cyrilzakka/clinical-trials huggingface dataset:
Expanding the UTHealth Medical Legal Partnership to Improve Mental Health for Low-Income Individuals

The aim of this study is to test whether participation of low-income patients with health-harming legal needs (HHLNs) in a medical legal partnership (MLP) results in improved mental health, improved quality of life, reduced utilization, and increased resolution of HHLNs.


Eligibility Criteria:
Inclusion Criteria:

* low-income individuals (Low-income is defined as earning less than 200% of the Federal Poverty Level)
* individuals with HHLNs
* English or Spanish speaking

Exclusion Criteria:

* self-identified as being at significant and immediate risk due to HHLNs (e.g., a situation that involves imminent risk to the patient such as domestic violence)
Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation

Anticoagulant treatment for non-valvular atrial fibrillation (AF) associated with cerebral infarction/ TIA is one of the recognized treatment of stroke prevention. The ACC/AHA and national guidelines for the management of anticoagulation recommend that most of AF patients with cerebral infarction or TIA should be administrated anticoagulant therapy within 14 days of symptom onset, while European guidelines recommend that the timing of the initiation of non-vitamin K antagonist oral anticoagulants (NOACs) for AF patients with cerebral infarction or TIA is association with stroke severity in light of the "1-3-6-12" principle. However, there are still many problems about the use of NOACs in ischemic stroke with AF. for example, it is unclear what time to begin NOACs as to difference in stroke severity, ages, comorbidity with hypertension, diabetes, heart failure, liver and kidney dysfunction and bleeding risks. Thus, the timing of the initiation of NOACs is yet to be further studied. Current urgent need is to develop a guideline-based specific regimen in which the benefit-risk factors are further balanced with a combination of NHISS, CHA2DS2-VASC and HAS-BLED score.

Rivaroxaban, a direct coagulation factor Ⅹa inhibitor, blocks the formation of the clot. ROCKET-AF study has shown that the efficacy of rivaroxaban is not inferior to that of warfarin in AF patients on stroke prevention, and rivaroxaban has a significantly decreased bleeding risk compared with warfarin. Recent study indicates that early administration with rivaroxaban for AF patients within 14 days of onset does not significantly increase hemorrhagic transformation. However, the relevant clinical data of the efficacy and safety of early initiation of rivaroxaban in AF patients with cerebral infarction or TIA are lacking in China.

Therefore, the investigators conduct a multicenter cohort study to investigate the safety of early rivaroxaban in the AF patient with cerebral infarction or TIA within 12 days of onset.


Eligibility Criteria:
Inclusion criteria:

1. Over 18 years
2. Acute cerebral infarction caused by non-valvular atrial fibrillation
3. NIHSS score ≤ 15
4. Within 12 days of onset
5. first stroke onset or past stroke without obvious neurological deficit (mRS score≤1)
6. Signed informed consent

Exclusion Criteria:

1. Hemorrhagic stroke or mixed stroke
2. Patients with valvular atrial fibrillation or non-cardiogenic cerebral infarction
3. Patients with severe infection or serious diseases
4. Gastrointestinal bleeding or major operation within 3 months
5. Planed cerebrovascular reconstruction or cardiac surgery within 3 months
6. Planed major surgery within 3 months
7. Participating in other clinical trials within 3 months
8. Unsuitable for this trial assessed by research
WBV and Acute Lateral Ankle Sprain

The aim of this bicentric, biphasic, randomized, controlled study is to compare of the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains over a period of 12 months

Background:

Ankle sprains often result in ankle instability, which is most likely caused by damage to passive and neurological structures. Whole body vibration (WBV) is a neuromuscular training method improving those neurologic parameters impaired. The aim of this study is to compare the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains.

