cyrilzakka/clinical-trials huggingface dataset:
Project Chill: Tailored Youth Drug Intervention In Primary Care

This study examines the impact of tailored computer-delivered and therapist-delivered brief motivations prevention/interventions both for adolescents who have not initiated marijuana use (prevention), and those who use marijuana (intervention). Key moderators of prevention/intervention effectiveness will be examined, including behavioral intentions, self-efficacy, stage of change, school involvement, susceptibility to peer pressure, and potential health consequences such as STD/HIV risk behaviors. This project will provide the critical first step toward the development and implementation of marijuana use prevention/intervention programs that have the potential to be delivered to a large segment of youth who seek care in our nation's primary care settings.

The primary care setting represents an underutilized venue for prevention interventions addressing drug use/abuse among youth. The purpose of the study is to: (1) develop and refine promising, empirically-derived, BMI prevention/intervention modules delivered by a clinician or a computer to target marijuana use, and (2) test the effectiveness of BMI in preventing initiation/escalation of marijuana use among youth in community health clinics. This randomized controlled trial screened adolescents in primary care clinics in Flint, MI. A random sample of those who screened negative for past year marijuana use were selected to participate in the study and all subjects who screened positive for past year use were enrolled in the study. These subjects were stratified by gender, age, and past year marijuana use and randomized to one of three conditions: 1) computer-delivered brief motivational approach (BMI-C); 2) therapist-delivered brief motivational approach (BMI-T); or 3) a NIDA drug education booklet. Primary outcomes are evaluated at 3-, 6- and 12-months and include marijuana, alcohol, tobacco and other drug use. Key moderators of effectiveness will be examined, including behavioral intentions, self-efficacy, stage of change, school involvement, susceptibility to peer pressure, and potential health consequences (e.g., STD/HIV risk behaviors). This project will provide the critical first step toward the implementation of tailored marijuana prevention and intervention in primary care clinics.

Eligibility Criteria:
Inclusion Criteria:

* adolescents (ages 12-18) presenting to the approved health clinics (except exclusions as noted below)
* ability to provide informed assent
* access to a parent or guardian for parental consent

Exclusion Criteria:

* adolescents who do not understand English
* adolescents deemed unable to provide informed consent by research staff (e.g., cognitive issues)
* adolescents who come to the clinic because of sexual assault or suicide attempt, or are presenting with high psychological distress requiring intensive attention
* prisoners
* adolescents who are deaf
* adolescents with a sibling or other household member in the study will be excluded from Phase II
Analgesia in Children Using Caudal Epidural Ropivacaine

Caudal epidural analgesia (caudal block)is used in standard pediatric anesthesia practice. It has been shown to be effective in managing postoperative pain in children undergoing abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown that children receiving caudal blocks have secondary benefits such as lower narcotic and anesthetic requirements, more rapid awakening from general anesthesia, decreased time to discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias et al 1995, Tobias 1996).

This proposed study involves the use of a caudal block in children undergoing elective inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a caudal block before the onset of a painful stimulus, we can decrease central nervous system sensitization and reduce postoperative analgesic requirements


Eligibility Criteria:
Inclusion Criteria:

1. Age 2 months to 2 years
2. Weight 25kg or less
3. ASA class 1, 2, 3
4. Elective inguinal herniorrhaphy or orchiopexy

Exclusion Criteria:

1. Contraindications to caudal epidural analgesia
2. parent's refusal
3. skeletal or spinal cord anomaly
4. coagulopathy
5. infection at the insertion site
6. ongoing bacteremia
7. allergy to ropivacaine
Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion

Background: Intrauterine adhesions are a difficult clinical problem for reproductive infertility. The most common cause is uterine cavity surgery and post-abortion (including abortion and spontaneous abortion). After the abortion, the uterine cavity adhesion, when is the key point, the literature is not much ink, early literature has mentioned that after the abortion, the uterus scraping action is scraped in four days and the uterine adhesion will be smaller than one to four weeks. Much more, it seems that the sooner the uterine adhesion factor is excluded, the more it can reduce uterine adhesion, but the uterine curettage itself is a risk factor for uterine adhesion. This early practice, the current clinical application, is not used, Instead, it is a hysteroscopy. Our past clinical observations, as soon as possible after the abortion, outpatient hysteroscopy, can find the tissue factors that may cause adhesion in the uterine cavity as soon as possible, and immediately remove it with an outpatient hysteroscope.

