cyrilzakka/clinical-trials huggingface dataset:
Diclofenac vs. Ropivacaine for Cesarean Section

A prospective, randomized, double blind study designed to investigate analgesic efficacy of wound infusion using diclofenac or ropivacaine following Cesarean section performed via a Pfannenstiel incision.

Study Objective: To assess the analgesic efficacy of diclofenac or ropivacaine when administered via wound infusion.

Design: Prospective, randomized, double-blind, placebo-controlled study. Setting: Large referral hospital. Patients: 75 women recovering from Cesarean section performed via a Pfannenstiel incision.

Interventions: On completion of the surgical procedure, a 15 cm 19G infusion catheter (PAINfusor™, Baxter) will be placed below the fascia. According to a computer generated randomization schedule, patients will be divided into one of three treatment groups (n = 25).

* In Group Control water for injection will be administered.
* In Group Ropivacaine 0.2 % ropivacaine will be administered.
* In Group Diclofenac diclofenac (300 mg/240 ml of water for injection) will be administered.

During the first 6 postoperative hours, a co-investigator will administer "rescue" analgesia (10 ml bolus of infusion drug or rescue morphine). Thereafter, the catheter will be connected to an elastometric pump (LV 10 Infusor, Baxter) filled with either water for injection, ropivacaine 0.2 %, or diclofenac (300 mg/240 ml water for injection). The fluid will be administered as a constant infusion rate (10 mL/hr). Continuous wound infusion will be continued for the subsequent 18 postoperative hours. During this 18 hour period, subcutaneous morphine 4 mg will be administered on patient request for additional analgesia.

Measurements and Main Results: The following parameters will be assessed and recorded:

1. Demographic data
2. Surgical milestones(Anesthetic time, surgical time etc).
3. Incidence of failed intrathecal anesthesia
4. VAS for pain every 15 min during first 6 postoperative hours
5. Time to first pain (intrathecal anesthesia to VAS \> 60 mm)
6. Number of infusion events (10 mL and 5 mL)
7. Rescue morphine administration during first 6 postoperative hours.
8. Subcutaneous morphine administration during subsequent 18 postoperative hours.
9. VAS for pain.
10. The incidence of nausea and vomiting.
11. Patient satisfaction at 24 hours, postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Cesarean section

Exclusion Criteria:

A history of clinically significant disease:

* cardiovascular
* pulmonary
* hepatic
* renal
* neurologic
* psychiatric
* metabolic disease
MOBILE Health Intervention in IntraCerebral Hemorrhage Survivors

This randomized controlled trial investigates the efficacy and safety of mobile health intervention in managing hypertension after Intracerebral Hemorrhage (ICH).

140 ICH survivors will be randomized into mobile health intervention (MOBILE) and the usual care group for hypertension management. All subjects will be educated on the importance of hypertension control after ICH and given lifestyle advice, including the DASH diet. Subjects in the MOBILE group will enter their home blood pressure (BP) measurements into a mobile stroke App (WeRISE) daily, and the study team will regularly review the BP measurements through a backend system. A protocol-based intervention via phone calls, which includes anti-hypertensive drug adjustment and reinforcement of lifestyle modification, will be implemented. Subjects in the usual care group will have their hypertension managed by their respective treating physicians. All subjects will be followed up for 26 weeks. The primary and secondary endpoints include the rate of controlled hypertension at 12 and 26 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Primary ICH Diagnosis
* Age ≥ 18 years
* Discharge Modified Rankin Scale of ≤4

Exclusion Criteria:

* Expected life expectancy of \<1 year
* Patient or caregiver does not have access to WeRISE App.
* Patient or caregiver does not know how to use WeRISE App .
* Inability to perform home BP monitoring
* Inability to participate in follow-up activity
* Contraindication for intensive and rapid lowering of blood pressure (Known \>70% cerebral vascular stenosis; History of fall, dizziness or syncope due to hypotension; Any other medical condition that is deemed contraindicated for low blood pressure
* Bleeding tendency (Platelet count \< 75 x 10\^9/L; Known coagulation disorder)
* Severe renal impairment (Estimated glomerular filtration rate using CKD-EPI formula \<30 ml/min/1.73m2)
* Severe liver impairment (Child-Pugh C cirrhosis)
* Known contraindication or allergy to two or more anti-hypertensive classes
Microbiological Examination of Children Operated for Congenital Lacrimal Stenosis

Children with congenital lacrimal stenosis are treated by probing and intubation of the lacrimal drainage system.

