cyrilzakka/clinical-trials huggingface dataset:
Adrenomedullin and Outcome in Severe Sepsis and Septic Shock

The aim of this prospective study is to assess the prognostic value of bioactive plasma adrenomedullin (ADM) in 600 patients with severe sepsis or septic shock in an international multicenter study and to validate the findings concerning the association of ADM concentration and the use of vasopressor therapy, organ failure and outcome.

Sepsis involves an overactive inflammatory response to severe bacterial infection that can compromise vascular integrity and cause tissue edema, organ dysfunction and death. Adrenomedullin (ADM) has attracted the interest of researchers because of its powerful physiological functions. An anti-ADM antibody reduced the norepinephrine infusion rates required to achieve hemodynamic targets, increased urine flow and improved creatinine clearance, which ultimately resulted in attenuated systemic inflammation and tissue apoptosis, during resuscitated cecal ligation and puncture (CLP)-induced septic shock in mice.

In humans, plasma ADM has been determined only in a small number of sepsis patients, and - except from one study - the assays used did not selectively measure the bioactive ADM form and have been considered not reliable. Therefore, the potential value of determining plasma ADM in such patients cannot yet be ascertained and the optimal cut off needs to be validated in future studies

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patients admitted in intensive care unit for severe sepsis or septic shock according to international, standardized criteria,transferred from another intensive care unit less than 24 hours after the primary admission, or being treated with vasopressors for less than 24 hours in the prior ICU
* Signed Consent form

Exclusion Criteria:

* Age \< 18 years
* Severe sepsis or septic shock patients transferred from another intensive care unit later than 24 hours after the primary admission or being treated with vasopressors for more than 24 hours in the prior ICU
* Pregnant women
* Vegetative coma
* Participation in an interventional clinical trial in the preceding month
A Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.

This is a multicenter, randomized, double blind, pramipexole-controlled parallel group study of pardoprunox as adjunctive treatment to levodopa.

Approximately 44 patients are to be randomized in a 3:1 ratio to two possible treatment groups, pardoprunox and pramipexole, respectively. The first part of the study will be blinded and consists of a minimum 1-week screening period, a 4-week switch and stabilization period and an 8-week maintenance period. The second part of the study will be open label pardoprunox treatment with a dose adjustment period of 4 weeks followed by long term maintenance treatment.

Eligibility Criteria:
Inclusion Criteria

* Patients who have signed informed consent
* Diagnosis of idiopathic Parkinson's Disease
* Stable treatment with L-dopa and dopamine agonist for at least 28 days prior to randomization
* Presence of a recognizable ON and OFF state (motor fluctuations)
* Minimum hours of OFF-time per day of 1.5 hours (during waking hours including early morning akinesia) as recorded per baseline diaries
* Minimum hours of ON time with troublesome dyskinesia of 2 hours (during waking hours) as recorded per baseline diaries
* Prevalent expression of severely disabling dyskinesias during the waking day, i.e. dyskinesias are present at least 25% of the waking hours (UPDRS Part 4 item 32 \>= 2) in combination with a degree of disability which is moderate or higher (UPDRS Part 4 item 33 \>=2)

Exclusion Criteria

* Diagnosis is unclear or a suspicion of other parkinsonian syndromes
* Patients who have undergone surgery for the treatment of PD
A Prospective Evaluation of the Catheter Science C3 "Umbrella Catheter."

The Catheter Science C3 "Umbrella Catheter" has been developed for management of urinary retention in patients who are either using a Foley or Self Intermittent Catheter. This device is inserted into the bladder in an extended state and once the stylet is removed the device folds into collapsed state. A thread is attached to the device and traverses thru the urethra and is attached to a bobber. With gentle traction on the thread the device engages the bladder neck and the central tube extends which allows for the flow of urine. Once voiding is complete, the thread is released and the device collapses back to the folded state into the bladder. Each voiding cycle is accomplished in a similar fashion. This is a novel technique in which the bladder is catheterized with the device from within the bladder into the bladder neck and urethra. The standard self catheter technique is for placement of a catheter from the outside into the urethra and into the bladder.

Interventional (clinical trial): Participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes.

