cyrilzakka/clinical-trials huggingface dataset:
Study of Degenerescence CSF Hallmarks in Older Bipolar Patients

Analysis of 4 CSF Alzheimer's disease biomarkers (total and phosphorylated tau protein, Aß40 and Aß1-42) and morphological brain MRI in older patients (\>60 year's old) with bipolar disorder, after an evaluation of their cognitive functions.

Comparison between two groups of patients : patients with cognitive disorders and patients without cognitive disorders.

The objective is to describe and compare the profile of those biomarkers in those two populations.

Describe the profile of the 4 neurodegeneration's biomarkers of Alzheimer's disease dosed in the cerebrospinal fluid (Total Tau proteins, phosphorylated, Aß40 and Aß1-42) for old subjects suffering from bipolar disorder with or without cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* male or female between 60 and 80
* french-speaking, reading and writing patient
* affiliation to the French Social Security
* written informed consent obtained from the patient
* agree to undergo a lumbar puncture
* easy accessibility for the lumbar puncture
* Mini Mental State Examination (MMSE) \> 20
* bipolar patients :

  * type I or II
  * state of euthymia for at least 4 weeks
  * stable psychotropic drug treatment for at least 8 weeks
  * no electroconvulsive therapy during the 6 months before inclusion
* distribution in the "with cognitive disorder" or "without cognitive disorder" group is function of the result of the neuropsychological evaluation

Non-inclusion Criteria :

* severe visual or auditory disorder
* advanced lumbar osteoarthritis
* history of severe head injury, neurological disorders, diagnosed dementia
* addiction weaned for less than 12 months
* forced hospitalization in psychiatry
* MRI contraindications
* LP contraindications

Exclusion Criteria:

- at least one of the outcome measures can't be performed :

* MRI
* LP : anticoagulation, bad accessibility
CAPTURE - Complete Automatic Pacing Threshold Utilization Recorded by EnPulse

This study compares the pacemaker's automatic pacing threshold measurements to the manual measurements conducted by a health care provider.

The purpose(s) of the study is (are) to evaluate several features available in EnPulse Series pacemaker and report the long term benefit of Atrial Capture Management (ACM) and Ventricular Capture Management (VCM) as demonstrated by accuracy in comparison with manual measurements and variability of ACM and VCM thresholds.

In addition, an evaluation of the timesaving and qualitative benefits of the device feature known as Quick Look II (the computer interface screen of the device programmer) will be measured through the use of a questionnaire completed by the health care professionals involved in patient follow-up care.

This is a one-to-one randomized, multicenter, prospective study in which patients receiving new EnPulse pacemaker implants will be randomized to each of three study arms, 1) routine manual follow-up and follow-up using the automatic features; 2) ACM diagnostics detail on or VCM diagnostics detail on; 3) PMOP on / off or PMOP off / on (6 month cycle).

Eligibility Criteria:
Inclusion Criteria:

• Patients that meet ACC/AHA/NASPE 2002 class I or II dual chamber pacing indications (intended for a Pacing Mode programmed to DDD or DDDR)

Exclusion Criteria:

* Patient with mechanical tricuspid heart valves
* Patients with medical conditions that preclude the testing required by the protocol or limit study participation
A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants

The purpose of this study is to characterize the intrapulmonary penetration of nacubactam in healthy volunteers. Nacubactam is a novel non-beta-lactam beta-lactamase inhibitor being developed as a combination therapy with the beta-lactam meropenem for the treatment of serious gram-negative bacterial infections. Adult male and female healthy participants will receive a single intravenous infusion of nacubactam co-administered with meropenem and then undergo a bronchoalveolar lavage (BAL) procedure to collect lung epithelial lining fluid (ELF) for measurement of intrapulmonary concentrations of nacubactam and meropenem.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 60 years of age, inclusive
* Healthy, as judged by the Investigator and defined by the absence of evidence of any active or clinically significant chronic disease identified from a detailed medical and surgical history, physical examination including vital signs and 12-lead electrocardiogram (ECG), and laboratory safety test results
* Body mass index (BMI) within the range 18-30 kilogram per square meter (kg/m\^2),inclusive
* Non-smoker, or former smoker who has abstained from smoking for at least 6 months
* Negative pregnancy test and agreement to comply with measures to prevent pregnancy in women
* Refrain from sperm donation and agreement to comply with measures to prevent pregnancy in partner of childbearing potential for men