Hypothesis: Microbiological findings at the time of insertion and removal of the silicon intubation have an influence on the clinical outcome and success rate of the surgical treatment. Microbiological specimens are taken from conjunctiva and nasal mucosa during the two procedures under general anaesthesia and from the silicon tube after removal and examined for bacterial contamination.

Children (age 0-14 years) with congenital lacrimal stenosis in whom probing and intubation of the lacrimal drainage system is indicated are included the study after informed written consent by their parents. Microbiological specimens are taken bilaterally from conjunctiva and nasal mucosa during the two procedures under general anaesthesia (insertion and removal of the silicon intubation) and from the silicon tube after removal. Specimens are examined for bacterial contamination. Microbiological findings are correlated with clinical data about the further clinical course and especially the success of the surgical treatment.

Eligibility Criteria:
Inclusion Criteria: age 0-14 years, congenital lacrimal stenosis, informed consent by the parents -

Exclusion Criteria: none

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Anatomic and Biomechanical Investigation on ACL: A Cadaveric Study

The present study was aimed to investigate the kinematics differences between round-tunnel (ROT) and flat-tunnel (FLT) techniques and compare the influence to the anterior root of lateral meniscus (ARLM ) in anterior cruciate ligament (ACL) reconstruction when using hamstring graft.

Nine matched pairs of fresh-frozen cadaveric knees were evaluated for the kinematics of intact, ACL-sectioned, and either ROT or FLT reconstructed knees. The graft bundles for FLT technique were separately tensioned. A 6 degrees of freedom robotic system was used to assess knee laxity: (1) 134-N anterior tibial load at 0°, 15°, 30°, 60°, and 90°of knee ﬂexion. (2) 10-Nm of valgus torque followed by 5-Nm of internal rotation torque simulates a pivot-shift test at 15°, 30°. (3) 5-Nm internal and external rotation torques at 0°, 15°, 30°, 60°, and 90°. (4) 10-Nm varus and valgus torques at 15°, 30°. Coverage of ACL tibial footprint and areas of ARLM attachment before and after reaming were measured using three-dimensional isotropic MRI scanning.

Eligibility Criteria:
Inclusion Criteria:

* intact knee with no previous injures

Exclusion Criteria:

* those with ligamentous injury or a limited range of motion
Trauma-Focused Equine-Assisted Therapy (TF-EAT) for Veterans With PTSD

This study seeks to examine feasibility, acceptability, safety, and preliminary efficacy of Equine-Assisted Therapy for veterans with posttraumatic stress disorder (EAT-PTSD). While several well-studied, validated treatments for PTSD exist, some individuals find these treatments ill-suited, ineffective, or undesirable. EAT is an alternative therapy widely used by organizations, such as PATH International Equine Services, that endorse its effectiveness for treating a variety of mental health issues. These claims have drawn criticism because the published research contains glaring methodological flaws, making it difficult to assess how effective these therapies actually are (Anestis et al., 2014). Equine-assisted therapies present a unique treatment modality that might effectively treat PTSD, particularly for individuals who have difficulty with other treatment modalities. In EAT, a psychotherapist and equine specialist work together to help the patients negotiate interactions with a horse using structured interventions or activities.

In this pilot study the investigators will develop the EAT intervention and determine whether research methods (evaluation interviews, assessment measures, videotaping procedures) are acceptable to participants. Specifically, the investigators will focus on issues such as session length, appropriateness of the "content" for treatment of PTSD, ordering of session content, adherence to the manual of the equine therapeutic team (based on observations made during supervision and feedback from the consultants), and will detail logistics of data collection and how best to record the sessions (camera angles, etc.).

