cyrilzakka/clinical-trials huggingface dataset:
LMCA Treatment Outcome

Left main coronary artery (LMCA) is a major branch of coronary artery and supplies a large bulk of myocardium.

Revascularization by either surgical coronary bypass grafting (CABG) or percutaneous coronary intervention (PCI) is recommended for significant unprotected LMCA disease, with CABG being preferred if there is significant involvement in other coronary arteries1,2. CABG has been demonstrated to confer survival benefit over medical therapies patients with LMCA in earlier clinical trials3,4,5. However, these trials were performed before the wide adoption of modern medical therapies such as antiplatelet and statin. Antiplatelet agents, for example, was only used in 32% of all patients in the Coronary Artery Surgery Study3. Modern day medical treatment for stable coronary artery diseases have been shown to be non-inferior to revascularization in both the COURAGE and ISCHEMIA trials6,7. However, patients with LMCA involvement were mostly excluded from both of these studies. In Hong Kong, the average waiting time for an elective CABG for stable patients with LMCA is around 18 months, during which time the patients are treated with modern medical therapies including high-intensity statin and antiplatelet.

Left main coronary artery (LMCA) is a major branch of coronary artery and supplies a large bulk of myocardium.

Revascularization by either surgical coronary bypass grafting (CABG) or percutaneous coronary intervention (PCI) is recommended for significant unprotected LMCA disease, with CABG being preferred if there is significant involvement in other coronary arteries1,2. CABG has been demonstrated to confer survival benefit over medical therapies patients with LMCA in earlier clinical trials3,4,5. However, these trials were performed before the wide adoption of modern medical therapies such as antiplatelet and statin. Antiplatelet agents, for example, was only used in 32% of all patients in the Coronary Artery Surgery Study3. Modern day medical treatment for stable coronary artery diseases have been shown to be non-inferior to revascularization in both the COURAGE and ISCHEMIA trials6,7. However, patients with LMCA involvement were mostly excluded from both of these studies. In Hong Kong, the average waiting time for an elective CABG for stable patients with LMCA is around 18 months, during which time the patients are treated with modern medical therapies including high-intensity statin and antiplatelet.

Eligibility Criteria:
Inclusion Criteria:

* Patients with significant LMCA disease who were on the waitlist for CABG since 1st January 2000 to 31st December 2020.
* The decision for CABG over PCI as a mode of revascularization for the patients on this waitlist were collectively made by the HEART team

Exclusion Criteria:

* patients with co-existing significant valvular heart disease requiring concomitant surgical intervention, and unstable patients in whom urgent surgical intervention was performed
Time-restricted Feeding to Reduce Inflammation in Fanconi Anemia

The main reason for this research study is to determine whether time-restricted eating will reduce inflammation in the bodies of persons with Fanconi anemia (FA) and whether time-restricted eating will improve function in people with FA and neurological changes. Participants will be asked to eat for only 8 hours out of 24 hours in a day.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of FA with neuroinflammation
* Age ≥ 12 years old

Exclusion Criteria:

* None
Environmental Exposure and Neurological Diseases Questionnaire

The proposed research is particularly relevant to the National ALS Registry and public environmental health issues because it addresses the potential environmental causes of sporadic ALS. The research will develop an ALS surveillance program in Ohio that can be compared with the national and State-Metro Surveillance Programs of the National ALS Registry, and novel methodologies to determine the role of the cyanobacterial toxin, BMAA (beta-methylamino-L-alanine), and other environmental toxins/toxicants as risk factors for ALS. This work will advance the mission of the Centers for Disease Control Agency for Toxic Substances and Disease Registry (CDC ATSDR) National ALS Registry by offering data on ALS cases in Ohio that address public health concerns over the effects of chronic exposure to cyanobacterial blooms in Lake Erie.