Objective: To verify the early outpatient hysteroscopy and reduce the occurrence of intrauterine adhesion after abortion.

Expected benefits to patients: Abortion is likely to cause intrauterine adhesions, which may further cause the incidence of reproductive infertility, should be involved before the formation of permanent injury, reduce the adhesion of the uterine cavity. Outpatient hysteroscopy is a simple and easy-to-use examination procedure that is painless and does not require anesthesia. Although it is invasive but has few complications, it is expected to reduce the occurrence of intrauterine adhesion after abortion.


Eligibility Criteria:
Inclusion Criteria:

* female age 20 to 45 years-old
* undergo induced abortion
* desire future fertility
* agree with the trial and sign the consent form

Exclusion Criteria:

* previous intrauterine surgery
* previous intrauterine adhesion
* previous having over(and/or equal to) 3 times of induced abortion
* infection condition
A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia

The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia according to DSM-IV-TR criteria
* Has been able to achieve outpatient status for more than 3 months in the past year
* Body mass index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
* Resides in a stable living situation
* Willing and able to be confined to an inpatient study unit for 2 weeks or longer

Exclusion Criteria:

* History of poor or inadequate clinical response to treatment with aripiprazole
* History of treatment resistance
* Known or suspected intolerance of, allergy, or hypersensitivity to aripiprazole, its ingredients, other antipsychotic agent, or INTRALIPID (including peanuts, soy, egg, or glycerol)
* Diagnosis of current substance dependence (including alcohol)
* Pregnant, lactating, or breastfeeding
* Receipt of any antipsychotic medication by IM injection within 60 days before Screening
* Current involuntary hospitalization or incarceration
* Hospitalized for more than 30 days during the 90 days before Screening

Additional inclusion/exclusion criteria may apply.
Menthol for Dyspnea Relief in Health and COPD

Menthol inhalation (MI) is a novel and promising treatment option for acute relief of dyspnea, however, the underlying ventilatory and/or neural related mechanisms for this relief in symptoms remain unknown. The overall aim of this research project is to systematically examine the mechanisms of dyspnea relief from MI in healthy individuals and those with COPD.

The project is structured in 4 work packages (WP), each including a different sample of healthy volunteers (WP1, 2) or patients with COPD (WP3, 4), respectively with a 1:1 female/male ratio in each WP. Each WP will be single-blind, placebo-controlled cross-over trial to investigate the effects of MI compared to placebo in healthy volunteers during resistive loaded breathing (WP1), in healthy volunteers during cycling exercise (WP2), in people with COPD who have dyspnea at rest (WP3), and in people with COPD during cycling exercise (WP4).

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years of age or older
* Able to speak, read, and write Dutch or English
* Normal pulmonary function: forced expiratory volume in 1 second (FEV1) to forced vital capacity ratio\>0.70; FEV1≥80%predicted (WP1 and 2 only)
* Non-smoker or former smokers (smoke-free ≥12 months prior to enrolment) (WP1 and 2 only)
* Clinically stable COPD (based on clinical judgment of the study physician that have not had exacerbations requiring escalation of medical therapy (i.e., short course of oral corticosteroids or antibiotics) within the preceding 14 days (WP3 and 4 only)

Exclusion Criteria:

