cyrilzakka/clinical-trials huggingface dataset:
The International Registry for Leigh Syndrome

The purpose of this study is to develop a database containing clinical and laboratory information for patients with Leigh syndrome. The goal is to provide a greater understanding of Leigh syndrome allowing further characterization of this disease.

Leigh syndrome, also known as juvenile sub-acute necrotizing encephalopathy, is a progressive neurodegenerative disorder associated with dysfunction of mitochondrial oxidative phosphorylation (OXPHOS). First described in 1951 by British neuropsychiatrist Archibald Denis Leigh, the condition has evolved from a post mortem diagnosis to a clinical entity with characteristic radiologic and laboratory findings.

Leigh syndrome is a rare and heterogeneous disease, finding a substantial number of patients to study is difficult. The lack of natural history data in Leigh syndrome and the small number of patients included in clinical reports thus far has limited the ability to fully comprehend the progression of this disease and assess prognostic factors. A Leigh syndrome database will help improve our understanding of this rare disease leading to an improved ability to predict outcomes and/or improve treatment paradigms. Collecting natural history data on Leigh syndrome and integrating this information into a database will be useful in understanding the course of the disease and identifying trends.

Eligibility Criteria:
Inclusion Criteria:

* All participants with a diagnosis of Leigh syndrome will be invited to participate

Exclusion Criteria:

* People without Leigh syndrome
TOGETHER: Track Outcomes and Guidance, Technology for Health and Effective Resources

The goal of this project is to iteratively develop and test a TOGETHER pilot mobile app product in preparation for commercialization. TOGETHER is a mobile application on a smart software system that informal caregivers can use to develop and implement home-based care for cancer patients/survivors.

The Technical Objectives are to:

1. Establish the project team and obtain stakeholder feedback on what to include in the product.
2. Evaluate IT customization requirements and HIPAA compliance security, and privacy protocols.
3. Develop a prototype to show NCI and then a pilot version for beta and usability testing among stakeholders.
4. Enhance interoperability and test integration into health system(s) - if feasible.
5. Develop user support documentation for stakeholders.


Eligibility Criteria:
Inclusion Criteria:

* Adults (aged 18 years or older) who are either:

  * Cancer patient/survivor receiving care or with plans to transition to care in the community setting.
  * Caregiver of cancer patient/survivor receiving care or with plans to transition to care in the community setting.
  * Clinician of cancer patient/survivor receiving care or with plans to transition to care in the community setting.
* Cancer patient is a patient of Stanford Health Care.
* Patient, Caregiver, and Clinician are willing to be connected on the app.
* Have a smartphone and data plan that allows for app installation and usage.
* Must speak, read and write in English, because all study materials and communication will be in English.

Exclusion Criteria:

* Patient does not have a cancer diagnosis.
* Cancer patient/survivor is not receiving care or does not have plans to transition to care in the community setting.
* Cancer patient is not a patient of Stanford Health Care.
* Patient, Caregiver, and Clinician are not willing to be connected on the app.
* Unable to speak, read and write in English.
* Does not have a smartphone nor data plan that allows for app installation and usage
A 3-YEAR CLINICAL INVESTIGATION ON THE NOBEL ACTIVE® TIULTRA™ IMPLANT AND ON1™ BASE XEAL1™ _____________________________________________________________

Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes


Eligibility Criteria:
Inclusion Criteria:

.The subject inclusion criteria are listed below. The subject is at least 18 years of age (or age of consent) and has passed cessation of growth.

Obtained informed consent from the subject. The patient is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).

The subject shall be healthy and compliant with good oral hygiene. Full-mouth bleeding score (FMBS) lower than 25 %\[10\]. Full-mouth plaque score (FMPI) lower than 20% \[11\]. Suitable for implant treatment in the posterior, pre-molar area in the mandible or maxilla.

The subject shall have a favorable and stable occlusal relationship. In need of one single tooth replacement Healed sites in need for implant placement (i.e. minimum of 6 weeks post extraction).

The implant sites are free from infection and extraction remnants. The subject is suitable for a 1-stage surgical procedure. Sufficient amount of buccal and lingual keratinized mucosa. The healed sites eligible will have natural teeth as neighboring structures. The subject is in such a physical and mental condition that a 3-year follow up period can be carried out without foreseeable problems.

The subject has a sufficient amount of bone for placing NobelActive TiUltra with a length of at least 7 mm.

The following subject inclusion criteria apply at time of surgery:

Primary implant stability as assessed by manual hand testing.

Exclusion Criteria:

* The subject is not able to give her/his informed consent of participating. Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure.

Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history.

Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area.

Infections in the planned implantation site or adjacent tissue. Acute, untreated periodontitis in the planned implantation site or adjacent tissue.

Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.).

Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake or A1c level above 8%.

Alcohol or drug abuse as noted in subject records or in subject history. Smoking less 10 cigarettes/day. Fresh extraction sites (up to 6 weeks). Severe bruxism or other destructive habits. Pregnant or lactating women at the time of implant insertion. Previous bone augmentation (lateral and/or vertical). Soft tissue augmentation less than 2 months before implant placement. Subject has allergic or adverse reactions to the restorative material
Noninvasive Cardiac Output Measurements in Patients With Pulmonary Hypertension Undergoing Exercise Testing

Subjects in this study have been diagnosed with pulmonary hypertension and their doctors have referred them for an exercise test as part of their normal, routine care. The exercise test will either be a treadmill test or a 6 minute walk test. During a treadmill test, a patient typically walks on a treadmill while their heart is monitored using an electrocardiogram, which records the electrical activity of the heart through 10 small electrode patches attached to the skin of the chest, arms and legs. Additionally, heart rate and blood pressure are monitored throughout the test. A 6-Minute Walk test requires patients to walk for up to 6 minutes to determine how far they can go in order to measure the heart function related to exercise.

The purpose of this study is to measure internal heart pressures using a device called Noninvasive Cardiac Output Monitoring (NICOM) during an exercise test. Normally heart pressures are measured during invasive (meaning that doctors have to go inside the body using a needle or surgery) heart procedures. The NICOM device is non-invasive which means the investigators do not have to go inside the body to obtain the heart pressure measurements. In this study, the investigators will evaluate the non-invasive measurements provided by the NICOM device during the exercise test and see how it relates to information from some of subjects' past heart procedures. This research is being done to devise better, less invasive ways to assess disease severity, track disease progression and evaluate response to therapy.

The NICOM device is approved by the US Food and Drug Administration (FDA) to measure heart pressures. This device is usually used when a patient can't undergo a right heart catheterization. In this study, the investigators are using the device to gather heart pressure measurements for research during the exercise test that is scheduled as part of the subjects' normal, routine care. The research data is being used to devise better, less invasive ways to assess disease severity, track disease progression and evaluate response to therapy. The NICOM device is made by Cheetah Medical.


Eligibility Criteria:
Inclusion Criteria:

* have Pulmonary Hypertension
* undergoing standard of care exercise testing
* 18 years or older

Exclusion Criteria:

* unable or unwilling to give informed consent
The Effects of Linezolid and Vancomycin on Inflammation and Cellular Signaling Vents

We will determine if linezolid inhibits cellular activation and production of pro-inflammatory cytokines, providing mechanistic rationale for its clinical efficacy and the justification for further investigations in S. Aureus sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, taking no medications, and not recently hospitalized

Exclusion Criteria:

* Infection (active)
Effects of Dietary Supplements on Sarcopenic Elders

Sarcopenia is defined as a syndrome characterized by decline of skeletal muscle mass and strength or an alteration in physical function. Although some studies showed nutritional supplementation alone might have health benefits for older sarcopenic patients, the results were inconsistent and remain controversial. The objective of this study was to evaluate if a sufficient protein diet including supplements with leucine-enriched whey protein and vitamin D can lead to better improvement than sufficient dietary protein alone in maintaining muscle mass and strength among sarcopenic elders.


Eligibility Criteria:
Inclusion Criteria:

* Older adults (≥ 65 years)
* Subject has lower appendicular muscle mass index (AMMI) (\<7 kg/m\^2 in men; \<5.7 kg/m\^2 in women) using Bioelectrical impedance analysis (BIA, TANITA BC-418®, Tokyo, Japan)
* Subject has lower handgrip strength (\<26 kg in men; \<18 kg in women) using dynamometer (CAMRY®, Zhongshan, Guangdong) or slowly gait speed (\<1 m/s)

Exclusion Criteria:

* Subject's life expectancy was shorter than 6 months
* Nursing home resident
* Subject has the history of kidney failure
* Subject has the history of liver failure
* Subject has the history of diabetes mellitus
* Subject has resistance exercise habit.
A Comparative Analysis of Preoperative Liver Volumetry in Living Donor Liver Transplantation

Accurate preoperative graft volume assessment is crucial for successful living donor liver transplantation (LDLT). Although manual and automated computed tomography (CT) volume measurement methods using various volumetric tools are widely used, their accuracy remains uncertain. This study aimed to determine the optimal dry weight correction factor for each method to enhance the prediction of actual graft weight (AGW) and compare the accuracy of different methods.

This study is a retrospective diagnostic accuracy study comparing three liver volumetry methods using preoperative donor CT scans in LDLT.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent hepatectomy for living donor liver transplantation performed by the Department of Surgery at Chungnam National University Hospital under the supervision of the principal investigator.

