cyrilzakka/clinical-trials huggingface dataset:
Effect of Intrathecal Fentanyl on Spinal Anesthesia During Dexmedetomidine Infusion

Intravenous infusion of dexmedetomidine during procedure was known to be associated prolonged duration of spinal anesthesia. In patients receiving dexmedetomidine infusion during procedure, it has been not evaluated whether use of adjuvant intrathecal fentanyl had additional prolonging effect on duration of spinal anesthesia or not. Therefore, the investigators planned this trial to compare clinical outcomes in patients receiving spinal anesthesia with heavy bupivacaine only and heavy bupivacaine plus fentanyl adjuvant.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing total knee replacement arthroplasty under spinal anesthesia

Exclusion Criteria:

* Contraindication of spinal anesthesia
* inability to communicate
* morbid obesity (BMI \> 30kg/m2)
* spine abnormality
* severe cardiac dysfunction
* Height \<155cm, or \> 180cm
* contraindication to fentanyl
The Polarization and Expression of Chemokine Receptors of T Help Cell in the Pathogenesis of Acute and Chronic GVHD

The purpose of this study is to see the correlation of polarization and the expresison of chemokine receptors of T help cells after allogeneic hematopoietic stem cell transplantation and clinical course graft-versus-host disease.


Eligibility Criteria:
Inclusion Criteria:

* patient received allogeneic stem cell transplantation at CMUH
* can be regularly followed at CMUH

Exclusion Criteria:

* patient who do not want to enter in this study
Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients

This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.

Double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations. The percentages of heavy drinking days and abstinent days were the primary outcome measures, and craving; distress and depression levels; self-efficacy; social support from family, friends and significant others; and health-related quality of life (HRQL) were secondary outcomes. Tolerability was also examined.

Eligibility Criteria:
Inclusion Criteria:

1. ICD-10 diagnosis of alcohol dependence (World Health Organization, 1993);
2. Seeking treatment with the aim to stop alcohol consumption;
3. Age ranging from 18 to 60 years;
4. Last alcohol intake reported in the 24 h preceding observation;
5. Presence of a referred family member;
6. Written informed consent provision.

Exclusion Criteria:.

1. Serious hepatic, kidney, lung, neurological and cardiovascular, diseases);
2. Suicide risk, acute psychosis, severe depression, organic brain syndromes;
3. Dependence on psychoactive substances other than nicotine.
Human Umbilical Cord Mesenchymal Stem Cells Treatment in Sepsis

The primary objective: To evaluate the efficacy of intravenous infusion of universal UC-MSCs and CD83+MSCs subpopulation injection in the treatment of sepsis by using the 28-day survival rate of the subjects as the primary efficacy criterion.The secondary objectives: 1. To systematically evaluate the safety of universal UC-MSCs and CD83+MSCs subpopulation in the treatment of sepsis; 2. To provide theoretical basis and clinical research data for establishing a safe, effective and feasible clinical treatment plan for sepsis using stem cells.


Eligibility Criteria:
Inclusion Criteria:

* Age: 0-65 years old, diagnosed with sepsis
* Clinical diagnosis of sepsis (based on Sepsis 3.0 International Guidelines)
* Confirmed or suspected infection

Exclusion Criteria:

* Violation of medical ethics
* Significant confounding factors likely to bias study outcomes
* Poor adherence to the study protocol
* Concurrent participation in other clinical trials
* Specific medical conditions:

  1. History of chronic enteritis, neuropsychiatric disorders, or transplantation (bone marrow, lung, liver, pancreas, or small intestine)
  2. Severe primary diseases affecting survival (e.g., life-limiting hepatic, renal, or endocrine disorders) or psychiatric disorders
  3. History of hypersensitivity or severe adverse reactions to biological products
  4. Imminent terminal status (e.g., septic shock, life expectancy \<7 days)
  5. Foreseeable risk of medical errors or disputes during hospitalization
  6. Active drug-resistant infections
  7. History of malignancy at screening
  8. Pregnancy, lactation, or plans for pregnancy within the next year
The SmokeFree App Smoking Cessation Study

SmokeFree is a theory-driven and evidence-based stop smoking mobile application. Based on NICE guidance and best practice for smoking cessation, the application employs over 30 behaviour change techniques used in NHS Stop Smoking Services. It has been downloaded over 4 million times and has an average user rating of 4.7 out of 5, from over 120,000 ratings. Whilst user feedback has been highly positive, there is a need for further objective studies to demonstrate its efficacy.

This is a prospective, observational, two arm feasibility study, which aims to evaluate the efficacy, attrition rate and user experience of the SmokeFree App.

