cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial skin or skin structure infection.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients 18 - 85 years of age.
2. Signed and dated informed consent document.
3. Major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by Gram-positive bacteria.
4. At least two (2) local signs and symptoms of ABSSSI and at least one (1) systemic sign of infection.
5. Requires a minimum of 3 days of IV therapy.
6. Patient willing and able to comply with study procedures.

Exclusion Criteria:

Patients presenting with any of the following:

1. A contra-indication to any required study drug.
2. Pregnant or nursing females.
3. Sustained shock.
4. Participation in another study of an investigational drug or device within 30 days.
5. Receipt of a systemically or topically administered antibiotic within 14 days prior to randomization, except receipt of a single dose of a short-acting antibacterial drug 3 or more days prior to randomization.
6. Infection due to a dalbavancin or vancomycin-resistant organism.
7. Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis, and/or endovascular infection.
8. Exclusively gram-negative bacterial or a fungal ABSSSI.
9. Venous catheter infection.
10. Infection of a diabetic foot ulcer or a decubitus ulcer.
11. Device-related infections.
12. Gram-negative bacteremia.
13. Infected burns.
14. Infected limb with critical ischemia.
15. Superficial/simple skin and skin structure infections.
16. Concomitant condition requiring non-study antibacterial therapy.
17. ABSSSI requiring therapy for longer than 14 days.
18. Adjunctive therapy with hyperbaric oxygen.
19. More than 2 surgical interventions for ABSSSI anticipated.
20. Chronic inflammatory condition precluding assessment of clinical response.
21. Absolute neutrophil count \< 500 cells/mm3.
22. Human immunodeficiency virus (HIV) infection with a CD4 cell count \< 200 cells/mm3.
23. Recent bone marrow transplant, \> 20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
24. Regular, chronic antipyretic use in patients unable to modify during the first three days of study drug therapy.
25. Life expectancy less than 3 months.
26. Conditions that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
27. Prior participation in the study.
Assessment of Trunk Muscle Endurance, Respiratory Functions and Respiratory Muscle Strength in Healthy Individuals

The diaphragm forms the upper segment of the core structure. At the same time, the diaphragm muscle acts as the first muscle in the inspiratory function. The aim of this study was to investigate the relationship between respiratory functions and trunk muscle endurance. In this context, respiratory muscle strengths, respiratory functions and body muscle endurance of the cases were measured.

The study was conducted on 60 healthy volunteers ranging in age from 20 to 36 years. 27 woman and 33 men participated in the study. Respiratory muscle strength, trunk muscle endurance, pulmonary function test values and physical activity levels were evaluated for the subjects participating in the study.Respiratory muscle strength and respiratory function tests were performed with a Cosmed Pony Fx portable spirometer. Trunk muscle endurance of the individuals were evaluated by prone bridge, side bridge, flexor endurance and sorensen test.

Eligibility Criteria:
Inclusion Criteria:

* Not having any chronic disease
* Not being pregnant

Exclusion Criteria:

* History of cardiopulmonary disease.
* Morbid obesity
* Major surgical history
Thin EBUS Pilot Study

This is a single-center pilot study at the Medical University of South Carolina (MUSC) to evaluate the safety and efficacy of the TCP-EBUS scope (Thin EBUS). This study will consist of a standard of care bronchoscopy and will be followed for approximately 3 months. While the device is not FDA approved, it is the same technology but a thinner version of the SCP-EBUS bronchoscope.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide informed consent.
2. \>21 years of age or older.
3. Target lesion(s) within the middle third of the lung, which will be determined radiographically prior to scheduling the procedure by the bronchoscopist or radiologist, or by being located at least 2 airway generations from the main carina as seen radiographically.
4. Target lesion(s) location documented on CT scan report.
5. Indicated for bronchosocpy.
6. Bronchoscopic procedure scheduled within 30 days of the CT scan report.