Exclusion Criteria:

* Patients deemed unsuitable for participation in this clinical study by the investigator.
FTIH to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses of GSK1322888 in Healthy Caucasian and Japanese Volunteers

This study is the First Time In Human study for the motilin receptor agonist, GSK1322888. GSK1322888 is a potent and selective small molecule motilin receptor agonist, distinct from the motilide compound structures. The aims of this study are to assess the safety, tolerance, and pharmacokinetics of single oral doses of GSK1322888 and to identify a well-tolerated and safe dose that will accelerate gastric emptying of a 13C stable isotope-labeled test meal in healthy volunteers.

The study will include assessment of ECGs, vital signs, safety laboratory sampling, adverse events, pharmacokinetics, and the 13C-Octanoic Acid Breath Test to measure gastric emptying.


Eligibility Criteria:
Inclusion Criteria:

* AST, ALT, alkaline phosphatase and bilirubin \< or =1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
* Healthy as determined by a responsible and experienced physician
* Male or female between 18 (20 for Japanese) and 65 years of age inclusive
* Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods
* Body weight \> or = 50 kg and BMI within the range 18.5 - 29.9 kg/m2 (inclusive).
* Capable of giving written informed consent
* Average QTc, QTcB or QTcF \< 430 msec.
* For Japanese subjects Japanese ancestry defined as being born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity papers and being able to speak Japanese.

Exclusion Criteria:

* Hepatitis B or Hepatitis C positive
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* A positive pre-study drug/alcohol screen.
* HIV positive
* History of regular alcohol consumption within 6 months of the study
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) prior to the first dose of study medication
* History of sensitivity to any of the study medications, or components thereof
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Pregnant females
* Unwillingness or inability to follow the procedures outlined in the protocol.
* Subject is mentally or legally incapacitated.
* Regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
* Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
* Subjects will be screened such that those subjects exhibiting rapid gastric emptying rates (t½b \< 75 min) will be excluded
Associations Between Pain Perceptions and Movement-evoked Pain.

The aim of this study is to investigate the associations between pain cognitions and movement-evoked pain in people with musculoskeletal pain complaints.

This study will investigate the associations between pain cognitions and movement-evoked pain in people with musculoskeletal pain complaints. This study will be carried out as a cross-sectional study. Participants will be recruited by means of flyers and social media.

Pain cognitions will be assessed using questionnaires (The Pain Catastrophizing Scale (PCS), The llness perception questionnaire-revised (IPQ-R), The Pain Vigilance and Awareness Questionnaire (PVAQ), The Tampa Scale for Kinesiophobia (TSK), The 36-item short form health survey (SF-36)), whilst movement-evoked pain will be assessed using a lifting task. Participants will need to rate the experienced pain immediately after completing the task. To estimate the extent to which pain cognitions explain movement-evoked pain, correlational analyses will first be conducted between all variables to determine what variables will be included in the hierarchical regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older,
* presence of musculoskeletal pain for more than three months,
* medically stable (no serious health conditions, no pending surgery or invasive medical procedure, no contraindication to physical activity).

Exclusion Criteria:

* Presence of co-existing pain conditions of other origins with chronic musculoskeletal pain not being the primary condition (i.e. predominant subject of symptom complaints)
* severe underlying comorbidity (like diagnosed diabetes, cardiovascular problems, etc.)
* pregnant or given birth in the preceding year.
Hydrocolloid Dressing for Catheter Exit Site Care in Peritoneal Dialysis Patients

The study aims to examine the use of hydrocolloid dressing for catheter exit-site care in peritoneal dialysis patients. It is a pilot study, and participants will be randomized to either receiving weekly hydrocolloid dressing or daily topical gentamicin cream for exit-site care in peritoneal dialysis patients.

Peritoneal dialysis (PD) related infection is one of the main reasons for patients to discontinue PD therapy. Routine exit-site care is crucial for the prevention of infections, however, daily antibiotics use has been associated with the risk of developing drug-resistant bacteria. Moreover, the burden of daily exit-site care can lead to non-compliance with treatment. Hydrocolloid dressing has been used in the management of acute and chronic wounds and is required to change once weekly, but its use has not been examined in the exit-site wound in PD patients.

The study primarily aims to examine PD-related infection (exit site infection or peritonitis rates) between patients using weekly hydrocolloid dressing (experimental group) and those using daily topical application of gentamicin (control group) for exit-site care in PD patients. Secondary aims include time to the first episode of PD-related infection, technique failure, PD infection-related hospitalization, and adverse events. The study will also assess the acceptability of dressing and quality of life between the two groups.

