cyrilzakka/clinical-trials huggingface dataset:
Parameters to Assess Response to Intra-Venous Antibiotic Treatment for Pulmonary Exacerbations in Cystic Fibrosis

Cystic fibrosis (CF) is a multisystem disease characterized by viscid secretions in multiple organ systems. Lung infection and damage account for most of the disease burden. Acute changes in respiratory signs and symptoms termed Pulmonary Exacerbations require treatment with intravenous antibiotics and hospital admission. These episodes cause substantial disruption to people's lives and impact on lung function, quality of life and lifespan. Current treatment regimes require improvement but further study is needed to identify who might benefit from a different approach.

This observational study aims to assess if multi-dimensional measurements taken during treatment correspond with later treatment response. This may allow us to personalise treatment more effectively in the future and to better understand how individuals respond to treatment.

Pulmonary Exacerbations in CF require treatment with intravenous (IV) antibiotics and hospital admission for between 10-21 days. These episodes cause substantial disruption to people's lives and impact on lung function, quality of life and lifespan.Robust evidence to support current treatment approaches is lacking with awareness that current regimes could be optimised.

As yet there is no model for predicting how patients with CF will respond to IV antibiotic treatment- other than clinical judgement and lung function response.This is due to lack of robust measures to identify clinical response at the time of treatment and safely predict later clinical outcomes. The heterogeneity of the 21st Century CF population means a multi-dimensional composite measure is needed. This study has therefore been designed to provide an overall picture of people's response including clinical, biochemical and patient related outcome measures. Using multi-dimensional assessment we hope the measures assessed in this study will give a better picture of how people feel and how they respond to treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients attending the adult service with a confirmed diagnosis of CF by sweat test or genotype
2. Able to provide written informed consent
3. Able to understand and comply with protocol requirements and instructions
4. Confirmed Pulmonary Exacerbation requiring treatment with intravenous antibiotics using defined criteria (Physician and patient agreed need for admission for intravenous antibiotic treatment)

Exclusion Criteria:

1. Previous recipient of a lung or other solid organ transplant
2. Inability to complete questionnaires
3. Current enrolment in other investigational medicinal product randomised trial
4. Admission for reasons other than pulmonary exacerbation of CF
Effect of Phenylephrine During Shoulder Arthroscopic Surgery

The purpose of this study is to determine whether phenylephrine infusion are effective in the prevention of hypotension after changing position to beach chair position during general anesthesia for shoulder arthroscopic surgery.

Investigators hypothesized that by increasing arterial blood pressure with phenylephrine infusion, incidence of hypotension would be decreased.

The beach chair position is associated with hypotension, risk of cerebral hypoperfusion, and cerebral injury. Sixty-six patients undergoing elective shoulder arthroscopic surgery are randomized to receive either phenylephrine low dose (0.5 mcg/kg/hr), phenylephrine high dose (1.0 mcg/kg/min), or normal saline 5 minute before being placed in the beach chair position.

General anesthesia is induced with propofol, remifentanil and rocuronium (0.6 mg/kg) and the trachea intubated. Anesthesia is maintained with sevoflurane and remifentanil targeting for a BIS value 40-60. After hemodynamic stabilization, patients received on infusion of either phenylephrine high dose (1.0 mcg/kg/min), phenylephrine low dose (0.5 mcg/kg/hr) or normal saline 5 minute before being placed in the beach chair position. Following 15 minutes of infusion study drugs, measurements of mean arterial blood pressure and cardiac function (stroke volume variation, stroke volume index, and cardiac index) using Vigileo/Flotrac system were made.

