cyrilzakka/clinical-trials huggingface dataset:
The Effect of Laparoscopic Splenectomy on the Immune Function for Cirrhosis Patients

In this study, the investigators compared the improvement of and azygoportal disconnection related indicators in patients with liver cirrhosis after laparoscopic splenectomy. To determine whether surgical treatment can help enhance postoperative immune function and improve patient prognosis.

The patients were enrolled according to the research criteria, and collected the general basic information of the patients. After the preoperative preparation was perfected, the same surgical team performed laparoscopic splenectomy, and the same nursing team performed the nursing after the operation. Then, patients received a unified treatment plan after surgery, including medication, other treatments and follow-up. During the treatment, the immune function related indicators of the patients were monitored before surgery, 3, 6, 12 and 24 months after surgery, including the counts of leukocytes, neutrophils, lymphocytes, and monocytes, and the levels of CD4+, CD8+, CD4+/CD8+, and CD19, CD20.

Eligibility Criteria:
Inclusion Criteria:

* A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
* Splenomegaly with secondary hypersplenism, Platelet count \< 50\*10\^9/L
* Informed consent to participate in the study

Exclusion Criteria:

* Hepatocellular carcinoma or any other malignancy,
* Child-Pugh grade C
* Recent peptic ulcer disease
* History of Hemorrhagic stroke
* Pregnancy.
* Uncontrolled Hypertension
* Bleeding portal hypertension
* Human immunodeficiency virus (HIV) infection
Study of High Efficient Killing Cell Therapy for Advanced NSCLC

The purpose of this study to preliminarily evaluate the safety and efficacy of High Efficient Killing Cell Therapy for refractory and advanced non-small cell lung cancer

Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients' age from 18 years to 70 years.
* Patients who have a life expectancy of at least 3 months.
* pathologically confirmed non-small cell lung cancer.
* failed in previous standard chemotherapy and targeted therapy.
* Karnofsky performance status 0-1.
* adequate organ functions.

Exclusion Criteria:

* Pregnant and lactating women.
* Patients with T cell lymphoma, syphilis, AIDS or combination
* Patients with highly allergic or have a history of severe allergies
* Patients with severe hepatic or renal dysfunction
* Patients with severe autoimmune disease or who is being treated with immunosuppressive agents
* Patients with severe infection not controlled or High fever
* Patients with organ transplantation or waiting for organ transplantation.
* Patients with brain metastasis
* Patients with severe coagulopathy (e.g. hemophilia)
* Patients without adequate ability to understand, sign informed consents and take part in the clinical research voluntarily.
Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder

Lycium barbarum, a traditional Chinese herbal medicine, is a commonly used herb in the traditional Chinese pharmacopoeia. Its main active ingredient, lycium barbarum polysaccharide (LBP), is reported to have neuroprotective effects. Animal studies suggested that LBP has neuroprotective effect on optic ganglion cells. In animal models of depression, LBP can improve depressive symptom by improving synaptic plasticity. However, its clinical effect remains to be studied. We will conduct a 6-week double-blind, randomized, placebo-con-trolled trial in patients with major depressive disorder (MDD). The purpose of this clinical trial is to investigate the efficacy of LBP in patients with MDD.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-60 years old
2. Sex: both men and women
3. Compliance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for major depressive disorder
4. Hamilton Depression Scale scored more than 18 points.
5. No contraindication of taking Lycium barbarum polysaccharide

Exclusion Criteria:

1. Comorbidity with other mental disorders
2. Severe somatic diseases
3. Current use of traditional Chinese medicine
4. Suicide concept, attempt, act and attempted suicide
5. Psychiatric symptoms
6. Taking hormones and endocrine drugs
7. Long-term use of wolfberry in recent three months
Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness

This multicenter, randomized, controlled, open-label, parallel-group, 30-day study took place at four centers in China. The primary objective of this study was to assess the efficacy and safety of hyaluronic acid vaginal gel in treating vaginal dryness. In the current study we tested the hypothesis that the efficacy of hyaluronic acid vaginal gel was not inferior to that of estriol cream, with no clinically significant difference between them, in the treatment of vaginal dryness symptoms.


Eligibility Criteria:
Inclusion Criteria:

* under 70 years old,
* had been naturally or surgically postmenopausal for more than 6 months,
* had symptoms of vaginal dryness due to various causes and had no contraindications to locally applied estrogen

Exclusion Criteria:

* unmarried, pregnant and breast-feeding women,
* patients with vaginal infections such as trichomonas,
* candida and bacterial vaginosis,
* patients with breast cancer, uterine cancer or estrogen hormone dependent tumors,
* genital bleeding of unknown origin,
* patients with acute hepatopathy, embolic disorders,
* severe primary disease of the kidney and hematopoietic system
* recent malignant tumors
Does Continuous Vital Sign Monitoring Increase Investigations and Interventions in Complication-free Patients?

