cyrilzakka/clinical-trials huggingface dataset:
Temporary Gastric Electrical Stimulation for Gastroparesis

This is a prospective study of temporary gastric mucosal electrical stimulation (tGES) in 30 patients with gastroparesis (GP). After a 7 day baseline assessment of symptoms, subjects will have an endoscopically-placed tGES lead implanted into the mucosa of the antrum. This lead is connected to a thin wire that runs up the esophagus and out the nostril, similar to a nasojejunal feeding tube, although much thinner. It is then attached to a programmable battery pack which provides the desired level of stimulation.

Patients will then be randomized to 7 days OFF or 7 days ON stimulation in a double-blind fashion. After 7 days, subjects will crossover to the other study arm (ie ON patients will be switched off; OFF patients will be switched on). Symptoms and QoL measures will be assessed at baseline, ON, and OFF periods. Serum ghrelin and other hormones, as well as EGG will be assayed after 6 days in each arm.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 or older
* Existing clinical diagnosis of gastroparesis for at least one year as judged by the study gastroenterologist based on past medical history, clinical symptoms
* Sufficiently symptomatic at time of proposed study (Minimum total baseline GCSI score of 1.5 or higher)
* Delayed gastric emptying (\>10% retention at 4 hours) on standard scintigraphic emptying study with patients off narcotics for at least 48 hours. Normal upper endoscopy (with the exception of small bezoars) since the onset of symptoms
* Medically fit to undergo endoscopy
* Able and willing to remain in Calgary for the duration of the study (baseline period excepted)
* Able to provide written informed consent

Exclusion Criteria:

* Clinical evidence (including physical exam and/or EKG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
* Current use of anticoagulants, ASA, NSAIDS, clopidogrel, etc. which cannot safely be stopped for up to 5 days prior to the procedure in the opinion of the investigators
* Bleeding diathesis
* Severe immunocompromise
* Physical, mental, or compliance issues which in the opinion of the investigators may prevent the patient from completing the study
* Pregnant or breastfeeding females
Anti-LPS Antibody Treatment for Pediatric NAFLD

The main objective of this pilot study is to evaluate whether 12 weeks of IMM-124E in children with nonalcoholic fatty liver disease (NAFLD) in combination with standard of care treatment will decrease inflammation in the liver as measured by alanine transaminase (ALT). Specifically, investigators will measure percent change in ALT from Week 0 to Week 12 in treatment compared to placebo.

This is a randomized, double blind, placebo controlled, three month treatment trial of children aged 6-19 years. Participants will be recruited from the Children's Healthcare of Atlanta pediatric liver clinical practice.The purpose of this study is to evaluate if a three month treatment with IMM-124E (a bovine colostrum enriched with anti-LPS antibodies) in combination with standard of care lifestyle advice is safe and leads to greater improvement in hepatic inflammation, insulin sensitivity, and blood lipids in children with nonalcoholic fatty liver disease (NAFLD) compared to placebo with standard of care treatment. Investigators also seek to define the mechanism of action in response to three months of treatment with IMM-124E.

Eligibility Criteria:
Inclusion Criteria:

* Nonalcoholic fatty liver disease (NAFLD) diagnosis confirmed by liver biopsy or MRI
* ALT ≥ 2 x ULN at screening (girls ≥ 46, boys ≥ 54)
* Written informed parent consent and child assent
* Willingness to take IMM-124E or placebo powder 3 x daily for 12 weeks
* At least 2 months of attempted lifestyle changes after diagnosis

Exclusion Criteria:

* Disease or condition deemed by physician to interfere with absorption, digestion, or mechanism of intervention of drug
* Diagnosis of diabetes and an HbA1c of \> 9%
* Change in supplement or anti-oxidant therapy within past 90 days (must be on a stable dose and willing to continue it throughout the trial or not on any vitamin or supplement, includes SAMe, vitamin E, betaine, Milk thistle etc)
* Use of probiotics or antibiotics in the past 30 days
* Use of anti-NAFLD medications (metformin, thiazolidinediones, UDCA) in the 30 days prior to randomization
* Acute illness within past 2 weeks prior to enrollment (defined as fever \> 100.4ºF)
* Planned pregnancy, nursing an infant, confirmed or suspected to be pregnant between screening and time of study enrollment
* Evidence of other chronic liver disease other than NAFLD (Hepatitis B and C, Alpha-1 antitrypsin, Wilson's disease)
* Intolerance to lactose or dairy-based products
* Unable to have blood drawn at study visits
* Unwillingness to provide and/or collect stool samples
* Current gastrointestinal (GI) bleeding or inflammatory bowel disease (irritable bowel disease (IBD), colitis)
* Current enrollment in another therapeutic clinical trial or receipt of an investigational study drug within 6 months prior to study enrollment
* Participants who are not able or willing to comply with the protocol or have any other condition that would impede compliance or hinder completion of the study, in the opinion of the investigator
Microbiome and Mycobiome Registry of Volunteers With and Without Autism Spectrum Disorder

Analyze, describe, and understand how the human gut microbiome (i.e. bacteriome and mycobiome) and Autism Spectrum Disorder (ASD) are related.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers \> 2 years of age
* Able to list all medical conditions and medications when applicable.
* Have already donated a stool sample to BIOHM™.