* Contraindication to exercise testing (e.g., significant cardiovascular, musculoskeletal, neurological disease; see Table 4 from ERS/ATS consensus statement)
* Significant pulmonary or extra-pulmonary disease that, based on clinical assessment, could influence dyspnea and/or impair exercise capacity (with the exception of COPD in WP3 and 4)
* Body mass index \<18.5 or \>35 kg/m2
* An ulcer or tumor in the esophagus, a nasal septum deviation, or recent nasopharyngeal surgery
* Severe facial trauma including cribriform plate disruption (bone separating brain from nasal cavity)
* Allergies to latex and sensitivities to local anesthetics
* Inability to give informed consent, including those with significant cognitive impairment
* Alcohol consumption within 12 hours of study visit
* Current smoker\*
* History of early menopause (age \<45 years)
* Pregnancy or desire to become pregnant while in trial
Pattern of Genitourinary Fistula in Upper Egypt

the pattern of genitourinary fistula in upper egypt

A genitourinary fistula is defined as an abnormal communication between the urinary (ureters, bladder, urethra) and the genital (uterus, cervix, vagina) systems.

The true incidence of genitourinary fistula is unknown. Uro-genital fistulas are a great challenge for women in developing countries.

The new classification of genitourinary fistula divides genitourinary fistulae into four main types, depending on the distance of the distal edge of the fistula from the external urinary meatus. These four types are further subclassified by the size of the fistula, extent of associated scarring, vaginal length or special considerations:

Type 1: Distal edge of fistula \> 3.5 cm from external urinary meatus Type 2: Distal edge of fistula 2.5-3.5 cm from external urinary meatus Type 3: Distal edge of fistula 1.5 - \< 2.5 cm from external urinary meatus

Eligibility Criteria:
Inclusion Criteria:

- any female with genitourinary fistula

Exclusion Criteria:

* no
Test Properties of Lower Quarter Y-Balance Test: Effect of Verbal Instructions and Focus Techniques

The Lower Quadrant Y-Balance Test (LQYBT) is a landmark test used in assessing lower extremity performance, determining risk factors for injury, and making return-to-sport decisions. Studies have shown that the individual's focus of attention affects balance. The literature, has shown that the use of external focus is more effective than the use of internal focus in the execution of a movement.Consistent with these findings, the use of an external focus instruction during the LQYBT may lead to achieve more realistic and a higher performance outcome than the test result with standard instructions. The primary aim of this study was to investigate the effects of using different instructions and focusing techniques on test performance on the LQYBT. The secondary aim was to investigate the reliability of the different instructions and focus tests we used for the LQYBT.

Hypothesis of the study that test performance can be further enhanced by differentiating the instructions and focus techniques. A more effective assessment of individual performance may help us to make a more realistic decision to return to sport.

This study is a prospective cross-sectional research. A total of 52 healthy individuals participated in this study. The test protocols were compeleted in two sessions for each participant. In the first session, participants whose eligibility for the study was determined, were recorded demographic data including age, height, body weight, body mass index, lower extremity dominance, and leg length. Subsequently, the Lower Quarter Y Balance Test (LQYBT) was conducted using three different focus instructions: (1) standardized instruction, (2) internal focus instruction, (3) external focus instruction. Each focus instruction was sequentially applied three times in each direction. The three different instructions were randomized and performed in a different sequence for each participant. In second session, to assess the test-retest reliability of different focus instructions during test, the LQYBT was repeated under the same conditions three days later, by the same researcher.

To ensure normalization, the average distances measured in the anterior, posteromedial, and posterolateral directions were obtained for each command, and the results were divided by the length of the leg and multiplied by 100. The total score for the dominant side in the LQYBT was determined by aggregating the average reach distance across three directions, dividing it by three times the length of the leg, and then multiplying by 100.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years,
* Currently without pain in lower extremity,
* No history of lower extremity musculoskeletal problems or surgery in the last 12 months.

Exclusion Criteria:

* Had neurological, systemic, or autoimmune disorders.
Ultrasound Guided Emergency Physician Performed Erector Spinae Nerve Block for Rib Fracture Analgesia

The study will be a prospective randomized double blinded placebo controlled clinical trial using ultrasound guided erector spinae plane block as an analgesic adjunct among adult emergency department (ED) patients with rib fractures using mean morphine milligram equivalents as the primary outcome.