This aim of this study is to investigate whether active alerts during CVSM result in an increased number of diagnostic tests and treatments in complication free patients, hypothesizing that more interventions are performed in the CVSM-group than standard of care (EWS) group.


Eligibility Criteria:
Inclusion Criteria:

* • Patients from WARD - RCT.

Exclusion Criteria:

-
Mindfulness Based Stress Reduction for Metabolic Syndrome

Mindfulness based stress reduction offered to couples where one has metabolic syndrome to see if their stress is reduced as measured by bio markers and surveys

This is a pilot study being designed to pilot a MBSR program for the purposes of future research.The investigators will be using two cohorts. One who will get the intervention and the other who will be wait listed and receive the intervention at a later date. Eight week mindfulness class offered to couples, who also attend an orientation session and a half day retreat with other couples to learn how to control stress through mindfulness meditation practices. Participants will come for lab work before intervention, eight weeks after initial class and at the end of entire program. Bio- markers to be measured are waist circumference, FBS and cholesterol.

Eligibility Criteria:
Inclusion Criteria:

* Participant has 3 of the following: a Abdominal Obesity; b. Hypertriglyceridemia; c. Low High Density Lipoproteins (HDL); d. High Blood Pressure; e. High Fasting Blood Sugar (FBS)
* Participant must be married or co- habituating
* Both partners are over sixty

Exclusion Criteria:

* Either partner is non- English speaking
* Either partner practices mind- body therapies more than once a week/
* Either partner taking psychiatric medicine
Ketorolac in Acute Pancreatitis

This study will compare pain management strategies for patients hospitalized with acute pancreatitis. Standard of care pain management will be compared to standard of care plus intravenous ketorolac.

Patients hospitalized for acute pancreatitis and admitted to an internal medicine team will be eligible for study. Patients enrolled will be blindly randomized to receive open-label pain management of standard of care or standard of care plus intravenous ketorolac. Patients will be enrolled between hour 24 and 48 of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old
* opioid order for pain secondary to acute pancreatitis
* diagnosis of acute pancreatitis defined by the presence of two of the following three criteria: abdominal pain, lipase \> 3x upper limit of normal, and/or findings of AP on imaging
* a patient with acute-on-chronic pancreatitis that does not exhibit elevated lipase levels is eligible for inclusion if the patient has the other two criteria
* received at least 3 L of IV crystalloid fluid within first 24 hours of admission to ensure patients have received initial volume expansion
* hemodynamically stable represented by a mean arterial blood pressure (MAP) of ≥65 mmHg
* female patients not documented in chart as post-menopause must have a negative pregnancy test

Exclusion Criteria:

* history of chronic heart failure
* history of acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI)) within last 6 months
* history of ischemic or hemorrhagic stroke within last 6 months
* history of upper gastrointestinal bleed (GI) within last 6 months
* history of inflammatory bowel disease
* history of cirrhosis
* any overt, active bleeding requiring blood transfusion
* considered to be high bleed risk (platelet \< 50,000/mcL)
* pregnant or breastfeeding
* prisoners
* cognitively impaired patients: not alert and oriented to person, place, and time (patient must be able to consent)
* allergy to NSAIDs, ketorolac, or aspirin
* admission to an intensive care unit
* evidence of infected pancreatitis (i.e. abscess) on imaging studies
* acute kidney injury or chronic kidney disease with CrCl\<30
The Effect of Intensive Inpatient Attending Supervision on Medical Errors, Patient Safety and Resident Education

Randomized cross over trial investigating the effect of intensive attending supervision of residents caring for inpatients on the medical service on both patient safety and educational outcomes. Hypothesis: increased attending supervision would improve patient safety and resident education.

Background While the relationship between resident work hours and patient safety has been extensively studied, little research has evaluated the role of attending supervision on patient safety and education.

Investigators conducted a 9-month randomized, cross-over trial on an inpatient medicine teaching service where 22 faculty provided either: 1) direct supervision where attendings joined work rounds on established (previously admitted) patients or 2) standard supervision where attendings were available, but did not join work rounds. Each faculty member participated in both arms in random order. The primary safety outcome was rate of medical errors. Secondary safety outcomes included deaths and transfers to the intensive care unit. Resident education was evaluated via a time motion study to assess resident participation on rounds and surveys to measure resident and attending educational ratings.