Methods/Design:

60 patients, aged 18-40 years, presenting with an isolated, unilateral, acute unstable inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled trial. Patients will be randomized by envelope drawing. All patients will be allowed early mobilization and pain-depending weight bearing, limited functional immobilization by orthesis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical therapy will take place twice a week, 30 minutes per session, for 6 weeks, following a standardized intervention protocol. During supervised physical therapy, the intervention group will perform similar exercises on a side-alternating sinusoidal vibration platform as the control group. Two time dependent primary outcome parameters will be assessed. Short-term outcome after six weeks will be postural control quantified by the sway index. Mid-term outcome after one year will be assessed by subjective instability, defined by the presence of giving-way attacks. Secondary outcome parameters include return to pre-injury level of activities, residual pain, recurrence, objective instability, energy / coordination, Foot and Ankle Disability Index and EQ 5D.

Eligibility Criteria:
Inclusion Criteria:

* Acute, unilateral, unstable, inversion ankle sprain (Grade II, III)

Exclusion Criteria:

* Pregnancy
* Conditions affecting the neuromuscular- or musculoskeletal System
* Previous surgical interventions to the foot, ankle, knee or hip; known FAI, CAI
* Conditions possibly affecting balance
* Cardiovascular disease including thrombosis
* Respiratory diseases
* Abdominal diseases (including gallstones)
* Urological diseases (including kidney- and bladder stones)
* Gynaecological diseases and + intrauterine devices
* Neurological diseases including epilepsia within the last 2 years
* Acute injuries to the head
* Patient is not available for follow up visits
* Patient unable to give informed consent
* Patient suspected to be non-compliant
A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer

To evaluate efficacy and toxicity of doxorubicin/Genexol-PM in metastatic breast cancer

1. Primary Purpose: response rate
2. Secondary purpose: toxicity, progression-free survival, overall survival


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older adult women
* Instrumentation measurable lesions with histologically confirmed advanced (recurrent or metastatic) breast cancer
* ECOG 0-2
* Advanced breast cancer in the past, patients who did not receive chemotherapy
* Recurrence if adjuvant chemotherapy and adjuvant chemotherapy in the past for more than 6 months until the patient
* life expectancy more than 3 months
* Agree in writing before the party to participate in a clinical trial to patients

Exclusion Criteria:

* immunohistochemical staining 3 + or FISH positive anti-HER 2 therapy patients
* Severe infections requiring antibiotic therapy
* Clinically significant heart disease
* Pregnant or lactating woman
* Uncontrolled symptoms in the central nervous system (CNS) metastases
* Patients diagnosed with malignant tumors of other organs
The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery

Obtaining adequate hemostasis is crucial during endoscopic sinus surgery. Submucosal injection of local anaesthetic containing adrenaline has frequently been used to improve surgical milieu. However, injection of adrenaline has potential side effects including tachycardia, hypertension as well as inducing arrhythmia. The aim of this randomized clinical trial is to assess the hemodynamic and hemostatic effects of two different concentrations of adrenaline in local anaesthetic used during endoscopic sinus surgery.


Eligibility Criteria:
Inclusion Criteria:

* recurrent acute sinusitis, chronic sinusitis, or nasal polyposis

Exclusion Criteria:

* bleeding disorders, under age of 18, history of cardiac disease or on antihypertensive medications
Effects of a Novel Physical Exercise Program in Patients With Cirrhosis (the LFN-exercise Protocol)

This study evaluates the effects of a structured exercise (The LFN-exercise protocol) program plus diet, on cerebral hemodynamics (cerebral blood flow) and hepatic hemodynamics (portal pressure), as well as on nutritional status (body composition and nutritional markers) in order to facilitate the prescription of exercise in patients with cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis of any aetiology (liver biopsy or a combination of clinical and biochemical variables plus evidence of portal hypertension); without decompensation during the past month; serum creatinine \<1.5 mg/dL; able to attend the appointed visits and willing to participate in the study.