Inpatients in the Acute Medical Unit and ambulatory emergency care unit at Chelsea and Westminster Hospital who are current smokers will be offered to participate in the study, in addition to all other smoking cessation interventions, which will also be offered to them. Care will be taken to ensure that all available options of smoking cessation support are offered in addition to the SmokeFree application. Subjects agreeing to participate will be given access to the application for a period of 12 weeks, with a target quit date no later than week 8 of use of the application. At the end of 12 weeks they will be offered a follow up appointment in a purposely designed clinic, where their CO level will be measured, as well as being invited to complete feedback questionnaires on their experience.

The primary end point of the study will be the quit rate for a period of minimum of 4 weeks by the completion of the 12 week trial. This will be confirmed with exhaled carbon monoxide testing.

Secondary endpoints include user experience, engagement with the mobile application and attrition rate.


Eligibility Criteria:
Inclusion Criteria:

Intervention:

* ≥ 18 years
* All new patients admitted via the Acute medical via AAU (or AEC)
* Current smoker and willing to quit
* Smartphone owner
* Fluent in English (verbal and written)
* Able to give informed consent
* Able and willing to attend a follow up visit in 12 weeks.

Control:

- Meet above inclusion criteria except ownership of smartphone.

Exclusion Criteria:

* \< 18 years
* Patient refusal
Artificial Intelligence System for Assessing Image Quality of Fundus Images and Its Effects on Diagnosis

Fundus images are widely used in ophthalmology for the detection of diabetic retinopathy, glaucoma and other diseases. In real-world practice, the quality of fundus images can be unacceptable, which can undermine diagnostic accuracy and efficiency. Here, the researchers established and validated an artificial intelligence system to achieve automatic quality assessment of fundus images upon capture. This system can also provide guidance to photographers according to the reasons for low quality.


Eligibility Criteria:
Inclusion Criteria:

* Patients should be aware of the contents and signed for the informed consent.

Exclusion Criteria:

* 1. Patients who cannot cooperate with a photographer such as some paralytics, the patients with dementia and severe psychopaths.
* 2. Patients who do not agree to sign informed consent.
Application of Patient Blood Management in the Oncology Patient Affected by Breast Cancer

Evaluation of the percentage of transfusions in patients with breast cancer undergoing surgery after preventive treatment with haematinics.

Preoperative anemia treatment is fundamental in Patient Blood Management (PBM) programs, a multidisciplinary and multimodal strategy that improves clinical outcomes based on the patient's blood resource, promoting strategies to optimize hematopoiesis in candidates for elective surgery, in order to significantly reduce the use of blood products, addressing all modifiable transfusion risk factors before it is even necessary to consider the use of transfusion therapy itself. Treatment with intravenous iron reduces the transfusion risk and consequently the adverse events related to the transfusion itself.

Nothing is specified in this regard for cancer patients; very often these patients come to surgery presenting an anaemic state that often requires correction with red blood cell transfusion. The aim of this clinical study is to prevent the number of perioperative transfusions in patients with breast cancer who have undergone or not undergone neoadjuvant chemotherapy and with Hb values lower than or equal to 11 g/dl, who are candidates for destructive and/or reconstructive surgery.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years;
* patients diagnosed with histologically confirmed breast cancer and whether or not they have undergone neoadjuvant chemotherapy;
* patients who are candidates for destructive and reconstructive breast surgery or not;
* Hb values less than or equal to 11 g/dL and/or transferrin saturation less than or equal to 20%;
* written informed consent.

Exclusion Criteria:

* patients with known allergies to ferric carboxymaltose or its excipients;
* ferritin values greater than 500 ng/ml;
* patients unable to sign consent and comply with procedures.
Zilver PTX Delivery System

The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.


Eligibility Criteria:
Inclusion Criteria:

* Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries
* Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery

Exclusion Criteria:

* Patient is \< 18 years of age
* Patient unable to complete required follow-up assessments
* Patient unwilling to sign and date the informed consent
* Simultaneous participation in another investigational drug or device study
* Pregnant, breastfeeding or planning to become pregnant in the next 5 years
* Additional medical/anatomical restrictions as specified in the Clinical Investigation Plan
A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD

The primary objective of this study is to evaluate the long-term safety and tolerability of methylphenidate hydrochloride extended-release capsules (Aptensio XR®) in children aged 4-5 years who have been diagnosed with attention-deficit/hyperactivity disorder (ADHD).

Safety and tolerability will be evaluated by assessing treatment-emergent adverse events (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory The primary objective of this study is to evaluate the long-term (12-month) safety and tolerability of Aptensio XR® in children aged 4 to less than 6 years who have been diagnosed with ADHD.

