cyrilzakka/clinical-trials huggingface dataset:
Prospective Comparison of Ampicillin / Amoxicillin Versus Ceftriaxone for the Treatment of Salmonella Infections in AIDS Patients

To compare the effectiveness of standard treatment with parenteral ampicillin and oral amoxicillin compared to initial daily therapy with ceftriaxone followed by 3 times weekly suppressive treatment for salmonella infections in AIDS patients.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Type I hypersensitivity to beta-lactam antibiotics.
* Not expected to survive 12 weeks.
* In a coma or with other central nervous system (CNS) impairment.

Patients with the following are excluded:

* Type I hypersensitivity to beta-lactam antibiotics.
* Not expected to survive 12 weeks.
* In a coma or with other central nervous system (CNS) impairment.

Prior Medication:

Excluded within 48 hours of study entry:

* Treatment with an antibiotic active in vitro against Salmonella.

HIV infection, AIDS, or AIDS related complex (ARC).

* Salmonella bacteremia or positive stool culture in patient with 3 or more stools per day.
Mindfulness and Acceptance Group Therapy for Substance Use

Randomized clinical trial comparing standard residential substance abuse treatment to standard residential treatment plus Mindfulness and Acceptance Group Therapy for substance use.


Eligibility Criteria:
Inclusion Criteria:

* participating in inpatient substance use treatment at treatment facility

Exclusion Criteria:

* psychosis and mental impairment
An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes

MTF116086 is an open-label, randomised, parallel-design study in subjects with type II diabetes. The study is site-based, with local pharmacies serving as the sites and pharmacists as principal investigators for the sites. All subjects will enter an initial 8-week observational phase during which purchase behaviour and compliance with usual metformin use will be observed and recorded. At the end of the observational phase, subjects will be randomised to one of the two arms (metformin small pack vs. metformin large pack) for a 20-week interventional phase. The medication in the interventional phase is provided to the subjects free of charge. HbA1c will be collected for all subjects during Week 0, Week 8, and Week 28. Subjects will be asked questions about their tablet compliance, their satisfaction with the pack size they received and reasons for missing doses throughout the interventional phase by the pharmacist. The pharmacy visit on Week 28 will be end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Males and females of age \>=18 years
* Diagnosis of type II diabetes
* HbA1c value no higher than 9.0%
* Evidence of physician-supplied prescription for metformin use
* Stable dose of metformin for 3 months prior to enrolment
* Written informed consent from the subject

Exclusion Criteria:

* Current use of any anti-diabetic medication other than metformin
Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone

The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.

Bioavailability

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive

Exclusion Criteria:

* Evidence or history of clinically significant diseases
Is it Really Necessary to Insert a Nephrostomy Tube or Double J Stent in Percutaneous Nephrolithotomy?

In this study, investigators aimed to compare the postoperative pain status and comfort situations depending on instruments used in the percutaneous nephrolithotomy operation

A total of 90 patients aged 18 and over will undergo percutaneous nephrolithotomy (PNL) for kidney stones of 2 cm or more between 01/08/2023 and 01/02/2024 will be included in the study. Preoperative demographic data of the patients, body mass index (BMI), stone size and stone location, hemogram, biochemistry, coagulation parameters, urine analysis, and urine culture test results will be recorded. Radiological evaluation will be obtained according to computerized tomography (CT) data. While patients aged 18 years and above with kidney stones larger than 2 cm were included in the study, patients under 18 years of age, patients with anatomical anomalies (horseshoe kidney, ectopic kidney, ureteropelvic junction stenosis, ureteral stenosis), patients with uncorrectable bleeding diathesis, bilateral kidney stones will not be included in the study.

Patients who do not have major complications (serious bleeding, renal pelvis perforation) after the PNL procedure and residual stones cannot be detected according to the scopic image obtained will be randomized and divided into three groups. Patients in the first group will not be fitted with a Double J (JJ) stent and/or nephrostomy (Completely Tubeless), patients in the second group will only be fitted with a JJ stent, and patients in the third group will only be fitted with a 14 French Malecot nephrostomy. The patients' pain scores, analgesic use, hemoglobin values, operation success, complications, and additional procedure requirements in the postoperative period will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and above
* Larger than 2 cm kidney stones

Exclusion Criteria:

* Under 18 years of age
* Anatomical anomalies (horseshoe kidney, ectopic kidney, ureteropelvic junction stenosis, ureteral stenosis),
* Uncorrectable bleeding diathesis
* Bilateral kidney stones
The Symptom Experience of Women With Perimenstrual Syndrome;Women's Health Related Quality of Life.

