cyrilzakka/clinical-trials huggingface dataset:
Empowering Veterans to Communicate With Healthcare Providers

The goal of this VA Innovation Seed project is to test the best approach for the delivery, feasibility, and usability of a patient-centered CKD-QPS to facilitate better Veteran understanding and engagement in their CKD-care in nephrology clinics at two geographically distinct VA hospitals (Chicago and Dallas) through on-going user feedback in real time.

The goal of this VA Innovation Seed project is to test the best approach for the delivery, feasibility, and usability of a patient-centered CKD-QPS to facilitate better Veteran understanding and engagement in their CKD-care in nephrology clinics at two geographically distinct VA hospitals (Chicago and Dallas) through on-going user feedback in real time. Specifically, the pilot goals are to:

1. Test the process of delivering the CKD-QPS into clinical workflow to optimize patient and provider use of the QPS. We will rely on user (patient and provider) feedback about the feasibility of using the QPS in a real world VA environment (e.g., time required for visits using the QPS, impact on clinical workflow, patient and providers' preferences for delivering the QPS to Veterans with CKD) to adjust delivery throughout the project period.
2. Obtain continuous provider and patient feedback during the project period about QPS feasibility, use, patient participation, and provider information-giving and encouragement of question-asking during outpatient clinic visits.
3. Test how well iterative adjustments to delivery can help improve CKD-QPS patient-reported outcome measures (e.g., satisfaction with provider).

The multi-site study will take place at Hines, VA, and at VA North Texas Health System, in Dallas, TX. The intervention entails providing the CKD-Question Prompt Sheet to patients to use during patient-nephrologist (or Nurse Practitioner or Physician Assistant) clinic visits. The CKD-QPS is a 31-item list of questions about treatment options for CKD. The QPS is designed to empower patients to ask questions by reminding them of questions that they may consider asking.

Data collection entails pre-post clinic visit surveys among CKD patients, a post-clinic interview with CKD patients and nephrologists (separately), and audio-recording the clinic visit.

The knowledge gained from this study may improve other patients' satisfaction with care and communication with providers.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (age 18+) English-speaking CKD patients stage 3 (eGFR = 30-70 mL/min) who are scheduled for a clinic visit will be eligible for participation.

   1. Up to 60 will receive the QPS and all data collection activities
   2. Up to 10 will be audio recorded only
2. Nephrologists (or Nurse Practitioners or Physician Assistants) seeing CKD patients in routine clinic visits will be eligible for participation at Hines, VA.

Exclusion Criteria:

1. CKD patients who are non-English speaking, blind, hard of hearing or deaf, unable to read, and/or who are cognitively impaired will not be eligible for participation.
Phase 1 Study to Determine Safety, Blood PK and Lung Penetration

Multiple center, double-blind, randomized, placebo-controlled study to see if it is safe to give ACHN-490 Injection for 5 consecutive days, to measure plasma pharmacokinetics, and to determine lung penetration of ACHN-490 (measured in ELF-epithelial lining fluid)after a single dose of ACHN-490 Injection in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Men or Women
* Within normal weight limits
* In good health with normal routine laboratory results
* Willing to not use media players (such as MP3 players) or devices with ear pieces and avoid exposure to loud noises

Exclusion Criteria:

* No ongoing medical conditions such as heart disease, high blood pressure, asthma, diabetes, seizures, or kidney problems
* No problems with hearing or balance
* No previous injury or surgery to the ears
* No family history of hearing loss before the age of 65
* Not taking any medications other than birth control medication
* Smokers or use of tobacco products
* Recent blood donors
* No excessive alcohol intake or illegal substances
* No allergy to aminoglycosides (a type of antibiotic)
Porfiromycin Used as an Adjuvant to Radiation Therapy in Postoperative Head and Neck Cancer Patients

Determination of efficacy and safety of porfiromycin versus placebo as an adjuvant to radiotherapy in postoperative head and neck a cancer patients as well as assessment of population pharmacokinetic parameters.


