cyrilzakka/clinical-trials huggingface dataset:
Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section

Maternal hypotension after spinal anesthesia in parturients undergoing cesarean section is a very common problem leading to several complications to both patients and their babies. It can cause maternal discomfort, lightheadedness, nausea and vomiting. The most important complication is the decreasing blood flow to babies; which may lead to fetal acidosis.

Many interventions has been studied in order to prevent hypotension after spinal anesthesia in cesarean section e.g., fluid loading: colloid vs crystalloid, medications: ephedrine, phenylephrine, and metaraminol, etc. The recent study showed ondansetron (the antiemetic drug) can be effectively used to prevent hypotension after spinal anesthesia in normal patients or parturients. The action of ondansetron is believed to inhibit Bezold-Jarish reflex.

This aim of this study is to compare the efficacy of ephedrine and ondansetron in the prevention of maternal hypotension after spinal anesthesia in cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Elective cesarean section
* Patient accept spinal anesthesia
* ASA classification I-II
* Term, Singleton pregnancy
* Understand all process in this study

Exclusion Criteria:

* DM any type that not the gestational DM
* Hypertensive disorder
* BMI\>40
* Complicated pregnancy such as placenta previa, preeclampsia
* Allergic to study drugs
* Long QT syndrome
* Contraindication to spinal anesthesia
Effectiveness of Exercise Programs Following Total Hip and Knee Joint Arthroplasty

The purpose of the study was to evaluate the effectiveness of balance exercises added to typical joint range of motion and muscle strengthening exercises on balance in patients following total hip or knee joint arthroplasty

Rehabilitation program following total hip and knee joint arthroplasty typically focus on joint range of motion and muscle strengthening exercises. Although the balance ability of these patients tends to be reduced, leading to limitations in mobility and activities of daily living, clinicians often assume that strength and joint range of motion exercises will ultimately lead to improvement in balance, making the typical exercise programs appropriate. However, the feasibility and effectiveness of introducing balance specific exercises during the post-operative period is unclear.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary unilateral total hip or knee joint arthroplasty.
* Patients who had been advised to weight bear as tolerated following surgery.

Exclusion Criteria:

* Patients who had been advised by their surgeon to remain non-weight bearing or partial weight bearing on the operated leg or unoperated leg.
* Patients with neurological conditions such as hemiplegia, peripheral neuropathy, Parkinsons disease, multiple sclerosis, or spinal cord compression that might affect balance.
Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)

This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.

This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections of the hip or knee caused by at least 1 of the following organisms: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus spp., Enterococcus faecium, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, or Klebsiella pneumoniae.

This study will compare the safety and efficacy of DAIR procedure + Phage Therapy + Antibiotics versus DAIR procedure + Placebo + Antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥18 years of age
* Recurrent PJI of the knee or hip
* Female patients of childbearing potential who agree to use contraception.
* Confirmed phage match
* No anticipated need for long-term antibiotics

Exclusion Criteria:

* Soft tissue defect requiring reconstruction
* Hardware misalignment
* Additional orthopedic hardware in connection with the infected prosthesis
* Active infection (other than PJI) requiring long term IV antibiotics
* Unable to tolerate SAT
* Septic shock or hemodynamic instability
* Stage 4 or greater chronic kidney disease
* Liver disease
* Decompensated heart failure
* Positive drug screen
* Receiving chemotherapy
* Immunocompromised
* Treatment with antiviral medication within 2 weeks prior to randomization
* Currently participating in another clinical trial
* Known phage allergy
* Pregnant/ breast feeding
* Lack of capacity to consent
Stroke Arrhythmia Monitoring Database

Cardiac arrhythmia are frequently observed after stroke. They may on one hand be causative for the stroke mainly in case of atrial fibrillation but on the other hand present severe complications of the stroke. In addition, cardiac comorbidity as well as acute myocardial infarction are frequently found in acute stroke patients. Diagnostics to identify cardiac arrhythmia in the acute phase of stroke care thus have an important role not only for adjusting the correct secondary prevention but also to prevent cardiac complications potentially reducing morbidity and mortality.

The aim of the SAMBA-Study is to systematically assess the prevalence of higher grade arrhythmias after stroke using a standardized reading of 72h telemetric monitoring in the first days after stroke onset. In addition, it evaluates different strategies to identify paroxysmal atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated on the stroke unit
* Patients with telemetric monitoring

Exclusion Criteria:

* None
Mandala Colouring On Anxiety, Depression, Pain And Quality of Life

The research was conducted as an experimental research to determine the effect of mandala painting on pain, anxiety, depression and quality of life in patients undergoing hemodialysis.