Eligibility Criteria:
Inclusion Criteria:

* ALS
* Non-neurodegenerative controls
* Can willingly give consent
* Over 18 years of age

Exclusion Criteria:

* Cannot give consent
* Under 18 years of age
Randomized Controlled Trial of Dietary Advice in Primary Care to Promote Healthy Feeding of Infants

A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.

A cluster randomized controlled trial. Twenty health care service sites were randomly assigned to the intervention or control groups. Health care workers of the intervention health care service sites received training based on the programme "Ten steps for healthy feeding for children from birth to two years old".

Pregnant women, in their third term, were enrolled in the study. At 6 and 12 months of age, the mothers were interviewed at home using a semi-structured questionnaire with pre-coded close- and open-ended questions and the children were evaluated.

Eligibility Criteria:
Inclusion Criteria:

- All pregnant women in the last quarter of the gestation.

Exclusion Criteria:

* HIV-positive mothers
* congenital malformation
Study of Thyroid Status in Patients With IBD

. The aim of the present study is to study thyroid state in patients with IBD

All patients were subjected to history taking and physical examination with emphasis on history of autoimmune disease, extraintestinal manifestations of IBD, neck examination for goiter, symptoms and signs of thyroid dysfunction.

b) Laboratory investigations: Thyroid function test (include T3-T4- TSH)

* ESR - CRP - thyroid antibodies: (Anti TPO -Anti Thyroglobulin)

  c)-Imaging:
* Neck U/S on thyroid gland to identify patients with ultrasonographic evidence of autoimmune thyroiditis (diffuse hypoechogenicity or heterogenicity echotexture or both) and to detect thyroid nodularity.

d ) Endoscopic findings regarding diagnosis of IBD confirmed by histopathological examination

Eligibility Criteria:
Inclusion Criteria: All patients with IBD

-

Exclusion Criteria:

* patients with
* Thyroid disease
* Acute or chronic kidney
* Acute or Chronic Liver Disease. Active Lupus -
* Malignancy
* patients taking medications that affect thyroid function as rifampin, amiodarone .....
Trial of Indole-3-Carbinol and Silibinin

This is a non-therapeutic, Phase 1 clinical trial to examine the safety, pharmacokinetic (PK) characteristics, and pharmacodynamics (PD) effect of indole-3-carbinol (I3C) and silibinin (Sil) in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years old
* Current smoker of ≥ 8 cigarettes per day for at least the last 6 months by self-report
* Adequate blood counts, and adequate liver and kidney function defined as follows:

  * Hemoglobin ≥ 9 g/dL for women, ≥ 10 g/dL for men
  * Platelet count ≥ 100 x 10\^9/L
  * Total bilirubin ≤ Institutional upper limit of normal (≤ 1.3 mg/dL for UMMC)
  * ALT ≤ 1.5 times institutional upper limit of normal
  * Creatinine ≤ 1.4 g/dL and estimated GFR ≥ 80 mL/min/1.7m2
* Able to understand the experimental nature of the study and provide informed written consent

Exclusion Criteria:

* Chronic proton pump inhibitor, H2-blocker (i.e., ranitidine, famotidine), and/or calcium carbonate use
* History of gastric bypass surgery, gastric banding, bowel resection, malabsorption syndromes such as celiac sprue or pancreatic insufficiency, or other conditions that may affect gastric or intestinal absorption of nutrients
* Current use of tobacco products other than cigarettes (i.e. snuff, snuz, smokeless tobacco, cigars, pipes), or use of these products within 3 months of study registration
* Major or chronic medical disease, including heart disease, poorly controlled diabetes, etc., to be adjudicated by the principal investigator
* Known active malignancy
* History of aerodigestive malignancies
* Women who are pregnant, intend to become pregnant within 3 months of study registration, or who are lactating. Women of childbearing potential must have a negative urine pregnancy test within 14 days of starting the assigned intervention
* Antibiotic use within 2 months of study registration by self-report
* History of respiratory tract cancer
* Known allergy to I3C, Sil, or its components
* Psychiatric and/or social situations that would potentially limit compliance with study requirements
Unraveling the Blood Microbiome in Postoperative Recurrence of Crohn's Disease

Crohn's disease, a chronic inflammation of the gastro-intestinal tract, is a disease with a complex pathogenetic background. Hereditary factors, environmental factors and the gut flora play a varying role in its onset, however, this role remains unclear to date. We hypothesize to detect tiny fragments of microbial DNA from the gut in the bloodstream, due to disruption in the natural defences of the gut lining. If this is true, it may hold the key to understanding why Crohn's disease recurs after surgery.

