cyrilzakka/clinical-trials huggingface dataset:
Pain After Laparoscopic Cholecystectomy With Bilateral Tranversus Abdominis Plane (TAP) Block Versus Local Anesthetic Infiltration

The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy.

Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce postoperative pain scores when compared to conventional postoperative pain control with local infiltration of trochar insertion sites.

The purpose if to find out if analgesia with bilateral ultrasound-guided Tranversus Abdominis Plane (TAP) block with Ropivacaine 0.5% is better than analgesia with local infiltration of trochar sites with Ropivacaine 0.5% in patients undergoing laparoscopic cholecystectomy.

Our hypothesis is that in laparoscopic cholecystectomy, bilateral TAP blocks will reduce postoperative pain scores when compared to conventional postoperative pain control with local infiltration of trochar insertion sites.

Eligibility Criteria:
Inclusion Criteria:

1. Patient ages 18-64
2. American Society of Anesthesiology Physical Status I, II or III
3. Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital

Exclusion Criteria:

1. Open cholecystectomy - excluded due to increased levels of pain in open procedures
2. Scheduled for ambulatory surgery
3. Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
4. Coagulopathy or anticoagulation - increased risk of bleeding from nerve block injection
5. Allergy or contraindication to any of the study medications or anesthetic agents
6. Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
7. Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
8. Pregnancy
9. Prisoners
10. Patient or surgeon refusal
Coherence Training for Military Personnel

Military operations and training situations present many physical and psychological challenges for service members to adapt to and overcome. The challenges of these changing conditions necessitate having to cope with stress, which is seen as the negative perceptions, feelings, and emotions that manifest from the subjective physical and/or mental strain on life processes. In addition, service members are returning from deployments having gone through traumatic experiences that can develop into posttraumatic stress disorder (PTSD), depression or other serious conditions. The Surface Warfare Independent Duty Corpsman (IDC) School is an example of a training environment where some students may be entering the program with symptoms of PTSD, which may preclude or make it more difficult for them to perform well. Autonomic nervous system (ANS) dysregulation has been observed in patients with PTSD and those experiencing chronic stress, such that there is more arousing, sympathetic input to the heart than calming, parasympathetic input, which is usually the dominant division of the ANS involved in controlling one's heart rate. The IDC training program is an example of an environment where the service member is expected to excel while being subjected to multiple sources of stress. The fast tempo coupled with performance expectations may induce stress and actually inhibit learning. The Institute of HeartMath has developed the Coherence Advantage program which teaches one to self-regulate their emotions while focusing on breathing to compliment the active process of self-regulation. In conjunction, the emWave Personal Stress Reliever allows the user to receive heart rate variability (HRV) biofeedback, hence giving the user the opportunity to self-regulate their ANS through breathing and self-regulation techniques. The proposed study will test the effectiveness of the Coherence Advantage program versus progressive muscle relaxation (PMR) in reducing stress symptomatology among Surface Warfare IDC students. The effectiveness of these two different interventions will be compared on outcomes of PTSD, depression, anxiety, sleep quality, perceived stress, attrition, and class performance.


Eligibility Criteria:
Inclusion Criteria:

* Sailors
* Enrolled as students in the Surface Warfare Medicine Institute's Independent Duty Corpsman School

Exclusion Criteria:

* Administratively rolled over into another class
* Dropped out of the school (due to academic or medical reasons)
A Clinical Study of Mass Balance of [14C]HRS-7535

The objective is to evaluate the mass balance of \[14C\]HRS-7535 in healthy adult Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must voluntarily sign the informed consent form (ICF) prior to any activities related to the study, demonstrate understanding of the study procedures and methods, and commit to strictly adhering to the clinical trial protocol to complete the study.
2. Healthy male subjects aged between 18 and 45 years (inclusive), determined at the time of signing the informed consent.
3. Male subjects must weigh ≥ 50 kg and have a body mass index (BMI) between 19 and 26 kg/m² (inclusive).
4. Male subjects with female partners of childbearing potential must have no plans for procreation or sperm donation from the time of signing the informed consent until one year after the last dose of the study drug. They must also agree to use highly effective contraception methods (including their partners) during this period.

Exclusion Criteria:

1. Subjects with abnormalities identified through a comprehensive physical examination, vital signs assessment, laboratory tests, chest X-ray, 12-lead ECG, or abdominal ultrasound that are deemed clinically significant by the investigator.
2. Subjects with QTcF ≥ 450 msec at screening or baseline, or any other abnormalities considered clinically significant by the investigator.
3. Subjects who test positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antigen/antibody combination, or syphilis-specific antibodies.
4. Subjects with a history of drug abuse, drug dependence (based on medical history), or those who test positive for drug abuse during urine screening prior to dosing.
5. Subjects who have used any prescription drugs, over-the-counter medications, herbal medicines, or dietary supplements within 2 weeks prior to screening.
Evaluate the Efficacy and Safety of DWJ108J

This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg) in patients with central precocious puberty.

