cyrilzakka/clinical-trials huggingface dataset:
Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain

The purpose of this study to evaluated Long term outcome after serial Lidocaine infusion when compared with placebo in peripheral neuropathic pain patients in acute stage (less than 6 months) at 3 months after first time of infusion

Peripheral nerve injury may give rise to severe and long-lasting types of pains which are often resistant to treatment such as opioid, tricyclic antidepressant or anticonvulsant. Lidocaine infusion has been the one of intractable neuropathic pain treatment . My hypothesis the serial lidocaine infusion can adequate pain control and can prevent chronic pain (central sensitisation). Therefore, we designed this prospective, randomised, double-blind, controlled study to evaluate the efficacy of serial lidocaine infusion in peripheral neuropathic pain compared with placebo in long term outcome (at 3 month).

Eligibility Criteria:
Inclusion Criteria:

* Peripheral neuropathic pain from peripheral nerve injury within 6 months after injury
* Well understand to Thai language in writing or listening

Exclusion Criteria:

* Underlying Heart disease or Arrhythmia
* Allergy to lidocaine, Gabapentin, Carbamazepine, tramadol
* History of epilepsy
* History of lidocaine used
* Underlying Psychiatric disease
* History of drug abuse
* Pregnancy and nursing
Effectiveness and Cost Effectiveness of Peer Mentors in Reducing Hospital Use

The current study, through a randomized controlled design, will evaluate the effectiveness of peer support, as compared to usual care and to an equivalent amount of support offered by peer case managers and non-peer recovery mentors, in reducing hospital days and readmissions and in promoting recovery and community inclusion among adults with mental illnesses with histories of multiple hospitalizations. The current study evaluates the cost-effectiveness of adding peer support to the array of services available to persons with serious mental illnesses who have histories of multiple hospitalizations and will test a theoretical model of the active ingredients of peer support, focusing specifically on the roles of 1) instillation of hope through positive self-disclosure; 2) role modeling of self-care and exploring new ways of using experiential knowledge; and 3) a trusting relationship characterized by acceptance, understanding, and empathy with conditional regard.


Eligibility Criteria:
Inclusion Criteria:

* 2 or more psychiatric hospitalizations in the past year
* A diagnosis of serious mental illness

Exclusion Criteria:

* Dementia or other organic condition limiting ability to provide informed consent
Assessing Knowledge & Attitude of Health Professionals Towards Anesthesia and the Anesthetist's Role.

Misconceptions about anesthesia and anesthetists in the health professional community may limit anesthetists' participation in their roles. These misconceptions affect the morals of anesthetists since their activity will be limited only to operation theater and the community at large, who did not get the desired care. Improving health professionals' awareness of anesthesia will make it easier for anesthetists to practice their full role and to develop a sense of validation by having their importance acknowledged. Moreover, society will gate the care offered by the anesthetist in different places of medical care.

Data were collected using self-administered, pretested questionnaires prepared in english and then translated into amharic. The Amharic version of the questionnaire was assessed for compatibility with the english version by a group of people who converted it back to english and compared the converted versions. The questionnaire consists of three parts. The first part was about socio-demographic characteristics; the second part was about participants' knowledge about anesthesia; and the third part was about professionals' attitudes towards anesthesia. After informing each participant about the purpose of the study and obtaining informed consent, data collection began. After the questionnaires were filled out by the participants, the two trained data collectors compiled and checked the data for any conflicts that may have occurred during the data collection.

The development and translation of the questionnaire was the most challenging task, and it was developed by both the anesthetists and anesthesiologists. The questionnaire was pre-tested on 25 randomly selected health professionals. After pre-testing, some questions were modified to make them more understandable.

Attitude-related questions were answered as strongly agree, agree, disagree, strongly disagree, and none. the investigators prepared a total of 15 knowledge-related questions, of them 10 were closed-ended and could be scored objectively.

Eligibility Criteria:
Inclusion Criteria:

* All health professionals in Dessie comprehensive specialized hospital who are voluntary to participate in the study.

Exclusion Criteria:

1. Group who are not voluntary,
2. Anesthetists/anesthesiologists
3. other institution medical staff worked as a contract at Dessie hospital
Diagnosis/Pathophysiology of Glucocorticoid Remediable Aldosteronism Hypertension

To identify and study a large cohort of glucocorticoid remediable aldosteronism (GRA) patients.

