cyrilzakka/clinical-trials huggingface dataset:
Analgesic Efficacy of Dexmedetomidine as Adjuvant to Levobupivacaine in Ultrasound-guided Erector Spinae Plan Block for Modified Radical Mastectomy

To evaluate the analgesic efficacy of dexmedetomidine as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery.

Premedication will be given, after complete fasting hours after applying standard monitors (noninvasive blood pressure, pulse oximetery, ECG, temperature and capnography), an intravenous cannula will be placed and secured.

Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle, are identified from surface, we deposite20 ml of 0.25% levobupivacaine into interfacial plane below erector spinae muscle.

General anesthesia will be induced with fentanyl l μg /kg, propofol 2mg /kg, muscle relaxant (atracurium 0.5 mg/kg) inhalational anesthesia (isoflurane or sevoflurane) No other narcotic, analgesic or sedative will be administrated during operative period.

Standard monitor (mean arterial blood pressure, heart rate , oxygen saturation \& end-tidal Co2) will observed and recorded every 30 min till end of surgery

Post-operative:

The patient will be transferred to the post anesthesia care unit (PACU) and will be monitored for:

1. Vital signs (heart rate, noninvasive blood pressure, and oxygen saturation).
2. RASS score (Richmond Agitation \& Sedation scale) with its +4:-5 score range will be used to assess sedation post-operative, considered sedation ≥-2 table (1)
3. Numerical Rating Score (NRS) pain score with its 0-10 score range will be used to assess pain immediately post-operative and then at 2, 4, 6, 8, 12,18and 24hour in the post-operative period figure (1). (4)Time and amount to request analgesia (PCA patient controlled analgesia morphine (demand dose 1-2 mg, lock out 6-10 min)) at NRS≥3. (5) Side effect of studied drugs as (hypotension, sedation , respiration depression and vomiting ) and complication of the block for 24h post- operative.

Eligibility Criteria:
Inclusion Criteria:

* female patient
* American society of anesthesiologists (ASA) I and II physical status
* age from 25 to 70 years old
* scheduled for either left or right modified radical mastectomy (MRM).

Exclusion Criteria:

* infection of the skin at or near site of needle puncture,
* coagulopathy,
* drug hypersensitivity or allergy to the studied drugs,
* central or peripheral neuropathy,
* significant organ dysfunction cardiac dysrrhythmias,
* obesity (BMI\>35kg/m2)
* recently use analgesic drugs.
Enabling Symptom Identification and Tracking in Children Receiving Cancer Treatment

Children with cancer and hematopoietic stem cell transplant (HSCT) recipients suffer from severe and bothersome symptoms because treatments are intense. So, the investigators developed SPARK (Supportive care Prioritization, Assessment and Recommendations for Kids), a website devoted to helping children track symptoms and providing a way to let doctors and nurses know which symptoms are bothersome. This study will examine the likelihood that children will complete SPARK once daily, help the investigators figure out how to improve the website so that children will use it, and help the investigators plan the large scale trial to test its efficacy in improving quality of life (QoL).

Participants will be children with cancer or HSCT recipients who are 8-18 years of age and who are expected to be in hospital or in clinic daily for 5 days.To determine the feasibility of a randomized controlled trial (RCT) of symptom feedback to healthcare providers

Methods: Participants will be children with cancer or HSCT recipients who are 8-18 years of age and who can understand English, and who are expected to be in hospital or in clinic daily for 5 days.

SPARK RCT will be a pilot multi-center RCT in which we will randomize children to either undergo daily symptom screening for 5 days with symptom reports provided to the healthcare team or standard of care. Feasibility will be met if at least 30 participants are enrolled within one year and at least 75% complete at least 60% of evaluations.

Quality of the Idea Children receiving cancer treatment have excellent survival outcomes, in part, related to the provision of intensive therapies. Unfortunately, most children suffer and experience severe and bothersome treatment-related symptoms. Symptoms not only impact on QoL and morbidity but, in addition, may negatively influence future psychosocial functioning.

Symptoms remain unaddressed even during healthcare encounters because children do not complain and clinicians fail to ask about them. We recently developed SSPedi, a pediatric-specific symptom screening tool on an iPad. SSPedi, however, consists only of the questions which ask about symptoms. SPARK is the web-based application which will facilitate access to SSPedi, encourage symptom screening, generate reports and allow children to track their symptoms. Careful thought to design is required to ensure SPARK optimizes future use and has clinical utility. The proposed project output is a product that facilitates longitudinal symptom screening and provides the groundwork for a future RCT of symptom feedback.

