by rate of pneumothoraces and bleeding events).

Eligibility Criteria:
Inclusion Criteria:

* Subject was 18 years or older at the time of the procedure
* Biopsy procedure attempted/performed using the Ion Endoluminal System

Exclusion Criteria:

* Biopsy procedure was not attempted with the Ion Endoluminal System
* Biopsy procedure attempted with the Ion Endoluminal System occurred less than 12 months prior to IRB approval
Optimize RV Selective Site Pacing Clinical Trial

The purpose of the Optimize RV study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed. The goal of select site pacing is to improve how the heart contracts when paced in the ventricle. By pacing in select sites, it is possible to better copy the natural pattern of contraction of the heart.


Eligibility Criteria:
Inclusion Criteria:

* Subjects that are expected to be paced in the right ventricle (RV) greater than 90 percent of the time
* Subjects with an ejection fraction of greater than 40 percent within 3 months prior to enrollment
* Subjects greater than 18 yrs of age
* Subjects that are indicated for a dual chamber pacemaker
* Subjects that will be implanted with a market released dual chamber Medtronic pacemaker and 3830 SelectSecure Lead in the ventricle

Exclusion Criteria:

* Subjects indicated for cardiac resynchronization therapy (CRT) device (based on American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines)
* Subjects indicated for an implantable cardiac defibrillator (ICD)
* Subjects with permanent atrial fibrillation (AF)
* Subjects with expected managed ventricular pacing turned on
* Subjects with a previously implanted pacemaker, ICD, or CRT device
* Subjects with an myocardial infarction (MI) within 3 months prior to enrollment
* Subjects that received bypass surgery within 3 months prior to enrollment
* Subjects that had valve replacement within 3 months prior to enrollment
* Subjects where a RV lead cannot be placed, (i.e., complex congenital heart disease
* Subjects with a mechanical right heart valve
* Women who are pregnant or nursing
* Significant co-morbidity preventing study completion
* Terminal conditions with a life expectancy of less than two years
* Participation in another study that would confound the results of this study
Prospective Multicenter Non-interventional Study in Patients With Knee or Hip Osteoarthritis Having a Theraflex Treatment

The main purpose of this study is to evaluate how a long-term treatment with Theraflex during 64 weeks affects pain intensity in the affected knee or hip joint, the activity in daily living, the quality of life and patient satisfaction with treatment.

Other information that is planned for evaluation in this study includes consumption of Theraflex, intake of analgesics for joint pain relief and description of basic patient characteristics such as age, weight and body mass index and others.

Eligibility Criteria:
Inclusion Criteria:

* Patients 45 to 75 years with Hip or Knee OA stage I to III
* Patient started current treatment with Theraflex not more than 2 weeks prior to inclusion into the study
* Personally signed and dated informed consent

Exclusion Criteria:

* Patients participating in an investigational program with interventions outside of routine clinical practice
* Patients with Hip or Knee OA stage 0 or stage IV
* Patients who have both Hip and Knee OA and OA of any other location
* Contraindications for use of Theraflex in accordance with approved label(known hypersensitivity, severe chronic renal failure)
* Females who are pregnant or breastfeeding
* Patients who completed a treatment with Theraflex or another combination of Gl+ Ch less than 5 months before start of the current treatment
* Patients who completed intra-articular corticosteroids treatment in the last 3 months to exclusion criteria
* Patients who completed hyaluronic injections of the lower limbs in the last 6 months
Brief Intervention for Socially Anxious College Drinkers

The purpose of this study is to develop and test a new brief intervention to reduce heavy drinking and social anxiety in college drinkers.

Episodic alcohol abuse is common among college students. Recently, brief interventions focusing on motivational strategies and behavior skills to reduce heavy drinking and alcohol-related problems have shown beneficial small to medium effects in college drinkers who reported heavy drinking and/or alcohol-related problems. Most interventions have not taken into account psychiatric comorbidity, in particular social anxiety, a frequent problem for college students that has been linked to excessive alcohol use. This project will extend knowledge on brief interventions by integrating cognitive-behavioral therapeutic strategies for social anxiety with an existing alcohol intervention designed for college students.