The purpose of these series research project is to investigate the prevalence, symptoms cluster and characteristic; establish the systemic symptom management nursing strategies (PMS-SMP); determine short-and long-term effectiveness of PMS-SMP. To enhance the health related quality of life of women with Perimenstrual syndrome. Simultaneously, the PMS-SMP offers a research and clinical based protocol to demonstrate the independent nursing role and practice care model. The 3-year series research process will include three research domains.

Symptoms are the most common reason people seek health care. Although the menstrual cycle, a normative process, but 10\~15% of western women experience sever recurring symptoms associated with the menstrual cycle that can be considered a chronic illness. There are many interventional researches focus on this issue in western countries. There is not only lack of evidence base prevalence of perimenstrual syndrome, but also never found any nursing intervention project focusing on women with perimenstrual syndrome.

The purpose of these series research project is to investigate the prevalence, symptoms cluster and characteristic; establish the systemic symptom management nursing strategies (PMS-SMP); determine short-and long-term effectiveness of PMS-SMP. To enhance the health related quality of life of women with Perimenstrual syndrome. Simultaneously, the PMS-SMP offers a research and clinical based protocol to demonstrate the independent nursing role and practice care model. The 3-year series research process will include three research domains.

Content analysis, descriptive statistics(percentage, mode, medium, quartile, rank), Chi-square, One way ANOVA, MANCOVA, and Step-Wise regression will be applied to examine the research finding. Although focused on perimenstrual symptoms relief and improve the health related quality of life of women with perimenstrual symptoms, these strategies are generally health promoting and can be applied to other women's health conditions.

Eligibility Criteria:
Inclusion Criteria:

* female

Exclusion Criteria:

* pregnancy,menopause,woman with breast-feeding
Neuromuscular Adaptations After Training in the Muscle Belly of Triceps Surae

This study aims to evaluate on an acute session of the central and peripheral contributions of electrical stimulation on the muscle belly of the triceps surae, electrical stimulation of the tibial nerve and voluntary exercise of the triceps surae muscle, and identify responders individuals and non-responders to stimulation of the tibial nerve. Another objective of the study is to compare the effects of conventional electrical stimulation applied to the sciatic triceps muscle, tibial nerve stimulation and voluntary exercise after eight weeks of training in healthy individuals.

A controlled randomized controlled trial will be carried out by university students, divided equally into four groups: control group (GC), long responding pulse group (PLR), non-responder long pulse group (PLNR) and pulsed current group (CP) after the acute fase of the protocol. Muscular architecture (muscle thickness, pennation angle and fascicle length) of the muscles composing the sural triceps, H-reflex and M-wave tests (central and peripheral contribution), electromyographic signals of the medial and lateral gastrocnemius muscles and sole, voluntary and evoked joint torque of the muscles composing the sural triceps and level of sensorial discomfort. The independent intervention with the neuromuscular electrical stimulation and the isometric exercises performed by the control group will be considered as an independent variable. All groups will have the dependent variables evaluated 6 times, before, during and after the intervention, which will consist of 24 sessions (8 weeks). The training with neuromuscular electrical stimulation (NMES) will be performed 3 times a week and will never be applied for two consecutive days, as well as the voluntary exercises performed by the control group.

Eligibility Criteria:
Inclusion Criteria:

* Classified as physically active according to the INTERNATIONAL QUESTIONNAIRE OF PHYSICAL ACTIVITY,
* To practice only recreational physical activity,
* Achieve minimum torque of 30% of the (maximal voluntary isometric contraction during conventional NMES
* Be at least 3 months without practicing strength training.

Exclusion Criteria:

* Present some type of skeletal muscle dysfunction that may interfere with the tests,
* Present intolerance to NMES in the muscular or tibial nerve, Make use of analgesics, antidepressants, tranquillizers or other agents of central action
* To present cardiovascular or peripheral vascular problems, chronic diseases, neurological or muscular affections that will undermine the complete execution of the study design by the volunteer.
Progression of Hematopoietic Diseases in Shanghai, China

The purpose of this study is to identify and characterize blood diseases presenting at Shanghai hospitals and to compare them with respect to clinical presentation, phenotype, molecular characteristics, benzene or other exposures and genetic susceptibility.

The purpose of this study is to identify and characterize blood diseases presenting at Shanghai hospitals and to compare them with respect to clinical presentation, phenotype, molecular characteristics, benzene or other exposures and genetic susceptibility. The format for these studies is a set of clinical series superimposed on a case-control design that enables integration of detailed clinical and molecular characterizations of disease pathogenesis together with an evaluation of potential confounding and interacting factors within a structured statistical analysis of benzene exposure.