The drug in this study is called leuprorelin. It is administered as a 3 month subcutaneous depot injection. Leuprorelin is used to treat children who have Central Precocious Puberty. This study will look at whether leuprorelin can stop early Central Precocious Puberty.

Eligibility Criteria:
Inclusion Criteria:

1. Exhibited pubertal response of LH (peak ≥ 5 IU/L) during GnRH stimulation test at screening
2. Diagnosis of central precocious puberty
3. For boys, those under 10 years old and for girls, those under 9 years old, based on Visit 2 (Enrollment), with Tanner Stage 2 or above
4. Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year
5. In cases where the legal guardian of the child listened to the explanation of this clinical trial and provided written consent

Exclusion Criteria:

1. Following conditions at Visit 1(Screening) :

   Conditions related to pseudo precocious puberty, Incomplete precocious puberty, Dysfunction of pituitary, adrenal, thyroid, or reproductive glands, Growth disorders or bone diseases that could affect bone growth, Brain tumor, Pituitary adenoma
2. requires treatment within 6 months of receiving a registration number during the trial period that could affect the hypothalamic-pituitary-gonadal axis
3. Prior treatment with GnRH analogues
4. Hypersensitive to the investigational drug for this clinical trial or GnRH analogues
5. Prior or current therapy with growth hormone
6. has taken the following medications within 8 weeks of Visit 1 (Screening): Sex hormone medications, Sex hormone antagonists, Steroids (local application is allowed; oral formulations are not allowed if taken within 3 days continuously, and use within 2 weeks of screening is prohibited), Herbal medicine
7. Meets the following criteria based on screening test results:

   AST, ALT levels exceed twice the upper limit of normal, Creatinine levels exceed 1.5 times the upper limit of normal, Bone age is above 11.5 years
8. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study
Accuracy of Open-source Software in Semi-automatic 3-Dimensional Reconstruction of the Mandible

Concomitant to the evolution of CBCT devices, several post-processing software packages were developed for producing 3D-printed models of anatomical structures. In the last few years, several open-source software used as an alternative to commercial software for 3D reconstruction of anatomical structures such as the mandible. However, no sufficient evidence validating the accuracy of this open-source software.

3D rendering of craniomaxillofacial structures is based on the segmentation process. Semi-automatic segmentation has been pointed out as the technique of choice since it combines the high efficiency and repeatability of the automatic methods with the experience of an operator. Although the creation of 3D models is very important, it is still not a common procedure, since commercial software often requires higher electronic computer power and is licensed by its manufacturer, increasing the financial costs. In the last few years, several open-source software can be obtained for free such as ITK-Snap and 3D Slicer, which could provide more economical options for clinicians or researchers in patient management. However, no sufficient evidence validating the accuracy of this open-source software in detecting the volumetric and morphological characteristics of craniomaxillofacial structures.

Eligibility Criteria:
Inclusion Criteria:

* Good quality CBCT scans.
* Field of view (FOV) including the whole mandibular bone.
* Absence of artifacts, dental implants, craniofacial deformities, and temporomandibular disorders.

Exclusion Criteria:

* Low-quality CBCT scans.
* FOV not including the whole mandibular bone.
* Presence of artifacts, dental implants, craniofacial deformities, and temporomandibular disorders.
Effect of Levodopa-Carbidopa on Visual Function in Patients With Recent-Onset Nonarteritic Anterior Ischemic Optic Neuropathy

Purpose: There are some controversies about the effect of Levodopa-Carbidopa on treatment of non-arteritic anterior ischemic optic neuropathy (NAION). This study was performed to evaluate the effect of Levodopa-Carbidopa on visual acuity, color vision, and visual field in patients with recent onset NAION (less than 6 weeks duration).

Patients and Methods: In this double-blind randomized clinical trial, 13 patients were treated with levodopa-carbidopa and 12 patients took placebo for 3 weeks. Visual acuity, color vision, and visual field were tested before and at 4th, 12th, 16th, and 24th weeks after enrollment, and evaluated.