Eligibility Criteria:
Inclusion Criteria:

* Male or female postoperative radical neck surgery patients with histologically proven Stage III or IV (without distant metastases) epidermoid (squamous cell) carcinoma of the head and neck limited to the following locations as defined by the American Joint Commission (AJC): lip and oral cavity, pharynx, or larynx.
* Postoperative radical patients whose specimen had a) microscopic positive tumor cell margins (\< 2mm from surgical margin) or b) extranodal capsular spread (perineural-vascular embolization) or c) two or more positive nodes
* Postoperative radical neck patients must have received Radiotherapy (RT).
* Performance status of ≥ 70 on the Karnofsky Performance Score (KPS) at screening.
* Patients ≥ 18 years of age
* Patients must have provided written informed consent prior to participation in the trial.
* Patients must have demonstrated an educational level and a degree of understanding such that they could communicate effectively with the investigator.

Exclusion Criteria:

* Patients that received any prior chemotherapy including mitomycin-C or porfiromycin.
* Treatment with granulocyte, granulocyte-macrophage stimulating factor (G-CSF, GM-CSF) or Interleukin-11 within 30 days prior to start of RT.
* RT within the treatment field for any malignancy within the past five years.
* Patients who had any gross (visible or palpable) residual disease left after surgery.
* Patients who met any of the following clinical laboratory criteria upon screening:

  1. Granulocyte (neutrophil) count of \< 1,500/cubic millimeters (mm3)
  2. Platelets \< 75,000/mm3
  3. Prothrombin time (PT) and partial thromboplastin time (PTT) \> 1.5 times the upper limit of normal (ULN) in seconds.
* Women who were pregnant or nursing.
* Women of childbearing potential who were unwilling to utilise a medically acceptable method of contraception (oral contraceptives, intrauterine devices, diaphragm or subdermal implants eg: Norplant®).
* Other malignancies active within the past five years (other than basal or squamous cell carcinomas of the skin outside the planned radiation portals, or in situ carcinoma of the cervix).
* The presence of more than one primary tumor or presence of distant metastases.
* The presence of any other life-threatening illness, such a severe chronic lung, liver, or heart disease that would be expected to be fatal within five years, regardless of the patient's cancer status.
* Patients who participated in a clinical trial with another investigational drug or treatment 30 days prior to screening.
Primary Sjögren Syndrome

Primary Sjögren syndrome (pSS) is an inflammatory, autoimmune, multiorgan disease often involving the central and peripheral nervous systems. Fifteen to twenty percent of patients with the primary Sjögren's syndrome have neurological complications involving the peripheral nervous system. Although some patients have large fiber neuropathy, around forty percent of patients with Sjögren's syndrome experience neuropathic pain with normal electrodiagnostic studies. Although these patients may be diagnosed with fibromyalgia or depressive symptoms, some have been shown to have small fiber neuropathy (SFN). A recent study proved that more than 90% of pSS patients with such neuropathic pain have SFN {Fauchais, 2010 #188}.

The aim of this study will be to investigate the occurrence of small fiber neuropathy in patients with pSS and neuropathic pain with normal electromyographic studies and to determine the existence of a conjoint local inflammatory process mediated by cellular, cytokinic or auto-antibody response. Quantification of epidermal nerve fiber density after skin biopsy is a valuable tool to diagnose small fiber neuropathy and the method has been widely validated. A skin biopsy will be performed in patients and control and will allow quantification of small fiber density in skin sample along with measurement of sweat gland innervation. Moreover, pathophysiological studies will be carried on in order to evaluate the causal relationship between cellular and humoral inflammation and small fiberneuropathy.

Recent studies have pointed out the inconstant efficacy of both corticosteroid and immunosuppressive drugs in pSS-related SFN. Dissecting the molecular mechanisms of small fiber neuropathy in these patients may help designing new therapeutic strategies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pSS according to revised European criteria and exhibiting neuropathic pain without any electromyographic abnormality will be included (Group I).
* Age of entry into the study ≥ 18 yrs (both groups).
* Affiliated or profit patient of a social security system (both groups).
* Informed consent signed up (both groups).