Eligibility Criteria:
Inclusion Criteria:

* shoulder arthroscopic surgery undergone beach chair position

Exclusion Criteria:

* History of cerebrovascular event,
* significant cardiac disease (New York Heart Association symptoms class ≥ 3)
* uncontrolled hypertensive patients.
* American society of anesthesiologist class 4,5
Difference Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With Spinal Cord Injury in China

The morbidity of spinal cord injury (SCI) is increasing significantly in China. The methods to treat SCI patients in sequela stage update are poor. Though traditional rehabilitation therapy is the routine method to treat SCI in sequela stage, its effect to improve the neurological disorders of these patients, such as the dysfunction of sense, motor, autologous adjustment of blood pressure control of urination and defecation, perspiration , etc. is unsatisfying. Rehabilitation Therapy can prevent the process of muscle atrophy and joint stiffness. However, it can not repair the damaged nerve function. Studies show that mesenchymal stem cell transplantation can remarkably improve the neurological function of SCI in animals without any severe side effect.

In this study, the investigators use mesenchymal stem cells derived from umbilical cord to treat 40 SCI patients (20 cases in early stage and 20 cases in sequela stage). The investigators also follow-up ten patients who only receive rehabilitation and another ten outpatients who accept neither stem cell therapy nor rehabilitation. On this basis, the investigators can compare the efficacy of these two treatments.

Patients enrolled in this study need to finish our whole follow-up survey, which is carried out by clinical doctors and epidemiologist.

Eligibility Criteria:
Inclusion Criteria:

1. Patients or their curator must be able to give voluntary consent.
2. Patients or their curator Must be able to understand the information of study and in which group they are.
3. 20 years - 50 years of age can be enrolled.
4. Both male and female can be enrolled.
5. Patients have clear history of traumatic injury, and the spinal cord injury are confirmed by all of the examinations including MRI, electromyogram and electrophysiology.

Exclusion Criteria:

1. Mental disorders
2. Myelitis
3. Women in pregnancy
4. Cancer
A Clinical Trial Using Metronomic Oral Low-dose Cyclophosphamide Alternating With Low-dose Oral Methotrexate With Continuous Celecoxib and Weekly Vinblastine in Children and Adolescents With Relapsed or Progressing soliD Tumours.

To establish the anti-tumour effect of this metronomic combination regimen defined by progression-free survival (PFS) after two cycles of treatment (4 months) and 12 months of treatment, as well as response rate after any number of cycles of treatment ("best response").

To define the safety profile of the combination. To characterize pharmacodynamics of the drug combination with the use of angiogenic markers (CEP, CEC, microparticles).

Multi-center, combination phase II study, open-label, non-comparative, non-randomized.

All progressive or recurrent solid tumours will be included in the Phase II study, provided there are no curative options anymore.

Total expected number of patients (minimum maximum): 54 to 90 (2-stage design)

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a histologically or cytologically confirmed malignant solid tumour.
* Progression or recurrence of the tumour radiologically established or confirmed within the 4 weeks prior to inclusion.
* Disease must be considered refractory to any line of conventional therapy or for which no effective conventional treatment exists.
* Age: ≥4 to 21 years of age at study entry
* Life expectancy: at least 8 weeks
* ECOG Performance status ≤ 1 or Lansky-Play Scale ≥ 70%
* Written informed consent of parent/guardian and patient assent
* Wash out of 4 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 6 weeks in case of prior radiotherapy (except palliative radiotherapy on non measurable lesions).
* Patients must have recovered from the acute toxic effects of all prior therapy before enrolment into the study
* Able to comply with scheduled follow-up and with management of toxicity
* All patients with reproductive potential must practice an effective method of birth control while on study.
* Female patients aged \> 12 years must have a negative pregnancy test within 7 days before study treatment.
* Capable of swallowing oral medication

Exclusion Criteria:

* Pregnant and breast feeding women.
* Uncontrolled intercurrent illness or active infection
* Inability to swallow oral medication.
* Patients on anticonvulsants will be allowed on study
Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial

Objectives: to compare intermittent mandatory ventilation (IMV) with synchronous intermittent mandatory ventilation associated with pressure support (SIMV/PS) related to duration of mechanical ventilation/weaning and length of stay in PICU (LS). Design: randomized clinical trial. Setting: Pediatric intensive care unit at a university-affiliated hospital.