Eligibility Criteria:
Inclusion Criteria:

* age greater than 50 years old
* first ophthalmic examination within 6 weeks after onset of disease
* presence of optic disc swelling followed by optic atrophy within 6 weeks
* altitudinal, central or generalized visual field defect
* normal ESR

Exclusion Criteria:

* confirmed giant cell arteritis
* history of any ocular surgeries
* optic neuropathy due to acute bleeding
* advanced diabetic retinopathy
* uncontrolled glaucoma
* any ocular disorders that cause visual acuity reduction rather than NAION
Neonatal Intensive Care Unit Virtual Family-Centered Rounds

The aim of this study is to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes.


Eligibility Criteria:
Enrolling family units (which consists of INFANTS and PARENTS \[SURVEYS\]):

INFANT Inclusion

* Infants aged less than 365 days who are admitted to the NICU
* Have at least one adult parent or guardian with English proficiency

INFANT Exclusion

* Have restrictions placed by child protective services, including visitation restrictions or restricted access to patient information
* Infants with a previous NICU admission (and enrollment) during the trial period

PARENTS \[SURVEYS\] Inclusion

* Parents/guardians of the eligible infants (described above)
* Age 18 years and older

PARENTS \[SURVEYS\] Exclusion

* Age less than 18 years
* Non-English speaking
Alogliptin/Pioglitazone (Liovel) Combination Tablets Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus

The purpose of this survey is to examine the safety and efficacy of long-term use of alogliptin/pioglitazone(Liovel) combination tablets in patients with type 2 diabetes mellitus determined as warranting combination therapy with alogliptin benzoate and pioglitazone hydrochloride

This is a special drug use surveillance on long-term use of alogliptin/pioglitazone combination tablets. This study is designed to investigate the safety and efficacy of long-term use of alogliptin/pioglitazone combination tablet in patients with type 2 diabetes mellitus in the routine clinical setting.

Participants will be patients with type 2 diabetes mellitus. The planned sample size is 3000.

The usual adult dosage is 1 tablet (containing alogliptin/pioglitazone at either 25 mg/15 mg or 25 mg/30 mg) taken orally once daily before or after breakfast.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus

Exclusion Criteria:

* Patients meeting any of the following criteria will be excluded:

  1. Patients with current cardiac failure or a past history of cardiac failure
  2. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
  3. Patients with serious hepatic dysfunction
  4. Patients with serious renal dysfunction
  5. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury
  6. Patients with a history of hypersensitivity to any ingredients of Alogliptin/Pioglitazone
  7. Pregnant or possibly pregnant women
Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis

To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1% OPA-15406 when applied twice daily for 4 weeks in pediatric patients with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka

Exclusion Criteria:

* Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a sudden intensification of atopic dermatitis.
* Subjects who have an active viral skin infection.
* Subjects with a current or history of malignancy.
Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.

This study is designed to determine whether intratracheal administration of budesonide combined with surfactant, as compared to surfactant alone, will modify ecographic (lung ultrasound score) and biological markers (IL-6 concentration in respiratory secretions) at 7 days of life in preterm infants ≤32 weeks of gestational age (GA).

Bronchopulmonary dysplasia (BPD) is one of the main morbidities associated with extreme prematurity and, despite the improvement of respiratory care in the latest years, overall incidence is not decreasing. Etiology of BPD is multifactorial and local inflammation plays an important role in it, therfore, local anti-inflammatory drugs could be effective in preventing BPD.

Recent randomised trials have shown a lower incidence of BPD/death with the use of a combination of budesonide with surfactat compared to surfactant alone, and further clinical trials are currently ongoing.

This is a controlled phase IV, randomised, unicenter clinical trial designed to evaluate the effect of intratracheal administration of budesonide combined with surfactant, as compared to surfactant alone, in BPD in preterm infants ≤32 weeks of GA. Investigators will compare ecographic and biological markers, as well as respiratory outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Infants born equal or earlier than 32 weeks of gestational age admitted in the Neonatal Intensive Care Unit.
* Parental consent signed.
* Less than or equal to 48 hours postnatal age.

Exclusion Criteria:

* Infants with known major congenital anomalies (eg. congenital upper airwayobstruction, congenital lung anomaly, severe pulmonary hypoplasia, hydrops,neuromuscular diseases, chromosomopaties)
* Infants with poor prognosis and risk of imminent death
* Infants who have received the first dose of surfactant before of the enrolment to the study.
Dexamethasone-implant for the Treatment of RVO

To evaluate the efficacy and safety of a dexamethasone-implant alone or in combination with bevacizumab. 64 eyes are prospectively investigated. Group 1 (22 CRVO and 16 BRVO) is treated with dexamethasone-implant alone, Group 2 (14 CRVO 12 BRVO) with three consecutive bevacizumab injections followed by a dexamethasone-implant. Recurrences are treated with dexamethasone-implant only. Patients are seen preoperatively and thereafter in monthly intervals. The primary endpoint was BCVA at twelve months.