Exclusion Criteria:

* Chronic alcoholism
* Type I or type II diabetes
* Peripheral neuropathy unrelated to pSS complications
* Coagulation disease
* Previous allergy to xylocaine, lidocaine, prilocaine or ricin oil
* Porphyria, methemoglobinemia
* Patients under measure of maintenance of justice.
* Patients unable to understand or to participate to the study.
* Child and major patients making the object of a measure of lawful protection.
* Patients deprived of freedom.
* Pregnant, nursing women.
* Participation in biomedical research within one month prior to inclusion.
The Discovery of the Double Sphincter in Gallbladder

We found a new Double sphincter which located in the neck of gallbladder，we supposed it may be related to control pressure of bile duct.Its formation is related to genetic factors.

To contrast the recurrence rate of gallstones between patients with gallbladder double sphincter and patients with general gallbladder sphincter who underwent the treatment of cholecystolithiasis by minimally invasive cholecystolithotomy with gallbladder reservation. Method:Patients with gallbladder double sphincter and patients with general gallbladder sphincter who underwent the treatment of cholecystolithiasis by minimally invasive cholecystolithotomy with gallbladder reservation in The Affiliated Hospital of Guiyang Medical College from May 2012 to December 2015. We collect these patients' bile during surgery.Patients with gallbladder double sphincter as trial group, patients with general gallbladder sphincter as control group.the overall follow-up period is 3 years. Then the investigators statistically analyze improvement of cholecystolithiasis symptoms, thickness of gall bladder wall, the gallbladder function and the rate of the recurrence of cholesterol gallstone in 2 groups.we also analysis of the genetic differences from bile between two groups.

Eligibility Criteria:
Inclusion Criteria:

- people with gallbladder double sphincter

Exclusion Criteria:

- people without gallbladder double sphincter
Raman Spectroscopic Analysis of Bronchoscopic Biopsy for Diagnosing Lung Cancer

The goal of this clinical trial is to evaluate raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer in visible lesions in the airway. The main question it aims to answer are: the diagnostic efficacy raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer.

The bronchoscopic biopsy sample of patients with visible lesions in the airway would undergo raman spectrum analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who plan to undergo bronchoscopic biopsy or EBUS-TBNA
* Visible intratracheal lesions under bronchoscope
* Non-visible lesions suspected of lung cancer

Exclusion Criteria:

* The patient could not tolerate further examination aimed at clarifying the cause of the disease or refused to accept further examination aimed at clarifying the cause of the disease due to poor general condition, serious organ dysfunction, etc
* The patient has no definite diagnosis
A Study in Subjects With Recurrent Malignant Glioma

An open-label phase 2, multicenter study in participants with recurrent malignant glioma.


Eligibility Criteria:
Inclusion Criteria

1. Histologically confirmed diagnosis of Grade 3 or 4 malignant glioma.
2. All subjects who have a first or second recurrence following primary management with surgical resection or biopsy, radiotherapy and up to 2 prior systemic treatments with addition of:

   * No prior bevacizumab treatment is allowed for Cohort 1 and Cohort 2.
   * Subjects must have disease progression following prior bevacizumab treatment for Cohort 3.
   * For all cohorts, no prior anti-vascular endothelial growth factor (VEGF/VEGFR) therapy except for bevacizumab as specified above.
3. Karnofsky score of 70% or greater.
4. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than 150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Screening Visit.
5. Adequate renal function, adequate bone marrow function, adequate blood coagulation function and adequate liver function, as defined in protocol.
6. No evidence of hemorrhage on the baseline magnetic resonance imaging (MRI) scan other than in those subjects who are stable grade 1.