The effect of mandala painting on pain, anxiety, depression and quality of life in patients undergoing hemodialysis.

Eligibility Criteria:
Inclusion Criteria:

be over 18 Ability to communicate adequately Absence of psychiatric problems Volunteering to participate in the research Receiving hemodialysis treatment for at least 3 months

Exclusion Criteria:

None
Costal Cartilage Donor-site Pain: Does Abdominal Muscle Infiltration Analgesia Work?

Donor-site pain is an adverse effect of autologous ear reconstruction. A well-planned pain management protocol is needed. The objective of this study was to introduce rectus abdominis and external oblique muscle infiltration analgesia (RAM+EOM-IA) in autologous ear reconstruction and to evaluate its efficacy and safety.

Patients were included in two cohorts: intermittent RAM+EOM-IA combined with intravenous patient-controlled anesthesia (IPCA) and IPCA alone. The primary outcome was the numerical rating score (NRS) of pain recorded during 48 h postoperatively. Secondary outcomes included the Barthel index and rescue analgesic consumption. Additionally, areas of sensory block were tested using a cold stimulus.

Eligibility Criteria:
Inclusion Criteria:

* All patients were microtia and underwent the first stage of autologous ear reconstruction by the same experienced surgeon in First Affiliated Hospital of Fujian Medical University.

Exclusion Criteria:

* Patients were excluded if they over 18 years old; discontinued analgesic therapy; regularly used opioids, other analgesics, sedative medications, or corticosteroids; were unable to express pain scores due to comorbidities such as mental retardation; or had incomplete data.
ATFL Evaluation With Ultrasound in Stroke Patients

ATFL thickness increases on the affected side of stroke patients and the homogeneous fibrillar structure is deteriorated.We aim to compare morphology of ATFL and Achilles tendon on the affected and unaffected sides using ultrasound in hemiplegic patients.

Age, gender, BMI, time elapsed after the event (months), Brunstrom motor stages and Barthel Activities of Daily Living index of the patients will be recorded. Modified Ashworth Scale and Tardieu scale are used to determine the muscle tone in the gastrocnemius, soleus and tibialis posterior of the hemiplegic side.

ATFL and Achilles tendon will be evaluated using a 12 MHz linear probe of the Toshibo Aplio 500 USG device.ATFL and Achilles tendon signal will be evaluated with reference to contralateral features.

ATFL will be evaluated while the patient lying in the supine position with knee flexion and ankle slight plantarflexion and inversion.The probe will be placed anterolaterally between the lateral malleolus and the talus and a longitudinal image of the ATFL is obtained.

Achilles tendon will be evaluated with the patient lying in the prone position and the ankle at 90 degrees neutral.

ATFL and Achilles tendon signal will be evaluated and noted as homogeneous normal fibrillary structure or heterogeneous.All ultrasound measurements will be performed twice with the patients in the same position.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering cerebrovascular accident associated stroke for the first time with a cortical or subcortical unilateral ischemia or hemorrhage
* Patients over the age of 18

Exclusion Criteria:

* Patients who were medically unstable
* Patients who had Botulinum Toxin A injection into any muscle in the last 6 months
* Patients who had other systemic neuromuscular disease
* Patients who had a previous orthopedic or neuromuscular injury to the lower extremity
* Patients who had a skin lesion at the measurement site
The Evaluation of a Noninvasive Respiratory Monitor in Pediatric Patients Undergoing General Anesthesia

Pediatric postoperative patients are at increased risk for post-operative respiratory complications such as hypoventilation. There is no objective measure of early respiratory parameters that would predict respiratory compromise after surgery efficiently in pediatric patients. Current respiratory assessment in non-intubated patients relies on oximetry data, impendence respiratory rate monitor and subjective clinical assessment. Pulse oximetry has been extremely helpful in recognizing oxygen desaturations but it is a late indicator of respiratory decline. New advances in technology and digital signal processing have led to the development of an improved impedance based Respiratory Volume Monitor (RVM). The RVM (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation (MV) and respiratory rate (RR) mostly in adult patients. The investigators' primary hypothesis is that the non-invasive, impedance-based RVM monitor will accurately reflect TV, RR and MV in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients between the ages of 1 year and 17 years
* ASA status of 1-3
* scheduled to undergo a procedure with general anesthesia at Boston Children's Hospital

Exclusion Criteria:

* Patients undergoing an emergency procedure or a
* patients undergoing a procedure where the study monitor will interfere with the surgical procedure site or standard of care
* preexisting respiratory disease
* muscular disease affecting the respiratory system
Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in infants and children aged from 6 months to 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Infants and children aged from 3 months to 5 years old;
* The legal representative voluntarily agrees to participate in the study and signed the informed consent form;
* The legal representative voluntarily agrees to comply with the requirements of the clinical study protocol, and they can participate in all planned follow-up;
* Subjects who didn't immuned with attenuated live vaccine within 14 days and inactivated vaccine within 7 days before vaccination;
* Axillary temperature ≤37.0℃;
* According to the medical history, physical examination and the judgment of the researcher, it is determined that the subject is in good physical condition.