Eligibility Criteria:
Inclusion Criteria: maximum duration of symptoms of four months and no known history of glaucoma or corticosteroid response in the past -

Exclusion Criteria: Glaucoma, Diabetic Retinopathy, prior IVOM, Uveitis

-
All in the Family: Promoting Family Function Through Physical Activity

While the primary aim is to improve family functioning via child moderate-vigorous physical activity (MVPA) and parent-child co-physical activity (PA), the proposed driver of these outcomes is parental support of child PA. Most theoretical models applied to understand parental support in family interventions have been social cognitive in nature, where intention is considered the proximal antecedent to behavior, it is not surprising that past approaches in family PA promotion center heavily on the antecedents of intention such as attitudes and perceived control. Nevertheless, a low correlation between intention and behavior in parental support of child PA has been demonstrated Thus, there is a need to continue to improve the effectiveness of family-based interventions in ways to sustain initial behavioral changes. Family-based promotion initiatives are also very timely because parents and children represent low activity groups

The primary objective of this study is to test the efficacy of three Physical Activity (PA) parenting support promotion approaches on key family function outcomes (e.g., cohesion, organization) among parents of children who were not participating in regular PA at baseline of the study. The secondary objectives are to examine whether these approaches: 1) produce differences in child moderate-vigorous intensity PA (MVPA) and parent-child intergenerational PA, and 2) predict PA using the Multi-Process Action Control Framework (MPAC) augmented to include family social PA identity. Primary Question: Does 1) the promotion of a PA parenting identities+self-regulation skills+education (ID) increase family function outcomes (particularly family cohesion, and family organization) compared with 2) promotion of PA parenting self-regulation skills+education (SR), and 3) an education about PA control condition (ED)? Secondary Question: Does 1) the ID condition increase child moderate to vigorous PA (MVPA) and parent-child co-PA compared with 2) the SR condition and 3) the ED condition? Hypothesis: The ID condition will show significantly larger changes in these PA outcomes compared to the two other conditions after six-months (primary end-point). Further, the SR condition will show significantly larger changes in PA outcomes compared to the ED condition after six-months.

Eligibility Criteria:
Inclusion Criteria:

Participants will be at least one parent with at least one child between the ages of 6 and 10 years.

Families (parents and/or guardians and children) residing in Canada. Children that participate in \<60 minutes/day of moderate to vigorous physical activity (MVPA

Exclusion Criteria:

If child is meeting the current physical activity guidelines \>=60 minutes a day of moderate to vigorous physical activity per day.

If participant does not pass Physical Activity Readiness Questionnaire (PARQ)
Improved Patient Safety for Acute Restless Medical Patients With Supplemental Observation

The aim of the study is to investigate whether supplemental camera observation directly linked to the nurse's phone will improve patient safety for acute medical care patients', who are restless, confused or in risk of development of acute delirium. The setting is an acute medical care ward.

The expected result is a reduced incidence of patients with delirious condition, patients who fall or unintentionally remove intravenous access or catheters. Thus, higher patient safety and more efficient patient trajectories are expected, as well as a reduced need for treatment, care and rehabilitation after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 years of age with a CAM score of 2 or higher.

Exclusion Criteria:

* paranoia
* severe dementia
* suicidal
* need for permanent guard
Claudication, Systematic Evaluation of Limp on Treadmill

Vascular claudication is a common cause of functional limitation. This painful condition is a source overall muscle deconditioning in the peripheral arterial diseased (PAD) patient leading gradually to a state accented inactivity. The characterization of the claudication as it results from a proximal or distal ischemia has never carried out. Investigators will analyze dynamic pedometer parameter throughout walking tests in PAD patients with claudication

Patients referred for exercise tests on treadmill for the quantification of walking ability will gave a recording of their walking parameters through an instrumented treadmill recording biomechanic parameters (surface electromyography, walking pace; force of the foot/treadmill interface, length of the step.. etc.) Analysis will be performed until walking is stopped due to usual claudication during a constant load 2 miles per hour 10% slope treadmill procedure.

Eligibility Criteria:
Inclusion Criteria:

* Referred for treadmill testing
* Age \> 18
* Claudication
* Covered by the French Healthcare system
* Consent to participate

Exclusion Criteria:

* Unstable angina
* History of lower limb osteo articular rheumatologic disease
* Lower limb amputation
* Cardiac or respiratory failure
* Neurologic disease