Eligibility Criteria:
Inclusion Criteria:

* We will include children with cancer and HSCT recipients who are 8-18 years of age at enrollment and who can understand English.
* Participants may be inpatients or outpatients, and may be actively receiving cancer treatment or may have completed treatment.

Exclusion Criteria:

* Exclusion criteria will be illness severity, cognitive disability, or visual impairment that precludes utilization of SPARK according to the healthcare team.
Study to Evaluate Smecta® vs Placebo on the Time to Recovery Following an Acute Diarrhoea Episode in Adults

The purpose of this study is to evaluate whether Smecta® is more effective than placebo with respect to time to recovery following an acute diarrhoea episode.


Eligibility Criteria:
Inclusion Criteria:

* Acute diarrhoea episode defined as at least 3 watery stools per day for 48 hours or less
* Patient with, usually, normal bowel habits, i.e. at least 3 stools per week and no more than 3 stools per day

Exclusion Criteria:

* Gross blood, pus in the stools
* Fever \>39ºC
* Other episode of acute watery diarrhoea within the last 30 days
* History of chronic diarrhoea or motor diarrhoea
Effects of Physical Training on Heart Rate Variability and Exercise Capacity in Diabetes With Autonomic Neuropathy

This study aimed to investigate effects of physical training on exercise capacity and changes of heart rate variability (HRV) at rest, during exercise, and post-exercise in the patient with diabetes with autonomic neuropathy (DAN).


Eligibility Criteria:
Inclusion Criteria:

* aged under 65 years old
* receiving regular treatment
* HbA1c \< 8.0
* decreased HR response in deep breathing maneuver

Exclusion Criteria:

* heart disease
* neuro-musculo-skeletal diseases
* taking any medication that may affect HRV (such as α or β-blockers)
Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control

The purpose of the present study is to evaluate the immunogenicity and safety of three consecutive production lots of the novel adjuvanted HBV vaccine. The safety of the candidate vaccine will be assessed using Engerix™-B as control.

Double-blind for the identity of the consistency lots, single-blind for the control group/study vaccine identity.

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* A male or female between, and including, 15 and 50 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject/ from the parents or guardians of the subject where applicable
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Planned administration/Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
* Previous vaccination against hepatitis B
* History of non-response to previous hepatitis B vaccination
* Known exposure to hepatitis B within the previous 6 weeks
* History of hepatitis B infection
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* Suspected or confirmed multiple sclerosis in the subject (applicable to Centre 5/France only)
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* Hepatomegaly, right upper quadrant abdominal pain or tenderness.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Pregnant or lactating female
PSMA PET Additive Value for Prostate Cancer Diagnosis in Men With Negative/Equivocal MRI

This clinical trial will evaluate PSMA PET additive value for significant prostate cancer (sPCa) diagnosis in men with negative/equivocal MRI

This open label, phase III, multi-centre, randomised trial with a non-inferiority objective will evaluate the additive diagnostic value of PSMA PET for men with negative/equivocal MRI in the diagnosis of significant prostate cancer. Patients with a clinical suspicion of prostate cancer with PI-RADS 2 or 3 on MRI, meeting all the inclusion and none of the exclusion criteria will be randomised into experimental and control arms. Patients in the experimental arm would be subjected to Pelvic PSMA PET/CT, wherein the PSMA negative patients would not undergo biopsy as opposed to PSMA positive patients who will be subjected to Transperineal targeted prostate biopsy. Whereas patients in the control arm will only receive Standard of Care (SOC) with no additional imaging (PSMA PET) and will undergo Transperineal template prostate biopsy. The co-primary objectives are to assess (1) the percentage of men with sPCa in the experimental arm (transperineal targeted biopsy) compared to the control arm (transperineal template biopsy) defined as the presence of a single biopsy core indicating disease Gleason score (GS) 3+4(\>10%)=7, grade group (GG) 2, and (2) the percentage of men who avoid transperineal prostate biopsy between both arms. The secondary objectives include determining the percentage of clinically insignificant PCa on targeted biopsy (experimental arm) versus transperineal template biopsy (control arm); estimating the difference in complications from transperineal prostate biopsy between both arms; the health economics impact between the experimental and control arms; estimating the mean difference between both arms in change from baseline in health-related quality of life (QoL); estimating the mean difference between both arms at each time point in generalised anxiety and cancer worry.

Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all the following criteria for study entry:

  1. Males aged ≥ 18 years at the time of consent
  2. No previously diagnosed prostate cancer
  3. No previous prostate biopsy
  4. Having undergone MRI within 9 months prior to randomisation and meet one of the following criteria:

     * PI-RADS 2 AND ≥1 red flag defined as:

       * PSA density \>0.1
       * Abnormal DRE
       * Strong family history (1 first degree relative or ≥2 second degree)
       * BRCA mutation
       * PSA \>10
       * PSA doubling time \<36 months
       * PSA velocity \>0.75/year
     * PI-RADS 3
  5. Intention for prostate biopsy
  6. Willing and able to comply with all study requirements

Exclusion Criteria:

* Patients who meet any of the following criteria will be excluded from study entry:

  1. Having a PSA \>20ng/ml
  2. Having ≥ cT3 on DRE
  3. Significant morbidity that, in the judgement of the investigator, would limit compliance with study protocol
A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN

This is a 28-week, open-label, multicenter, single-group Phase 2 exploratory study to determine the safety and effect of sparsentan in participants with IgAN who are at risk of disease progression to kidney failure despite being on both stable RAASi and SGLT2 inhibitor treatment for at least 12 weeks prior to study entry

This is a 28-week, open-label, multicenter, single-group Phase 2 exploratory study to determine the safety and effect of sparsentan in participants with Immunoglobulin A Nephropathy (IgAN) who are at risk of disease progression to kidney failure (KF) despite being on both stable renin angiotensin aldosterone system inhibitor (RAASi) and sodium glucose cotransporter-2 (SGLT2) inhibitor treatment for at least 12 weeks prior to study entry.

Participants who provide written informed consent will be assessed for eligibility and will undergo baseline evaluations including clinical laboratory tests. Per the eligibility criteria, all participants are required to be on a stable dose(s) of angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) and on a stable dose of a SGLT2 inhibitor at screening and will continue their stable treatments through the screening period. Eligible participants will discontinue ACEI and/or ARB therapy the day before the Day 1 visit and remain on stable SGLT2 inhibitor dosing for the duration of the study.

Study intervention will be administered daily for a treatment period of 24 weeks with study visits conducted at weeks 2-, 4-, 12-, and 24- following Day 1. Following the 24-week treatment period, study intervention will be discontinued for 4 weeks and standard of care RAASi treatment resumed, with a safety visit at Week 28.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years at the time of signing the informed consent.
* Biopsy-proven IgAN. The biopsy may have been performed at any time in the past.
* UA/C ≥0.3 g/g at screening
* An eGFR value of ≥25 mL/min/1.73m2 at screening.
* On a stable dose of an SGLT2 inhibitor for at least 12 weeks prior to screening.
* On a stable dose of ACEI and/or ARB therapy for at least 12 weeks prior to screening that is:

  * The participant's maximum tolerated dose (MTD), and
  * at least one half of the maximum labeled dose (MLD)

Exclusion Criteria:

* IgAN secondary to another condition or immunoglobulin A (IgA) vasculitis.
* Undergone any organ transplant, with the exception of corneal transplants.
* Documented history of heart failure, clinically significant cardiovascular or liver disease.
* Taking high dose (defined as \>10 mg/day prednisone) or other any systemic immunosuppressive medications within 12 weeks of prior to screening.
A Study of Retrovir in the Prevention of HIV Infection in Health Care Workers Accidentally Exposed to the Virus

To evaluate the safety and effectiveness of Retrovir (AZT) when used as prophylaxis for health care workers at risk for HIV infection from exposure to HIV-contaminated blood or blood components.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* A prior history of a malignancy other than cutaneous basal cell or cervical carcinomas.
* Other significant, chronic underlying medical illness which, in the physician's judgment, would impair study completion.
* Evidence of compromised bone marrow function (lab results) with a blood transfusion within the last month.
* Liver dysfunction as indicated by lab results.

Patients are excluded if there is a prior diagnosis of HIV infection by one of the following criteria:

* HIV antibody positive by ELISA and Western blot assays or by other certified test method. (Patients who are ELISA positive but Western blot or other confirmatory tests are negative may continue in study).
* HIV antigen positive.
* Clinical symptoms which lead to a diagnosis by a licensed physician of AIDS or AIDS related complex or AIDS-related dementia. Also excluded are individuals who have experienced similar HIV exposure as described in this protocol in the past month and individuals who have previously been enrolled in this study. The purpose of these exclusions is to eliminate possible seroconversion in an individual that could be attributed to HIV exposure other than the single exposure experienced just prior to entry into the study.