Exclusion Criteria:

* Volunteers \< 2 years of age
Rate of Prolonged Response After Stopping Thrombopoietin-receptor Agonists Treatment in ITP

Thrombopoietin-receptor agonists (Tpo-RAs) have profoundly changed the management of ITP. However, today, there are no international recommendations concerning the long-term use of these costly, potentially pro-thrombotic agents, and that could induce bone marrow fibrosis in case of prolonged treatment. Tpo-RAs have been thought to play only a supporting role in ITP management. But our center along with many other research centers, have reported unexpected cases of durable remission after Tpo-RAs discontinuation in adult chronic ITP. In these retrospective studies, more than 20 % of patients were able to achieve prolonged remission.

The purpose of this study is to demonstrate that a substantial proportion of ITP patients may achieve a prolonged response after Tpo-RA discontinuation.

The investigators developed, in this study, a standardized procedure to discontinue Eltrombopag and Romiplostim, wherein the dose will be slowly tapered to limit the risk of bleeding. In case of relapse after Tpo-RA discontinuation, the decision to start a new therapy will be based on the clinician's judgment.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years
2. Diagnosis of ITP according to the standard definition
3. Disease duration of more than 3 months at Tpo-RA initiation
4. Platelet count \> 100 x 109/L for more than 2 months on Tpo-RA Therapy, with at least 3 platelet counts \> 100 x 109/L
5. Blood count lasting for less than 7 days
6. Normal marrow aspirate for patients aged of 60 and over
7. Informed signed consent
8. Treatment with Tpo-RA for at least 3 months

Exclusion Criteria:

1) Anticoagulation or anti-platelet treatment 2) Recent treatment with corticosteroids ± intravenous immunoglobulins (less than 2 months) 3) Rituximab or splenectomy within the 2 months preceding the Tpo-RA initiation 4) Rituximab or splenectomy after Tpo-RA initiation/RA initiation 5) Previous failure of Tpo-RA discontinuation 6) Pregnant or breastfeeding women 7) No affiliation to a social security scheme or other social protection scheme 8) Inability or refusal to understand or refusal to sign the informed consent from study participation 9) Patient deprived of freedom or under legal protection (guardianship, curatorship) 10) Hypersensitivity to Romiplostin or to any of the excipients or to E. coli derived proteins

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FCI Effectiveness in NAFLD Stratification

The goal of this pilot study is exploring whether field-cycling imaging may be able to detect characteristics of liver disease in patients with different degree of non-alcoholic fatty liver disease (NAFLD) that could be important in reflecting disease progression.

Non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of diseases extending from simple steatosis to non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). Currently, there is a pressing unmet clinical need to develop an effective non-invasive method to differentiate between different types of NAFLD and to support the initiation and monitoring of treatments designed to slow or halt progression of the disease.

Field-cycling imaging (FCI) is an innovative imaging technology pioneered at the University of Aberdeen. It has the ability to image human tissues non-invasively over a wide range of magnetic field strengths, directly informing on multi-scale tissue structure from nanometres to micrometres. This is not possible with traditional MRI. The potential of FCI in imaging NAFLD is particularly promising, due to its high sensitivity in quantifying and distinguishing protein content from fat.

The purpose of this pilot study is exploring whether FCI may be able to detect characteristics of liver disease, in patients with different degree of steatohepatitis and NAFLD, that could be important in reflecting progression of steatosis to liver fibrosis and HCC thereby potentially offering new diagnostic information that cannot be readily obtained with currently available imaging techniques.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of NAFLD
* Participants must be aged 18 and above
* Participants who meet the safety criteria for undergoing an MRI scan
* Participants who are able to fit inside the scanner
* Participants must be able to give fully informed consent
* Participants must be mobile enough to be positioned onto the FCI scanner couch

Exclusion Criteria:

* MRI-incompatible conditions, as detected in the MRI safety screening sheet
* Participants under 18 years old
* Participants who are unable to communicate in English
* Participants who are unable to give fully informed consent
* Women who are pregnant
* Restrictions to mobility that would prevent the correct positioning in the scanner
* Participants who suffer from claustrophobia
Efficacy of Proprioceptive Neuromuscular Facilitation in Older Women With Gonarthrosis

To evaluate the effectiveness of the method Proprioceptive Neuromuscular Facilitation (PNF) as physical therapy approach to the reduction of pain and improvement in functional performance and quality of life in women with knee osteoarthritis.

Patients will be divided into two groups: group perform proprioceptive neuromuscular facilitation and other group submit performing resistance exercises.

