cyrilzakka/clinical-trials huggingface dataset:
An Observational, Prospective, Multicenter Study to Evaluate the Biologic Use and Outcomes in Chinese Asthma Patients

This study is a multicenter, observational, prospective study to evaluate the asthma biologic use features and clinical outcomes in China. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician.

This study is a multicenter, observational, prospective study to evaluate the asthma biologic use features and clinical outcomes in China. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician.

Approximately 200 patients with a physician diagnosis of asthma and prescribed with asthma biologics at visit 1 will be enrolled in this study, distributed among 50 sites across different regions in China.

During the study period, patients will be identified consecutively and, if they meet eligibility criteria and provide informed consent will be entered into this observational study. Patients should have an asthma diagnosis and be prescribed at least once with biologics for asthma treatment at enrollment (Visit 1, Week 0).

After the enrollment, subjects will be followed up at Visit 2(Week 24) and Visit 3 (Week 52). V1, V2 and V3 will be followed up by on-site visit. At Visit 1, data within last 12 months will be retrospectively collected as baseline. Patients existing medical record (MR) data will be collected in week 24 and week 52. PROs (Asthma control test \[ACT\], Asthma Quality of Life Questionnaire (+12) \[AQLQ(S)+12\]) should be performed at Visit 1, Visit 2 and Visit 3.

No additional mandated interventions on top of routinely performed physician visits, examinations or treatments will be required. Patients will not receive any experimental disease management intervention or experimental treatment as a result of their participation in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese, Female or Male
2. Age: no limitation
3. Physician-confirmed asthma diagnosis with documented evidence of diagnosis or evidence of variable expiratory airflow limitation (e.g., from bronchodilator reversibility testing or other tests).
4. Participants or their legal guardians must be able to provide informed consent.
5. Prescription of asthma biologics at enrolment.

   Exclusion Criteria:
6. Participation in an interventional study within the last 3 months.
7. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study with the usage of biologics, or may influence the results of the study, or the patient's ability to participate in the study
Integrated Behavioral Health Prevention in Pediatric Primary Care for Infants

The purpose of the study is to evaluate the acceptability and preliminary efficacy of a universal prevention program delivered by psychologists in conjunction with pediatric primary care well-child visits.

Integrated behavioral health has emerged as an effective approach to addressing emotional and behavioral health needs of children in the pediatric setting, yet there is little evidence for a standardized model of care for providing universal preventive services in pediatric primary care. Current models are typically loosely constructed, inconsistently applied, and unspecified. Our aim is to evaluate a model of care developed to address these gaps. Integrated Behavioral Health-Prevention (IBH-P) is a collection of clinical strategies and structured approaches designed to promote emotional and behavioral health. IBH-P is delivered by psychologists in the pediatric setting as part of scheduled well-child visits. The overall objective of this study is to evaluate the efficacy of the intervention in promoting infant self-regulation. Maternal experience and satisfaction, adherence to well-child visits and immunizations will also be examined.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Biological mother of a newborn infant presenting at the newborn well-child visit
* Intends to continue to receive infant's pediatric care at one of the three participating clinics over the next year.

Exclusion Criteria:

* Infant diagnosed as failure to thrive
* Infant exposure to illicit drugs in utero with the exception of THC
* Extensive care in the Neonatal Intensive Care Unit (\>7 days)
* Child has other serious medical condition or acute psychosocial circumstances that results in child not receiving medical clearance from the pediatrician or psychologist for randomization
* mother or father of infant has received Building Futures intervention training
COVID-19 Pandemic and General Surgery Emergencies

A retrospective analysis of emergency general surgical admissions during the first six months of the pandemic (from March 11 to September 11, 2020) and the same period in 2019, will be conducted.

The volume and disease severity of emergency general surgery admissions between the first six-month period of the pandemic and the similar time period in the prepandemic period in 2019 will be compared.