A total of 60 adult peritoneal dialysis patients will be recruited for the study. Patients will be randomly assigned to either the experimental group or the control group. Participants will be followed up at the 4th, 12th, and 24th week of study. The acceptability of the dressing will be assessed using the treatment acceptability questionnaires. The quality of life will be assessed using the ED 5D-5L questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* All adult peritoneal dialysis patients (≥ 21 years old) and are followed up at Singapore General Hospital (SGH)

Exclusion Criteria:

* Patients who are unable to provide valid consent, patients who have known allergy to hydrocolloid dressing, patients who have peritoneal dialysis catheter exit site infection or peritonitis within the past 3 months, patients who have dialysate leak at PD catheter exit site, pregnant women, patients with life-expectancy of \< 1 year or patients who are currently involved in another study for peritoneal dialysis catheter exit site care.
A Study of the Cost Effectiveness of Generalist Care Managers for Depression Treatment in Medicaid Recipients

This project will enable the investigators to conduct a randomized clinical trial to demonstrate the value of generalist care managers in the treatment of depression in Medicaid patients seen in primary health care practices. Depressed patients will be recruited at two primary care practices in Western North Carolina and randomly assigned to either generalist care management or usual care. Patients in each condition will be assessed at baseline and six months follow-up. Outcomes will include depressive symptoms, level of functioning, and cost-effectiveness measures.

Randomized trial among depressed Medicaid patients aged 18 years and older in 2 primary care practices in Western NC comparing an intervention with a GCM to usual care (UC) between July 2003 and February 2005. GCMs, already providing diabetes and asthma services, were further trained and given ongoing supervision to provide algorithm-based depression care to enhance guideline concordant treatment. GCMs provided elements of self-management, decision support, use of information systems, and core care management components.

Eligibility Criteria:
Inclusion Criteria:

* scoring 10 or greater on PHQ-9 and primary care physician verification of major depression by clinical exam; and
* willing to begin or continue antidepressant medication

Exclusion Criteria:

* bipolar disorder, psychotic symptoms, or active suicidal ideation requiring psychiatric admission (
Etiologic Mechanisms, Myocardial Changes and Prognosis of Patients With MINOCA

This prospective trial will include 150 patients with myocardial infarction with non-obstructive coronary arteries (MINOCA). A thorough clinical, laboratory and imaging evaluation will be performed by novel biomarkers and modern imaging techniques (heart magnetic resonance imaging and noninvasive testing). Moreover, two different treatment groups will be distinguished. Additionally, a retrospective analysis of patients meeting MINOCA criteria will be performed.

Primary goals The primary trial goal is to assess the etiologic mechanisms of myocardial damage in patients with MINOCA as well as to evaluate a variety of therapeutic strategies for these patients.

Secondary goals

1. To assess functional and morphological myocardial changes in patients with MINOCA;
2. To assess the true prevalence and prognostic relevance of MINOCA (all-cause mortality and MACE);
3. To test the effect of conventional acute MI therapies (BB, ACEI, ARB, CCB, statins, anti-platelet agents) on MACE (death and myocardial infarction) and all-cause mortality in patients with MINOCA;
4. To test the diagnostic and prognostic role of several biomarkers (sST2, BNP, cTnI, CRP, copeptin, procalcitonin, MR-proADM, galectin-3) in patients with MINOCA;
5. To assess the impact of MINOCA with respect to chronic health status, such as persistent angina symptoms, impairment in quality of life, and depression;
6. To evaluate systemic microcirculation status and assess its effect on long term outcomes.
7. To evaluate hospital mortality and all-cause death within 6 and 12 months follow-up;
8. To determine recurrent hospitalizations within 30-days, 6 and 12 months follow-up;
9. To assess peak creatine kinase, creatine kinase-MB and troponin levels during hospital stay;
10. To determine quality of life at 6 and 12 months assessed using the Euroqol 5D (EQ-5D) questionnaire (www.euroqol.org).

Eligibility Criteria:
Inclusion Criteria:

1. acute MI:

   * detection of a rise and/or fall of cardiac troponin(cTn) values with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:
   * symptoms of acute myocardial ischaemia;
   * new ischaemic ECG changes;
   * development of pathological Q waves;
   * imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology
2. non-obstructive coronary arteries on angiography:

   - the absence of obstructive coronary artery disease (CAD) on angiography, (i.e. no coronary artery stenosis ≥50%), in any potential infarct-related artery;

   This includes both patients with:
   * normal or near normal coronary arteries (no stenosis \>30%)
   * mild coronary atheromatosis (stenosis \>30% but \<50%).
3. angiography performed within 24 - 48 hours
4. age \>18 years
5. informed consent

Exclusion Criteria:

* acute kidney failure
* stage 4-5 chronic kidney disease
* contraindications for coronary angiography or CMR
* patients involved in another biomedical trial
* inability to make a decision to participate in the investigation