Exclusion Criteria:

* Presence of high-risk varices in upper endoscopy (red marks, large varices or gastric varices); concomitant cardiopulmonary diseases; decompensated Type 2 Diabetes Mellitus, insulin use or proliferative diabetic retinopathy; orthopaedic or osteomuscular limitations; any type of cancer, primary sclerosing cholangitis and Inflammatory bowel disease.
Effects of Passive Smoking on Children During Gastrointestinal Endoscopy

To evaluate the effect of passive smoking in children during Gastrointestinal Endoscopy.

When the patients and their parents are arrived in the endoscopy unıt about 1 h before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment. Then the parents smoking habits are documented about to detect the magnitude of passive smoking. Endoscopist and anesthesiologist are blinded to the patients passive smoking history. Then the sedation is applied and esophagogastroduodenoscopy procedures performed. Side effects (e.g laryngospasm, coughing) during the study are recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA ( American Society of Anesthesiologists) I- ASA II patients
* Aged 1- 18 Year old patients

Exclusion Criteria:

* Smoker patients
Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)

Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ED


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 64 years
* Heterosexual males
* Erectile dysfunction for more than 6 months

Exclusion Criteria:

* Penile anatomical abnormalities
* Spinal cord injury
* History of surgical prostatectomy
Effect of Melatonin in Pediatric Hemodialysis Patients

A Prospective, randomized, double-blinded, placebo-controlled trial will be conducted at the pediatric dialysis unit, Children's Hospital, Ain Shams University in order to investigate the benefits of melatonin supplementation on oxidative stress, inflammation and to assess sleep quality by using PSQI questionnaire in pediatric hemodialysis patients.

1. Patients will be recruited and evaluated for eligibility.
2. Patients who meet the eligibility criteria will be randomly assigned to either placebo or intervention group.
3. Patient demographics, clinical characteristics and full medical and medication history: will be obtained at baseline and every 4 weeks after the beginning of the study.
4. Blood samples will be withdrawn from each patient before the dialysis session for assay of each of the following:

1.Oxidative stress marker malondialdehyde (MDA) by ELISA assay. 2. Inflammatory marker level nuclear factor kappa B (NF-KB) by ELISA assay 3. Complete blood picture (CBC). 4. Lipid profile (total cholesterol(TC), triglycerides(TG), high-density lipoprotein (HDL) and low-density lipoprotein (LDL) 5)Safety will be assessed weekly after the beginning of the study by monitoring the side effects or any adverse drug reactions.

* A total of (40) patients on regular HD will be enrolled in the study. These patients will be randomly assigned in a 1:1 ratio into two groups:

  * The first group (n=20):The patients in the first group will receive a total daily dose of 5mg of melatonin tablets 1-hour before bedtime for 12 weeks.
  * The second group (n=20): The patients will receive one tablet of placebo for the same duration.
* All subjects will sign an informed consent statement prior to inclusion in the study.
* All subjects will be followed up weekly for 12 weeks and blood samples will be withdrawn at baseline and the end of the study.

Eligibility Criteria:
All patients will be assessed for eligibility according to the following inclusion and exclusion criteria:

Inclusion Criteria:

1. Male or female patients age from 6-18 years old.
2. Undergoing regular HD for at least 6 months prior to enrollment
3. Not enrolled in any other clinical trial.
4. Judged by the physician to be physically stable

Exclusion Criteria:

1. Patients receiving anti-epileptics.
2. Patients with some autoimmune conditions as SLE, RA or post-organ transplant
3. Patients taking immunosuppressants.
4. Patients taking warfarin.
5. Patients receiving vitamin E, green tea or zinc during the past 3 months
6. Patients with malignancy and/or active inflammatory disease
7. Patients with mal absorption, mental retardation or psychiatric illness.
8. Patients who had hemorrhagic episodes or received blood transfusion in the past 3 months prior to the enrollment.
Effects of TEAS on Postoperative Recovery of Intestinal Function in Children Undergoing Laparoscopic Appendectomy

