cyrilzakka/clinical-trials huggingface dataset:
Comparison of Interscalene Block and Suprascapular With Axillary Block

In this study, the investigators are going to compare the analgesia effectiveness of interscalane block and suprascapular with axillary block in shoulder arthroplasties

In the preoperative period, the participants will be taken to the block room. The participants will be monitored, standard sedation will be applied.

The first group will be get interscalene block. The second group will be get suprascapular and axillary block. The third group patient will be get no block. Afterwards, the participants will be operated under general anesthesia. A patient-controlled analgesia device will be attached to each group of participants and their postoperative follow-up will be made.

Eligibility Criteria:
Inclusion Criteria:

* accepting the study protocol,
* age older than 18 years and younger than 90 years,
* undergoing shoulder arthroplasty surgery
* the American Society of Anesthesiologist (ASA) physical status of I-II-III-IV

Exclusion Criteria:

* severe respiratory distress
* patients with local anesthetic allergy
* contralateral hemidiaphragmatic parrhesia
* recurrent laryngeal nerve palsy
* infection at the injection site
* coagulation disorder
Randomized Trial of the Positive Action Program in Hawaii Schools

The purpose of this study is to determine the effectiveness of the Positive Action program on reducing negative behaviors, increasing positive behaviors and improving academic achievement of elementary school students.

This project will: 1) evaluate the efficacy of a comprehensive, multi-grade, multi-year program, the Positive Action program (PA) designed to reduce student problem behaviors (including drug use and violence), disciplinary referrals and suspensions, and academic underachievement; 2) evaluate the effects of the program on the presumed/theoretical mediator variables; and 3) assess which of these changes in mediator variables actually mediate the effects of the program on behavior and school performance. The Hawaiian school district has agreed to implement a randomized trial of the PA program. We randomly assigned schools to PA or control conditions from strata matched on multiple indicators of risk. PA schools will receive the full PA program for four years (the 2002-03 through 2005-06 school years). This includes all materials for all students (at all grades), families, teachers, and principal, plus community kits; training for teachers and other interested staff; and continuous technical support and monitoring by a PA staff person. Data on behavior and academic achievement will be obtained from school archival records for all students for all years and, where appropriate for several years prior to the study. Students in grades 1 and 3 in the 2001-02 school year and their parents and teachers will also be followed through the project with surveys every year. The subject population will contain equal portions of males and females, and proportionate numbers of the major ethnic groups on Oahu (Hawaiian or part-Hawaiian, white, Asian, Other). Analyses will test for program effects on all hypothesized mediating variables and outcomes, and the hypothesized mediational pathways.

Eligibility Criteria:
Inclusion Criteria:

* Public elementary schools K-5 or K-6
* All students in the study cohorts

Exclusion Criteria:

* Schools performing in top 50%
Bridging the Evidence-to-practice Gap

The proposed project will address this evidence-to-practice gap by evaluating the effect of practice facilitation (PF) of the intervention implementation fidelity (primary outcome) and clinical measures at 12 months (secondary outcomes).

Advancing Medication Adherence for Latinx with Hypertension through a Team-based Care Approach (ALTA) evaluates the effectiveness of using a quality improvement method called practice facilitation (PF) to implement our evidence-based systems-level intervention for improving medication adherence and blood pressure control.

The ALTA intervention focuses on identifying Latinx patients with uncontrolled hypertension who are non-adherent to their antihypertensive medication, referring them to health coaches, coaching patients on medication adherence and self-management, care planning, and monitoring patients to improve patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Latino
* Be fluent in English or Spanish
* Be age 18 years or older
* Receiving care in a safety-net primary care practice
* Have uncontrolled HTN documented in the electronic health record (EHR) on at least two visits in the past year (defined as an average BP ≥ 140/90 mmHg)
* Have been prescribed at least one anti-hypertensive medication and be non- adherent to their medications, defined as adherence \<80% in the preceding 12 months, as determined by prescription orders obtained from the clinic EHR.

Clinic and nonclinical staff inclusion criteria:

• Primary care provider (MD/DO, NP), Nurse, Medical Assistant, or administrative staff employed at the participating practices and (b) interacts with at least five patients with a diagnosis of hypertension.