The efficacy of a new integrated treatment, the Brief Intervention for Socially Anxious Drinkers (BISAD) was developed and tested. All participants reported heavy alcohol use, alcohol-related problems and social anxiety based on standardized measures. Phase I of the study focused on the development of the treatment manuals and measures of therapy integrity for BISAD and an alcohol-focused intervention, a modified treatment-as-usual at the local university. During this phase therapists were trained to administer the manualized interventions to study participants (N=12). Phase II included further refinement of the therapy integrity measures and data collection for the pilot study (N=41). Participants were randomized to either BISAD (n=21) or a modified treatment-as-usual (n=20) condition. The pilot study provide preliminary data on the efficacy of the proposed intervention in reducing heavy drinking, social anxiety, and their negative consequences at 1-month and 4-month follow-ups after treatment termination. These data provide estimated effect sizes for future testing of BISAD in a full-scale clinical trial. Furthermore, the study results contribute to the conceptualization and methodological development of combined interventions for other substance use and psychiatric problems.

Eligibility Criteria:
Inclusion Criteria:

1. at least one heavy drinking episode (4 or more drinks for women and 5 or more for men)
2. occasional to frequent drinking related problems
3. moderate social anxiety symptoms

Exclusion Criteria:

1. history of schizophrenia, bipolar disorder, organic brain syndrome or mental retardation
2. current illicit substance dependence, severe alcohol dependence, anxiety disorders (except simple phobia), unipolar depression, major medical illness, pregnancy, suicidality, or homicidality
Decitabine in Treating Patients With Advanced Solid Tumors

This phase I trial is studying the side effects and best dose of decitabine in treating patients with advanced solid tumors that have not responded to previous treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of decitabine in patients with advanced solid tumors.

II. Determine the toxic effects of this drug in these patients. III. Determine the dose of this drug with biologic activity in these patients. IV. Determine the pharmacokinetics of this drug in these patients. V. Determine clinical response to this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive decitabine IV over 30 minutes on days 1-5 weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of decitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced metastatic solid tumor for which all standard therapy has failed, including, but not limited to the following:

  * Stage III or IV melanoma

    * Mucosal melanoma allowed
    * No resectable stage III melanoma
  * Bladder cancer
  * Breast cancer
* No active symptomatic CNS disease
* No radiographically evident cerebral edema
* Hormone receptor status:

  * Not specified
* Male or female
* Performance status - ECOG 0-1
* Hemoglobin at least 9.0 g/dL
* Platelet count at least 100,000/mm\^3
* WBC at least 3,500/mm\^3
* Absolute granulocyte count at least 1,500/mm\^3
* No coagulation disorders
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT and SGPT less than 2.5 times ULN
* Hepatitis B surface antigen negative
* Hepatitis C antibody negative
* Creatinine no greater than 1.5 times ULN
* No major cardiovascular system illness
* No major respiratory system illness
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No major systemic infection
* At least 1 month since prior radiotherapy
* At least 1 month since any prior anticancer therapy or adjuvant therapy
* No other experimental treatment within 30 days prior to, during, and for 30 days after study therapy
A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris

A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne Vulgaris (Study FX2017-22)

This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy over 12 weeks of FMX101 topical foam containing 4% minocycline compared to vehicle in the treatment of subjects with moderate-to-severe facial acne vulgaris. Qualified subjects will be randomized to receive 1 of the following 2 treatments:

* FMX101 4% minocycline foam
* Vehicle foam

Eligibility Criteria:
Inclusion Criteria:

1. Has facial acne vulgaris with:

   1. 20 to 50 inflammatory lesions (papules, pustules, and nodules)
   2. 25 to 100 non-inflammatory lesions (open and closed comedones)
   3. No more than 2 nodules on the face
   4. IGA score of moderate (3) to severe (4)
2. Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study.

Exclusion Criteria:

1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
2. Sunburn on the face.
REal World Assessment for Patients Implanted With Implantable CardioverTer DefibrIllatOr Using Bluetooth Technology

The objective of this observational study is to assess clinical benefits of innovative features (e.g. Bluetooth technology and smartphone patient applications) in a patient population that is implanted with standard indication for implantable cardiac defibrillator.

REACTION is an observational study in which patients will be followed as for clinical practice and no specific study tests/procedures will be perfprmed. After implanting a device, the patient will be assigned to an arm or to the other based on the technology of the device (bluetooth or RF) he/she wears, if he/she gives the consent to partecipate. It is not a randomized study. Patients will be enrolled consecutively until reaching the sample defined for both the arms.