Eligibility Criteria:
Inclusion Criteria:

Men and women 18 years or older Diagnosis of hematologic abnormality

Exclusion Criteria:

Children Non hematologic diseases
Real-world CMV Outcomes Among Kidney Transplant Recipients in Brazil

This is a single-center, non-interventional, retrospective study of data, at the level of the individual without identification, extracted from medical records of adult patients undergoing a kidney transplant procedure after 1st from January 2018 until reaching the sample size enrollment (around 500 individuals); this refers to the period of verification of individuals' eligibility for entry into the study. Individuals under strategy preemptive patients who developed CMV infection/disease within 12 months after transplantation. The data will be collected from date of transplant (including pre-transplant clinical history) until completion of at least 12 months after transplantation, or until graft loss, or recipient death or loss to follow-up, when/if applicable.

Data will be collected from medical records and will include transplant recipient characteristics, transplant-related information, CMV status, clinical outcomes, treatment patterns, healthcare resource utilization and captured on an electronic Intake Form.

Study-specific Case Report (eCRF) The sponsor will create a Statistical Analysis Plan (SAP) before collection begins of data. The eCRF system will comply with research regulations

Eligibility Criteria:
Inclusion Criteria:

* Received a single kidney transplant after January 1, 2018
* Age over 18 years at time of kidney transplant.
* It was under preemptive strategy.
* Diagnosed with CMV infection/disease within the first 12 months after kidney transplant.
* Follow-up information is available in medical records for at least 12 months after confirmation of CMV infection, or even loss of the allograft, death of the recipient or loss of follow-up of the receiver, when/if applicable.

Exclusion Criteria:

* Diagnosed as a carrier of the human immunodeficiency virus (HIV+), hepatitis B virus and/or hepatitis C before kidney transplantation.
* Participation in any interventional study during the period between kidney transplantation and a period of 12 months after CMV diagnosis.
Surgical Site Infection With 0.05% Chlorhexidine (CHG) Compared to Triple Antibiotic Irrigation

The investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast reconstruction. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.

Breast reconstruction with tissue expander (TE) remains the gold standard of breast restoration after mastectomy. During the first stage of reconstruction, a TE is placed under chest muscles and slowly inflated postoperatively over the period of several weeks. After desired volume of TE is achieved it is exchanged for permanent breast prosthesis during another surgery (second stage of reconstruction). Postoperative wound infection after placement of TE can lead to devastating consequences both for patients and a surgeon. Frequently, surgical site infection requires additional surgeries and resulting in the removal of TE and long term IV antibiotic therapy. Therefore, during breast reconstruction procedures all possible measures are implemented to reduce postoperative infection rate. Several studies demonstrated that intra-operative irrigation of surgical wounds with antibiotic containing solution before insertion of breast TE decreases postoperative infection rate. This approach is currently adopted as a standard of care within plastic surgery clinical community.

The investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* females between 18 - 81 years of age
* and are undergoing bilateral mastectomy
* and are candidates for immediate breast reconstruction with tissue expanders.

Exclusion Criteria:

* females younger than 18 and older than 81 years of age;
* undergoing unilateral mastectomy and reconstruction;
* bilateral reconstruction using other techniques,
* patients allergic to one or more components of the antibiotic solution;
* allergy to CHG
Ultrasound Guided Erector Spinae Muscle Block in Pediatric Surgeries

Surgical repair of the hip can be extremely painful and is associated with considerable postoperative pain in children despite the use of systemic opioids. These patients may benefit from neuraxial analgesia in adjunction with general anesthesia.

Regional anesthetic techniques have been widely used for pain management in a variety of pediatric surgeries, as they increase the efficiency of postoperative pain control; minimize parenteral opioid requirements, and improve both patient and parent satisfaction as well. The erector spinae muscle plane block (ESB) is an evolving regional anesthetic technique gaining popularity in pediatric procedures. Erector spinae block is an effective regional anesthesia method as it blocks both somatic and visceral pain by injecting the local anesthetic solution into the inter-fascial space between the transverse process and the erector spinae muscle, it is performed by distributing local anesthetic into several paravertebral spaces. it was reported a successful ultrasound-guided ESP block performed at the L4 transverse process level provided postoperative analgesia in adult patients undergoing hip and proximal femur surgeries.

Caudal block (CB) is a well-established remarkable practice because of its simplicity, safety, and effectiveness. A single-shot caudal block with a local anesthetic agent, such as bupivacaine, is a standard procedure, and analgesia is provided during pediatric orthopedic surgeries in the lower limbs; unfortunately, its action stops early in the postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* • ASA I and II,

  * aged 2-6 years
  * scheduled for unilateral surgical hip reconstruction under general anaesthesia.