With the development of surgical techniques, laparoscopic appendectomy has become a standard therapeutic procedure for acute appendicitis in many hospitals in recent years, which is considered as an effective and safe treatment option in children. Even so, patients still experience gastrointestinal dysfunction after surgery, which is one of the most common complications in patients who have undergone major abdominal surgery. The application of laparoscopy reduces trauma in some degree, however, postoperative nausea and vomiting (PONV), abdominal distension, fart, and delayed bowel movement caused by postoperative gastrointestinal dysfunction(PGD), severely disturb patients and seriously affect the quality of patients' postoperative recovery. Previous studies have shown that the incidence of PGD can be as high as 10%-30%. For PGD, the main treatment options include the use of gastric dynamics promoting drug, non-steroidal anti-inflammatory drug, gastrointestinal (GI) decompression, nutritional support, and so forth. However, the effect of these treatments is limited, and there are varying degrees of adverse reactions, which indirectly leads to the low satisfaction of patients. Acupuncture is a form of traditional Chinese medicine and has unique advantages in the treatment of PGD, which have gradually obtained more acceptance from physicians as an alternative therapy. While transcutaneous electrical acupoint stimulation (TEAS) is one of the acupuncture-related technologies and can allow for accurate control of stimulation parameters. For this reason, it is helpful for quantitative research and widely practiced in China. Many studies have shown that TEAS combining with anesthetics can significantly enhance the analgesic effect and reduce the dosage of anesthetics, and can offer certain beneficial effects, such as alleviating preoperative anxiety and reducing postoperative pain and PONV by lessening need for anesthetic usage. It also has been found to help protect the brain, heart and other tissues, with positive benefits for gastrointestinal function by regulating vasoactive intestinal peptide levels. In practice, however, the current TEAS study focused on adults，with relatively little research on their use in children. Because of that, we applied TEAS for use in our study to observe the effect of TEAS in children's laparoscopic surgery and explore its possible mechanism.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists grade I\&II,16kg/m2 ≤BMI≤30kg/m2, undergoing laparoscopic appendectomy

Exclusion Criteria:

* previous history of gastrointestinal surgery or abnormal anesthesia recovery, allergy, broken and infection skin at and around the related points, long-term use of analgesic and sedative drugs, presence of severe systemic disease,and the patients drop out or are unable to complete a full follow-up for any reason
Study of the Prevalence of Autistic Traits in Angelman Syndrome

The goal of this observational cross-sectional study is to establish the prevalence of autism spectrum disorder in children and adolescents with Angelman syndrome. The main questions it aims to answer are:

* which clinical variables differentiate AS patients with and without Autism Spectrum Disorder between genetics, epilepsy, pharmacotherapy, behavioural problems, parenting style and parents' perceived stress.
* which clinical variables differentiate parenting styles and levels of perceived stress.

Data from neuropsychological, speech therapy and physiotherapeutic assessments are collected during regular clinical follow-ups, regarding: cognitive development ("Bayely Scales of Infant Development-III", Cognitive Scale) and adaptive behaviour; Autism and Autism Spectrum Disorder ("Autism Diagnostic Observational Schedule-2"); parental stress and parenting styles; social-communicative skills; motor development.


Eligibility Criteria:
Inclusion Criteria:

* genetically confirmed diagnosis of Angelman Syndrome
* chronological age between 4-15 years

Exclusion Criteria:

* genetic examination pending report
* mental age lower than 12 months
* brain injury acquired in the peri- or postnatal period
Volume-targeted Versus Pressure-limited Noninvasive Ventilation in Patients With Acute Hypercapnic Respiratory Failure

Volume-targeted noninvasive ventilation (VT-NIV), a hybrid mode that targets a preseted tidal volume (VT) by automated adjustment of pressure support, could guarantee the delivered VT over pressure-limited noninvasive ventilation (PL-NIV) with fixed level pressure support. Whether VT-NIV is more effective in improving gas exchange in patients with acute hypercapnic respiratory failure (AHRF) as compared with PL-NIV remains unclear. Our aim was to verify whether in comparison with PL-NIV, use of VT-NIV was more effective in correcting hypercapnia, hence reducing the need for intubation and improving survival in patients with AHRF.