Patients admitted during the first six months of the COVID-19 pandemic, from March 11 to September 11, 2020, will be included. As a comparison group, similar data will be collected on patients admitted to the general surgery department during the same period in 2019. Patient and disease characteristics, including demographics, initial leukocyte and C-reactive protein levels, diagnosis, treatment strategies, complications, duration of hospital stay, 30-day rehospitalization rate, and 30-day reoperation rate will be reviewed. Complications will be classified according to Clavien-Dindo classification. Tokyo Guidelines 2018/2013 will be used to assess the severity of the acute cholecystitis.

After the patients are divided into two groups: (1) prepandemic period and (2) pandemic period, descriptive statistics will be presented as the medians and ranges, and frequencies (%). Associations between variables will be evaluated using the Mann-Whitney U test (for continuous variables) or Pearson's chi-square and Fisher exact tests (for categorical variables), where appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older
* Patients admitted during the first six months of the pandemic, from March 11 to September 11, 2020, and patients admitted during the same period in 2019

Exclusion Criteria:

* Patients younger than 18 years
* Patients positive for COVID-19
* Patients required elective surgery
* Patients re-operated because of a postoperative complication of an elective surgical procedure
Risk Stratification Using MEESSI-AHF Scale in ED and Impact on AHF Outcomes

Evaluate the impact the application of the MESSI-AHF scale (a risk stratification scale specifically derived and validated in patients diagnosed with acute heart failure, AHF) in decision making (admission vs. discharge) by emergency physicians in emergency departments (ED) and its potential impact on on the short-term prognosis of patients with AHF.

Study 1: A non-intervention study involving the consecutive inclusion of 3,200 patients with AHF in 16 Spanish EDs managed according to the usual practice. Individual risk will be retrospectively stratified according to the MEESSI-AHF scale, and we will analyze the distribution of the categories of risk in patients admitted and discharged and the prognosis of patients with low risk discharged from the ED and compare the events observed in this subgroup of patients with the recommended international standards. Study 2: This is a cuasiexperimental study in 8 EDs with consecutive inclusion of 1,600 patients with AHF managed according to the usual practice (without stratification of risk, pre-phase) and 1,600 patients managed after the implementation of the MEESSI-AHF scales for risk stratification before the final decision making in the ED (post-phase). If the patient has low risk the calculator will propose discharge; for the remaining categories of risk the calculator will propose patient admission. The final decision corresponds to the attending physician and if this decision differs from what was proposed, a reason will be given. Study 3: Open multicentre (8 EDs) randomized clinical trial (1:1) comparing the results obtained in the patients randomized to usual clinical practice (1,600 patients) with those obtained in the patients randomized to the use of the MEESSI-AHF scale for risk stratification (1,600 patients) prior to decision making. The dynamics of the decision proposed by the scale will be the same as that in Study 2. Main outcomes (Studies 1, 2, 3): Death (by any cause and cardiovascular cause) at 30 days and at 1 year; combined event (revisit to the ED or hospitalization for AHF or death) at 30 days post-discharge (global analysis of all the patients with AHF stratified by categories of risk); days alive and outside the hospital at 30 days after the index event (consultation to the ED); and proportion of patients managed without hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of AHF based on Framinham criteria
* NT-proBNP \>300 pg/mL
* Patient able to consent

Exclusion Criteria:

* ST-elevation acute coronary syndrome
The Relationship Between the Flow of Arteriovenous Fistula and Cardiac Function in Haemodialysis Patients

A prospective longitudinal surveillance for a period of 2 months. Sample - identify suitable Chronic Kidney Disease (CKD) patients who undergo HD with functioning AVF. Participants at various age range and both sexes are recruited to observe their access flow, access recirculation and cardiac function and assess their relationship.