Exclusion Criteria:

* Children with spinal anomalies,

  * altered mental status or a history of developmental delay,
  * infection at the site of injection,
  * history of allergy to local anaesthetics
  * history of blood disease or coagulopathy,
  * Patient's guardian refusal to participate in the study
Validation Study for Endometriosis PRO

Assess the psychometric properties of the Endometriosis Symptom Diary (ESD) and the Endometriosis Impact Scale (EIS) and provide evidence whether the PRO measures are reliable, valid and able to detect changes over time in approximately 250 patients with mild, moderate or severe endometriosis confirmed by laparoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Women with endometriosis confirmed by laparoscopy or laparotomy within five years before the baseline visit
* Good general health (except for findings related to endometriosis) as proven by medical history
* Patient has experienced endometriosis symptoms (i.e. pain) in the past 4 weeks, as assessed by a numerical rating scale (NRS)

Exclusion Criteria:

* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Undiagnosed abnormal genital bleeding
* Abuse of alcohol, drugs, or medicine (e.g., laxatives)
* Simultaneous participation in another clinical trial. Participation in another clinical trial prior to study entry that might have an impact on the study objectives, at the discretion of the investigator.
* Major surgery scheduled for the study period, except therapeutic surgical procedure for endometriosis
* Close affiliation with the study site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of study site)
* Inability to cooperate with the study procedures for any reason, including the following examples: language comprehension, psychiatric illness, inability to get to the study site
* Previous enrollment to this study
* Regular use of pain medication due to other underlying diseases
* Known pregnancy
Art and Science of Human Flourishing Microsupport Study

The purpose of this study is to determine whether providing small amounts of digital support impacts students in the Art and Science of Human Flourishing (ASHF) course. Approximately 300 participants will be enrolled and can expect to be on study for up to 4 months.

Participants will be currently enrolled students in the ASHF course. Students will complete measures at baseline, daily during the 1-month intervention period, at post-treatment, and 3 months later. During the 1-month intervention period, half of the participants will be randomized to receive small amounts of digital support in the form of text messages.

Context (from the course website): The Art and Science of Human Flourishing course is taught in tandem with the Healthy Minds Program (HMP) app. The overall framework of the ASHF course largely aligns with the HMP app and is composed of the following modules and sub-themes which are covered throughout the course of a 15-week semester:

Foundations: Flourishing, Transformation, Resilience

* Awareness: Focus, Emotions, Mindfulness
* Connection: Interdependence, Compassion, Diversity
* Wisdom: Identity, Values, Gratitude
* Integration: Courage, Community

Small amounts of digital support will be tested on half the participants. Primary Outcomes for measuring the effect of this support will be the PROMIS Depression and Anxiety Measures.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled in ASHF course

Exclusion Criteria:

* N/A
Myasthenia Gravis Foundation of America Global MG Patient Registry

The goal of this observational study is to learn about the experiences of people living with Myasthenia Gravis (MG) in the United States. The main questions it aims to answer are:

* How and when are people with MG diagnosed?
* What are the most common symptoms associated with MG?
* What treatments are being used to treat MG?
* What are the impacts of MG on activities of daily living, employment and quality of life?
* What are the experiences with exacerbation, hospitalization and healthcare access for people with MG? Participants will answer a survey to enroll in the study, and be invited to fill out an update survey twice a year.

This is a longitudinal, observational, patient reported registry.

Eligibility Criteria:
Inclusion Criteria:

* age over 18
* positive MG diagnosis

Exclusion Criteria:

* age under 18
* misdiagnosed with MG
The Consistency of Cardiac Output Measurements by Different Methods in VA-ECMO Patients

Objective：

1. To evaluate the consistency of cardiac output measured by different hemodynamic monitoring methods in patients with VA-ECMO
2. To evaluate whether different hemodynamic monitoring methods can accurately detect the trend of cardiac output changes

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) has been used for profound cardiogenic shock to bridge to decision,ventricular assist devices,or transplant.Close monitoring of cardiac output, especially in patients before and after intervention (such as volume expansion, diuresis, vasoconstriction, vasodilation therapy), can help to adjust the treatment strategy. Hemodynamic monitoring in ECMO patients requires familiarity with the underlying pathophysiology and circulatory mechanics of extracorporeal flow.Limited to the actual clinical situation of patients, one or two hemodynamic monitoring methods may be accepted. Is there consistency between different hemodynamic monitoring results? And whether hemodynamic monitoring can accurately detect the changes of these parameters before and after intervention is an important issue in clinical practice. This study will provide important reference for VA-ECMO patients how to choose appropriate hemodynamic monitoring tools and how to interpret the results of hemodynamic monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. cardiac surgery
2. treatment with VA-ECMO
3. mechanical ventilation
4. hemodynamic monitoring according to patient's condition (PAC, Flotrac, echocardiography)

Exclusion Criteria:

1. age \< 18
2. cardiac arrhythmia
3. moderate to severe aortic, mitral and tricuspid regurgitation
4. active hemorrhage
5. IABP
6. spontaneous triggering of the ventilator