Safety and tolerability will be evaluated by assessing treatment-emergent adverse events (TEAEs) blood pressure, pulse, height, weight, electrocardiograms (ECGs), laboratory values and Columbia Suicide Severity Rating Scale (C-SSRS). Disturbances in sleep (quantity and quality) patterns will also be assessed using the Child Sleep Habits Questionnaire (CSHQ).

Secondary objectives include assessment of long-term efficacy of Aptensio XR®.

Secondary measures include:

* Investigator administered Attention-Deficit/Hyperactivity Disorder Rating Scale Preschool Version (ADHD-RS-IV Preschool Version)
* Clinical Global Impressions-Severity Scale (CGI-S )
* Connors Early Childhood Behavior-Parent Short form \[Conners EC BEH-P(S)\]


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 4 to less than 6 years inclusive at the time consent was given to participate in Prior Studies. New Subjects must be at least 4 years but less than 6 years of age when written consent is given to participate in this trial.
Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI

This pilot study is a prospective, randomized, open-label trial that aims to assess the feasibility of comparing a primary Computed tomography/Cardiac computed tomography angiography (CT/CCTA) strategy (test arm) to a strategy combining routine use of CT/CCTA and invasive CA (control arm) prior to a Transcatheter aortic valve implantation (TAVI) procedure. The study will also estimate the rate of composite coronary adverse events (myocardial infarction, post procedural coronary revascularization and cardiovascular mortality) between the two arms at 90 days follow-up. The primary endpoint will be the feasibility of recruitment and compliance with the study protocol at 2 sites in Canada and 1 site in Denmark. Additional clinical endpoints including: all-cause death at 90 days post procedure, myocardial infarction at 90 days post procedure, unplanned PCI or CABG at 90 days post procedure, stroke at 90 days post procedure, CA and PCI related cumulative vascular complications events. This information will be used to inform the design of the definitive efficacy trial.


Eligibility Criteria:
Inclusion Criteria:

* Severe aortic stenosis (Peak transvalvular gradient of ≥ 40mmHg on TTE or stress Echo, Aortic valve area of \< 1.0cm2)
* Symptoms suggestive of aortic stenosis (dyspnea, syncope, angina)
* Eligible for TAVI (Upon evaluation by a multidisciplinary team composed of at least one interventional cardiologist and one cardiothoracic surgeon)

Exclusion Criteria:

* Severe renal dysfunction Glomerular filtration rate \< 30 ml/min.
* Severe left ventricular dysfunction LVEF ≤ 30%
* Recent coronary angiography ≤ 6months from randomization
* Recent PCI ≤ 6months from randomization
* Recent or active acute coronary syndrome (New or worsening angina with or without positive biomarkers or ECG changes).
Prevention of Malnutrition in Children with Sickle Cell Disease

The investigators are studying how to prevent malnutrition in children with sickle cell disease (SCD) in northern Nigeria. Community health workers will teach mothers about nutritious local foods that might help children grow better than the usual advice from doctors. The investigators will enroll 148 children with SCD aged 6 to 18 months old. The investigators will determine if their weight and diet improve and check for low vitamin A levels. This information will help us find better ways to improve growth for children with SCD.

Despite efforts to improve nutrition, 45% of under-5 mortality is at least partially attributable to malnutrition. Children with SCD have high nutrient demands and energy expenditures with a risk of impaired growth. The investigators will test the hypothesis that maternal nutrition education on locally available nutrient-dense foods will lead to improved childhood growth compared to standard pediatrician-delivered nutrition counseling. The research will involve a randomized controlled trial with 148 children aged 6 to 18 months with SCD, assessing changes in weight-for-age z-scores and dietary adequacy, as well as determining the prevalence of vitamin A deficiency. These preliminary findings will inform evidence-based interventions for the primary prevention of malnutrition (underweight and vitamin A deficiency) in children with SCD.

Eligibility Criteria:
Inclusion Criteria:

* laboratory confirmed SCD (HbSS, HbSβ0 thalassemia, or HbSC)
* aged 6 to 18 months.

Exclusion Criteria:

* severe acute malnutrition (weight-for-length z-score \<-3 or mid-upper arm circumference \<11.5 cm)
* diagnosis of HIV or other chronic illnesses
Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)

A Phase II trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).

The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis.

In PTK 0796-CSSI-0702 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients, ages 18 years to 80 years
2. Has an acute complicated skin and skin structure infection
3. Female patients must not be pregnant at the time of enrollment and must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria:

1. Has received an investigational drug within past 1 month
2. Has been previously enrolled in this protocol
3. Has received \>48 hr of a potentially effective systemic antibiotic immediately prior to study drug
4. Is nursing
Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation

Patients with severe aortic stenosis candidates for a TAVI procedure harbor a high burden of silent arrhythmic events. Pre-procedural detection of such arrhythmias should help the investigators to implement specific therapeutic measures that may improve patient outcomes and reduce hospitalization length post-TAVI.