Our objective in this study is to test retrospectively, if we can detect any difference in microbial DNA from the blood of ileocolonic resection (ICR) patients that do and do not show recurrence at the time of follow-up endoscopy at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Crohn's Disease
* Adult ≥ 16 years
* Undergoing an ileocolonic resection or reresection
* Written informed consent

Exclusion Criteria:

* Use of antibiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.
* Use of probiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.
* Not willing to collect extra biosamples
Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis

Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic and aggressive polyarthritis. The prevalence of RA in China is about 0.42%. Arthroscopic synovectomy (AS) is an important method to save the function of joint in the treatment of refractory RA. The clinical trial is to study the value of AS combine with DMARDs in the early stage of refractory RA.


Eligibility Criteria:
Inclusion Criteria:

* The patients who fulfilled the 1987 ACR（American College of Rheumatology) or 2010 ACR/EULAR（European League Against Rheumatism） RA classification criteria.
* The age is more than 18 years old and less than 60 years old.
* They received stable traditional DMARDs (including Chrysopidae, leflunomide, sulfasalazine, hydroxychloroquine, eilamod) or biological dmrads (including tumor necrosis factor antagonists, IL(Interleukin)-6 receptor antagonists, CD20 monoclonal antibodies) for at least 6 months.
* The disease is still in the active stage, which means the disease activity score (DAS28) is more than 3.2, and the elbow joint function is obviously limited.
* The patient agreed to undergo arthroscopic synovectomy.
* No contraindications were found.

Exclusion Criteria:

* The disease is in remission.
* The patient has contraindications.
* Arthroscopic synovectomy was performed in different patients.
Prognostic Value for Predicting Outcome Using Functional Near-infrared Spectroscopy in Stroke Rehabilitation

To investigate the prognostic value of Functional Near-Infrared Spectroscopy (fNIRS) in stroke rehabilitation with serial measurements.

Serial measurements (immediately after being transferred to rehabilitation department \[T0\], at discharge from inpatient rehabilitation \[T1\], and follow up at one to three months from stroke onset \[T3\]) using Functional Near-Infrared Spectroscopy (fNIRS) was done in all participants. The primary outcome was the outcome prediction rate using fNIRS parameter and clinical parameters. Secondary outcomes were as follows: fNIRS activation pattern, Laterality Index, Functional Connectivity, Fugl-Meyer Score, Modified Barthel Index, , Brunnstrom Stage, Box and Block Test, Grip Strength (handgrip, pinch grip, lateral prehension, three-jaw chuck), Modified Ashworth Scale (wrist flexor and extensor spasticity, elbow flexor, and extensor spasticity, long finger flexor spasticity), modified Rankin Scale score, Functional Ambulation Category, Glasgow Coma Scale, Neglect Evaluation Battery, Korean Version Western Aphasia Battery, and Scale for the Assessment and Rating of Ataxia.

The changes in the fNIRS measurements and clinical parameters will be analyzed and also the correlation between the two will be analyzed to identify the prognostic value of fNIRS.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above.
* Diagnosed as stroke (infarction/hemorrhage) with imaging studies.
* Participants who have given consent after listening to the full explanations of this study.
* Able to understand the contents of this study and is able to sign to the written consent by his/herself.
* A legal representative has given written consent for those who meet the inclusion criteria but is unable to understand and agree by themselves due to impaired cognition, a legal representative.