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 70
* Current DSM-5 diagnosis of PTSD as determined by a) full criteria met on CAPS, and b) clinical assessment
* Able to give consent, fluent in English

Exclusion Criteria:

* History of psychiatric diagnosis of psychotic disorder, unstable bipolar disorder
* Elevated depression of clinical concern and/or score of \>25 on the Hamilton Rating Scale for Depression
* At elevated risk for suicide based on history and current mental state
* History of substance/alcohol use disorder at severe level within the past six months, and current diagnosis of substance/alcohol use disorder at a moderate level within past two months
* Fear of horses or other large animals
* Orthopedic or other physical conditions and/or limitations that prevent people from walking unassisted and/or walking freely in the ring.
Alternatives for Reducing Tics in Tourette Syndrome (TS): A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents

This is a study to evaluate the efficacy and safety of deutetrabenazine (TEV-50717) tablets for the reduction of motor and phonic tics associated with TS in children and adolescents 6 through 16 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Participant is 6 to 16 years of age, inclusive.
* Participant weighs at least 44 pounds (20 kilograms \[kg\]).
* The participant's active tics are causing distress or impairment.
* Participant is able to swallow study medication whole.
* Participant is in good general health.
* Women/girls of childbearing potential whose male partners are of childbearing potential must use contraception for the duration of the study.

  * Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Participant has a neurologic disorder other than TS that could obscure the evaluation of tics.
* Participant has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
* Participant has clinically significant depression at screening or baseline.
* Participant has a history of suicidal intent or related behaviors within 2 years of screening.
* Participant has a history of a previous actual, interrupted, or aborted suicide attempt.
* Participant has a first-degree relative who has completed suicide.
* Participant has received comprehensive behavioral intervention for tics (CBIT) for TS or cognitive behavioral therapy (CBT) for obsessive-compulsive disorder (OCD) within 4 weeks of screening.
* Participant has an unstable or serious medical illness at screening or baseline.
* Participant is pregnant or breastfeeding.

  * Additional criteria apply, please contact the investigator for more information.
GER Poses a Potential Risk for Late Complications of BPD

Bronchopulmonary dysplasia (BPD) is a common condition in the low birth weight infants. Although most of the BPD symptoms improved after a regular treatment in infancy, there are still a few late complications left such as the frequent respiratory symptoms, a slower weight gain and even sudden death. These late complications have made so much trouble to the healthcare of BPD infants. How to find the risk factors and to reduce the prevalence of these late symptoms becomes necessary. In this study, a cohort of BPD infants was observed with the late complications obtained by a monthly followed up for 18 months after discharge, the prevalence and risk factors of the late complications of BPD were analyzed by logistic regression. As one of the risk factors, GER was verified whether to play a critical role in these late complications.


Eligibility Criteria:
Inclusion Criteria:

* the extremely premature infants with bronchopulmonary dysplasia

Exclusion Criteria:

* other congenital malformations such as gastrointestinal and or neurogenic disease
High Intensity Interval Training (HIIT) for Patients With Cancer-related Lymphedema in the Lower Limbs

The aim of the study is to explore the feasibility and safety of High Intensity Interval Training on a stationary bike for patients with lymphedema in the lower limbs and the role of compression garments during exercise.

The design of the study is a cross-over randomized clinical trial. Participants will be randomized into two groups. Both will perform two separate exercise sessions.Group A will perform the first exercise with compression garment and the second session without compression garment, with wash-out period of 1 week between sessions. Group B will perform the exercise sessions in the opposite order.

Lymphedema is a condition afflicting cancer patients who undergo surgery with removal of lymph nodes, chemotherapy and radiation. Lymphedema is a consequence of impaired lymphatic drainage in the interstitium, which causes edema and inflammation in the subcutaneous tissue. The symptoms are swelling, puffiness, tightness, heaviness and pain in the affected area.