Exclusion Criteria:

* History of asthma or clinically significant lung disease
* Any condition which contraindicates a BAL procedure
* History of clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, dermatological, immunological or allergic disease, metabolic disorder, cancer or cirrhosis
* Clinically significant change in health status, as judged by the Investigator, or any major illness within the four weeks before screening, or clinically significant acute infection or febrile illness within the 14 days before screening
* History of epilepsy (or known seizure disorder), brain lesions or other significant neurological disorders
* Participation in any other clinical study involving an investigational medicinal product or device within 3 months before screening
* Known history of clinically significant hypersensitivity or urticaria, or severe allergic reaction to any drug, in particular antibiotics
* Donation or loss of over 500 milliliter (mL) of blood within the three months before screening
A Study to Examine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Exenatide Once Weekly in Japanese Patients With Type 2 Diabetes

Exenatide twice daily has been studied in Japanese type 2 diabetes patients. A once-weekly version of exenatide is currently being evaluated. Study GWBW is the first study of exenatide once weekly in Japanese patients. This study is designed to evaluate safety and tolerability of exenatide once weekly in Japanese patients and determine whether the dose selected for US and European development is appropriate for Japanese patients with Type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Body weight ≥50 kg.
* Have suboptimal glycemic control as evidenced by an HbA1c defined by the following criteria: \*6.5% to 10.0%, inclusive, at study start for patients managed with diet modification and exercise or treated with oral antidiabetics drug but not alpha glucosidase inhibitor or meglitinide derivatives; \*6.5% to 9.5%, inclusive, at study start for patients treated with oral antidiabetics including alpha glucosidase inhibitor or meglitinide derivatives.
* Have been treated with diet modification and exercise alone or in combination with a stable regimen of oral antidiabetic drugs (sulfonylurea, metformin and thiazolidinedione) for at least 2 months prior to study start. In the case of patients with concomitant use of sulfonylurea, the dose of sulfonylurea must not be more than maximum recommended dose. The patients with concomitant use of alpha glucosidase inhibitors (Glucobay® \[acarbose\], Basen® \[voglibose\], or Seibule® \[miglitol\]) or meglitinide derivatives (Glufast® \[mitiglinide\] or Fastic®/Starsis® \[nateglinide\]) can be included in this study, but these drugs must be discontinued after confirmation of eligibility at study start.

Exclusion Criteria:

* Subjects who have donated more than 200 mL of blood and component blood donation within one month of study start, or those who have donated more than 400 mL of blood within three months of study start.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Have participated and received at least one dose of exenatide or other GLP-1 analogs in this study previously, or any other study using exenatide or other GLP-1 analogs.
* Are treated with any exogenous insulin within 3 months of screening.
* Are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): \*Drugs that directly affect gastrointestinal motility, including Nauzelin® (domperidone), Primperan®/Terperan® (metoclopramide), Ganaton® (itopride), Acenalin® (cisapride), Gasmotin® (mosapride), or Cerekinon® (trimebutine).
* Females who are breastfeeding.
Feasibility of a Molecular Characterisation Approach to Treatment

This study will assess the feasibility of sequencing locally advanced/metastatic gastrointestinal cancers in real-time to enable future treatment stratification by molecular characteristics. Targeted next generation sequencing of a panel of genes will be performed on tumour specimens and results will be discussed at a Sequencing Tumour Board to establish if a patient is potentially suitable for a targeted therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Locally advanced or metastatic gastrointestinal cancer (including oesophageal, oesophagogastric junction, gastric, pancreatic, biliary and colorectal cancers).
2. Histological or cytological confirmation of diagnosis of malignancy.
3. Patients must either:

   1. Have received at least one line of treatment for locally advanced/metastatic disease OR
   2. Be about to start/currently undergoing their first line of treatment for locally advanced/metastatic disease
4. 18 years of age and over .
5. Performance status less than or equal to 2.
6. Able to provide fully informed consent.
7. Patients must either:

   1. Have an available tumour specimen (FFPE or fresh frozen) from either the primary tumour or a metastasis. Metastatic samples may be from any site with the exception of bone. OR
   2. Have a site of disease which is amendable to biopsy

Exclusion Criteria:

* There are no specific exclusion criteria for this study.
COMPASS: A Group ACT Program for Cancer Patients Treated at UCSF

Cancer Center Psychosocial services (Psycho-Oncology) offers group psychoeducational and behavioral programs as part of its clinical service for cancer patients and services at the Helen Diller Family Comprehensive Cancer Center. Clinical outcomes and acceptability/feasibility and implementation process data from these programs are routinely gathered in an effort to engage in continuous quality improvement for the department.

For this project, the study team is proposing to retrospectively analyze a de-identified data set of these data to report on pilot data on preliminary outcomes, acceptability and feasibility of the implementation of the COMPASS: Acting Mindfully for a Valued Life, based upon Acceptance and Commitment Therapy, an evidence-based behavioral intervention and facilitated by a licensed clinical psychologist in our department. This intervention was implemented as a series of clinical offerings for seven 7-session groups between September 2015 and October 2018 for 113 individual cancer patients and survivors. Outcomes measured include anxiety, depression, fear of recurrence, psychological flexibility, mindfulness; values based living, and quality of life. Participants completed surveys at 4 time points, pre and post, and two followup time points. Measures of demographics, satisfaction and feasibility/acceptability were also collected. Insights gathered from this study will be used to inform articles, grant applications and conference presentations on the implementation of behavioral interventions for cancer patients and survivors.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Treated for any kind of cancer at University of California, San Francisco
* Sufficient cognitive ability to participate in group activities as determined by their attending medical oncologist or surgeon

Exclusion Criteria:

* Non-English speaking
* Treated elsewhere for cancer
* Psychiatric illness that would affect the ability to participate in a group activity
A Study of SHR-1802 in Combination With Adebrelimab in Patients With Advanced Solid Tumors

The aim of this study is to observe and evaluate the tolerability, safety, pharmacokinetics and immunogenicity of SHR-1802 combined with adebrelimab in patients with advanced solid tumors, determine the RP2D of SHR-1802 combined with adebrelimab ± chemotherapy, and evaluate the efficacy of SHR-1802 combined with adebrelimab ± chemotherapy in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent；
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
3. Has a life expectancy≥ 12 weeks；
4. At least one measurable lesion according to RECIST v1.1；
5. Pathologically confirmed advanced solid tumor；
6. Adequate bone marrow reserve and organ function.

Exclusion Criteria:

1. Have received anti-PD-1 or PD-L1 antibody therapy;
2. Subjects with other malignant tumors in the past 3 years;
3. Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
4. Previous or current interstitial pneumonia/interstitial lung disease ;
5. History of autoimmune disease with the possibility of recurrence or active autoimmune disease;
6. Severe infection within 1 month before the first study drug administration;
7. The presence of other serious physical or mental disorders or abnormalities in laboratory tests that may increase the risk of study participation or interfere with study results, as well as patients deemed unsuitable for study participation by the investigator.
Protected Versus Early Weight Bearing Post Microfracture Surgery

To test using a randomised control trial, whether conservative rehabilitation and protected weight bearing versus early weight bearing and accelerated rehabilitation affects patient outcomes post microfracture surgery of the knee.

To test using a randomised control trial, whether conservative rehabilitation and protected weight bearing versus early weight bearing and accelerated rehabilitation affects patient outcomes post microfracture surgery of the knee.