All patients recruited who met the inclusion criteria were investigated access flow, access recirculation and cardiac function(including cardiac output,cardiac index,central blood volume,et al).Measurement time is the beginning of HD session (first 30min to 1 hr),Middle of HD session (optional),and the end of the HD session (1hr to 30 min prior to end of session). The follow-up duration is 6 months and 12 months.Repeat the assessment at the above time points.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergo HD with native AVF
* AF of AVF between 300ml/min and 1800ml/min

Exclusion Criteria:

* Patients whose AVF developed Access Recirculation (AR) which cannot be resolved at the time of measurement
* Patients developed access or systemic infection during the study period
Casodex - Nolvadex Combination

This study looks at the relationship in the dose of nolvadex and the incidence of gynaecomastia and also Prostate Specific Antigen (PSA) inhibition when co-administered with Casodex. The aim of the study is to assess the optimal dose of nolvadex which will reduce the breast tissue adverse effects without reducing the efficacy of Casodex.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with adenocarcinoma of the prostate gland but with no evidence of distant metastasis. The stage of disease should be T1-T4, any N, M0 confirmed histologically or cytologically
* Subjects in need of immediate hormonal therapy.
* PSA equal or above 4 ng/ml

Exclusion Criteria:

* Presence of gynaecomastia and/or breast pain at screening visit
* Any previous endocrine therapy for prostate cancer other than neoadjuvant LHRH therapy prior to primary therapy of curative intent.
* Current use, or within the previous 6 months, of any medication known to have a high risk of causing gynaecomastia .
* Previous mastectomy or radiation to chest wall
The REACH Study: A Novel Values-Based Intervention to Increase Endocrine Therapy Adherence Among Breast Cancer Survivors

This pilot trial compares two online interventions to improve adherence to anti-hormonal medication among women with the most common form of breast cancer (estrogen receptor-positive).


Eligibility Criteria:
Inclusion Criteria include:

1. Women in Colorado treated for Stage 0 to III estrogen receptor-positive breast cancer who have completed primary cancer treatment (surgery, chemotherapy, and/or radiation) and within the past 2.5 years, have been prescribed anti-hormonal therapy
2. Take their anti-hormonal therapy medication at least occasionally and have at least 1 more year left on their prescription
3. Report at least 1 factor that makes taking their anti-hormonal therapy medication difficult
4. Have internet access
Functional Brain Imaging in Recreational Users of Ecstasy

Recreational use of "ecstasy" (MDMA; 3,4-methylenedioxymethamphetamine) is associated with long-lasting effects on metabolism in the human brain. The investigators propose to investigate whether chronic use of "ecstasy" is associated with impairment in motor skills and function of the dopaminergic system in recreational users of "ecstasy" compared with healthy volunteers. This will be done by scanning control subjects and "ecstasy" users at baseline and after performing on a motorbike riding computer game, while imaging dopamine in vivo with I123-IBZM (a D2 receptor radiotracer), using single photon emission computed tomography (SPECT).

Recreational use of "ecstasy" (MDMA; 3, 4-Methylenedioxymethamphetamine) is associated with long-lasting effects on metabolism in the human brain. In particular, there is evidence of long-term damage to the brains' neurotransmitter serotonin (5-HT). It is also known that chronic use of Methamphetamine (which is similar in its chemical structure to "ecstasy") is linked to impaired cognitive and motor skills despite recovery of dopamine transporters (DAT). We have investigated whether chronic use of "ecstasy" is causing any impairment in motor skills and function of the dopaminergic system in recreational users of "ecstasy". In our preliminary study, we have scanned control subjects and "ecstasy" users, at baseline and after performing on a motorbike riding computer game while imaging dopamine in vivo with \[123I\] IBZM (a D2 receptor radiotracer) in Single Photon Emission Computed Tomography (SPECT). We showed:

1. Lower measures of D2 at baseline in ecstasy users compared with control subjects, that means lower level of dopaminergic activity in "ecstasy" users.
2. Significant displacement of \[123I\] IBZM by endogenous dopamine released during the game in healthy subjects unlike "ecstasy" users, that means that recreational users of "ecstasy" release much less natural dopamine.
3. No difference between the groups in performance (reaction time) on riding the game after a year of recovery.