Exclusion Criteria:

* Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks)
* Participation in other hypertension-related clinical trials
* Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR)
* Plan to discontinue care at their practice within the next 12 months

Clinic and nonclinical staff exclusion criteria:

• Refuse to participate
Treatment of Uterine Fibroids With Asoprisnil(J867)

The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women
* History of regular menstrual cycles (21-42 days)
* Diagnosis of uterine fibroid(s)
* Abnormal vaginal bleeding associated with uterine fibroids
* Otherwise in good health
* Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails
* Negative pregnancy test
* Agrees to Double-barrier method of contraception
* Pap smear with no evidence of malignancy or pre-malignant changes
* Endometrial biopsy with no significant histological disorder

Exclusion Criteria:

* Any abnormal lab or procedure result the study-doctor considers important
* Severe reaction(s) to or are currently using any hormone therapy
* History of osteoporosis or other bone disease
* Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months
* History of Polycystic Ovary Syndrome or prolactinoma
* MRI shows significant gynecologic disorder
* Uterine size \> 25 weeks gestation
* Hemoglobin \< 8 g/dL at Day -1
Movement Control Exercises and Fascial Manipulation in Chronic Low Back Pain

Subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in University Hospital of Oulu at Physical and Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor at PRM unit. The volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. After that the subjects are measured at baseline measurement. Subjects are randomized into the five groups. After the 3 months treatment and training the follow-up measurements are performed. Same questionnaires are filled in at that point as well. At 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.

Subjects are recruited from the attendees of the multidisciplinary low back pain rehabilitation group before it takes place in University Hospital of Oulu at Physical and Rehabilitation Medicine (PRM) unit. Subjects were invited to participate by letter 2 weeks before the beginning of the rehabilitation. Subjects to rehabilitation are picked by doctor at PRM unit. The volunteered subjects are invited to the briefing of the study and those who are willing to participate, they filled in several questionnaires about pain, participation, disability and mood. After that the subjects are measured at baseline measurement. Subjects are randomized into the five groups: 1) control group, 2) fascial manipulation (FM) and movement control exercises (MCE), 3) sham-FM and MCE, 4) FM and sham-MCE and 5) sham-FM and sham-MCE. Physical therapists who perform treatments (FM), prescribing MCE and performing the measurements are blinded to each other. Physical therapist who is performing measurements is also blinded for the baseline measurements. There and 4 treatments of sham-FM, 4-5 treatments of FM, 4 treatments of sham-MCE and 4-6 treatments of MCE. Control group will receive only university hospital rehabilitation and will participate into the baseline and follow-up measurements. After the 3 months treatment and training the follow-up measurements are performed. Same questionnaires are filled in as at baseline. At 6 and 12 months the follow-up questionnaires (same as before) are sent to subjects.

Eligibility Criteria:
Inclusion Criteria:

* Chronic non-operatively treated low back pain or pain after the low back operation. Participation in multidisciplinary rehabilitation at University Hospital of Oulu.

Exclusion Criteria:

* Specific low back pain cause and earlier fascial manipulation treatment given.
Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block

Interscalene brachial plexus block provides excellent but time limited analgesia. Intravenous dexamethasone increases the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder arthroscopic surgery. We want to evaluate the effect of two different doses (dexamethasone 10 mg i.v. vs 4 mg i.v. vs placebo) on the analgesic duration of a single-shot inter scalene block. Our study hypothesis is that dexamethasone 4 mg i.v. is equivalent to dexamethasone10 mg i.v. in prolonging the analgesic duration of a single-shot interscalene block with ropivacaine.

75 patients will be randomly assigned to three groups:

* D10: dexamethasone 10 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
* D4: dexamethasone 4 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
* C: control: Normal saline 20cc I.V., immediately after inter scalene block. These patient will be recruited from 3 hospitals, with two surgeons performing the surgeries.

All patients will have their surgery under regional anesthesia only provided by the inter scalene plexus block, with ropivacaine 0.5% 20cc.

In the postoperative period, patients will be given analgesic medication on an as needed basis. They will be instructed to take the first analgesic medication once postoperative shoulder pain has reached \>3/10. They will note the time and day at which this outcome occurs.