DESIGN NARRATIVE:

The spectrum of the severity and the natural history of the disorder was characterized. Modifying environmental and genetic factors important in regulation of blood pressure were determined. Also, renal physiology was studied in GRA patients to determine how these patients escaped hypokalemia in spite of mineralocorticoid excess. There were four specific aims including: 1) to determine the natural history and prevalence of GRA in various hypertensive populations, 2) to characterize the magnitude of effect imparted on blood pressure by inheritance of GRA and the sources of variation in phenotype expression of the hypertension, 3) to investigate the renal and hormonal mechanisms regulating potassium conservation and loss in GRA, and 4) to characterize the disequilibrium of GRA with Irish and Scottish descent and specific alleles of the aldosterone synthase gene.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML

The trial investigates the efficacy of adoptive immunotherapy with haploidentical natural killer cells compared to standard chemotherapy (after first complete remission) in patients with a high-risk acute myeloid leukemia being older than 65 years of age and not eligible for allogeneic transplantation

Randomised controlled phase-2 trial to determine the efficacy of adoptive immunotherapy with haploidentical natural killer cells in high-risk acute myeloid leukemia

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria
* In AML defined by cytogenetic aberrations the proportion of blasts may be \<20%
* Age ≥60 years
* Clinical performance corresponding to ECOG score 0-2
* High-risk karyotype
* \<5% myeloblasts in bone marrow ≥21 days after beginning of most recent chemotherapy
* maximal two preceding chemotherapy cycles
* Potentially available haploidentical family donor (child/ sibling), willing and fit for NK cell donation

Exclusion Criteria:

* AML with favorable or intermediate risk cytogenetic features
* Persistent aplasia following preceding chemotherapy
* Relapsed or refractory AML
* Known pre-existing autoimmune diseases
* Any severe concomitant condition which makes it undesirable for the patient to participate in the study
* Any condition which could jeorpadize compliance of the protocol
* Participation in another clinical trial during or within 4 weeks before study entry
Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

A clinical study determines the safety and efficacy of sitagliptin (MK0431) in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy


Eligibility Criteria:
Inclusion Criteria:

* Patients Have Type 2 Diabetes Mellitus On Diet/Exercise Therapy

Exclusion Criteria:

* Patients Have Type 1 Diabetes Mellitus
Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function

An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Sustaining Training Effects Through Physical Activity

This randomized control trial will investigate whether the implementation of a telecoaching program, initiated during pulmonary rehabilitation, is able to increase and maintain physical activity and general benefits until six months after rehabilitation discharge.

After three months of pulmonary rehabilitation (3 times a week), patients with COPD will be randomized to either an intervention group which receives an additional telecoaching program on top of the pulmonary rehabilitation, or to the usual care group, which only receives rehabilitation program. Apart from the added telecoaching program to the intervention group, the rehabilitation program will be identical and last for another three months (2 times a week). After discharge, both groups will be followed up for six months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a primary diagnosis of COPD according to internationally accepted guidelines
* Patients that completed three months of the outpatient pulmonary rehabilitation program of Gasthuisberg University Hospital (Leuven, Belgium)
* Current or previous smoking exposure of at least 10 pack years
* Ability to manage electronic devices (smartphone, step counter)

Exclusion Criteria:

* Other predominant respiratory diseases than COPD (asthma, pulmonary hypertension)
* Orthopedic, neurological and muscular co morbidities that could interfere with normal biomechanical movement patterns and the ability to increase physical activity levels
* Patients on the waiting list for lung transplantation
A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics for the Treatment of COVID-19.

A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics of ADX-629 Administered Orally for the Treatment of COVID-19


Eligibility Criteria:
Inclusion Criteria:

* Is a male or female greater than or equal to18 years of age at Screening;
* Is willing and able to sign and date (or has a legally authorized representative willing to sign and date) a written (or electronic) informed consent form or provide equivalent consent per Food and Drug Administration guidelines on COVID-19 clinical trials;
* Has a documented, laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection as determined by polymerase chain reaction, a SARS-CoV-2 antigen test, or another commercial or public health assay, within 3 days (72 hours) of randomization;
* Has COVID-19 of moderate severity, as defined by the following: Positive testing by standard reverse transcription polymerase chain reaction assay or equivalent testing; Symptoms of illness with COVID-19, which could include any of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, or new loss of taste or smell; Clinical signs suggestive of illness with COVID-19, such as respiratory rate greater than or equal to 20 breaths per minute, saturation of oxygen greater than 93% on room air at sea level, or heart rate greater than or equal to 90 beats per minute; and No clinical signs indicative of severe or critical severity.