Our results show preliminary evidence for dopaminergic deficiency in "ecstasy" users, a finding that has not been shown before. However, similar to other drugs of abuse, it is not known whether dopaminergic deficiency is the cause or consequence of the use of "ecstasy". We now propose to proceed to scan more recreational users of "ecstasy" in order to assess whether chronic use of "ecstasy" is associated with deficient dopaminergic neurotransmission in the brain.

Eligibility Criteria:
Inclusion Criteria:

* Chronic users of ecstasy, and healthy controls, with no other diseases or drug abuse

Exclusion Criteria:

* Pregnant and breast feeding women
* Aged below 18
* Neurological disorders
* Drug abuse
Comparison of Tidal Volume Between Pediatric Anaesthesia and Paediatric Intensive Care Patients

Paediatric anaesthesiology and paediatric intensive care unit data will be retrospectively screened for the data regarding mechanical ventilation. The primary aim will be the tidal volume setting and the secondary the level of positive end-expiration pressure (PEEP) according to the inspired oxygen fraction (FIO2), and the level of driving pressure.

Protective positive pressure ventilation (tidal volume ≤6 mL/kg) in adult patients in intensive care is currently considered as a standard procedure. It is associated with a reduction of morbidity and positive outcome. In paediatric patients there are available only limited information related to the size of the tidal volume and it is recommended to use the volume between 5 and 8 mL per kg for the whole spectrum of ages of pediatric patients. The aim of this retrospective observational study is to evaluate the tidal volumes used in clinical practice in pediatric patients during general anesthesia and compared it to the tidal volumes used in paediatric critical care. Data will be harvested from the anaesthesiology records and from the paediatric intensive care unit charts. The tidal volume will calculated per kg of actual weight.

Eligibility Criteria:
Inclusion Criteria:

* Paediatric patients on mechanical ventilation in anaesthesia department
* Paediatric patients on mechanical ventilation in intensive care department
* In selected study period between 1.1.2018 - 31.1.2019

Exclusion Criteria:

* Age outside selected limits
* Insufficient data
Is Access to Liver Transplantation Similar in Alcoholic or Not Patients?

The purpose of this study is to determine whether there are reasons other than medical reasons that could limit access to liver transplantation in alcoholic patients.

The investigators perform a study combining the follow up of a previous cohort of 450 patients and the inclusion of 150 new patients.

The study is performed in medical or hepatogastroenterology departments of nine French public hospitals mostly non-teaching. They lay in three French area, selected according to the density of patients with alcoholic liver disease (ALD) in the area, respectively, "high" as in Brittany-Loire, 'average' in Ile de France and "low" as in the Languedoc-Roussillon.

The patients included in the cohort must respond to the following criteria: having liver cirrhosis of whatever origin and age over 18 years. The cirrhosis must be confirmed by the morphological or histological criteria.

Structured forms and questionnaires will allow the collection of data. Information collected from patients include socio demographic characteristics, medical history, history of consumption of psychotropic (i.e., alcohol or drugs), clinical, biological, histological characteristics and psychological. Inpatients complete a self-assessment structured questionnaire "Hospital Anxiety Depression Scale" (HAD).

Patients are followed until they are registered or not on the national waiting list or die, every 6 months after inclusion until 2 years.

Statistical analysis will focus on descriptive analysis, survival analysis by Kaplan-Meier, and analytic analysis. Association with registration on the national waiting list of inpatients will be searched using Cox and logistic regression models. Further analyzes will be conducted for example on the differences of opinion between physicians and patients, on regional differences.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients
* Age over 18
* Having liver cirrhosis of whatever origin (Cirrhosis was confirmed if morphological or histological criteria with or without esophageal varicoses were met)

Exclusion Criteria:

* Outpatients
* Age less to 18
* With acute liver failure or hepatocarcinoma without liver cirrhosis
Pain Management After Surgery