Exclusion Criteria:

* Previous proven history of bacillary dysentery;
* Subjects who are allergic to tetanus toxoid, and have any history of other vaccination or drug allergy, or a fever above 39.5 ℃ after previous vaccination;
* Within 3 days before vaccination, suffering from acute diseases or in the acute episode of chronic disease or using antipyretic, analgesic and antiallergic drugs (such as acetaminophen, ibuprofen, etc.);
* Had severe bowel disease, and had symptoms such as diarrhea, abdominal pain, pus and blood stool and other symptoms in the past 3 days;
* With pathological jaundice confirmed by existing diagnosis;
* History of thrombocytopenia or other coagulation disorders with definite diagnosis;
* Known or suspected immunological deficiency (such as perianal abscess, which indicates that infants may have immune deficiency), and received long-term (≥14 days) immunosuppressive therapy (radiotherapy, chemotherapy, systemic glucocorticosteroids≥2 mg/kg/day, antimetabolic drugs and cytotoxic drugs) within half a year before vaccination, or confirmed that the parents were HIV infected;
* Received immunoglobulin / blood products treatment within 3 months before vaccination;
* Severe congenital malformations (functional impairment of important organs), severe malnutrition, developmental disorders and serious genetic diseases (such as severe thalassemia);
* Subjects with the following diseases:

  1. Serious liver and kidney diseases, cardiovascular diseases, malignant tumors and other chronic diseases;
  2. Diagnosis with infectious diseases such as tuberculosis, viral hepatitis and so on;
  3. Severe asthma;
  4. Systemic rash, dermatophyte, skin suppuration or blister;
  5. History or family history of convulsion, epilepsy, encephalopathy, mental illness;
* Planning to participate or currently participating in clinical trials of other vaccines or drugs;
* Any situation that the investigator believed may affect the study evaluation.
Prosocial Behavior and Volunteerism to Promote Physical Activity in Older Adults

The purpose of this 12-month study is to compare how well two programs help older adults make physical activity a regular habit.

Although only a small percentage of older adults engage in habitual physical activity, previous studies have demonstrated interventions that include cognitive-behavioral strategies can enhance long-term, independent physical activity. In addition, there are episodic charity events, such as charity walks, that attract large numbers of participants of all age ranges to engage in moderate-intensity physical activity. These actions are a form of prosocial behavior, defined as voluntary, intentional behavior that results in benefits for another. The opportunity to help others seems to be a motive in inspiring these individuals to at least engage in one session of moderate physical activity. Thus, the current research project contemplates whether prosocial behavior may be implemented as a viable behavioral incentive for long-term physical activity.

Participants in the Prosocial Behavior Physical Activity (PBPA) intervention will receive a cognitive-behavioral intervention to teach participants the behavioral skills necessary to engage in long-term (12-month) independent physical activity. Participants in the Healthy Aging (HA) intervention will receive excellent educational sessions based on a number of topics of relevance to older adults. Both programs will provide supervised stretching sessions so that participants learn how to safely and effectively improve flexibility, which helps reduce the likelihood of falls and disability. However, the PBPA intervention will also allow participants to earn food for donation to Second Harvest Food Bank based on their regular physical activity and volunteer time.

Eligibility Criteria:
Inclusion Criteria:

* age 55 years or older
* physically underactive
* no evidence of any major psychological illness
* residence within 20 miles of study site
* plans to remain in area for duration of study

Exclusion Criteria:

* currently engaging in regular physical activity
* self-reported evidence of cardiovascular disease
* self-reported evidence of diabetes
* self-reported falling within the past year
* alcohol consumption greater than 14 drinks per week
* inability to understand English
* plans to move from area
* participation in another medical intervention study
* severe hearing or sight impairments
Effect of Botulinum Toxin Type A Associated With Physical Therapy on Children With Spastic Cerebral Palsy