Exclusion Criteria:

1. Not suitable for flexible bronchoscopy as determined by the treating physician prior to the procedure.
2. Currently on anticoagulation medications with INR \>1.5.
3. Currently using DOAC and does not suspend use at least 7 days prior to the index procedure
4. Currently using Plavix and does not suspend use for at least 7 days prior to the index procedure.
Effect of Education on Treatment Decision Making for Patients With Prostate Cancer on Chronic Hormone Treatments

The purpose of this study is to learn how an educational intervention about orchiectomy as an alternative to medical castration for those who are already on medical castration will impact the number of patients willing to undergo an orchiectomy (surgery to remove the testicles).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic prostatic adenocarcinoma
* Receiving luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist therapy continuously for at least 1 year with anticipated lifelong therapy
* Able to complete written surveys in English

Exclusion Criteria:

* More than 2 prior systemic treatment regimens utilized in addition to castration.
Observational Non-Interventional Study Of Febrile Neutropenia Patients To Evaluate Antibacterial Therapeutical Options

The purpose of this study was to define and classify antibacterial agents used in Turkey for patients with febrile neutropenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 years old and above.
* Patients who have undergone allogeneic/autologous or peripheral stem cell transplantation following induction or consolidation treatment due to acute hematological malignancy.
* Patients who have a neutrophil count below 500 cells per cubic millimeter (cells/mm\^3) or below 1000 cells/mm\^3 with an expectancy to rapidly decrease below 500 cells/mm\^3.
* Patients with a body temperature more than or equal to (≥)38.3 degrees Celsius (101 degrees Fahrenheit) on single oral measurement or detected ≥38.0 degrees Celsius for at least an hour and thus started on antibacterial treatment will be included in the trial.

Exclusion Criteria:

- Patients who are pregnant or considering pregnancy.
Insulin Pump-RT Advisor (IPRA©): a Decision Support Software for Diabetic Patients Treated by Insulin Pump and Using Continuous Glucose Monitoring. Experimental Study. Evaluation by an Expert Patient Panel.

The purpose of the study is to assess the relevance of the advices provided by the IPRA© smartphone application for guiding the responses of insulin pump treated type 1 diabetes patients using real-time continuous glucose monitoring.

Patients will be asked to evaluate the IPRA advices by connecting to IPRA© application by using their smartphone, 30 times a week for two weeks. At the end of this two week period, a satisfaction questionnaire will be completed.

Eligibility Criteria:
Inclusion Criteria:

* men and women ≥ 18 years of age,
* patients with type 1 diabetes for more than 2 years,
* patients treated by insulin pump for more than 6 months,
* patients using of real-time continuous glucose monitoring for more than 3 months,
* patients able to evaluate the IPRA advices by connecting to IPRA© application 30 times a week,
* patient able to provide written informed consent,
* patient able to provide written non-disclosure agreement

Exclusion Criteria:

* pregnancy or breastfeeding,
* current infectious disease,
* patients with no smartphone® or Internet access,
* adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty
Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma

This is a single arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+，CD19+ relapsed or refractory multiple myeloma.

CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory multiple myeloma by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to preliminary explore the safety, tolerability and cellular pharmacokinetics of Anti-BCMA and Anti-CD19 CAR-T cells in the treatment of relapsed or refractory multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18-70 years old
2. Estimated Survival time \> 12 weeks
3. Relapsed and refractory multiple myeloma were confirmed by physical examination, pathological examination, laboratory examination and imaging
4. Chemotherapy failure or recurrent multiple myeloma
5. Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level
6. Bilirubin\<2.0mg/dl
7. Karnofsky Performance Status\>50% at the time of screening
8. Adequate pulmonary, renal, hepatic, and cardiac function
9. Fail in autologous haemopoietic stem cell transplantation
10. Not suitable for stem cell transplantation conditions or abandoned due to conditions
11. Free of leukocytes removal contraindications
12. Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent

Exclusion Criteria:

1. The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months
2. Patients have infectious diseases (such as HIV, active tuberculosis, etc.)
3. The patient is an active hepatitis B or hepatitis C infection
4. Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated
5. Abnormal vital signs
6. Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation.
7. Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
8. General infection or local severe infection, or other infection that is not controlled
9. Dysfunction in lung, heart, kidney and brain
10. Severe autoimmune diseases
11. Other symptoms that are not applicable for CAR-T
A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)