This single arm, prospective study is designed to produce valid scientific evidence regarding:

1. Safety and efficacy of the Catheter Science C3 "Umbrella Catheter" in establishing urinary drainage and allowing the control of micturition when indwelling for up to 7 days.
2. The reduction in Catheter Acquired Urinary Tract Infection (CAUTI)

A single arm study design was chosen because there is no alternative treatment to serve as an appropriate control. The C3 catheterizes the bladder with engagement into the bladder neck under the control of the patient or care giver. A Foley catheter, a pre- amendment device, was considered for a control treatment. However, although a Foley catheter is used to establish urinary drainage with close to 100% efficacy, it does not restore voiding function like the C3, and severely impairs activities of daily life.

The intrinsic design flaws of a Foley catheter traversing thru the urinary passage which violates the anatomical protective points which help to avoid bacterial contamination. The distal 1/3 portion of the urethra in females is commonly colonized with bacteria. Standard Catheter technique traverses from the outside into the entire length of the urethra to drain the bladder. The standard self catheter flow characteristics are impacted due to the placements of the "eyes" to the catheter lumen. The C3 lumen is open in line with the flow.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Bladder Dysfunction requiring mechanical drainage.
2. Patients with actual urinary retention

Exclusion Criteria:

1. Inability to undergo bladder catheterization (e.g., urethral stricture or history of urethral stricture)
2. Gross hematuria
Study of Aminolevulinic Acid to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain

Tumors of the central nervous system are potentially curable. For tumors of comparable histology and grade, resectability is the most important prognostic factor affecting survival particularly in children. However, the infiltrative nature of the malignant cells produces indistinct borders between normal and malignant tissues, and the lack of easily identifiable tumor margins confounds attempts toward total resection. The investigators propose to identify the borders of tumors intraoperatively using protoporphyrin fluorescence of the malignant cells and thereby provide more complete tumor resection.


Eligibility Criteria:
Inclusion Criteria:

* patients must have clinically documented primary brain tumor for which resection is clinically indicated. Anticipated histology at resection should include:anaplastic astrocytoma, astrocytoma malignant NOS,brain stem glioma, ependymoma malignant, glioblastoma, glioblastoma multiforme, gliosarcoma, malignant oligodendroglioma, medulloblastoma, mixed astrocytoma-ependymoma
* prior therapy is not a consideration in protocol entry
* age unrestricted
* ECOG performance status\<2(Karnofsky\>60%,)
* life expectancy is not a consideration for protocol entry
* patients must have normal organ and marrow function as defined below:
* leukocytes _\> 3,000/ml
* absolute neutrophil count _\>1,500/ml
* platelets \>_100,000/ml
* total bilirubin:within normal institutional limits
* AST (SGOT)/ALT (SGPT) _\<2.5 X institutional upper limit of normal
* creatinine:within normal institutional limits or creatinine clearance \>_60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal
* women of child-bearing potential and men must agree to use adequate contraception(hormonal or barrier method of birth control;abstinence) prior to study entry and for the duration of study participation.
* ability to understand and the willingness to sign a written informed consent document or have a parent or guardian with the ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* prior therapy is not an exclusion criterion
* patients may not be receiving any other investigational agents history of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic adic (ALA)
* personal or family history of porphyrias
* uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* pregnant women are excluded, breastfeeding should be discontinued if mother is treated with aminolevulinic acid.
Gestational Diabetes Mellitus (GDM) in Pregnant Women

The purpose of the trial is to discover and predict the development of GDM of pregnant women in their first trimester.

Gestational Diabetes Mellitus (GDM) is a type of diabetes that affects pregnant women and often develops in the middle and later stages of pregnancy. GDM can lead to adverse maternal outcomes such as preeclampsia, and postpartum hemorrhage, and undesirable infant outcomes such as macrosomia and neonatal hypoglycemia. GDM also increases the risk of long-term consequences such as the development of type 2 diabetes in mothers, metabolic syndrome, and cardiovascular diseases. Gut microbiota has been shown to play a significant role in the etiology of metabolic illnesses, and recent studies have demonstrated that the gut microbiota of GDM women is altered compared to those of healthy women.

This trial aims to identify biomarkers during the first trimester (week 8-week 12) that can predict the likelihood of developing GDM while also examining potential links between GDM and gut microbiota. To achieve these objectives, the investigators have designed a trial that involves the collection of fecal samples from pregnant women for microbiome analysis at different stages of pregnancy. Although GDM is diagnosed at or after 24 weeks, the investigators will collect samples at the first, second, and third trimesters to determine if any alterations in the microbiome occur prior to symptom onset.