Aim 1: Given the novelty of the erector spinae plane nerve block and limited data from anesthesia literature, aim 1 is to obtain preliminary data regarding quantity of mean morphine equivalents received by control and experimental groups for an initial subset of 50 patients to improve sample size calculation and better power the study.

Aim 2: Evaluate efficacy of ED performed ultrasound guided ESP block in delivering analgesia by evaluating difference in morphine milligram equivalents (MME) as well as pain scores during ED stay and hospital admission between the experimental and control groups.

Aim 3: Evaluate adverse event rates related to ultrasound guided ESP block placement as well as rates of rib-fracture related complications between control and experimental groups.

Eligibility Criteria:
Inclusion Criteria:

1. radiographic evidence of unilateral rib fracture(s).
2. able to consent and actively participate in the study.
3. moderate to severe pain (defined as numerical pain rating score \>/ 4 ) at time of enrollment.

Exclusion Criteria:

1. known allergy or hypersensitivity to local anesthetics or morphine.
2. infection at site of ESP block placement.
3. depth over 5 cm from skin to transverse process visualized with ultrasound.
4. additional injuries that preclude positioning for ESP block placement.
5. severe traumatic brain or spinal cord injury.
6. severe altered mental status, such that pain could not be assessed.
7. extra thoracic injuries for which rib pain is reported as less than the rest of the injuries.
8. adjunctive epidural catheter pain control.
9. other regional anesthetic blocks.
10. pregnancy or prisoner status.
11. unstable vital signs.
Efficacy and Safety of Voice Inception Technique Based U-healthcare Service in Patients With Type 2 Diabetes Mellitus

Ubiquitous healthcare service for elderly patients with type 2 diabetes have been developed and improved glycemic control. However, previous U-healthcare service had some limitations, which needs specific devices to check blood glucose and send it to central system. Voice inception technique based U-healthcare service is expected to improve glycemic control without specific devices.

To evaluate the clinical efficacy of this system, researchers plan to compare the improvement of glycemic control, self-management, and quality of life between U-health care group (intervention) and conventional treatment group (control).

Ubiquitous healthcare for chronic disease such as diabetes is intensively developing field. Nowadays, various methods are tried to find the most effective and easiest way for supplying U-health care.

Here, researchers are going to investigate the efficacy and safety of voice inception technique based U-healthcare service.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* age: 60 \~ 85 yrs
* HbA1c: 7.0%-11.0%
* Basal insulin or premixed insulin user

Exclusion Criteria:

* Type 1 diabetes
* short acting insulin or insulin pump user
* systemic corticosteroid administered within previous 6 months
* history of myocardial ischemia
* Heart failure, New York Heart Association (NYHA) Class II-IV
* Thyroid disease with abnormal thyroid function test
* Anti-obesity drugs or slimming products within previous 3 months
* severe liver or kidney disease
Apixaban in Patients Who Undergo CIED Procedure- Randomized Pilot Study

This study is being done to determine if apixaban is more safe, when compared to warfarin, at reducing the risk of bleeding during CIED procedures.


Eligibility Criteria:
1. Signed informed written consent
2. Patients are taking warfarin or apixaban chronically
3. Patients are at risk of stroke or systemic embolism
4. Patients have NVAF
5. Patients will undergo CIED generator change
6. Age 18-90
7. Either gender
8. All eligibility criteria must be met

Exclusion:

1. Patient is critically ill, or in unstable condition
2. Patient is at high risk for bleeding, HAS-BLED score ≥ 3
3. Patient is required to take dual antiplatelet agents in addition to anticoagulant drug. (e.g. recent cardiac stent placement)
4. Patients have mechanical cardiac valve or another condition other than NVAF that requires chronic anticoagulation
5. Women of childbearing potential with positive pregnant test
6. Bilirubin \>2x upper limit of normal, in association with AST/ALT/ALP \>3x upper limit normal
7. Allergy to apixaban and warfarin
8. Subjects requiring taking strong dual inhibitors of CYP3A4 and P-gp who already meet the criteria to take 2.5 mg apixaban
9. Subjects requiring taking strong dual inducers of CYP3A4 and P-gp (.e.g., rifampin, carbamazepine, phenytoin, St. John's wort)
10. Patients who take any investigational drugs within 30 days of enrolling in study.
11. Prisoners or subjects who are involuntarily incarcerated.
12. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
German Spondyloarthritis Inception Cohort