Lymphedema can be reduced by complete decongestive therapy, which consists of skin care, manual lymphatic drainage, compression bandaging and exercise. At the end of treatment, patients are provided with custommade compression garments to be worn during daytime in order to maintain the reduction in the edema.

Lymphedema has a negative impact on activities of daily living and health-related quality of life. Patients with lymphedema should be encouraged to engage in physical activity despite their condition in order to prevent relapse of cancer and development of other diseases. Likewise physical activity helps to maintain a healthy weight, which is important as obesity has a negative impact on lymphedema. The lymphatic system is also stimulated by physical activity and exercise and can reduce the symptoms from the lymphedema.

Several studies have been published on the safety and benefits of exercise for women with breastcancer related lymphedema. However, only a few studies have investigated the feasibility of exercise to patients with lymphedema in the lower limbs. Also the role of compression garments during exercise have not been throughly explored.

Eligibility Criteria:
Inclusion Criteria:

* unilateral or bilateral lymphedema in the lower limbs
* secondary lymphedema
* wears custommade compression stockings during daytime
* lymphedema in stage 1, 2A or 2B (Classification from the International Society of Lymphology)
* legally competent persons with ability to read and understand Danish.

Exclusion Criteria:

* inability to perform the intervention, as assessed by the person performing inclusion.
* lymphedema in stage 0 or 3 (Classification from the International Society of Lymphology)
* ongoing complete decongestive lymphedema therapy
* untreated erysipelas
* ongoing oncologic treatment: chemotherapy, radiation, immune therapy,
* known metastatic cancer
* comorbidities e.g. deep venenous thrombosis, serious heart disease, renal insufficiency
Sevelamer Hydrochloride in Peritoneal Dialysis Patients

To test the hypothesis that second-line fixed low-dose sevelamer hydrochloride therapy is as effective as first-line high-dose sevelamer hydrochloride therapy in limiting the progression of cardiovascular calcification.

Cardiovascular disease accounts for nearly 50% of the mortality and is the most frequent cause of hospitalization in ESRD patients. Hyperphosphatemia is increasingly recognized to be an important predictor of mortality and cardiovascular death in ESRD patients and is largely attributed to the increased prevalence of vascular calcification.

Eligibility Criteria:
Inclusion Criteria:

* ESRD patients receiving long-term peritoneal dialysis treatment with hyperphosphatemia currently receiving aluminum-based phosphorus binders or whose phosphorus control remains suboptimal with calcium-based binders only
* Patients who cannot afford to self-pay sevelamer hydrochloride.
* Patients who provided informed consent for the study

Exclusion Criteria:

* Patients with underlying active malignancy
* Patients with cyanotic congenital heart disease
* Patients with poor general condition
* Patients with plan for living related kidney transplant within coming 1 year
* Female patients with pregnancy
Penetrating Cardiac Injuries: Outcome of Treatment From a Level 1 Trauma Centre in South

Retrospective observational study design auditing the outcomes of cardiac injuries in a single centre

retrospective study over a two-year period. The demographics, injury sustained, clinical physiological parameters, mechanism of injury, injury site and patterns, outcomes and in-hospital mortality description of patients who were admitted at a single centre for further management of their cardiac injuries. Investigations performed, and procedures that were undertaken were also documented. Descriptive statistical analysis was performed. P-value of \<0,05 was considered clinically significant.

Eligibility Criteria:
Inclusion Criteria: All Priority one penetrating cardiac injuries seen at CMJAH in patients who were 18 years and older -

Exclusion Criteria: Dead on arrival

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Virtual Reality Decreases Child Anxiety and Pain as Well as Caregiver Anxiety and Pain Perception During Orthopaedic Clinic Office Procedures

The purpose of this study is to demonstrate that the use of a virtual reality experience can decrease child and caregiver anxiety and pain for simple orthopaedic office procedures.