Exclusion Criteria:

* Has an NIAID ordinal scale score \<5;
* Is on high-flow oxygen or any form of noninvasive ventilation, excluding continuous positive airway pressure (CPAP) alone for sleep disorders (e.g., obstructive sleep apnea);
* Has significant cardiovascular disease, defined by myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism within 3 months prior to randomization; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; Grade 3 hypertension (diastolic blood pressure greater than or equal to 100 mmHg or systolic blood pressure greater than or equal to 160 mmHg); history of congenital prolonged QT syndrome, or known dyslipidemia;
* Is currently taking any investigational products, other than the study drug;
* Has any other condition that, in the opinion of the Investigator, could interfere with (or for which the treatment might interfere with) the conduct of the clinical trial or interpretation of the clinical trial results or that would place the subject at undue risk by participating in the clinical trial.
Study On the Expression Level and Clinical Significance of VISTA in Patients With Vascular Cognitive Impairment

1. Explore the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors; 2. Discuss the correlation between different risk factors (mainly hypertension, diabetes, smoking, hyperlipidemia, hyperhomocysteinemia, etc.) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cerebrovascular diseases and immune-inflammatory related diseases of the nervous system; 3. Explore the correlation between different immune inflammatory factors (IL1, IL6, IL10, INFγ, TNFα) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients; 4. Track and explore the dynamic changes of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors in 3 months, 1 year, 3 years, and 5 years.

The prospective observational study design was adopted to screen patients with cardiovascular risk factors who visited the Department of Neurology in the First Hospital of Harbin Medical University since November 2022. The patients mainly categorize into two groups: without cognitive impairment (control) and with cognitive impairment (VCI).. General information, imaging, functional assessment, immune checkpoint VISTA in peripheral blood and cerebrospinal fluid, and blood-related indicators were collected. Some patients who could cooperate were followed up for 3-5 years. By analyzing the correlation between the content of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid, disease risk factors, imaging, functional scores and blood indicators, the relationship between immune checkpoints and nervous system diseases was better understood.

Eligibility Criteria:
Inclusion Criteria:

1. The study included 100 subjects, including 50 patients with VCI and 50 normal controls. The diagnosis of VCI was based on the diagnostic criteria for psychiatric disorders in the fifth revised edition of the "Diagnostic and Statistical Manual of Mental Disorders" of the American Psychiatric Association;
2. All relevant examination and cognitive testing work in this study obtained informed consent from the subjects and their families.

Exclusion Criteria:

1. In line with the exclusion criteria for VCI diagnosis in the "Chinese guidelines for the treatment of vascular cognitive impairment 2019"; complicated with autoimmune diseases, blood diseases, malignant tumors, heart, liver, and kidney dysfunction, infectious diseases, family genetic diseases, recent acute or chronic inflammatory diseases, myocardial infarction, etc.; taking antibiotics, steroids, immunosuppressants before the trial; having a history of cranial trauma or surgery.
Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients

Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C levels in hypercholesterolemic patients previously controlled on oral atorvastatin.


Eligibility Criteria:
Inclusion Criteria:

* On stable dose of daily oral atorvastatin for \>= 5 weeks (oral atorvastatin may be provided during a lead-in period for subjects not previously taking atorvastatin)
* Stable LDL-C confirmed in the previous 7 to 10 days prior to enrollment into the treatment phase.

Exclusion Criteria:

* History of myopathy or rhabdomyolysis
* Liver disease including current biliary disorders
* Positive for HIV, Hepatitis B or Hepatitis C Virus
* Abuse of alcohol or non-prescribed drugs
* Unstable angina or arrhythmias or a cardiac event in the previous three months
* hypothyroidism, diabetes, or hypertension that is not under control
* pregnant or plans to be pregnant
Intraperitoneal Application of Levobupivacaine During Laparoscopic Surgery in Kids.