The German Spondyloarthritis Inception cohort (GESPIC) was started 2000 as a prospective, longitudinal, multicentre, nationwide study in Germany on patients with early SpA including ankylosing spondylitis (AS, also known as radiographic axial spondyloarthritis) and non-radiographic axial SpA. The objectives of GESPIC are to learn about the course of SpA during the very early stage of the disease, to appropriately assess the outcome including radiographic progression of patients after several years of follow-up, to identify outcome predictors, to assess quality of life, function, and costs (direct and indirect costs). GESPIC has been recently expanded to recruit patients with other forms of SpA / conditions associated with SpA: acute anterior uveitis, Crohn's disease as well as with psoriasis / axial psoriatic arthritis.


Eligibility Criteria:
Main inclusion Criteria:

* Patients with definite diagnosis of axial spondyloarthritis or juvenile spondyloarthritis.
* Patients with definite diagnosis of Crohn's disease.
* Patients with definite diagnosis of acute anterior uveitis.
* Patients with definite diagnosis of psoriatic arthritis with axial involvement.
The Surgery After Stenting (SAS) Registry

The SAS registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure at the participating Centers. The relevant clinical, procedural and outcome data (within index surgical admission and at 30 days) will be entered in a specifically designed electronic case record form (eCRF).


Eligibility Criteria:
Inclusion Criteria:

* Eligible will be male and female patients \> 18 years of age.
* Eligible will be patients with previous coronary stenting undergoing any kind of surgical or operative endoscopic procedure at the participating Centers, irrespective of the distance in time between stenting and surgery.
* Both candidates to elective/urgent operations and those undergoing emergency operations will be included in the SAS registry, and will be considered as two separate cohorts.

Exclusion Criteria:

- Unwillingess/inability to sign the Informed Consent Form (ICF). There are no other selection criteria.
Cocoa Butter for Prevention of Stretch Marks

This study will check to see if using cocoa butter lotion on the belly, breasts and thighs will help reduce the appearance of stretch marks in pregnancy. Women entering the study will either receive a lotion containing cocoa butter with vitamin E or a lotion containing only vitamin E. After delivery, the study investigators will evaluate whether the women who used cocoa butter lotion were less likely to develop stretch marks.

Primigravid women presenting for prenatal care in the first trimester will be recruited to participate in the study. They will be randomly assigned to receive the study lotion (a commercially available lotion containing cocoa butter with viatmin E), a placebo lotion (a lotion containing vitamin E but no cocoa butter). Participants and investigators will be blinded to the lotion assignment.

Women will be asked to apply a thin layer of the lotion to their abdomen, breasts and thighs once daily until the date of delivery. Participants will be recruited as early in their pregnancy as possible but will not be asked to start applying the lotion before 12 weeks of pregnancy. Women presenting after 20 weeks of pregnancy will not be eligible to participate in the study. The cocoa butter and placebo lotions have been made up to look, smell and feel the same and will be provided to the participants in identical containers. Women who have known hypersensitivity to cocoa butter or any of the components of the lotion will be excluded from the study.

Participants will be assessed at study entry for presence of stretch marks. Baseline information will be collected at that time including pre-pregnancy weight, skin type, and history of stretch marks in the mother or siblings. Women will then be followed up monthly by telephone to assess compliance with the regimen and ensure that they are not developing skin reactions.

Participants will be assessed for the development of stretch marks after delivery. Women will also be asked to provide their own assessment of their skin condition in terms of presence/absence of stretch marks and their severity.

Eligibility Criteria:
Inclusion Criteria:

* Primigravid women in first trimester of pregnancy

Exclusion Criteria:

* Hypersensitivity of cocoa butter