Current practice in most units is to protect patients from weight bearing prior to entering a conservative physiotherapy rehabilitation program following microfracture surgery of the knee. At our unit we believe that protecting patients from weight bearing post microfracture surgery makes no difference to their outcome and only leads to a longer rehabilitation time and a delayed return to work and sports. Therefore we want to randomise patients who require microfracture surgery of the knee for cartilage defects into 2 post operative rehabilitation groups. One group will be able to weight bear early and will undergo an accelerated rehabilitation program whilst the other will be protected from weight bearing and will undergo a more conservative rehabilitation program. We will then follow patients up over a year and compare outcome data collected at 6 weeks, 3 months, 6 months and 1 year post operatively to see if there was any difference in outcomes between the 2 groups. As secondary outcomes we will also compare the patients in the two groups to see if there is a difference in time taken to return to work and sporting activities

Eligibility Criteria:
Inclusion Criteria:

* Aged 16-60 years. Mechanically stable knee joint at outpatient examination. MRI confirmed grade 3 or 4 non-kissing cartilage defect within the knee. Able to fully understand the process and study and give informed consent to participate.

Able to comply with the physiotherapy rehabilitation and follow up process.

Exclusion Criteria:

* Kissing cartilage defects. Defects deemed too large to undergo microfracture on MRI scan. Clinically unstable knee joint. Patients unable to consent to participation. Under 16 years of age or over 60 years of age. Patients likely to drop out of physiotherapy rehabilitation and study follow up.
Angiogenic Cytokines and Fibrinolytic Activity in Parapneumonic Effusions

Angiogenesis is a key process in the formation of exudative pleural effusions. Fluid loculation is common in parapneumonic effusion and is associated with depressed pleural fibrinolytic activity and poor clinical outcome. However, the relationship between angiogenic cytokines and fibrinolytic activity in the pleural space remains unclear. The researchers's hypothesis is that the levels of angiogenic cytokines were increased and associated with decreased fibrinolytic activity in parapneumonic effusions which may contribute to fibrin deposition and fluid loculation in the pleural space.

Formation of parapneumonic effusions (PPE) involves increased pleural vascular permeability induced by the contiguous pneumonia. It has been demonstrated that exposure of pleural mesothelial cells to bacteria or lipopolysaccharide (LPS) leads to increased release of angiogenic factors, including vascular endothelial growth factor (VEGF) and interleukin (IL)-8, which induce vascular hyperpermeability, fluid exudation, and neutrophil influx into the pleural space, and may play a pivotal role in development of PPE. With persistent inflammation and angiogenesis, amplified vascular and mesothelial permeability leads to increased plasma extravasation, activation of the coagulation cascade, and repression of fibrinolytic activity within the pleural cavity, which contribute to the development of a ''complicated'' PPE, manifested with fibrin deposition and pleural fluid loculation. Fibrin turnover in the pleural cavity is greatly affected by fibrinolytic activity mediated by plasmin, which is regulated mainly by the equilibrium between plasminogen activators (PAs) and plasminogen activator inhibitors (PAIs).VEGF induces vascular hyperpermeability and may facilitate the genesis of fibrin gel in PPE. Previous studies reported that VEGF plays a role in the modulation of tPA and PAI-1, and that anti-VEGF antibody attenuates pleurodesis induced by transforming growth factor-β2. These findings suggest that VEGF may be involved in the regulation of fibrin turnover, fluid loculation and tissue fibrosis in the pleural space. Enhanced procoagulant and depressed fibrinolytic activities have been observed in PPE. However, the relationship between angiogenic cytokines and fibrinolytic activity in PPE remains unclear.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pleural effusions of unknown causes admitted to Taipei Medical University Hospital were included if parapneumonic effusion was diagnosed as one associated with pneumonia according to the criteria of the American Thoracic Society (ie, patients with newly acquired respiratory symptoms, fever, and abnormal breath sounds, plus a new lung infiltrate seen on a chest radiograph).

Exclusion Criteria:

* History of chest trauma or invasive procedures directed into the pleural cavity; bleeding disorder or anticoagulant therapy
* Use of streptokinase in the previous 2 years; and likely survival less than 6 months.
Electromyography and Yoga

This study examined the muscle activity, movement patterns, and oxygen consumption during a series of yoga poses with slow and rapid transitions.