Objectives: to compare intermittent mandatory ventilation (IMV) with synchronous intermittent mandatory ventilation associated with pressure support (SIMV/PS) related to duration of mechanical ventilation/weaning and length of stay in PICU (LS). Design: randomized clinical trial. Setting: Pediatric intensive care unit at a university-affiliated hospital. Patients: children between 28 days and 4 years old, admitted between 10/2002 and 06/2004, and receiving mechanical ventilation (MV) for more than 48 hours. Patients were randomly assigned into two groups: IMV (IMVG; n=35) and SIMV/PS (SIMVG; n=35). Children with acute respiratory distress syndrome and tracheostomy were excluded. Ventilation and oxygenation data were recorded at admission and beginning of weaning. Results: Groups were not statistically different for age, gender, MV indications, PRISM score, COMFORT scale, sedatives, and ventilation and oxygenation parameters. Median of MV duration was 5 days for both groups (p\>0.05). Also, there were no statistical differences for duration of weaning \[IMVG: 1 day (1 - 6) vs. SIMVG: 1 day (1 - 6); p\>0.05\] and LS \[IMVG: 8 days (2 - 22) vs. SIMVG: 6 days (3 - 20); p\>0.05\]. Conclusion: There was no statistically significant difference between IMV and SIMV/PS in these children related to MV and weaning duration, and PICU length of stay.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 28 days and four years, who were consecutively admitted to the PICU and required MV for more than 48h were included.

Exclusion Criteria:

* Children who had chronic respiratory failure, tracheostomy, those transferred from the hospital, or died were excluded as were patients with acute respiratory distress syndrome (ARDS).
Examining Cognitive Mechanisms of Clinical Improvement Following Mindfulness Based Therapy for Depressed Individuals

Depression one of the leading causes of disability worldwide. Individuals suffering from depression typically exhibit impairments in various mental abilities, such as the ability to effectively direct and control attention and the ability to switch between thinking about different things and concepts (commonly referred to as "cognitive flexibility").

Mindfulness meditation training is a technique which involves focusing one's awareness on the present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations. It has been well documented to improve depressive symptoms and prevent recurrence of depressive episodes, yet little is known about how mindfulness does so and what are the underlying mental mechanisms involved. Here the investigators propose to examine the efficacy of an 8-week mindfulness training program in improving the ability to direct and control attention, as well as in cognitive flexibility.

Individuals diagnosed with recurrent depression will undergo an 8-week mindfulness training program. Participants' depressive symptoms as well as their performance on measures of attention and cognitive flexibility will be examined. Participants will be assigned to mindfulness training or a wait-list control group. Half of the participants will be examined before and after the mindfulness training program and the other half will be tested 8-weeks apart and then begin their training.


Eligibility Criteria:
Inclusion Criteria:

* Reporting dysphoria for at least two months prior
* HAM-D score of at least 11
* No history of psychiatric disorders of psychotic features, neurological disorders, or substance abuse in the past 6 months
* Verified age between 18-65 years old
* Had no suicidal attempts during the past six months
* No prior experience with MBCT or other systematic meditation programs

Exclusion Criteria:

* History of psychosis, neurological disorder, and substance abuse for the past 6 months
* Suicide attempt in past 6 months
* Prior experience with MBCT or other systematic meditation program
Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy

Patients with serious chronic renal insufficiency usually develop secondary osteoporosis or bone loss, especially those with chronic dialysis, and the degree of bone loss is corrected with decrease of renal function. In traditional Chinese medicine, kidney function is considered to dominate bone development and metabolism. Kidney Yin and Yang replenishment will help improve bone development and metabolism.

In this study patients with chronic renal insufficiency and secondary osteoporosis or bone loss will be evaluated with traditional Chinese medicine standard and allocated into kidney Yin deficiency and kidney Yang deficiency groups. In Yin deficiency group, patients will be divided into Zuogui granules treatment group and placebo group. In Yang deficiency group, patients will be divided into Yuogui granules treatment group and placebo group. All the patients will also accept basic treatment.