Exclusion criteria:

1. Females who are pregnant or breastfeeding.
2. Subjects who received enzyme-inducing anti-epileptic agents within 14 days before the first dose of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine).
3. Active infection requiring intravenous antibiotics.
4. Therapeutic anti-coagulation with warfarin, aspirin, nonsteroidal anti-inflammatory drugs or clopidogrel (low molecular weight heparin is acceptable).
5. Subjects with 24-hour urine protein greater than or equal to 1 gm.
6. Prior surgical resection within 4 weeks, or prior stereotactic biopsy within 2 weeks, of Screening Visit.
7. Prior radiotherapy within 12 weeks unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field, or there is biopsy-proven unequivocal viable tumor on histopathologic sampling.
8. Prior chemotherapy (6 weeks for nitrosoureas), or any investigational agent within 4 weeks unless the subject has recovered from all anticipated toxicities associated with that therapy; prior bevacizumab therapy (Cohorts 1 and 2); for Cohort 3, prior bevacizumab therapy within 3 weeks.
9. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II ; unstable angina; myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.
10. Prolongation of QTc interval to greater than 480 msec.
11. Active hemoptysis (bright red blood of at least 1/2 teaspoon) within 3 weeks prior to the first dose of study drug.
Mitochondrial Donation: An 18 Month Outcome Study.

The Investigator proposes to record the fetal and postnatal development of children conceived using Mitochondrial Donation (MD) and to perform expert assessment of development at 18 months (corrected for gestational age) using the internationally validated Bayley-III developmental assessment tool.

To record the fetal and postnatal development of children conceived using Mitochondrial Donation and to perform internationally validated Bayley-III developmental assessment tool at 18 months (corrected for gestational age).

The null hypothesis for this research is that children born following the use of Mitochondrial Donation (IVF) techniques have normal neurodevelopment developmental outcomes at 18 months.

Eligibility Criteria:
Inclusion Criteria:

Women will only be eligible if they meet all of the following criteria.

* Women with confirmed mtDNA mutation
* Suitable to undergo Mitochondrial Donation as a treatment (in line with HFEA license)
* Informed Consent for the study obtained before Mitochondrial Donation treatment commences
* Ability and willingness to adhere to the protocol including evaluation schedule
* Willingness to make available information collected during pregnancy, delivery and up to the child's age of 18 months (corrected for gestational age)

Exclusion Criteria:

Women will not be eligible if they meet any of the following criteria

* Declined Mitochondrial Donation as a treatment (in line with HFEA license)
* Inability or unwillingness to adhere to the protocol including evaluation schedule
* Unwillingness to make available information collected during pregnancy, delivery and up to the child's age of 18 months (corrected for gestational age)
Prevalence of Myofascial Pain Syndrome in Adolescent Idiopathic Scoliosis

this is an observational and cross-sectional prevalence study. 10-18 years aged participants with adolescent idiopathic scoliosis were recruited in the study. Myofascial pain syndrome will be questioned to the participants. additionally, all participants will be evaluated using their findings for scoliosis and myofascial pain syndrome diagnostic criteria. Cobb angle, coronal balance, shoulder and pelvis asymmetry, sagittal spino-pelvic parameters of the spine (cervical lordosis, thoracic kyphosis, lumbar lordosis angles and sagittal vertical axis, sacral slop angle and pelvic incidence) will be measured.

This is an observational and cross-sectional prevalence study. Patients diagnosed with adolescent idiopathic scoliosis who applied to the Physical Medicine and Rehabilitation Clinic of Kanuni Sultan Süleyman Training and Research Hospital will be included in our study. These participants will be aged between 10-18 years. These patients will be evaluated using their findings for scoliosis and myofascial pain syndrome diagnostic criteria. Cobb angle, coronal balance, shoulder and pelvis asymmetry, sagittal spino-pelvic parameters of the spine (cervical lordosis, thoracic kyphosis, lumbar lordosis angles and sagittal vertical axis, sacral slop angle and pelvic incidence) will be measured. Diagnostic criteria of Myofascial Pain Syndrome; As the Major Criteria;

1. Regional pain complaint
2. Pain or sensory change reflected from trigger points to a specific area 3. Palpable taut band in accessible muscles

4. Extreme tenderness at one point along the taut band 5. Decreased range of motion that can be measured As for the Minor Criteria;

1. Complaint of clinical pain and/or sensory change on pressurized palpation of the trigger point
2. Local twitch response of the tender point on the taut band with palpation and needling 3. Reduction of pain by injection of the tender point or stretching of the muscle Five major and at least 1 minor criteria are required for the clinical diagnosis of myofascial pain syndrome.