Eligibility Criteria:
Inclusion Criteria for pediatric patient:

* Undergoing cast removal, pin removal, or suture removal in study affiliated clinic
* Less than 17 years old

Exclusion Criteria for pediatric patient:

* History of seizures
* Pregnant, have preexisting binocular vision abnormalities or psychiatric disorders, or suffer from a heart condition or other serious medical condition
* Patients can't have implanted medical devices including cardiac pacemakers, hearing aids and defibrillators

There is no minimum or maximum age for the Caretakers/Parents.
Short-Term Outcomes of Total Shoulder Arthroplasty Using the Titan Modular Total Shoulder System

The goals of total, reverse total and hemi shoulder arthroplasty are the same, to alleviate the patient's pain and obtain a full functional recovery. This outcome depends on the surgeon's ability to reproduce normal glenohumeral anatomy including bone morphology, capsular tension and rotator cuff function. Shoulder arthroplasty has become a safe and effective treatment for various diseases of the shoulder. This study goal is to document and report the short-term functional, radiographic, and quality of life outcomes of total shoulder arthroplasty (TSA) using the titan modular shoulder system.


Eligibility Criteria:
Inclusion Criteria:

* Total shoulder arthroplasty using the Titan Modular Total Shoulder System

Exclusion Criteria:

* Declining to participate
Validation IMU and EMG Algorithms in Stroke Patients

The objective is to validate the algorithms for movement analysis that were developed previously in healthy participants, in a small study with stroke patients. Stroke subjects will be measured while performing tasks like walking, sitting and standing while wearing light-weight inertial measurements units (IMUs) incorporating 3D accelerometers, 3D gyroscopes and surface electromyography. During the measurements subjects will be recorded on video that serves as ground truth when validating the implemented algorithms for movement analysis. A face blurring program will be used for all video footage.

Subjects will perform the following tasks: 30 sec stationary sitting/standing/lying; 10m walk test; L-test; 8-figure walking test; daily life task; stepping over small obstacles; walk in the corridor. During the measurments IMU will be placed at: sternum; sacrum; bilateral wrists; bilateral shanks; bilateral upper legs; both feet. Surface EMG of bilateral rectus femoris; vastus lateralis; medial gastrocnemius and soleus will be measured.

Eligibility Criteria:
Inclusion Criteria:

* min 18 yrs of age; history of previous stroke; unilateral affected;able to walk without supervision (FAC-score min 4);able to perform activities of daily living without assistance (self-reported); written informed consent.

Exclusion Criteria:

* subjects with neurological or motor disorders that could interfere with the measurements (other than stroke) or severe deficits in communication, memory and understanding.
The Efficacy of 10-day or 14-day Course of Bismuth-containing Quadruple Therapy:A Randomized Clinical Trial

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. The subjects were randomized to receive a 10-day or 14-day course of Tegoprazan bismuth-containing quadruple eradication therapy at 6 weeks after treatment, subjects underwent another 13C-urea breath test. Calculate the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group.

The researchers collect treatment-naive H.pylori-positive patients from the outpatient clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a 10-day or 14-day course of Tegoprazan bismuth-containing quadruple eradication therapy. The medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13C-urea breath test, and the researcher records the results.

After all subjects were tested, the eradication rates, adverse reaction rates, patient compliance and cost-effectiveness index of each group were calculated.

According to the course of treatment, it is randomized into a 10-day treatment group and a 14-day treatment group. The two groups of bismuth quadruple regimens are the same, as follows:

Amoxicillin 1000mg bid+ Tetracycline 500mg qid+ Bismuth + Tegoprazan 50mg bid

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70.
* Patients with H.pylori infection (Positive for any of the following: 13C/14C-urea breath test, histopathology test, rapid urease test, stool H.pylori antigen test).
* Patients who have not previously received helicobacter pylori eradication therapy

Exclusion Criteria:

* Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
* Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
* Patients with active gastrointestinal bleeding.
* Patients with a history of upper gastrointestinal surgery.
* Patients allergic to treatment drugs.
* Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
* Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
* Patients who are unwilling or incapable to provide informed consents.