After 3-month-treatment, we will detect blood urea nitrogen, creatinine, bone mineral density, bone metabolism markers including FGF23, 1,25(OH)2D3, Osteocalcin, PTH, BALP, serum and urinal Ca, P. We will also perform miRNA array. The data before treatment and after treatment will be compared. The data of treatment groups and placebo groups will also be compared.

Eligibility Criteria:
Inclusion Criteria:

* chronic renal insufficiency
* bone loss or osteoporosis
* 30-50 years old
* kidney Yin or Yang deficiency evaluated with traditional Chinese medicine
* be willing to and be able to join in the study and signed Informed consent
* have not accepted systematical treatment on bone loss or osteoporosis

Exclusion Criteria:

* allergies
* secondary osteoporosis caused by other diseases.
* postmenopausal women
* mental illness or psychosis
* patients with bone fracture and need surgery treatment
* taking any medicine that will affect bone metabolism for a long time and can not stop
* women during pregnant stage and breast-feed stage
Increasing Seat Belt Wearing and Decreasing Handheld Phone Use While Driving

The study team is proposing to conduct a randomized controlled trial to determine the effectiveness of behavioral and financial incentives on phone use while driving and seat belt adherence. Each arm will receive a support text if their app is not collecting data. The behavioral engagement intervention includes persuasive education, mental contrasting with implementation intentions, customized habit tips, weekly feedback about participants' streaks, and encouraging SMS texts. The two financial incentive interventions add on weekly raffles or shared pots for participants with perfect streaks.


Eligibility Criteria:
Inclusion Criteria:

* Are a GM/OnStar customer.
* Are 18 or older.
* Meet minimum trip requirements.
* Uses vehicle with OnStar
* At least 5 weeks of baseline trip data with \>=8 trips/week at baseline on average
* Baseline seat belt use \<= 75% on trips less than 2 miles and \<= 90 on trips greater than 2 miles
* English reading ability
* Have an email address
* Have a smartphone with iPhone iOS 12 or later or Android OS 7 or later

Exclusion Criteria:

* You are unable to read and understand English
Prediction of Volume Responsiveness in Presence of Left Ventricular Diastolic Dysfunction

The ability of the global end-diastolic volume index (GEDVI), stroke volume variation (SVV) and pulse pressure variation (PPV) for prediction of fluid responsiveness in presence of left ventricular diastolic dysfunction is still unknown. The aim of the present study was to challenge the predictive power of GEDVI, SVV and PPV in cardiac surgery patients undergoing aortic valve replacement.

All patients receive premedication with midazolam 7.5 mg p.o.. After induction of anesthesia with sufentanil (0.5 µg/kg) and propofol (1.5 mg/kg), orotracheal intubation is facilitated with rocuronium (0.6 mg/kg). Anesthesia is maintained with sufentanil (1 µg/kg/h) and propofol (3 mg/kg/h) and patients are ventilated with an oxygen/air mixture in volume-controlled mode, using a tidal volume of 8 ml/kg related to the ideal body weight. Positive end-expiratory pressure is set at 5 cmH2O. Continuous monitoring is performed including electrocardiogram, radial arterial pressure catheter and a central venous catheter in the right or left internal jugular vein. Before placement of a transpulmonary thermodilution catheter a transesophageal echocardiography (TOE) is performed. TOE is used to detect diastolic dysfunction of the left ventricle and to exclude right ventricular dysfunction. In presence of left ventricular dysfunction a transpulmonary thermodilution catheter is placed in the femoral artery and connected to a PiCCO2 monitor (PiCCO2, Pulsion Medical Systems, Munich, Germany). Additionally capnography, urine output, temperature (blood, bladder and nasopharyngeal), airway pressure, and pulse oximetry are recorded.

Before starting operation a passive leg raising is performed. The passive leg raising maneuver (PLR) involves a leg elevation up to 45° with the trunk in a horizontal position and was performed to induce hemodynamic effects by a volume challenge, turning unstressed blood volume to stressed volume proportional to body size. In case of an increase of stroke volume index (SVI) \>15% during PLR, patients were defined as responders.