Eligibility Criteria:
Inclusion Criteria

* Teaching attending on the medicine service at Massachusetts General Hospital
* Resident physician on the medical service at Massachusetts General Hospital

Exclusion Criteria

* Faculty unable to complete both control and intervention arms of the study.
* Faculty unwilling to participate
* Residents unwilling to participate
Topical Timolol for Infantile Hemangioma in Early Proliferative Phase

Infantile hemangioma (IH) is the most common benign vascular tumor in pediatric population. Oral propranolol is the treatment of choice for complicated hemangiomas. Topical timolol, a non-selective beta-blocker, is an emerging treatment which has been reported to be effective and safe for the treatment of IH, especially for superficial hemangiomas. Investigators hypothesize that treatment with topical timolol in the first two months of life, before the proliferative phase or in early proliferative phase, may prevent from further growing and the need to treat with oral propranolol.

A multicentric, randomized, double-blind, placebo-controlled, phase II clinical trial to evaluate the efficacy and safety of 0.5% timolol maleate solution for the early treatment of infantile hemangioma.

Patients with less of 60 days of life with focal or segmental hemangiomas, superficial, mixed or abortive will be treated with topical timolol 0.5% twice a day for 24 weeks.

Changes in lesion size, color and thickness will be evaluated from photographs taken at 2,4,8,12,24 and 36 weeks. Vital signs and side effects will be recorded at each visit. Response to treatment will be evaluated by a blinded investigator in a semiquantitative scale (complete resolution, improve, stabilization, worsening).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent for study participation and the use of the patient's photographs from the patient's parent(s) or guardian(s),
* The patient is between 10 and 60 days of age at the time of enrollment,
* The patient should have:

  * at least one focal or segmental hemangioma, mixed or superficial, present anywhere on the body of at least 0.3 cm of minimum diameter and not greater of 5 cm.
  * abortive or minimal growth hemangioma
  * Infantile hemangioma precursors

Exclusion Criteria:

* Patients \> 60 days of age
* Complicated hemangiomas (life-threatening, function-threatening, or ulcerated)
* Children who have previously received systemic, intra-lesional or topical corticosteroids, imiquimod, vincristine, alpha-interferon, propranolol or other beta blockers, PDL laser.
* Patients with PHACES, LUMBAR, SACRAL or PELVIS syndrome.
* Internal involvement hemangiomas (liver, GI tract, larynx)
* Children with a personal history of asthma or cardiac conditions that may predispose to heart block.
* Children with congenital birth defects
* Children with Cancer (leukemia, sarcoma, neuroblastoma, retinoblastoma)
* Children with a history of hypersensitivity to beta blockers or excipients.
Backpack Load and Spine Muscles Activity

The purpose of the present study is to analyze the influence of four backpack loading conditions (0, 10, 15 and 20% of body weight) on the electromyographic activity of the neck and lumbar muscles of elementary school children.

Elementary school children participated in the present study, between the ages of 6 and 10. Bilateral sternocleidomastoid, rectus abdominis and erector spinae muscles activity were recorded using surface electromyography (sEMG), while tested for the effect of four randomized backpack loading conditions.

Eligibility Criteria:
Inclusion Criteria:

* children with tutor consent

Exclusion Criteria:

* children with cognitive impairment
The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults

We conducted an observational prospective pilot study to assess the efficacy of the VL3 videolaryngoscope for routinely tracheal intubation in 56 adults, in terms of successful rate, no. attempts and manoeuvre duration, including both normal and difficult airways.


Eligibility Criteria:
Inclusion Criteria:

* Patients candidates for general anesthesia in elective surgery
* Age over 18 years
* ASA physical status I-III.

Exclusion Criteria:

* Paediatric population
* ASA physical status IV
* Emergency tracheal intubation
Enhanced Smoking Cessation Intervention for Smokers Exposed to the World Trade Center (WTC) Disaster

The purpose of this study was to test the efficacy of a CBT-based smoking cessation treatment enhanced with transdiagnostic skills for the management of anxiety and fear-based avoidance behaviors (CBT-A) relative to a standard CBT-based smoking cessation treatment (CBT-S) for smokers with elevated PTSD symptoms who were exposed to the 9/11 World Trade Center disaster. The investigators hypothesized that the CBT-A treatment would yield more favorable outcomes with regard to smoking abstinence as well as improvements in PTSD and respiratory symptoms over a 6-month follow-up period.