Eligibility Criteria:
Inclusion Criteria:

Women between the age of 18-45 Groups A and B have to be confirmed pregnant by blood test (confirmed by medical records) Subgroups A1 and B1 are pregnant women in their first trimester Subgroups A2 and B2 are pregnant women in their second trimester Subgroups A3 and B3 are pregnant women in their third trimester

Exclusion Criteria:

History of smoking or drinking during the pregnancy History of chronic diseases (cardiac, kidney, diabetes, hypertension, IBD,etc). Laxative use within 2 days prior to sample collection (The participant will be informed of the collection procedure by the recruiter and will be made aware of this requirement, we will also confirm when the first sample is taken through a phone call if for any reason the participant still made a mistake, will ask her to collect another sample to replace it) Development of any serious pregnancy complication during the participation period (e.g preeclampsia, preterm birth, miscarriage, etc) Excessive vomiting, diarrhea, or gastrointestinal symptoms for more than 5 consecutive days during the participation period. This will be confirmed through a weekly check-up call by the on-site recruiter or by Dr.Yin if the patient seeks treatment
PDO/PDO-TIL/PDOTS for Drug Screen

This clinical trial aims to use the patient-derived organoid (PDO), Patient-derived organoids-tumor-infiltrating lymphocyte coculture system (PDO-TIL) and patient-derived organotypic tissue spheroids (PDOTS) to simulate the tumor microenvironment in cancer patients. The culture system can be used for pre-clinical validation of drugs and screening of drugs to treat sensitive people and provide individualized treatment for patients with liver cancer. This model is used to explore the molecular mechanism of drug resistance and to find intervention strategies to further improve the response rate of drugs. This study is expected to provide an ideal platform for drug screening and drug resistance research in liver cancer patients, which can replace experimental animal models, and guide personalized medication for liver cancer patients, so as to improve the overall prognosis of patients.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old, male or female.
2. Liver cancer or metastatic liver cancer diagnosed clinically or pathologically, at least one measurable lesion.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
4. Patient has given written informed consent.
5. The function of important organs meets the requirements.
6. Non-surgical sterilization or women of childbearing age need to use a medically-accepted contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period.

Exclusion Criteria:

1. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included).
2. The patient is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount \> 10 mg/day of prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment.
3. Have clinical symptoms or diseases that are not well controlled.
4. Significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to randomization.
5. Arterial/venous thrombosis in the first 6 months of randomization.
6. According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory abnormalities.
Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States

This pilot randomized clinical trial will randomize 60 participants 1:1 to either enhanced usual care or to adapted Common Elements Treatment Approach (CETA), a counseling intervention for HIV care engagement plus depression, anxiety, PTSD, and/or substance use.

Patient participants in this study will be randomized 1:1 to either enhanced usual care or the adapted CETA intervention. Enhanced usual care will include provision of feedback about psychiatric diagnoses to the HIV provider and the clinic's behavioral health team for follow-up according to the clinic's standard care. Participants randomized to the adapted CETA arm will initiate CETA with the trained counselor. The number of CETA sessions will depend on the patient's presentation but will range from 7-13 weekly in-person 1-hour sessions.Before randomization, enrolled participants will complete a baseline assessment including sociodemographic information; self-reported health; standardized assessments of depressive, anxiety, and post-traumatic stress symptoms and substance use; and key related structural and psychosocial factors including housing stability,intimate partner violence (IPV), other violence in the home, coping, social support, and experiences of stigma related to mental health.

Participants in the Enhanced Contact arm will complete a follow-up research assessment at 3 months post baseline.Participants in the adapted CETA arm will complete this assessment after the final CETA session,also expected to be at approximately 3 months post-baseline. All participants will complete a final research assessment at 9 months post-baseline (approximately 6 months post-treatment exit for those in the adapted CETA arm). These follow-up assessments will assess the same domains as the baseline assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years.
2. Patient receiving HIV care at University of Alabama at Birmingham (UAB) 1917 Clinic.
3. Elevated symptoms of depression, anxiety, post-traumatic stress, or substance use disorder: At least one of the following:

   1. Patient Health Questionnaire-9 score \>= 10;
   2. Generalized Anxiety Disorder 7-Item Scale score \>= 10;
   3. Post-Traumatic Stress Symptoms Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) score \>= 33;
   4. ASSIST score \>=11 for alcohol or \>=4 for any other substance
4. At risk for suboptimal HIV care engagement: At least one of the following:

   1. Engaged in HIV care for the first time within the past 6 months;
   2. Have an HIV RNA viral load \>1,000 copies/mL within the past 6 months;
   3. Antiretroviral regimen was changed due to treatment failure within the past 6 months;
   4. No-showed to an HIV primary care appointment within the past year.
5. Willing to provide written informed consent.