All patients were studied with no changes in anesthesia management. Measurements of SVI, GEDVI, SVV and PPV are performed before, during and after PLR. Thereafter, patients receive a fluid Bolus of 500 ml crystalloids. Again, measurements are performed before and after fluid replacement.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 yrs of age
* Patients with a left ventricular ejection fraction ≥0.5
* Patients with left ventricular diastolic dysfunction.

Exclusion Criteria:

* Emergency procedures
* Right ventricular dysfunction
* Hemodynamic instability requiring pharmacologic Support
* Ongoing arrhythmia
* Intracardiac Shunts
* Severe mitral stenosis or insufficiency
* Aortic aneurysm \> 4 cm
* Use of an artificial left ventricular assist device or intra - aortic balloon pump.
The Comparison of EBUS-TBNA, TBMC Via a Tunnel, and TBFB Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy.

The goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic yield and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB via a tunnel) in mediastinal/hilar lymph node biopsies.

Participants will divided into EBUS-TBNA group, EBUS-TBMC via a tunnel group, and EBUS-TBFB via a tunnel group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake EBUS-TBNA, EBUS-TBMC via a tunnel, or EBUS-TBFB according to the group.

Researchers will compare the diagnostic yield and incidence of adverse events of the three biopsy techniques.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* At least 1 hilar/mediastinal lesion (short axis ≥ 1 cm) requiring diagnostic bronchoscopy procedure;
* Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.

Exclusion Criteria:

* The lesion is a mediastinal cyst or abscess;
* Combined severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, combined psychiatric disorders or severe neurosis and other relevant contraindications to bronchoscopy;
* EBUS assessment reveals that the lesion is rich in blood flow or adjacent to a large vessel, etc. Consider biopsy to be high risk and inappropriate for continuation of biopsy;
* EBUS did not detect lesions in the hilum and/or mediastinum;
* Those who, in the judgement of the investigator, have poor patient compliance and are unable to complete the study as required due to mental disorders, etc.
Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects

The purpose of this study is to test the safety and observe the pharmacokinetics (distribution and elimination of the drug) of the compound dexanabinol (ETS2101) in healthy male subjects following a single oral dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males aged 18 to 45 years
* Body mass index 18.0 to 32.0 kg/m2, or if outside the range, considered not clinically significant by the investigator

Exclusion Criteria:

* Participation in a clinical research study within the previous 3 months
* Current smokers and those who have smoked within the last 12 months
* History of any drug or alcohol abuse in the past 2 years
Modification of Cue Reactivity by Neurofeedback in Human Addiction

The project is geared towards the understanding of how to increase cognitive control over cue reactivity and drug craving.

Project C04 aims at assessing the combined effect of two interventions targeting at reducing striatal cue reactivity and increasing cognitive control, namely mindfulness-based intervention and real-time fMRI neurofeedback. Firstly, the investigators will test whether a prior mindfulness-based intervention (WP1) is able to enhance the effect of rtfMRI NFB (WP2) and change the networks involved in regulation of cue reactivity by providing participants with explicit strategies. Secondly, the investigators will investigate whether this combined intervention leads to a better clinical outcome in terms of decreased heavy drinking days and a reduced sum of alcohol consumption three months later.

Eligibility Criteria:
Inclusion Criteria:

* alcohol use disorder according to DSM-5
* ability to provide fully informed consent and to use self-rating scales
* abstinent after detoxification for at least 5 days
* sufficient understanding of the German language

Exclusion Criteria:

* lifetime history of DSM-5 bipolar, psychotic disorder, or substance dependence other than alcohol or nicotine dependence
* current substance use other than nicotine and/or mild to moderate recreational use of cannabis as evidenced by positive urine test
* current threshold DSM-5 diagnosis of any of the following disorders: current (hypo)manic episode, major depressive disorder, generalized anxiety disorder, PTSD, borderline personality disorder, or obsessive compulsive disorder
* history of severe head trauma or other severe central neurological disorders (dementia, Parkinson's disease, multiple sclerosis)
* pregnancy or nursing infants
* use of medications or drugs known to interact with the CNS within the last 10 days, with testing at least four half-lives post last intake