Respiratory illness and post-traumatic stress disorder (PTSD) are the primary health sequelae of the World Trade Center (WTC) disaster on September 11th 2001 and are often comorbid. Cigarette smoking is a modifiable health behavior associated with both lower respiratory symptoms (LRS) and PTSD. Smoking cessation programs are considered the crucial front-line intervention for smokers with pulmonary problems. Unfortunately, trauma exposed smokers with elevated PTSD symptoms have greater difficulty quitting, are more likely to fail standard cessation programs, and are more likely to relapse than smokers with other anxiety disorders and those without mental illness. Interventions that concurrently target mechanisms thought to maintain the comorbidity between PTSD and LRS (e.g., anxious reactivity to nicotine withdrawal, smoking to reduce negative affect) may offer a means of improving smoking quit rates in trauma exposed populations. Thus, the purpose of this study was to test the efficacy of a combined CBT smoking cessation treatment enhanced with transdiagnostic skills for the management of anxiety and fear-based avoidance behaviors (CBT-A). The investigators randomized 90 WTC disaster exposed daily smokers with elevated PTSD symptoms to either CBT-A (N=44) or a standard CBT-based smoking cessation program (CBT-S; N=46). Participants were followed up to six months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* smoking at least five cigarettes per day
* reporting interest in smoking cessation treatment
* direct exposure to the WTC disaster (e.g., responding to the event or witnessing the event in person)
* scoring \>30 on the Posttraumatic Stress Disorder Checklist

Exclusion Criteria:

* current participation in another smoking cessation treatment
* alcohol dependence within the last six months
* serious mental illness (e.g., psychosis, mania)
Does Chemotherapy Train the Mutation of the Pig-A Gene? (PIGA)

The PIG-A gene (in humans)/Pig-a (in rodents) may be a useful reporter of acquired gene mutation. A simple and reproductive test based on flow cytometry allows detection of Pig-a mutants in a few minutes with low blood volumes. Many studies in rodents showed that detecting Pig-a mutations is useful for identifying genotoxic exposure, but studies are needed in humans to validate this biological marker. The investigators propose to carry out a study to assess the prevalence of PIG-A mutated reticulocytes among 30 patients exposed to genotoxic chemotherapy for breast cancer treatment. The investigators will prospectively collect, for each patient, 4 blood samples of 10mL during chemotherapy: the first one (T0) before chemotherapy (before genotoxic exposure), T1 during treatment (after the third cure), T2 (just at the end of chemotherapy) and T3 (five weeks after the end of chemotherapy). PIG-A mutated cells frequency distributions will be compared between T0, T1, T2 and T3. At the same time, the investigators will document the impact of such a genotoxic exposure using the micronuclei test on in vitro binucleate lymphocytes. The micronuclei test reveals structural or numerical chromosome aberrations caused by aneugenic or clastogenic exposure. This test will be done on T0 and T3 blood samples of each patient.


Eligibility Criteria:
Inclusion Criteria:

* Major patients
* Patients with breast cancer
* Who have benefited from breast surgical treatment and have a poly-chemotherapy adjuvanted by FEC100 and Docetaxel.
* Patients should be able to read and understand French.

Exclusion Criteria:

* Minor Patients
* Pregnant women
* Patients who do not speak French and/or are unable to read and understand French.
* Patients who have had a history of radiotherapy, including those who have received a per-operative radiation therapy as part of the initial management of breast cancer
* Patients who have had a history of chemotherapy outside of the chemotherapy possibly received in the treatment of current breast cancer.
Quality of Life Evaluation with the SRI Questionnaire of ALS Patient with Non-invasive Ventilation

This study aims to measure the quality of life of ALS patients by the SRI questionnaire, in two distinct patient groups : Patient requiring initiation of NIV, and patients 24 hours dependent on NIV

This study also seeks to assess the quality of life of the caregivers with the Zarit Burden interview in those two populations

The course of the study is as follows:

Patient newly ventilated with NIV :

inclusion is done on the day of starting NIV. On the day of inclusion: Clinical examination, completion of the ALS-FRS score, completion of the SRI score.

For the caregiver: Completion of the Zarit Burden Inerview Reassessment of scores (SRI, Zarit-burden, ALS-FRS), at three-month and six-month follow-up

Patient dependent of NIV :

On the day of inclusion: Clinical examination, completion of the ALS-FRS score, completion of the SRI score.

For the caregiver: Completion of the Zarit Burden Inerview Reassessment of scores (SRI, Zarit-burden, ALS-FRS), at three-month follow-up

Eligibility Criteria:
Inclusion Criteria:

Patients :

* 18 years or more
* Patient followed for ALS probable or certain with Awaji criteria
* group 1 : severe chronic respiratory failure, with a decision by the attending physician to start NIV
* group 2 : complete dependence on NIV

Caregivers :

* 18 years or more
* Informed and does not object to the study
* Primary caregiver for more than 3 months of an ALS patient on NIV (either at initiation or with 24 hours NIV dependence)
* More than 30 hours spent at home per week
* Met the inclusion criteria for group 1 (NIV initiation) or group 2 (24 hours NIV dependence)

Exclusion Criteria:

Patients :

* Patient under legal protection/ guardianship
* insufficient command of French
* Severe cognitive impairment, particularly in relation to frontotemporal degeneration
* No indication criteria for NIV.

Caregivers :

* insufficient command of French
* Caregiver of a patient with another chronic pathology