Exclusion Criteria:

* 1. Non-English speaking 2. Unable to attend counseling sessions 3. Unwilling to provide informed consent
Different Efficacy Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With SCI in China

The morbidity of spinal cord injury (SCI) is increasing year by year 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, aiming to improve the neurological disorders of these patients, such as sensory disturbance, dyskinesia, autologous adjustment of blood pressure, dysfunction of urination, defecation and perspiration , etc. What's a pity, the efficacy of the rehabilitation therapy is unsatisfactory. 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, 300 patients will be divided into three groups and the investigators will use mesenchymal stem cells derived from umbilical cord to treat 100 SCI patients. They will also follow up 100 patients who only receive rehabilitation and another 100 patients 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 have clear history of traumatic injury.
3. 20 years - 65 years of age can be enrolled.
4. Both male and female can be enrolled.
5. The diagnosis of spinal cord injury are confirmed by all of the examinations including MRI, electromyogram and electrophysiology.
6. The time of injury was longer than 1 year.

Exclusion Criteria:

1. Mental disorders
2. Myelitis
3. Women in pregnancy
4. Cancer
Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis: A Randomized, Multi-center, Double-blind Study

This is a multi-center, randomized, double-blind, parallel-group trial. After a 2-week run-in period, eligible patients will be, based on the randomization codes kept in sealed envelopes, randomly assigned to receive usual care (mucolytics and/or chest physiotherapy) plus oxygen inahaltion (1 hr daily for 12 consecutive months) or hydrogen inhalation (1 hr daily for 12 consecutive months) provided by the sponsor. At 3 months after the end-of-treatment, a follow-up visit will be scheduled for all patients.

This is a multi-center, randomized, double-blind, parallel-group trial. After 2-week run-in period, eligible patients will be, based on the randomization codes kept in sealed envelopes, randomly assigned to two groups.On the basis of usual care \[ambroxool (30mg thrice daily), or N-acetylcysteine (0.2g thrice daily)/ serrapeptase (10mg thrice daily), or carbocisteine (500mg thrice daily) and/or chest physiotherapy (10 min, twice daily)\], patients were randomized to receive either hydrogen (66.7%, 3L/min, 1 hr twice daily) inhalation or oxygen inhalation (3L/min, 1 hr twice daily) via nasal canula for 12 months. A follow-up visit at month 3 following end-of-treatment was also scheduled. The primary endpoint was the annual frequency of bronchiectasis exacerbations. Hospital visits were scheduled at baseline and months 1, 3, 6, 9, 12 and 15, respectively. At 3 months after the end-of-treatment, a follow-up visit will be scheduled for all patients.

Eligibility Criteria:
Inclusion Criteria:

* Out-patients of either gender, ex- or never-smokers, aged between 18 and 75 years
* Clinically stable bronchiectasis, defined as respiratory symptoms and lung function parameters not exceeding normal daily variations and no acute upper respiratory tract infections for 4 consecutive weeks
* Patients with a history of 2 or more bronchiectasis exacerbations (BEs) within the previous 2 years

Exclusion Criteria:

* Other unstable concomitant systemic illnesses (i.e. coronary heart disease, recent cerebral stroke, severe uncontrolled hypertension, active gastric or duodenal ulcer, uncontrolled diabetes, malignancy, hepatic or renal dysfunction)
* Concomitant asthma, allergic bronchopulmonary aspergillosis, or active tuberculosis
* Concomitant chronic obstructive pulmonary disease as the predominant diagnosis
* Treatment with inhaled, oral or systemic antibiotics within 4 weeks
* Type 2 respiratory failure needing oxygen therapy or non-invasive mechanical ventilation
* Females during lactation or pregnancy
* Poor understanding or failure to properly operate the instrument
* Participation in other clinical trials within 3 months.
Impact of tDCS on Cerebral Autoregulation

The aim of the study is to investigate whether there is a polarity-specific influence of tDCS on cerebral vasomotor reactivity monitored by transcranial doppler sonography.


Eligibility Criteria:
Inclusion Criteria:

1. severe cerebral Microangiopathy
2. NOTCH3 carrier
3. Migraine with aura (IHS Classification ICHD-II)
4. Stenosis \>80%, ECST-Criteria

Exclusion Criteria:

* seizure disorder
* history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity
* dementia

(1+2) history of stroke in past 3 months (3) migraine prophylaxis (4) contralateral stenosis \>50%,