Eligibility Criteria:
Inclusion Criteria:

* Have at least 1 year of yoga experience;
* Practice a minimum of twice per week (app 2 hours or more);
* Demonstrate good form in the poses (asanas) making up the Sun A and Sun B sequences;

Exclusion Criteria:

* If they have any uncontrolled neuromuscular, orthopedic or cardiovascular disease;
* If they have been advised by their physicians that they should not exercise;
* If they cannot complete three cycles each of the Sun A and B sequence in good form.
Ultrasound Findings in Diabetic Pregnancies

The goal of our study is to identify ultrasonographic markers that can predict adverse neonatal outcomes. Specifically, we hypothesize that an increase in fetal liver volumes will increase transcutaneous bilirubin (TcB) in the newborn and thus jaundice requiring phototherapy. This information can be used in patient counseling and to guide future screening protocols for ultrasound in individuals with diabetes.

This is a single center, prospective case control study. Cases will be collected prospectively and control subjects will be data collected retrospectively from the reference population of the human placenta project (IRB #15-09-FB-0179). If patients agree to participate, one ultrasound will be performed at 30-34 weeks' gestation to look at the fetal parameters as described below. It is standard of care for all patients with pregestational diabetes to receive growth ultrasounds throughout their pregnancy. Patients who are diagnosed with pregestational diabetes at EVMS routinely undergo an ultrasound at 30-34 weeks' gestation. Therefore, ultrasound data will be collected during their scheduled 30-34 week ultrasound visit and no additional ultrasounds will need to be performed. At the time of enrollment, the PI or other study collaborator will ensure that the patient has previously had a detailed ultrasound evaluation (Code 76811). These patients will then be followed prospectively until delivery. The neonates of the study patients will be followed via chart review after delivery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who enter pregnancy with a diagnosis of type I or type II diabetes mellitus.
* Pregnant women between the ages of 18-45
* Live, singleton gestation
* Understanding and ability to give informed consent

Exclusion Criteria:

* Patient unwilling or unable to provide consent
* Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians)
* Age less than 18 years of age
* Multifetal gestation
* Chromosomal abnormality
* Congenital infection (Toxoplasmosis, Cytomegalovirus, Rubella, Varicella Zoster, Parvovirus B19
* Major fetal congenital malformations (such as: major congenital heart defect, omphalocele, open neural tube defect, etc)
Topical Dexamethasone - Cyclodextrin Microparticle Eye Drops for Diabetic Macular Edema

The research group has developed new ocular drug delivery technology based on cyclodextrin nanoparticles (NP). The investigators plan to develop and test this technology to help treat diabetic macular edema (DME).

An important step in research was the invention of cyclodextrin nanoparticles, which has just received a US patent. The investigators pre-clinical and clinical work has demonstrated the investigators eye drop suspension with cyclodextrin nano-particles to be superior to conventional eye drops. They increase drug absorbance into the eye and decrease systematic distribution of the drug, hence reducing side effects. Cyclodextrin nanoparticle eye drops deliver drugs to the posterior part of the eye, thus solving one of the biggest obstacles in ocular pharmacology.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Pseudophakic in study eye, i.e. with IOL (intra ocular lens) after cataract surgery
* Diabetic macular edema with central macular thickness over 300 µm on OCT in study eye. If both eyes have DME, then the treatment will be applied to the eye with thicker central macula on OCT.
* Age 18 years or older

Exclusion Criteria:

* Glaucoma or use of any glaucoma medication
* Known steroid IOP response
* Any infectious eye disease
* Treatment for DME within 6 months, such as laser treatment, intravitreal or subtenon injections of steroids, intravitreal injections of anti vascular endothelelial growth factor medication.
* Any eye surgery within 3 months or other eye conditions e.g. corneal disorders, ocular hypotony and retinal detachments.
* Crystalline lens present in study eye
* Known allergy to cyclodextrins, dexamethasone, ranibizumab or any of the components of the study medications