Following outpatient orthopaedic surgery, adequate pain control is imperative both for patient satisfaction and for improved recovery and rehabilitation. Opioids are frequently utilized for postoperative pain control, however they can be addictive and are known to have many deleterious effects. Recent studies have demonstrated the effectiveness of a wide variety of multi-modal postoperative pain regimens in providing adequate pain control while also decreasing opioid usage. However, the most effective multi-modal pain regimen for postoperative pain control remains unclear. This prospective, randomized study intends to investigate the efficacy of a multi-modal postoperative pain regimen compared to a traditional opioid-only pain regimen following elective outpatient orthopaedic surgery of the hand, wrist, foot, or ankle.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* undergoing elective outpatient orthopaedic surgery under general anesthesia.

Exclusion Criteria:

* Age \< 18 years old
* Non-English speaking
* allergy to or medical contraindication to taking oxycodone (or other opioids), acetaminophen, or Naprosyn (or other NSAIDs).
* currently taking opioid medications
* history of chronic opioid therapy for chronic pain
* surgery being performed under local anesthesia only, without general anesthesia or sedation
Study Comparing Isolated Pelvic Perfusion With TNF-α 0.3 mg and Melphalan 1.5 mg/kg Versus Standard Treatment in Patients With Non Resectable, Recurrent Gynaecologic or Digestive Pelvic Cancer

Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery).

Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer.

The aim of the study is to show a 25% increase in 1 year overall survival rate with isolated pelvic perfusion.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proved locally advanced gynaecologic or digestive tumours (epidermoid carcinomas, adenocarcinomas, neuroendocrine tumours, sarcomas or melanomas), (cervix, vagina, rectal, anal).
* Locally recurrent tumours for which surgical treatment will be mutilating or marginal (R1 or R2) and/or for cervix cancer, primary tumours non accessible for standard treatment (radiotherapy- chemotherapy - brachytherapy and surgery).
* Surgically resectable tumour (R0 type) but for which patient does not agree with surgery.
* Patients aged over 18 and under 76 ans
* Performance OMS Index ≤ 2
* Normal biologic parameters
* Good general and cardiac state (ASA I or II and NYHA I or II)

Exclusion Criteria:

* Surgically resectable tumour (RO) or peritoneal tumour extension or distant metastasis.
* Cardiac or vascular pathology
* Pulmonary disease
* Uncontrolled Sepsis disease
* Pregnancy
Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)

Epilepsy is the second commonest chronic neurological disorder in developed countries ,comorbidity refers to the co-occurrence of two conditions with greater frequency than found in the general population


Eligibility Criteria:
Inclusion Criteria:

Patients with primary epilepsy. Aged above 18 years old.

Exclusion Criteria:

* patient diagnosed as secondary epilepsy or epilepsy syndromes
Repetitive Transcranial Magnetic Stimulation Associated With Physical Therapy to Reduce Upper Limb Spasticity in Post Stroke Patients

In this study, it is being investigated if the association between high frequency repetitive transcranial magnetic stimulation associated with motor physical therapy reduces spasticity, increases upper limb motor function, and quality of life of post-chronic stroke patients than motor physical therapy alone. For this purpose, patients included will be submitted to ten sessions with active or sham hf-rTMS followed by a protocol of physical therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age 30 to 75 years;
* Both sexes;
* With diagnosis of ischemic or hemorrhagic stroke proven by means of computed tomography or magnetic resonance imaging;
* Spasticity grade will be assessed using the Ashworth modified scale (BOHANNON \& SMITH, 1987), with score +1, 2 or 3 for the wrist flexors of the affected upper limb;
* With absence of cognitive deficit verified by the Folstein Mini Mental State Examination (score ≥ 20) modified for the Brazilian population (BRUCKI et al., 2003)

Exclusion Criteria:

* Contraindications to and EMT (ROSSINI et al., 2015)
* Clinical evidence of multiple brain lesions
* Trauma-orthopedic injury that limits the range of motion of the upper limb
* Presence of visual and / or communication deficit
* Involvement of other interventions focused on reducing spasticity
* Modification of medications in the last 30 days.