Eligibility Criteria:
Inclusion Criteria:

* acute hypercapnic respiratory failure (AHRF)
* arterial pH \<7.35 and ≥7.25
* PaCO2 \>45 mmHg

Exclusion Criteria:

* age \<18 years
* excessive amount of respiratory secretions or weak cough
* upper airway obstruction
* recent oral, facial or cranial trauma or surgery
* recent gastric or esophageal surgery
* severe metabolic acidosis; severe abdominal distension
* cardiac or respiratory arrest
* PaO2/FiO2 \<150 mmHg
* pneumothorax
* severe ventricular arrhythmia or myocardial ischemia
* severe hemodynamic instability despite fluid repletion and use of vasoactive agents
* active upper gastrointestinal bleeding
* lack of cooperation
* refusal to receive NIV
Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy

The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components.

Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xa may increase inflammation by promoting the production of proinflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. Recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation induced thrombosis.

Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk of thromboembolism. The purpose of this project is to analyze hemostasis and coagulation of every hospitalized patient with infection of COVID-19.

Blood sample for coagulation and hemostasis analysis will be collected on every patient hospitalized in Amiens hospital for COVID-19 infection. Thrombin time, factors V and II, fibrin/fibrinogen degradation products, antithrombin will be assessed every week. Anticardiolipin, anti-beta2 glycoprotein I and anti-annexin A2 antibodies IgG and IgM at day of admission and at fourth week after admission will be assessed. SARS-CoV2 viral load and serodiagnosis will be performed at the same time. At the same time venous ultrasound to diagnose thrombosis will be performed.


Eligibility Criteria:
Inclusion Criteria:

* all patients hospitalized in Amiens Hospital with COVID-19 infection

Exclusion Criteria:

* patients\< 18 years
Visibility of Lesion Characteristics With Phase Contrast Mammography

To determine if diagnostic phase contrast mammography (PCM) will provide improved image detail in assessing lesion characteristics when compared to diagnostic x-ray mammography (XM).

The ability to detect lesions in mammography before they can be felt is the benefit of using this imaging modality for screening of breast cancer. Screening mammography has been proven to decrease mortality from breast cancer. Radiologists identify abnormal breast tissue in the form of microcalcifications, masses, architectural distortion, and asymmetric density by careful assessment of the characteristics of these types of lesions using the Breast Imaging Reporting and Diagnostic System (BIRADS). BIRADS was developed to provide standardization of reporting of mammographic exams. In screening mammography, while it is possible to detect lesions, often more detailed diagnostic imaging is necessary to improve the visibility of margins and edges of lesions through magnification and compression views of the lesion of interest due to spatial resolution limitations which causes geometric blurring of edges in x-ray mammography.

If the ability to clearly see margins and edges of lesions is possible at screening mammography, this would potentially decrease the overall radiation exposure currently needed to allow radiologists to be confident of their characterizations for the majority of patients using x-ray mammography. Digital mammography was developed to improve the visibility of lesions primarily in dense breasts. The reasoning was that the improved contrast range would allow for wider range of gray level differentiation but with digital mammography comes a spatial resolution limitation that blurred edges of lesions. Phase contrast mammography (PCM) was developed to improve digital mammography by providing improvement in sharpness of edges utilizing the x-ray properties of refraction.

Comparison: Phase Contrast Mammography to X-Ray Mammography for Lesion Visibility of Diagnostic Population

Eligibility Criteria:
Inclusion Criteria:

* At least 40 years old
* Female
* Scheduled for diagnostic work-up including compression/magnification views of screening detected breast lesion

Exclusion Criteria:

* \< age 40
* Male
* No screening detected findings
* Breast implants
* Any women who is pregnant or has reason to believe she is pregnant or lactating
* Women with breasts larger than the 24 x 30 cm receptor