cyrilzakka/clinical-trials huggingface dataset:
Lumbar Erector Spinae Plane Block vs Fascia Iliaca Block vs Lumbar Plexus Block for Postoperative Analgesia for Total Hip Arthroplasty

This study aims to compare lumbar erector spinae plane block, fascia iliaca block, and lumbar plexus block for postoperative analgesia for hip surgery.

Approximately 500,000 hip arthroplasties are performed each year in the United States. Traditionally, this procedure has been performed under general anesthesia. However, neuraxial and regional anesthesia have become more commonly utilized to aid in postoperative analgesia and reduce the side effects of opioids, namely sedation, nausea, and vomiting. Postoperative pain control has a significant impact on earlier ambulation, initiation of physical therapy, better functional recovery, and overall patient satisfaction.

Lumbar erector spinae plane block (LESPB) was reported to lead to effective postoperative analgesia in hip and proximal femoral surgery.

The fascia iliaca block (FIB) is an established and effective technique, especially when US guidance and proximal approaches are used.

lumbar plexus block (LPB) could be safe because of the targeted somatic nerve block in the psoas region which prevents dispensable sympathetic block even in cardiovascular-compromised patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-III.
* Undergoing total hip arthroplasty under spinal anesthesia.

Exclusion Criteria:

* Obesity (Body Mass Index \> 30 kg/m2).
* Allergy to any drug used in the study.
* Contraindications to spinal anesthesia (such as Thrombocytopenia (platelets \<100,000/mCL) and coagulopathy (INR \>1.4 or insufficient time since stopping systemic anticoagulation)).
* Epilepsy.
* Psychiatric disease.
* Pre-existing neurologic deficits or neuropathies.
* Pregnancy.
* Pre-existing alcohol/opioid use disorder.
* Previously diagnosed with chronic pain.
Saddle Block With IT Morphine for Penile Inversion Vaginoplasty

Penile Inversion Vaginoplasty (PIV) is a transition-related surgery (TRS) that is associated with severe postoperative pain. The optimal pain management strategies for this surgery remain unknown. We hypothesized that the addition of a saddle block with intrathecal morphine would yield clinically important analgesic benefits.

PIV is a TRS offered for male-to-female transition associated with severe postoperative pain despite contemporary analgesic strategies, including opioid-based multimodal systemic analgesia and local anesthetic-based pudendal nerve block. Intrathecal opioids directly target the nociceptors in the spinal cord and can provide potent analgesia for abdominopelvic procedures, including PIV, but are associated with important dose-related adverse effects with rostral spread within the cerebrospinal fluid.

Motor-sparing saddle block using ultra-low dose hyperbaric spinal anesthesia has been successfully implemented as the standard of care for anesthesia in patients undergoing ambulatory perianal procedures at WCH. Saddle block produces reliable sensory anesthesia and long-lasting analgesia of the perineum ("saddle") as the hyperbaric local anesthetic preferentially blocks the small pain fibers of the sacral nerve roots with gravity when the patient is placed in the seated position. With the aim to directly target the opioid nociceptors in the sacral roots and limit rostral opioid spread (and associated opioid-related adverse effects), we recently began to offer a presurgical saddle block with a low dose of intrathecal morphine (100mcg) to patients undergoing PIV at WCH with excellent anecdotal results. Therefore, we are undertaking the present randomized placebo-controlled study to determine whether or not the addition of a saddle block with IT morphine to multimodal systemic analgesia and surgeon-administered pudendal nerve block provides superior analgesia to multimodal systemic analgesia and surgeon-administered pudendal nerve block alone.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III patients
* Ages 18-70 years
* Penile Inversion Vaginoplasty

Exclusion Criteria:

* Local infection
* History of use of over 30mg oxycodone or equivalent per day.
* Contraindication to a component of multi-modal analgesia
* Complications or adverse events unrelated to the local anesthetic that precludes evaluation of the primary and secondary outcome measures.
* Unable to speak or read English.
* Revision and Vulvaplasty surgeries
Vital Pulp Therapy (VPT) Using Calcium Enriched Mixture (CEM) to Treat Irreversible Pulpitis

To compare the effect of different VPT methods using Calcium Enriched Mixture (CEM) cement for management of human dental pulp with irreversible pulpitis.

The purpose of this randomized clinical trial is to demonstrate the effect of four methods of Vital Pulp Therapy (VPT) using a new endodontic bio-material \[calcium enriched mixture (CEM) cement\] in pain relief as well as clinical/radiographic success, for management of irreversible pulpitis of human permanent teeth.