Prior Medication:

Excluded within 4 weeks of study entry:

* Any potentially myelosuppressive drug.
* Nephrotoxic agent.
* Other experimental therapy.

Exposure of a health care worker to HIV-contaminated blood or blood component within 5 days prior to beginning therapy, defined as one of the following:

* Penetrating wound from needle recently removed from patient or sample container (e.g., blood bag, blood tube) or from sharp object visibly contaminated with HIV-positive blood or blood component. In the case of needlesticks or cuts with sharp objects, blood or blood component must not have been exposed to the air for more than 1 hour. If actual infusion of blood occurs, the 1-hour time limit does not apply.
* Hypodermic needles should come in contact with the blood and blood component from an HIV source but need not be visibly contaminated with blood to be considered a source of contamination.
* Significant exposure to HIV-positive blood or blood component as the result of splash on abraded skin.
* Significant exposure to HIV-positive blood or blood component as the result of splash on mucous membranes.
* Participant must be able to give informed consent.

Active drug or alcohol abuse sufficient in the physician's opinion to prevent compliance with the study regimen.
Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)

The purpose of this study is to determine the safety and effectiveness of a drug called atomoxetine for the treatment of cognitive impairment for Parkinson 's disease. Atomoxetine (ATM) is an approved drug currently on the market for the treatment of attention deficit. It works to increase the amount of norepinephrine (a chemical in the brain that helps keep us awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration (FDA) to be used in the treatment of PD.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of idiopathic PD according to the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria
* Male or female subjects aged between 35 and 75 years, inclusive at the time of consent
* Hoehn \& Yahr Stage I-IV
* Diagnosis of PD mild cognitive impairment (MCI), Montreal Cognitive Assessment (MoCa) score 21-25
* Stable concomitant medications for 60 days

Exclusion Criteria:

* Secondary parkinsonism or atypical parkinsonism, Prior Deep Brain Stimulation (DBS) or other brain surgery
* PD Dementia; MoCA score \<21
* Presence of Psychosis, pregnancy, suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) type 4 or 5 in past 3 months.
* Current treatment with anticholinergics, monoamine oxidase (MAO) inhibitors or neuroleptics (including quetiapine)
* Serious cardiac abnormalities, Narrow angle glaucoma, Pheochromocytoma, Bipolar Disorder
* Liver Function Tests (LFTs) \>1.5 X upper limit of normal value
Anti-viral Action Against Type 1 Diabetes Autoimmunity

The study GPPAD-05 AVAnT1A is a phase 4 clinical trial intending to enroll 2252 children, who will be randomly assigned to receive COVID-19 vaccination (Comirnaty® 3 μg Omicron XBB.1.5 or new variant Comirnaty vaccines ) or placebo from age 6 months.

The study is an investigator initiated, randomized, controlled, multicentre, multinational, primary prevention trial for children at increased risk of type 1 diabetes.

The primary objective is to determine whether vaccination of children with elevated genetic risk for type 1 diabetes against COVID-19 from 6 months of age reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in childhood.

Secondary objectives are:

1. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of multiple islet autoantibodies in childhood.
2. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of type 1 diabetes in childhood and
3. to determine whether vaccination against COVID-19 similarly reduces the cumulative incidence of celiac disease-associated transglutaminase autoantibodies in childhood.

Further exploratory objectives are described in the study protocol.

Study participants will be identified through an ongoing study screening for genetic risk of type 1 diabetes using a polygenic risk score (NCT03316261).

Eligible participants will be enrolled at age 3.00 to 4.00 months (baseline visit).

Randomization to vaccine or placebo will occur at age 6.00 to 7.00 months at visit 2. Consent will be obtained by the custodial parents prior to enrollment.


Eligibility Criteria:
Inclusion Criteria:

1. Ages between 3.00 and 4.00 months at the time of enrollment.
2. A high genetic risk (\>10%) to develop islet autoantibodies by age 6 years as determined by a HLA DR/DQ genotype, polygenic risk score and first-degree family history of type 1 diabetes status.
3. Written informed consent signed by the custodial parent(s).

Exclusion Criteria:

1. Previous hypersensitivity to the excipients of the vaccine.
2. Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study. These include immune deficiencies, and conditions or treatments that lead to immune suppression.
3. Likely poor compliance due to expected change in residency.
4. Diagnosis of diabetes prior to recruitment or randomisation
5. Current use of any other investigational drug