Eligibility Criteria:
Inclusion Criteria:

* Elective shoulder arthroscopy under ropivacaine single-shot interscalene brachial plexus block anesthesia (rotator cuff repair and shoulder decompression)
* ASA I-III
* Age 18-80 years old

Exclusion Criteria:

* Any contraindication to interscalene brachial plexus block anesthesia
* Interscalene brachial plexus block failure
* Known local anesthetics allergy
* Dexamethasone allergy or intolerance
* Any contraindication to acetaminophen
* Any contraindication to morphine or hydromorphone
* Brachial plexus neuropathies
* Chronic pain syndrome other than shoulder pain
* Routine use of opioid medication
* Routine use of systemic corticosteroid
* Pregnancy
* Weight below 50 kilograms
* Incapability to understand a numeric verbal pain scale
* Incapability to consent
* Patient refusal
The Effect of Stress Ball Application on Anxiety and Fetal Heart Rate Before Cesarean Section

This study will be conducted to determine the effect of stress ball application on anxiety and fetal heart rate in risk pregnant women before cesarean section. Women with risk pregnancies randomly assigned to intervention (n=44) and control (n=44) groups in a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be instructed how to use the stress ball in the obstetrics ward before cesarean section. During the practice, pregnant women will be asked to demonstrate the movements of tightening and loosening the stress ball to ensure correct use. It will be emphasized to the pregnant women that they should squeeze the ball once after counting to three, inhale when they squeeze the ball, exhale when they loosen their grip and focus only on the ball. Pregnant women in the control group will not receive any intervention other than routine general care. Data will be collected face-to-face by the researcher based on the self-reports of the pregnant women before cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research,
* Be over 18 years of age,
* Having a medically diagnosed risky condition during pregnancy (diabetes, hypertension, threat of preterm labor, pre-eclampsia, etc.),
* Compliance with at least one of the criteria in the "Ministry of Health Risk Assessment Form for Pregnancy" in the evaluation of current pregnancy,
* Planning a cesarean delivery,
* Being in the last trimester of pregnancy (28 weeks and above)
* Having a single live fetus,
* To be able to read and write Turkish.

Exclusion Criteria:

* A diagnosed psychiatric illness,
* Visual, hearing, speech, physical or mental disability,
* Any communication barriers,
* Cardiovascular disease in the pregnant woman and fetus,
* Fetal distress,
* Fetal anomaly,
* Any physical or medical condition that prevents the use of a stress ball,
* Need for urgent intervention before caesarean section according to the physician.
A Clinical Registry of Spontaneous Intracranial Hypotension

The purpose of this research is to determine the efficacy of paraspinal vein embolization for treatment of digital subtraction myelography (DSM) or CT myelography (CTM) confirmed cerebrospinal fluid (CSF)-venous fistulas so that researchers can inform the development and design of future clinical trials of this technique.


Eligibility Criteria:
Inclusion Criteria:

* Study subjects will be patients who meet the International Classification of Headache - Disorders 3rd Edition (ICHD-3) criteria for a diagnosis of SIH or the Schievink criteria with imaging confirmed CSF-venous fistulas on DSM or CTM.
* Availability of a clinically prescribed contrast enhanced MRI positive for SIH.
* Negative urine or serum pregnancy test at time of study consent and three-months.

Exclusion Criteria:

* Patients who have a contraindication or inability to undergo the procedure (i.e., severe contrast allergy).
* Inability to provide informed consent.
* Expected inability to complete the follow-up assessment.
* Current pregnancy or breast-feeding during study enrollment (from consent to study conclusion approximately 90-days).
Post Market Clinical Follow Up of ResMed Mask Systems

Post Market follow up study to systematically and proactively collect supplementary real world data to confirm the usability and performance of the new generation mask systems. .

This is an open label, prospective, multi-centre, single arm study for post market clinical follow up. The study will be conducted in the home environment remotely. Eligible participants currently using older generations of CPAP masks will use the new generation ResMed mask system in the same mask category to their own (nasal, full face, pillow) in place of their own mask for 90 nights and complete a series of questionnaires at specified study checkpoints.

Eligibility Criteria:
Inclusion Criteria:

* Participants willing to give written informed consent
* Participants who can read and comprehend English
* Participants who ≥ 18 years of age
* Participants being treated for OSA for ≥ 6 months
* Participants currently using a suitable mask system
* Participants currently using CPAP device compatible with AirView, or with download capacity from CPAP machine from data cards

Exclusion Criteria:

* Participants using Bilevel flow generators
* Participants who are or may be pregnant
* Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury.
* Participants believed to be unsuitable for inclusion by the researcher
* Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable) (for masks with magnetic clips only)
Assessments of Sarcopenia Prevalence in Chronic Heart Failure Patients and in Subjects Before TAVI

The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation.