Exclusion Criteria:

* Traumatic brain injury.
* Unable to perform simple commands (motor task during fNIRS scan) due to impaired cognition.
* Current symptoms are caused by diseases other than stroke (e.g., dementia, Parkinson's disease)
* Participants with any symptoms that may hinder the compliance or evaluation (e.g., delirium and agitation) process.
* Participants with any uncontrolled disorders.
Evaluation of Gallium-68-HBED-CC-PSMA Imaging in Prostate Cancer Patients

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy, patients with biochemical recurrence and patients with castrate resistant prostate cancer.

Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled HBED-CC PSMA in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the HBED-CC PSMA compound, so that this agent will become available for clinical imaging in prostate cancer patients.

This compound has been shown to be superior to choline based PET agents for the staging of prostate cancer, both Carbon-11 and Fluorine-18 compounds. But this compound was not patented and therefore no company or private entity will make the investment required to bring HBED-CC PSMA to market. In the vacuum of availability, academic groups must take the lead in order to collect the necessary data for future FDA approval.

This study focuses on three patients populations that are imaged. In the pre-prostatectomy population, the primary objective is to determine the sensitivity and specificity for detection on nodal metastasis. In the biochemical recurrence population, the primary objective is to determine the sensitivity of recurrence location. In the castrate resistant prostate cancer population the primary objective is to determine if PSMA PET detects more metastatic lesions than conventional imaging.

Eligibility Criteria:
Inclusion Criteria:

1. Known prostate cancer with a clinical concern for the presence of metastatic disease as delineated below:

   * Treatment naïve patients with one of the following risk factors: CAPRA (Cancer of the Prostate Risk Assessment) score ≥ 5, Prostate-specific antigen (PSA) ≥ 15 ng/mL and/or Gleason score ≥ 4+4.
   * Patients with biochemical recurrence after prostatectomy or radiation therapy with a PSA doubling time less than 12 months.

     i. These patients may have received androgen deprivation therapy prior to imaging.
   * Patients with castrate resistant prostate cancer with progressive disease as defined by Prostate Cancer Clinical Trials Working Group (PCWG2) criteria (27).

     i. Patients with castrate resistant prostate cancer can be either on treatment or off treatment
2. Age \> 18.
3. Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
4. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
2. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
3. Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
The Effect of Deep Neuromuscular Block on the Perioperative Stress Response Reduction and Postoperative Recovery Enhancement in Robot-assisted Stomach Cancer Surgery

Stress reactions caused by surgical stimuli can cause sympathetic nervous system activation and increased stress hormones, such as catecholamines, inflammatory cytokines, and pituitary hormones, and insulin resistance. In addition, increased catecholamine levels may exacerbate postoperative outcomes, especially delayed wound recovery, increased cardiovascular and respiratory complications, and immunosuppression. In particular, it is important to reduce the stress response for cancer patients during surgery because they are already immunocompromised status and more vulnerable to perioperative stressful situation. However, there are insufficient results on the benefits of deep neuromuscular block in these patients, although some have reported a reduction of postoperative pain and fewer complications in the deep neuromuscular block compared with moderate neuromuscular block. Therefore, the investigators aim to investigate the difference in the stress response of patients who received conventional moderate neuromuscular block or deep neuromuscular block in robot-assisted gastric cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

* 1. ASA Ⅰ - Ⅱ patients between 20 and 65 years undergoing robot-assisted gastric cancer surgery

Exclusion Criteria:

* 1. Patients with neuromuscular disease
* 2. Hypertensive patients with β-blockers
* 3. Diabetic patients receiving insulin therapy
* 4. Patients with severe heart (EF \<45%), kidney (GFR \<60), liver dysfunction (ALT / AST\> 100)
* 5. Patients with obesity (BMI ≥30)
* 6. Do not understand Korean language
* 7. For vulnerable subjects who are unable to obtain consent
Allograft Meniscal Arthroplasty for the Treatment of Basal Joint Arthritis of the Thumb

Hypothesis:

The use of knee meniscal allograft as a joint spacer and stabilizer is a viable option for the surgical treatment of basal joint arthritis of the thumb.