Eligibility Criteria:
Inclusion Criteria:

1. Carious permanent vital mature molar tooth with closed apex (with preoperative X-ray)
2. Positive response to EPT or cold test
3. patients willing to participate in study
4. Healthy subjects; absence of any systematic disorder
5. Age ≥ 10 years old
6. Both gender
7. Written informed consent

Exclusion Criteria:

1. Moderate or severe periodontitis; pockets \>3mm
2. None restorable tooth
3. Internal or external root resorption
4. Root canal calcification
5. Non vital pulps
6. Analgesic taken within the last 8h
7. Active systemic disease
8. Pregnancy or nursing
9. History of opioid addiction/abuse
10. Temporary residency
Patient Compliance for Metabolic Evaluation and Medical Management in Calcium Stone Patients

Calcium oxalate stone, the most common type worldwide, has a recurrence rate of around 50% in ten years. Therefore, identifying the underlying pathophysiological aspects via metabolic evaluation and suggestions for medical \& dietary prophylaxis in calcium stone patients is of upmost importance.

However, one of the greatest problem with metabolic evaluation and subsequent therapeutic advices is the patient compliance. Therefore, it is important to identify factors related to patient compliance for metabolic evaluation and medical \& dietary prophylaxis in calcium stone patients

Nephrolithiasis is an important health problem that can deteriorate the renal functions in long term and affects the patients' quality of life. One of the major problems about renal stones is the high rate of recurrence. Calcium oxalate stone, the most common type worldwide, has a recurrence rate of around 50% in ten years. Therefore, identifying the underlying pathophysiological aspects via metabolic evaluation and suggestions for medical \& dietary prophylaxis in calcium stone patients is of upmost importance.

However, one of the greatest problem with metabolic evaluation and subsequent therapeutic advices is the patient compliance. In the previous studies, even in case of a dedicated stone clinic, the drop out rate for preventive measures were over 37% per year. The patients' non-compliance may be related to a number of factors associated with the stone clinic, demographic characteristics of the patients, past medical history of the patients, and even the recommended tests and the therapeutic advices.

Therefore, it is important to identify factors related to patient compliance for metabolic evaluation and medical \& dietary prophylaxis in calcium stone patients

Methods:

Parameters to be recorded

Age Gender Level of education

* of stone episodes
* of surgical intervention Type of surgical intervention History of SWL Concomitant diseases Other medications Type of metabolic evaluation (24 hour urine, spot morning urine, serum etc.) Drug for medical prophylaxis Dosage of medication (bid/tid, etc.) Side effects Dietary recommendations Compliance to metabolic evaluation Compliance to medical treatment

Statistics:

Patients will be grouped based on:

compliance to metabolic evaluation compliance to medical treatment

The parameters listed above will be compared between the groups with univariate analysis (logistic regression).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of calcium oxalate kidney stones
* Suggested metabolic evaluation for kidney stone
* Suggested dietary and/or medical treatment for kidney stone
* Accepted participation in the study

Exclusion Criteria:

* Age less than 18
* Mental disorders
Influence of Preoperative Anxiety on Shivering During Elective Caesarean Section Under Spinal Anaesthesia

Background Shivering occurs in circa 50 percent of cases during caesarean section under spinal anesthesia. The phenomenon's reasons and its mechanism are unclear, and while it does not endanger the patients' health, the sensations proved to be unpleasant and a subject of a number of patients' complains.

Objectives The main objective of the study is to establish the anxiety factors that influence the risk of muscle-shivering and a detailed assessment of the probability of existence of the link between increased anxiety levels with the shivering in case of patients undergoing the elective caesarean section.

Moreover, the outcomes of the study could help to further understand the phenomenon, reduce its occurence and as a result of that - improve the comfort of the patients in the perioperative period, as well as reduce the frequency of pharmacological treatment to halt the symptoms of muscle shivering.

Methodology Patients would be asked to fill the STAI (State - Trait Anxiety Inventory) questionaire in the morning preceding the surgery. Results would be interpreted by one of the investigators, who obtained a masters degree in psychology. Caesarean section under spinal anesthesia would be performed according to standard procedures used in the Samodzielny Publiczny Szpital Kliniczny Centrum Medyczne Kształcenia Podyplomowego (SPSK CMKP) hospital, with standard non-invasive monitoring (HR, noninvasive blood pressure (NIBP), oxygen saturation (SpO2), Temperature). Additionally, the anesthesiologist would note the incidence of shivering and its precise timing 1. since the spinal block 2. since the child-birth. Moreover, patients would rate anesthesiology team influence on her anxiety level during the cesarean section in 5 grade scale - data would be collected by psychologist.