Patients with a previous history of surgery for scoliosis and neuromuscular scoliosis were excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* aged between 10-18 years
* diagnosed as adolescent idiopathic scoliosis
* agreed to participate in the study

Exclusion Criteria:

* neuromuscular or any other type of scoliosis
* any surgical treatment for scoliosis or spine.
Daily Life Activities in Patients Treated With Continuous-Flow Left Ventricular Assist Devices

Investigation of oxygen uptake during daily life activities in HF patients with and without LVADs.

In patients with terminal HF the gold standard for treatment is heart transplantation, though the Worldwide shortage of donor organs has led to increased use of implantable mechanical circulatory support devices. The treatment with implantable pumps in the form of a Continuous Flow Left Ventricular Assist Device (CF-LVAD, or simply LVAD) is extremely effective for a selected patient groups leading to significant improvement in survival and quality of life.

The device is a battery-powered flow pump that carries the blood from the left ventricle to the main artery, via a cannula, and thus relieves the failing left ventricle with up to 10 liters of blood per minute. An LVAD can be used both as lifelong support therapy (Destination Therapy, DT) or until transplantation can take place (Bridge therapy).

As patients today live for more than 10 years with the device as DT, the focus has shifted from mere survival to quality of life and physical ability.

In recent years, our research group showed that the pump speed and the patient's baseline heart rhythm (sinus rhythm vs atrial fibrillation) and reduced ability to regulate the intrinsic rhythm after implantation (chronotropic incompetence) are significant contributors to the reduced exercise capacity seen in this patient group.

Until now, studies have elucidated the work capacity of this patient group using a 6-minute walk test or bicycle test - none of these reflect how well the patient actually functions in his everyday life.

In this study, we will describe oxygen uptake related to specific daily activities (ADL-VO2) and compare these with the well-known maximum work capacity (percentage of expected oxygen uptake / pVO2) in this patient group.

Eligibility Criteria:
LVADs:

Inclusion Criteria:

* Implanted durable left ventricular assist device
* Age\>18yrs
* Signed informed consent

Exclusion Criteria:

* No consent
* Not able to complete VO2 test (physicians decision)
Dynamic Effects of Online HDF on Cardiac Function and Myocardial Perfusion Utilising Cardiac MRI (CAMRID)

The purpose of this study is to characterise, in detail, the cardiac structure, function and perfusion of those on haemodialysis and haemodiafiltration, comparing the two modalities to ascertain if haemodiafiltration provides relative myocardial protection compared to conventional haemodialysis.

Trial Configuration: Non-blinded crossover pilot study Setting: Secondary care Sample size estimate: This is a pilot study therefore power calculations are not appropriate. A group size of 12 participants has been selected for feasibility.

Number of participants: 12 patients to complete study Description of interventions

* 6 sessions of conventional haemodialysis each lasting 4 hours
* 6 sessions of online haemodiafiltration each lasting 4 hours
* 2 sessions of Cardiac MRI each lasting 6 hours in total to take place around 6th session of dialysis Randomisation and blinding: This is an open study. Statistical methods: All continuous variables will be tested for normality. The primary and continuous secondary endpoints will be compared between the two modalities using a paired t test or Wilcoxon signed rank test as appropriate. The association between categorical variables will be tested using the Chi squared or Fischer's Exact test. An alpha error at 0.05 will be judged as significant.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Able to give informed consent
* CKD5 on chronic haemodialysis
* Receiving dialysis via an arteriovenous fistula
* Must be able to follow simple instruction in English (on safety grounds for MRI scans)

Exclusion Criteria:

* Change in ideal dry weight in 4 weeks prior to recruitment
* Instability on dialysis in 4 weeks prior to recruitment leading to either:

  * Emergency medical attention
  * Infusion of additional fluid
  * Loss in consciousness
  * Arrhythmia
  * Chest pain
* Dialysed via a synthetic line or graft
* Qa \< 500ml/min
* NYHA Stage IV heart failure
* Active infection or malignancy
* Contraindication to MRI scanning including claustrophobia
* Mental incapacity to consent
* Pregnancy or planning pregnancy