Eligibility Criteria:
Inclusion Criteria:

* All patients implanted with an ICD as for standard indications
* Over 18 years of age
* Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations

Exclusion Criteria:

* Subject who is, or is expected to be inaccessible for follow-up
* pregnancy
Prevalence of Pelvic Floor Dysfunctions in Female Badminton Athletes and Sedentary

The objective of the study is to know the prevalence of pelvic floor dysfunctions in female badminton athletes compared to sedentary women, and the hypothesis is that the prevalence of pelvic floor dysfunctions is going to be higher in female badminton athletes.

After being informed about the study, all participants giving written informed consent will complete the personal data questionnaire and the questionnaires validated to Spanish population "International Consultation on Incontinence Questionnaire-Short Form" (ICIQ-SF), "Pelvic Floor Distress Inventory Short Form" (PFDI-20), "Female Sexual Function Index" (FSFI) and the SF-12 questionnaire. After that, inclusion and exclusion criteria will be assessed, and participants will be allocated into cases and controls group. Both groups will undergo the same procedures. Firstly, the evaluation of stress urinary incontinence and pelvic organ prolapse signs will be performed by using the cough stress test and Pelvic Organ Prolapse Quantification System; and secondly, the evaluation of pelvic floor muscle strength by using manometry.

Eligibility Criteria:
Inclusion Criteria:

* Cases: women who practice recreational badminton and/or are federated and compete.
* Controls: sedentary women and/or do not meet the recommendations of the World Health Organization (150-300 minutes of moderate-intensity aerobic physical activity or 75-150 minutes of vigorous-intensity aerobic physical activity).

Exclusion Criteria:

* Connective tissue diseases (Ehlers-Danlos syndrome, Marfan syndrome or hypermobility syndrome).
* Pregnant at the time of the study.
* Give birth in the last 12 months.
* Not understanding Spanish language.
Empowering Families of Migrant Children and Youth with Special Healthcare Needs

The goal of this randomized controlled trial is to test if a patient navigator program improves healthcare experiences and outcomes for migrant families caring for a child or youth with special healthcare needs (i.e. chronic health condition).

The main questions are, for migrant families with a child or youth with special healthcare needs:

Does a patient navigator reduces barriers to care? Does a patient navigator improve care coordination, caregiver empowerment, caregiver stress and quality of life? What are the healthcare experiences for families with and without the patient navigator intervention?

Participants will:

* Receive the intervention, i.e., the patient navigator program, or continue with standard of care for 12 months
* Fill out questionnaires at 3 time points on barriers to care, caregiver stress, care coordination, and their child's health


Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver of child/youth ≤18 years who is first- or second-generation migrant, defined as born outside of Canada or having parents born elsewhere, respectively (migrants include immigrants, resettled refugees, refugee claimants (asylum seekers), temporary workers or international students, and other individuals without formal immigration status (undocumented)).
* Children or youth with special health care needs, as defined by the CYSHCN Screener, which identifies children who are experiencing one or more functional limitation or service use due to a physical, emotional, behavioural, developmental, or other health condition that has lasted or is expected to last at least 12 months.
* Experiencing care transitions between at least 2 of the following: primary care, community-based care, secondary specialist care, and/or hospital-based (acute) care.

Exclusion Criteria:

* Caregiver living in Canada ≥10 years
* Families who are receiving available peer navigation support at sites will be excluded to limit cross-over of interventions.
Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors

This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors.

A study of PEGylated recombinant human hyaluronidase (PEGPH20) administered on a twice weekly schedule for 28 days followed by a weekly dosing schedule in patients with advanced solid tumors who have either failed to respond to standard therapy or for whom no standard therapy exists.

Eligibility Criteria:
Inclusion Criteria:

* Written, signed, IRB-approved informed consent form.
* Pathologic (histologic or cytologic) confirmation of metastatic or locally advanced solid tumor.
* Patients must have a pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available or the patient refuses standard therapy.
* One or more tumors measurable by RECIST criteria.
* Karnofsky performance status ≥ 70%.
* Ejection fraction ≥ 50%, determined by echocardiogram.
* Life expectancy at least 3 months.
* Age ≥ 18 years.
* Acceptable organ function; normal hepatic, renal and hematopoietic function.
* Negative serum or urine pregnancy test result in women of childbearing potential.