The survey is planned for a one year timespan or until 200 patients have enrolled.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 y.o.
* ASA 1-2
* signed informed consent form after reading the information about the study and talking with one of the investigators

Exclusion Criteria:

* conversion to general anesthesia
* any severe obstetric complications, which affects obstetric or anesthesiology procedure
* severe bleeding
* language barrier
* anxiolytic/psychotropic drugs use
Effectiveness of Human Rotavirus Vaccine, Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants

This study aims to evaluate the effectiveness of Rotarix™ vaccine in the general population in Singapore by monitoring the overall reduction in RV SGE and also by assessing the direct protection offered by the vaccine in hospitalised infants through a case-control study.

This Protocol Posting has been updated following an amendment of the Protocol.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for surveillance subjects

* A male or female child aged \< 60 months at the time of admission (a child becomes ineligible on the day of its fifth birthday).
* Subject admitted with acute GE as an inpatient to the study site during the study period.
* Written informed consent obtained from the parent or guardian of the subject. Selection criteria for cases

Cases will be limited to those surveillance subjects:

* who are born after 1 November 2005 (date of availability of Rotarix™ vaccination in Singapore),
* who are aged at least 16 weeks at the time of hospital admission.
* whose stool samples are tested positive for RV. Selection criteria for controls

All controls must satisfy the following criteria at study entry:

* Admitted for acute disease with non-GE causes in the same hospital as the case , with the closest admission date to the cases.
* Aged at least 16 weeks at the time of hospital admission.
* Born within a range of ± 2 weeks from the date of birth of cases. In case there is no suitable match, then the range would be extended to ± 4 weeks.
* Written informed consent obtained from the subject's parents/guardians.

Exclusion Criteria:

For enrolment of surveillance subjects

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

* The diagnoses at admission to the study site do not include acute GE.
* Children for whom stool samples are not available up to 48 hours after admission.
* The onset of GE is after 48 hours of admission to the hospital (i.e. nosocomial GE).
* Children with a history of chronic and genetic diseases. For selection of cases

In addition to the exclusion criteria for surveillance subjects, cases will not be selected if the following criterion applies:

* Subjects who had a previous episode of acute GE less than a week back i.e. recurrent GE episode.
* Subjects who have been already enrolled in the study.
* Subjects whose vaccination history could not be ascertained. For selection of controls

The following criteria should be checked at the time of study entry. If any apply, the controls must not be included in the study:

* Child who has symptoms of GE on the day of interview of his/her parent or guardian or had an episode of GE within 14 days prior to the day of interview.
* Child who has been already enrolled in the study as case or control.
* The onset of GE occurs after admission at the hospital.
* Child whose vaccination history could not be ascertained.
Pain and Disability Outcomes in Post Amputation Patients

The objective of this study is to evaluate efficacy of varied medical and procedural therapies used to treat pain after surgical amputation of a limb. The primary outcome will be assessment of pain severity at rest and with movement as measured by pain scores on Numerical Rating Scale (NRS) 0 to 10, where 0 is not pain and 10 is the worst pain possible, taken on post-operative day 1, day 7, 30 days, 90 days, 6 months, and 1 year (+/- 3 days at each time point).

The objective of this study is to evaluate efficacy of varied medical and procedural therapies used to treat pain for surgical amputation of a limb.

At present there are number of different type of therapies are performed in the patients who is going through an amputation of any limb for management of their pain adequately such as peripheral nerve block, epidurals, peripheral nerve stimulators etc. However, the effects of these different procedures performed at different time intervals have not been evaluated for their effects on phantom pain and somatic pain long term after the procedures in these group of patients.

We will be collecting the following data from these patients to see if there is any particular intervention done at particular time of the procedure ( before the amputation vs. after the amputation) affect the long term outcome of these patients such as development of Phantom pain, or chronic pain

The primary outcome will be assessment of pain severity at rest and with movement as measured by pain scores on Numerical Rating Scale (NRS) 0 to 10, where 0 is not pain and 10 is the worst pain possible, taken on postoperative day 1, day 7, 30 days, 90 days, 6 months, and 1 year (+/- 3 days at each time point).

The secondary outcomes will be 1) phantom limb pain severity as rated on NRS 2) Residual limb (stump) pain as rated on NRS 3) phantom limb sensations 4) Pain Disability Index scores 5) Morphine milligram equivalents. These secondary outcomes will be assessed at the same intervals as the primary outcome.

This study will help us to find out if there is any utility of any of these procedures performed at particular time of the procedure helps them more than the others for development of somatic or phantom pain.