This is a prospective registry including patients accepted by the heart team for a TAVI procedure. Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure. The duration of the ECG monitoring will be of 1 week. There will be no restriction regarding the type of valve and approach used for the TAVI procedure. All type of arrhythmic events will be recorded, as well as the specific therapeutic measures implemented upon the occurrence of the arrhythmic event. Following the TAVI procedure, the patients will be monitored (telemetry) until hospital discharge. All arrhythmic events during the hospitalization period will be recorded. Clinical follow-up will be performed at 30 days, and 1 year post-TAVI, and yearly thereafter up to 5-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe aortic stenosis accepted for a TAVI procedure by the Heart Team.

Exclusion Criteria:

* Urgent TAVI procedure or logistic reasons precluding an ECG monitoring of at least 1 week within the 3 months prior to the TAVI procedure.
* Prior permanent pacemaker.
Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site

The aim of the study is to Evaluate of the analgesic effect of ropivacaine in topical use at the thin skin graft donor site.

For Patient needing a thin skin graft \< 320 cm2, randomization will be done in 2 groups, one receiving the standard treatment (20 mL of physiologic serum) during the surgical intervention in topical use to recover an alginate dressing (Algosteril)and the other receive 20 mL of Naropein during the surgical intervention on alginate dressing.

The hypothesis of the study is the administration of ropivacaine will decrease the post-operative pain compared to physiologic serum


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years old
* Patient needing a thin skin graft \< 320 cm2 and which is possible on the thigh
* Patient who read the information letter and signed the informed consent
* Patient affiliated at a social security system
* Effective contraceptive method for more than 3 months for women of childbearing age

Exclusion Criteria:

* Contraindication to one of the medicine used (allergy, intolerance, potential drug interaction)
* Treatment by classII or III of analgesics or analgesic dose of aspirin(\>500mg per day) at the inclusion or randomization time
* Preoperative EVA\>0 at the skin graft donor site on the thigh
* Sensory disturbances of the lower limbs
* Cognitive disturbances not allowing investigations
* Pregnant or lactating women
* People deprived of discernment
* People deprived of their liberty by judicial or administrative authority
* Protected adult (guardianship or trusteeship)
Pregnancy Registry in West China

With the Healthy China 2030 Plan for further reducing maternal mortality ratio (MMR), and increasing number of high-risk pregnancies in China, we aimed to develop a registry of pregnant women based on hospital-based Electronic Medical Records (EMR) data in West China, through integrating information technology and medical knowledge, by linking multi-resource data covering information regarding the whole cycle from pregnancy registration till delivery, and process of diagnosis, treatment and pregnancy outcomes, in order to provide reliable, valuable and efficient data resources for researches about high-risk pregnancy safety and MMR reduction in southwestern China.

From January 29, 2014 to November 29, 2019, 64,468 pregnancies of 62,690 women were registered around gestational 13th weeks in the hospital, collecting over 47 million records (including repeated measurement data) from Health Information System (HIS), Laboratory Information System (LIS), and Picture Archiving and Communication System (PACS). After excluding 3476 pregnancies lost to follow-up and 7325 newly-pregnancies with expected date of delivery out of the study time, a total of 53,667 pregnancies about 51,964 women were finally included in the registry, who had been followed up till the occurrence of at least one outcome, including any pregnancy complication, abortion, stillbirth, induced labor, and live birth between January 1, 2015 and November 30, 2019.

Till now, through data linkage, data collection, cleaning and recoding, we have generated more than 2100 structured variables regarding pre-pregnancy conditions, prenatal visit records, hospitalized diagnosis, treatment and discharge outcomes. The diagnoses of pregnancy complications, maternal and fetal outcomes, recorded by ICD-10 coding or free terms in original fields, were uniformly encoded by the Classification and Codes of Diseases released by Chinese National Standards Institute (GB/T14396-2016) and National Health Standard Criteria for Birth Defects (WS 377.6-2013).


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who registered prenatal information during first trimester at target hospital, and had been followed up till the occurrence of at least one outcome, including any pregnancy complication, abortion, stillbirth, induced labor, and live birth.

Exclusion Criteria:

* They only registered in the hospital, but lost to follow-up for various reasons, such as transferring out for treatment or delivery; or they were hospitalized for termination of pregnancy (e.g. induced labor) or treatment of any complications (e.g. pregnancy-induced hypertension syndrome), but had no pregnancy registry records at the first trimester; or they registered pre-pregnancy information in the hospital just before the end of the study, none of pregnancy outcomes such as live-birth delivery, has been followed-up within the study period.