Exclusion Criteria:

* Known brain metastasis.
* New York Heart Association Class III or IV cardiac disease, myocardial infarction within 6 months of enrollment, or cardiac arrhythmia requiring medical therapy.
* Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
* Patients with uncontrolled diabetes (requiring medication change within 30 days of screening), or requiring insulin therapy.
* Heparin therapy.
* Known infection with HIV, hepatitis B, or hepatitis C.
* Known allergy to hyaluronidase.
* Women currently breast feeding.
Pharmaceutical Consultation and Exchange Between the Pharmacy and the Hospital

Investigators hypothesize that the implementation of a hospital pharmacy consultation and the transmission of its report to pharmacies may improve knowledge, adherence and encourage the development of pharmacist medication reviews. A before-and-after study of the implementation of pharmaceutical consultations will allow the investigators to evaluate the validity of the hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient admitted in the endocrinology service for a type 2 Diabetes who has more than 5 concomitant treatments
* Adult patient that is being discharged for a return home
* Good comprehension of French

Exclusion Criteria:

* Bad comprehension of French
Mobilization With Movement Technique on the Stiffness of Cervical Muscles in Individuals With Mechanical Neck Pain

Mobilisation with movement (Mulligan Sustained Natural Apophyseal Glides (SNAG)). method has been shown to have significant effects on pain, joint range of motion, and functionality in patients with neck pain. However, there is a lack of studies examining the effects of this technique on muscle stiffness associated with neck pain. Considering the immediate effects of a single session of lumbar SNAG application on lumbar muscle stiffness in patients with low back pain, it raises curiosity about the effects it would have on cervical spinal segments and surrounding muscles. The aim of this study is to investigate the immediate effects of Mulligan SNAG application on muscle stiffness, pain, and joint range of motion in patients with mechanical neck pain.

This study is designed as a parallel double-blind randomized controlled trial. Patients will be divided into two groups: the Mobilization with Movement Group (MMG) and the Sham Group (SG). The MMG will receive cervical mobilization (SNAG) treatment. The SG, on the other hand, will receive active joint movements without the 'sliding' motion applied to the spinal segment. Prior to and immediately after the intervention, participants will undergo myometric evaluation of neck muscles, joint range of motion measurements, and pressure pain threshold measurements bilaterally, followed by assessment of the individual's pain and level of disability using questionnaires related to pain and pain-associated disability. A 2-minute break will be provided after the intervention before reassessment is conducted. Patients will not be followed up.

Eligibility Criteria:
Inclusion Criteria:

* Having widespread neck pain lasting more than 3 months
* Pain symptoms that increase with neck movements or palpation
* Volunteering to participate in the study

Exclusion Criteria:

* History of neck trauma
* Previous cervical surgery
* Cervical radiculopathy or myelopathy
* Fibromyalgia syndrome diagnosis
* Any physiotherapy intervention in the previous 12 months
* Sign of vertebrobasilar insufficiency
* Upper cervical spine ligament instability
* Those using steroids or muscle relaxants
Bedside Ultrasound by Anesthesiologists for Screening Deep Venous Thrombosis

The study is designed as a prospective comparative study. All patients will receive prophylactic anticoagulation according to routine hospital protocol after surgery. A bedside ultrasound examination will be performed by a trained anesthesiologist prior to the surgery and then daily beginning on postoperative day 2 until patient discharge.

Recent studies conducted at the emergency department evaluated the usefulness of an abbreviated bedside compression ultrasound test for diagnosis of Deep Venous Thrombosis (DVT) in the proximal region. This abbreviated ultrasound test conducted in the groin and popliteal regions to assess the compressibility of the femoral and popliteal veins required as little as 3.5 min to complete 15 and can be easily mastered by residents with minimum training. These studies showed a promising sensitivity ranging from 70% to 100% and a specificity ranging from 75.9% to 99.6%.

Anesthesiologists are now well-trained in performing ultrasound scans as they perform ultrasound-guided peripheral nerve blocks routinely. Scanning for significant proximal DVT could potentially be anesthesiologists' extended role as they follow up patients who underwent orthopedic surgeries for postoperative pain control as part of the acute pain service.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III
* 18-85 years of age, inclusive
* 50-110 kg, inclusive
* 150 cm of height or greater
* Patients who are scheduled to have surgical repair of the fractured hip and those who will have unilateral or bilateral, primary or revision, hip or knee arthroplasty.

Exclusion Criteria:

* The presence of indwelling femoral vascular catheter or dialysis vascular shunts in the operative leg
* An above-knee amputation
* The inability to access all two landmarks (femoral and popliteal veins) for two-point ultrasonography because of the presence of a cast, external fixation apparatus, or other obstacles