Eligibility Criteria:
Inclusion Criteria:

1. Ages between 18 and 89 years old, inclusive
2. Patients scheduled for surgical limb amputation at Penn State Hershey Medical Center

Exclusion Criteria:

1. Patients who cannot cooperate or consent
2. Patients who cannot understand or speak English
3. Patients with a history of chronic regional pain syndromes
4. Patients suffering from alcohol and/or drug abuse -based on previous Dx listed in the MRN
5. BMI \>50
Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

This is an 80-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Only patients successfully completing study CLAF237A2327 are eligible
* Written informed consent
* Ability to comply with all study requirements

Exclusion Criteria:

* Premature discontinuation from study CLAF237A2327
* Other protocol-defined exclusion criteria may apply
PASSION - P Trial: Ph Adjusted Sulfur-Colloid, Sentinel Initiative ON Pain Trial

Patients with breast cancer scheduled to undergo sentinel lymph node mapping and biopsy will be randomly assigned to one of four treatment groups:

I: (Standard of Care at WRAMC): Application of L-M-X topical anesthetic cream 4% to the breast within one hour of sub-areaolar injection of 4 ml 99mTc-sulfur colloid (1 mCi in normal saline)

II. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium bicarbonate)

III. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in 1% Lidocaine)

IV. Sub-areolar injection of 4 ml pH-adjusted 99mTc-sulfur colloid (1 mCi in sodium bicarbonate + 1% Lidocaine)

The primary study outcome is pain, which will be evaluated for each study group before, and after radiocolloid injection utilizing a standardized 10-point Likert scale, the Wong-Baker FACES Pain Rating Scale, and the McGill Pain Questionnaire. Physician appraisal of patient pain (Wong-Baker FACES Pain Rating Scale) will be estimated during the radiocolloid injection and compared with that of the patient.

Null hypothesis: There is no difference in overall pain intensity between standard and pH adjusted radiocolloid for patients undergoing sentinel lymph node mapping and biopsy for breast cancer.

Objectives and scientific aims:

To compare the intensity of pain (Wong-Baker FACES Pain Rating Scale + McGill Pain Questionnaire) associated with WRAMC's current standard and pH-adjusted radiocolloid for patients undergoing sentinel lymph node mapping and biopsy for breast cancer.

To assess objectively physician appraisal of patient pain during the radiocolloid injection and compare physician interpreted pain score with patient reported pain score.

Define the success rate of intra-operative SLN identification for each study group.

Eligibility Criteria:
Inclusion criteria:

1. Female military healthcare beneficiaries should be over 18 years of age and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with institutional policy.
2. Written informed consent must be obtained from each patient prior to entering the study.
3. Female military healthcare beneficiaries with early breast cancer scheduled to undergo sentinel lymph node mapping and biopsy at WRAMC

Exclusion criteria:

1. Female military healthcare beneficiaries with chronic pain syndrome (e.g. fibromyalgia) undergoing active narcotic-based treatment.
2. Female military healthcare beneficiaries participating in other clinical trials the requirements of which may preclude complete involvement in this study.
3. Female military healthcare beneficiaries with significant allergy to local anesthetics.
4. Female military healthcare beneficiaries presenting with large (\>4cm), clinically node positive, painful, locally advanced breast cancer.
A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease

To assess the proximity of the catheter to the vessel wall and to correlate excised tissue with images collected by the integrated Optical coherence Tomography (OCT) imaging system. The primary endpoints are correlation between OCT images and histological characterization of excised tissue.


Eligibility Criteria:
Inclusion Criteria:

1. Patient requires treatment for peripheral arterial disease (PAD).
2. Patient is willing and able to provide Informed Consent.
3. Patient has at least one focal, de novo infrainguinal lesion in a native vessel.
4. The minimum reference vessel diameter is 2.0 - 4.5 mm, dependent on the NightHawk device used.
5. The lesion is ≥ 50% stenosed by quantitative vascular angiography.
6. The lesion is ≤ 7 cm in length.
7. The patient must be able to take at least one form of anti-platelet or anti-thrombotic therapy.

Exclusion Criteria:

1. Patient presents with degree of limb disease or a co-existing medical condition that makes revascularization inappropriate.
2. The patient has diffuse peripheral arterial disease and/or the disease is heavily calcified.
3. Patient presents with concomitant disease contraindicating an endovascular intervention.
4. Patient is pregnant.
5. The patient has a hypersensitivity to contrast materials that cannot be adequately pretreated.
Assessment of the New Lateral Sinus Floor Elevation Technique Using Piezosurgery: A Clinical and Radiographic Retrospective Study

All patients who received lateral sinus floor elevation using this new piezosurgery technique, were selected. The personal file of each patient was retrieved and the following data were taken: age, sex, smoking habits, occurrence of per-operative complications (mucosal perforation, hemorrhage) and post-operative infectious complications. Pre-operative CBCT of included patients were all performed using the same Newtom VGI radiographic machine and collected from the radiology unit at the Faculty of Dental Medicine at Saint Joseph University of Beirut. The measurement of the studied factors was performed on Newtom VGI viewer software, by two evaluators J.B. and A.M.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received lateral sinus floor elevation using this new piezosurgery technique.

Exclusion Criteria:

* the usual exclsion criteria for external sinus lift procedure