A variety of surgical procedures have been developed for the treatment of basal joint osteoarthritis of the thumb. Problems with persistent pain and poor function have been reported to some degree for each of these procedures. Using the concept of an implant acting as a spacer and stabilizer the investigators proposed and implemented a novel surgical technique using allograft knee meniscus as a biologic implant for the treatment of basal joint arthritis of the thumb.

Hypothesis:

The use of knee meniscal allograft as a joint spacer and stabilizer is a viable option for the surgical treatment of basal joint arthritis of the thumb.

Introduction:

A variety of surgical procedures have been developed for the treatment of basal joint osteoarthritis of the thumb. Problems with persistent pain and poor function have been reported to some degree for each of these procedures. Promising results were originally reported (2004) for the Artelon carpometacarpal (CMC) implant (Small Bone Innovations, Morrisville, PA) procedure which utilized the concept of a spacer and stabilizer of the CMC joint . Recent studies however, have demonstrated problems due to a foreign body reaction with the Artelon implant requiring revision surgery. Using the concept of an implant acting as a spacer and stabilizer we proposed and implemented the use of allograft knee meniscus as a biologic implant in the treatment of basal joint arthritis of the thumb

Methods:

A prospective study was performed on four thumbs using an allograft knee meniscus transplanted into the thumb CMC joint using the surgical technique described for that of the Artelon implant (Small Bone Innovations, Morrisville, PA). Data collected included: pain level, grip strength, tip, key and pinch strength, carpometacarpal, metacarpophalangeal, interphalangeal, and oppositional range of motion, as well as Disabilities of the Arm, Shoulder, and Hand (DASH) scores. Interval radiographic analysis is to be performed. Endpoints for data collection will be at three months, six months, one, two, three, four, and five years follow up.

Eligibility Criteria:
Inclusion Criteria:

* Stage I - III osteoarthritis / traumatic arthritis of the thumb.

Exclusion Criteria:

* Exclusion criteria were diabetes mellitus, kidney insufficiency, OA in the STT joint, or malignancy within the past 10 years.
The Robot-LVA Study: Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema

This study assesses the performance of robot-assisted microsurgery. Lymphaticovenous anastomosis (LVA) is the most difficult procedure in microsurgery at this moment. The LVA technique is applied to treat for example breast cancer-related lymphedema (BCRL). Therefore, this LVA procedure is compared using a manual expert and the same expert applying robot-assisted LVA.

Microsurgery facilitates procedures such as transplantation of tissue as well as lymphedema treatment. Currently, the plastic surgeon's hands are the limiting factor in microsurgical performance. Robot-assistence increases the movement in precision and might therefore be of great importance for the advancement of microsurgery in the world.

It is a prospective study in Maastricht University Medical Center assessing 60 patients undergoing either robot-assisted or manual lymphaticovenous anastomosis (LVA) tot treat breast cancer-related lymphedema (BCRL). The primary outcome parameter is LVA technique. Secondary outcome measures include duration of surgery, technical errors during \& complications peri-operatively, surgeon's satisfaction with the LVA procedure, teh patients' convenience during surgery, arm volume over time and patient's symptoms development over time.

Eligibility Criteria:
Inclusion Criteria:

* Female gender;
* Treated for primary early stage breast cancer;
* Early stage lymphedema of the arm (stage 1 or 2 on ISL classification);
* ELV \> 10%;
* Suffering from unilateral disease.

Exclusion Criteria:

* Male gender;
* Stage 3 lymphedema of the arm;
* Receiving current breast cancer treatment;
* Distant breast cancer metastases;
* Current substance abuse;
* History of marcaine or indocyanine green allergy;
* Non-viable lymphatic system as determined by near infrared imaging;
* Previous LVA (\<10 years) in the arm with lymphedema.