Pain after laparoscopic surgery has been associated with surgical manipulations, including intraperitoneal insufflation of carbon dioxide (CO2), resulting in peritoneal stretching, diaphragmatic irritation, changes in intra-abdominal pH, and retention of the insufflated gas in the abdominal cavity after surgery. These effects may result in the irritation of peritoneal nerves causing visceral pain, as commonly reported after laparoscopic procedures in pediatrics.

The study hypothesis is that Intraperitoneal local anesthetic (levobupivacaine) instillation can provide pain relief after laparoscopic surgery, but local anesthetic distribution may not always be uniform throughout the peritoneal surface. Many methods were tried for intraperitoneal application of local anesthetics in laparoscopic surgery such as local anesthetic (LA) instillation and LA nebulization.

-But these methods are not widely used in pediatrics upon our knowledge


Eligibility Criteria:
Inclusion Criteria:

1. Patient undergoing laparoscopic surgeries
2. Pediatric weighing 4 kg or more
3. Patients with free medical history

Exclusion Criteria:

1. Parents refusal
2. Known allergy to levobupivacaine
3. Acute preoperative pain other than biliary colic
4. chronic pain treatment or antiepileptic therapy
5. Severe hepatic or renal impairment
6. Cognitive impairment or communication problems.
Hypothalamic-pituitary Dysfunction in Diabetes

Type 2 Diabetes mellitus (T2DM) is a chronic disease with a high prevalence and several comorbidities impacting on public health and society. Among the complications of T2DM it has been showed a high prevalence of hypogonadotropic hypogonadism. Even if hypogonadism is associated to a worse metabolic profile and cardiovascular risk, it is discussed whether and when to treat this potentially reversible form associated to diabetes. In fact, the pathogenic mechanism of this condition in diabetic patients is not fully understood, and its clinical correlates, including the prevalence of other possible associated hypothalamic-pituitary axes dysfunctioning, questioned. The aim of the present study is to assess with an observational, cross sectional study on a large series of type 2 diabetic patients, enrolled consecutively: all the suspected etiologies of this complication in one single evaluation (both acquired and genetic congenital predisposition), its clinical correlates and the real prevalence of the disease using the lastly validated criteria for late onset hypogonadotropic hypogonadism.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years old
* males
* proved diagnosis of T2DM

Exclusion Criteria:

* patients affected with known hypothalamic-pituitary diseases at the enrollment.
* patients affected with severe systemic diseases, fever, chronic inflammatory disorders with PCR \> 10 mg/dL
* malnutrition with BMI \<17 Kg/m2
* use of glucocorticoids at the enrollment
* poor understanding of spoken and written Italian
* patients affected with known primary diseases of the testes at the enrollment
Outcome and Related Factors of Necrotizing Fasciitis of the Limb

Soft tissue necrotizing fasciitis of limbs are lethal infections and associated with high morbidity and mortality rates. The purpose of this study is to determine the clinical manifestations and factors affected the treatment outcome to predict the prognosis and make timely decision for appropriate management and prevent limb loss.

Patients that are admitted to hospital with the diagnosis of necrotizing fasciitis of a limb will be entered to this study. A questionnaire will be completed for each patient included demographic data, admission and diagnosis date, treatment onset, medical history for diabetes mellitus, HIV infection, use of immunosuppressor drugs, peripheral vascular disease, cancer, renal disease, intravenous drug abuse, and disease outcome that can be recovery, amputation or death.

Eligibility Criteria:
Inclusion Criteria:

* Necrotizing fasciitis of the limb
Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers

The purpose of this prospective study is to evaluate the benefits of using the Bruder Moist Heat Compress in contact lens wearers who report reduced comfortable wear time. This will be done by assessing for improvement in ocular oil gland function and comfortable contact lens wearing time after one month of daily warm compress application. The efficacy of the Bruder Moist Heat Compress applied once will be compared to twice daily application as well as compared to warm compress application using a wash cloth.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Provide informed consent and authorization to disclose protected health information
* Have habitual contact lens corrected visual acuity in each eye of at least 20/30
* Willing to comply with protocol
* Wear soft daily contact lenses for total wear time of at least 4 hours a day and at least 4 days a week on average over at least a 30 day period before enrollment

Exclusion Criteria:

* Have any uncontrolled systemic disease that in the investigator's opinion could be expected to interfere with the study, for example, conditions associated with dry eye disease
* Pregnant by self-report
* Active ocular conditions: infection, allergic conjunctivitis, severe eyelid inflammation including anterior blepharitis