This study will assess whether daclizumab impairs the ability of children receiving a kidney transplant to elicit a primary immune response. The anticipated time on study treatment is 1 day, and the target sample size is 82 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Primary renal transplant recipients between 2 and 19 years of age
* Receiving or have received daclizumab in the previous 4-18 months
* Receiving or have received daclizumab less than (\<) 24 hours pretransplant and additional courses every other week
* Single organ recipients (kidney only)
* Previous vaccination with tetanus toxoid (TT) prior to transplant
* Receiving a maintenance immunosuppression regimen of a calcineurin inhibitor, mycophenolate mofetil, and prednisone (or equivalent corticosteroid)

Exclusion Criteria:

* Received intravenous gamma globulin or a TT vaccination since transplant
* Experienced rejection within 3 months of receiving study vaccinations and/or treated with lymphocyte preparation or methylprednisolone to reverse suspected acute rejection within 3 months of receiving study vaccinations
* Received any vaccine within 30 days of receiving study vaccinations
* Received plasmapheresis treatment or growth hormone treatment since transplant
Effects of Pressure Release of Myofascial Trigger Points on Mechanical Neck Pain.

The study aims to compare the effectiveness of myofascial trigger point treatment using pressure release versus a control group in patients with mechanical neck pain, randomly assigned. In both groups a protocol of therapeutic exercise and postural correction will be carried out

With the present investigation it is wondered whether the choice of manual therapy techniques, specifically the pressure release of myofascial trigger points in the upper trapezius and sternocleidomastoid muscles, provide significant benefits in combination with therapeutic exercise and postural hygiene (treatment group), as opposed to the unique application of therapeutic exercise and postural hygiene (control group), thus constituting a treatment of choice in patients with mechanical neck pain.

A treatment protocol of one session per week will be carried out, and a follow-up two weeks after the end of the treatment protocol.

If, as postulated, pressure release is more effective than the treatment received by the control group, the choice of this type of technique for myofascial pain syndrome would benefit a high percentage of people who often come asking for treatment in pain treatment centers. Pressure release provides a painless manual stimulus, thus effectively resolving the symptomatology of myofascial trigger points without the need for invasive treatments or medication, which may have more contraindications.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between 18 and 55 years of age in order to avoid degenerative phenomena.
* Have suffered from neck pain at least once in the last month.
* Active or latent myofascial trigger points in the Upper Trapezius and Sternocleidomastoid muscles.

Exclusion Criteria:

* Patients with recent trauma (last 6 months) to the upper quadrant or spine.
* Patients with pathologies involving malignant neoplasms.
* Surgery on the trunk or upper limb in the last six months.
* Patients undergoing pharmacological or physiotherapy treatment at the time of the test.
* Pregnancy.
* No myofascial trigger points in the upper trapezius or sternocleidomastoid muscles.
* Refusal to sign the consent form for the study or not being able to do so.
Measuring Geographic Atrophy in AMD Patients Using the Nidek MP-3 Microperimetry Device

The investigators would like to know if different imaging devices can improve the quality of images and visualization of imaged tissues. Also, the investigators would like to find out whether these changes are useful in the diagnosis and treatment of eye diseases. Using images of previous participants will allow us to demonstrate the advancement of different technologies, as well be used to allow comparisons between current technologies.

To test the quality of images from the Nidek MP-3 device and to measure Geographic Atrophy (GA) in patients with Age-related Macular Degeneration (AMD).

Eligibility Criteria:
Inclusion Criteria:

* Normal, healthy participants and patients with AMD

Exclusion Criteria:

1. Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging
2. Participants who are unable to maintain retinal fixation on a specified target
3. Participants unable to achieve sufficient pupil dilation and alignment stability for imaging to take place
4. Patients with media opacity which preclude high quality imaging will be excluded.
5. Exclusion criteria include vulnerable patients; patients under 18, pregnant, economically and educationally disadvantaged, decision impaired, or homeless people. We exclude pregnant women because pregnancy often can alter eye anatomy.
The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain

Background: Despite similar treatment outcomes for surgery or conservative care, the number of surgeries for the care of rotator cuff (RTC) related shoulder pain has increased. With the increase in surgery, there is an increased risk of harms, increased costs, and high re-tear rates. Patient expectations are beliefs or attitudes that include pre-treatment thoughts and beliefs regarding the need for specific treatment methods and the timing and intensity of these methods. Brief interventions designed to alter and enhance treatment expectations for conservative care and have been shown to improve patient expectations, but to date, no studies have explored whether such interventions can influence patient decisions to pursue surgical care. The investigators propose a comprehensive intervention that involves Patient Engagement Education, and Restructuring of Cognitions (PEERC) that is designed to change expectations, will reduce the likelihood that patients will choose to have shoulder surgery and improve functional outcomes. The cognitive behavioral therapy (CBT) approaches that form the core of our PEERC protocol are patient-centered and are designed to empower the patient in their own recovery process.

Purpose/Aims: To examine the effect of the PEERC protocol on the decision to have surgery (primary), and improve global well-being, pain catastrophizing, pain, functional outcomes, and follow up expectations (secondary).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70
* A rotator cuff related shoulder pain diagnosis
* A mobile or land-line telephone
* Ability to read and write English for completion of the self-report forms.

Exclusion Criteria:

* The investigators will exclude patients who have received or are scheduled for a surgical intervention for their shoulder condition
* Demonstrate any evidence of cervicogenic pain and/or radiculopathy from cervical origin
* Who demonstrate symptoms consistent with thoracic outlet syndrome
* The investigators will also exclude individuals who are undergoing treatment for a serious psychological disorder (e.g., severe depression, psychosis).
Comparison Between Raloxifene and Bazedoxifene

Although there are two kinds of selective estrogen receptor modulator (SERM) :raloxifene (RLX) and bazedoxifene (BZA), the difference is still unclear. In this study, we plan to compare clinical efficacy and safety between RLX and BZA.

Selective estrogen receptor modulator (SERM) is an important option for postmenopausal osteoporosis. There are two SERM approved in Japan for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. One is raloxifene (RLX), and the other is bazedoxifene (BZA). There are few reports concerning to the clinical efficacy and safety data. In this study, we plan to compare clinical efficacy and safety between RLX and BZA.

The main objective of this study is to reveal the effects of RLX and BZA on bone mineral density, bone turnover markers, and bone quality markers.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women

Exclusion Criteria:

* Patients who could not use SERM
Evaluation of the Stability of Sulfur Volatile Compounds From Exhaled Air for Halitosis Diagnosis

Halitosis or bad breath is a problem affecting 30% of the world's population. There are many causes, and oral pathologies, including periodontitis, are the main etiology. In order to make a diagnosis, a clinical interview is necessary to distinguish true halitosis from psychological halitosis. In addition, a measurement of volatile sulfur compounds (VSC), the main molecules involved in bad breath, is necessary. This is done during the consultation by measuring the concentration of VSCs in exhaled air. However, few private practices or hospitals have the necessary equipment to measure VSC. As a result, patients are often obliged to travel long distances to obtain a consultation including this specific VSC analysis. The aim of this study is to evaluate the stability of VSC values obtained in gaseous samples up to 7 days after sampling, in order to assess the clinical relevance of analyzing samples at a distance from sampling. The clinical aim is to determine whether self-sampling by the patient at home and extemporaneous analysis could be considered in the diagnosis of halitosis.


Eligibility Criteria:
Inclusion Criteria:

* Adult, male or female
* Subject affiliated with a social health insurance plan
* Able to understand the objectives and risks of the research and to give dated and signed informed consent
* Subject presenting for consultation for diagnosis and treatment of periodontal pathology

Exclusion Criteria:

* Subject under safeguard of justice
* Subject under guardianship or curatorship
* Pregnancy or breast-feeding
* Impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject, etc.)
* Subject currently included in another clinical research protocol or in an exclusion period
Study to Test an Approved Product in the Early Treatment of Migraine (0462-065)

The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine while the pain is still mild.


Eligibility Criteria:
Inclusion Criteria:

* 6-month history of migraine
* Migraine attacks typically mild when they begin with 1-4 migraine attacks per month

Exclusion Criteria:

* Heart disease
* High blood pressure