The loss of muscle mass in chronic heart failure patients is a prognostic factor for sarcopenia. The purpose was to identify in these patients signs of sarcopenia for a better management.

Age-related muscle loss, termed sarcopenia, affects 10% of elderly subjects aged 60-70 years and more than 30% above the age of 80. The concept of sarcopenia has been supported by the recent findings of muscular atrophy which was related to the decrease of protein synthesis because of the "anabolic resistance", affecting the muscular fibers type II. In fact, sarcopenia could be a consequence of chronic disease and not only an issue in the elderly people. The diagnosis is assessed by the weak muscle mass and the muscle strength and function. A description of these muscle parameters has been described in a study of 200 patients with NYHA class II-III and showed that 19,5 % have a decrease in muscle mass. They also showed that these patients have a lower functional ability. These findings prompted us to investigate the prevalence of sarcopenia in chronic heart failure subjects for a better management of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Major patients (\>18 years)
* Men or women
* Hospitalized in pre- trans aortic valvular implantation assessment in the cardiology department of the university hospital centre of Clermont-Ferrand or
* Patients with chronic heart failure in charge in the hospital of Clermont-Ferrand or convalescence in the pneumocardiological clinic of Durtol

Exclusion Criteria:

* Patient not affiliated to social security
* Inability to understand the information consent letter
* Not having signed informed consent
* Has a mental or legal incapacitation and is unable to provide informed consent.
An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia

This is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy and safety of APX001 for the first-line treatment for candidemia including suspected or confirmed antifungal-resistant candidemia in non-neutropenic patients 18 yeas of age and older.

Suspicion of antifungal-resistant candidemia is sufficient (documented resistance is not required for enrollment). The Study Drug Treatment Period of APX001 will be a maximum of 14 days. After completion of 14 days study drug therapy, if further antifungal treatment is indicated to complete treatment of candidemia in accordance with standard practice guidelines, fluconazole (unless susceptibility results warrant alternative antifungal therapy) may commence for up to a further 7 days. There will be a Follow up Period of 4 weeks (+4 days) after EOT. The total duration of participation in the study is up to approximately 7.5 weeks.

This study will be conducted at approximately 20 sites in the United States and globally.


Eligibility Criteria:
Key Inclusion Criteria:

* Provision of written consent
* Adults ages 18 and above male or female
* New diagnosis of candidemia
* Able to have pre-existing intravascular catheters removed and replaced (as necessary)

Key Exclusion Criteria:

* neutropenia
* deep-seated Candida-related infections
* hepatosplenic candidiasis
* received more than 2 days of prior systemic antifungal treatment for current candidemia episode
* severe hepatic impairment
Opioid Antagonism in Hypogonadotropic Hypogonadism

The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with idiopathic hypogonadotropic hypogonadism (HH).

Assignment: Each study subject will serve as their own control.

Delivery of Interventions:

* Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
* During the study, the subjects will undergo the following:

  * Period 1: Undergo q10 min blood sampling for up to 12 hours
  * Period 2: Undergo q10 min blood sampling for up to 12 hours

    * Receive a naloxone bolus followed by a naloxone infusion

Eligibility Criteria:
Inclusion

* Age 18-75 years
* Confirmed diagnosis of hypogonadotropic hypogonadism
* Genetic sequencing data available
* All medical conditions stable and well controlled
* If applicable, willing to use birth control methods (as approved by a study medical professional) during protocol participation
* Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg)
* Negative urine drug screening panel
* Hemoglobin
* Women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women
* Men on adequate testosterone replacement therapy: normal male reference range
* Men off testosterone replacement therapy: no lower than 0.5 gm/dL below the lower limit of the reference range for normal women
* For women, negative serum hCG pregnancy test

Exclusion

* Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
* Current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis and, if applicable, unwilling to complete an appropriate washout for that particular medication and its method of administration
* Current or recent use of a medication that affects the opioid pathway
* Active illicit drug use
* Excessive alcohol consumption (\> 10 drinks/week)
* For women, pregnant or breastfeeding