Purpose: The aim of this study was investigate the effects of botulinum toxin type A (BoNT-A) associated with physical therapy on the functional capacity of children with spastic cerebral palsy (CP). Material and methods: Twenty-four children with spastic CP were concealed and randomly assigned to the Experimental Group (EG) consisting of 12 patients treated with BoNT-A and physical therapy and Control with 12 patients treated only with physical therapy. All participants were assessed through motor and functional scales (GMFM-88, Ashworth, Berg Balance Scale, TUG test and Pediatric Evaluation of Disability Inventory) at three different times: before and after 30 days of treatment as well as 3 months after the end of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of spastic Cerebral Palsy
* Clinical diagnosis of Dynamic equine feet

Exclusion Criteria:

* Use of phenol in the last 12 months
* Neurological blocks in the last 6 months
* Clinical diagnosis of structured orthopedic deformities with surgical indications
A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients

The purpose of this study is to evaluate the efficacy, safety and tolerability of QCZ484 or placebo, given subcutaneously, every 6 months, at different dose levels in patients with mild to moderate hypertension

Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and pharmacodynamics of QCZ484 with mild to moderate hypertension (HTN). Multiple doses of QCZ484 will be tested against placebo, administered as subcutaneous injection.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. Males or females aged 18 to 75 years.
3. Diagnosis of hypertension.
4. Hypertension treatment naive or on maximum 2 anti-HTN medications and able to undergo washout for 4 weeks.
5. Mean sitting SBP ≥140 mmHg measured by OBPM and mean 24 hr SBP ≥130 mmHg and \<160 mmHg measured by ABPM.
6. Participants able to understand and comply with study procedures.

Exclusion Criteria:

1. Known history of secondary hypertension.
2. Orthostatic hypotension.
3. Laboratory parameter assessments outside of range at screening.
4. Evidence of hepatic disease.
5. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
6. Any history of congestive heart failure.
7. Current or history of intolerance to ACEi and/or ARBs.
8. Clinically significant cardiac arrhythmias, high-grade AV block and third-degree AV block within 6 months prior to screening.
9. Acute myocardial infarction (AMI) or unstable angina, or any percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 12 months prior to screening. Any history of ischemic or hemorrhagic stroke or transient ischemic attack any time prior to screening.

Other protocol-defined inclusion/exclusion criteria may apply
Fluorine F 18 Sodium Fluoride PET/CT and Whole Body and Axial MRI in Finding Metastases in Patients With Recurrent Prostate Cancer

This phase II trial studies how well fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) and whole body and axial magnetic resonance imaging (MRI) work in finding metastases in patients with recurrent prostate cancer. New imaging techniques, such as fluorine F 18 sodium fluoride PET/CT and whole body and axial MRI, may be more effective than standard CT and bone scan in finding metastatic prostate cancer.

PRIMARY OBJECTIVES:

I. To determine the proportion of patients with biochemically-recurrent prostate cancer (PC) in whom imaging with whole body (WB)/axial MRI and F-18 NaF (fluorine F 18 sodium fluoride) PET/CT results in detection of metastatic disease not visualized on CT scan and bone scan.

SECONDARY OBJECTIVES:

I. To estimate the percent of eligible patients with negative, indeterminate and positive CT scan/bone scan and targeted X-rays if done.

II. To determine the proportion of patients with biochemically-recurrent PC in whom recurrence in the prostate bed can be visualized using MRI in the absence of detection using CT scan.

III. To correlate the presence of metastatic disease detected using WB/axial MRI and/or F-18 NaF PET/CT with the predicted 6-year probability of progression-free survival based on the Memorial Sloan Kettering Cancer Center salvage radiation therapy (RT) PC nomogram, and with prostate-specific antigen (PSA) level at baseline.

IV. To compare the role of axial MRI of the spine to WB/axial MRI with respect to their ability to identify sites of disease. Similarly, to evaluate the relative contribution of F-18 NaF PET and WB/axial MRI.

OUTLINE:

Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.

After completion of study, patients are followed up at 4-6 months and periodically until week 52.

Eligibility Criteria:
Inclusion Criteria:

* History of prior radical prostatectomy for prostate cancer
* Two PSA values \>= 0.2 ng/mL at least 4 weeks after prostatectomy
* Patients who have started radiographic evaluation and underwent CT scan and/or bone scan prior to registration to the study will be able to participate under a late registration provision, provided that the more modern scans (WB/axial MRI and F-18 NaF PET/CT) can be completed within 8 weeks after CT scan and bone scan

Exclusion Criteria:

* Patients with known metastatic disease
* PSA recurrence not verified by elevated PSA as discussed in the eligibility section
* Patients who initiated androgen deprivation therapy or other systemic therapy (chemotherapy, immunotherapy, targeted therapy) for PSA recurrence; nutritional supplements used for treatment of PSA recurrence will be allowed