Eligibility Criteria:
Inclusion Criteria:

* Women;
* Age between 50 and 80 years;
* Clinical diagnosis of Osteoarthritis of knees ;
* Patients with presence of at least 90 ° range of motion of knee flexion ;
* Do not practitioners of physical exercise and physical therapy during the period of participation in the survey

Exclusion Criteria:

* Diagnosis of other rheumatological and neurological diseases ;
* orthopedic surgery History in the lower limbs ;
* Individuals with muscle strength of the lower limbs \<3 ;
* Cognitive impairment or neurological disease that compromises the understanding and implementation of the Protocol (Mini Mental State Examination \<18 for the illiterate and \<24 for others);
* Body mass index ≥ 30.0 (obesity , according to the World Health Organization ) .
* Individuals classified as physical activity level "very active" by the IPAQ (International Physical Activity Questionnaire ) .
Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament Reconstruction

This study aims to study differences in clinical and functional outcomes at 2 years based on hamstring graft size after single bundle anatomic ACL reconstruction using either 4-strand or 5-strand hamstring grafts. We also propose to study the characteristics of hamstring graft in our subset of patients in Asian population context.

This will be a prospective, randomized interventional study conducted at the National University Hospital under University Orthopaedics and Hand surgery Cluster during the period of December 2015 to December 2018. Study participants: The study will include 80 patients with complete Anterior Cruciate Ligament (ACL) tear undergoing primary arthroscopic reconstruction with ipsilateral hamstring autograft after written informed consent to participate in the study.

The subjects will be divided into two groups A) 4-strand hamstring or B) 5-strand hamstring group by block randomization using an online randomization generator (http://www.graphpad.com/quickcalcs). All the subjects will undergo the procedure by otherwise identical technique performed by single surgeon. At 1 and 2 years functional and subjective outcomes will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years
2. Clinical and MRI confirmed complete ACL tear
3. Ipsilateral hamstring autograft
4. Concomitant meniscus injury requiring either meniscus repair or partial menisectomy
5. Concomitant chondral injury Grade 0,1,2 (International Cartilage Repair Society)
6. Regular scheduled follow up with adherence to prescribed rehab protocol

Exclusion Criteria:

1. Non consent
2. Paediatric patient; age less than 18 years
3. Partial or incomplete ACL tear
4. Revision ACL surgery
5. Hamstring allograft
6. Multi-ligament injury of the knee (ACL and/or Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament, Postero Lateral Corner)
7. Past history of knee surgery
8. Contra-lateral ACL injury or other ligament injury
9. Chondral injury Grade 3,4 (International Cartilage Repair Society)
10. Intra-articular fracture (past or current)
11. Radiologically evident osteoarthritis changes
Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction

The size of a heart attack will be decreased by the use of timed balloon inflations to open the blocked blood vessel.

The intervention of "post conditioning" at the time of reperfusion, in patients with acute myocardial infarction (AMI), will attenuate the degree of ischemia-reperfusion injury, as manifested by infarct size. This intervention is hypothesized to be safe in humans.

Eligibility Criteria:
Inclusion Criteria:

* STEMI
* Onset of symptoms within 6 hours
* TIMI 0 to TIMI 1 flow in infarct related artery

Exclusion Criteria:

* collaterals to infarct related artery
* previous infarct in related territory
* thrombolytics
* cardiogenic shock
* TIMI 2 to TIMI 3 flow
Serratus Anterior Plane Block and Costotransverse Block for Analgesia Following Modified Radical Mastectomy Surgeries

Adequate pain management following modified radical mastectomy (MRM) is crucial for early ambulation and patient satisfaction. Breast cancer is the most common malignancy in females, with an increasing incidence in recent years. Surgery is one of the mainstays of therapy for breast cancer, and modified radical mastectomy (MRM) is the most effective and common type of invasive surgical treatment. Post-mastectomy pain syndrome (PMPS) is a surgical complication of breast surgery characterized by chronic neuropathic pain. The aim of this study is to investigate the efficacy and safety of single injection CTB versus SAPB on post-operative acute pain as a part of a multimodal analgesia plan in patients undergoing MRM.

Patients will be divided randomly by the computer into three groups, group (A): will receive serratus anterior plane block, group (B): will receive costotransverse block and group(C): patient controlled analgesia group (PCA).

Group (A) (SAPB):

SAPB will be performed using an ultrasound machine with a high-frequency linear probe . All patients will be in lateral position to perform the block. At the level of the fourth rib with 45-degree angle, targeting the plane between the latissimus dorsi and serratus muscles, SAPB block will be performed unilaterally on the ipsilateral side of surgery.

Group (B) (CTB):

CTB will be performed using an ultrasound machine with a high-frequency linear probe. All patients will be in lateral position to perform the block. CTB block will be performed unilaterally on the ipsilateral side of surgery at the level of fourth rib.

Group (C) (patient controlled analgesia):

After successful extubation, patients will be transferred to PACU. Patients will receive a bolus dose of 5 mg nalbuphine then PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr with self-administration bolus of 0.5ml with 15 min lock-out time.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anaesthesiologists (ASA) Physical Status Class I, II.
2. Scheduled for modified radical mastectomy (MRM).
3. Body weight ranging from 60 to 100 kilograms.

Exclusion Criteria:

1. Declining to give a written informed consent.
2. History of allergy to the medications used in the study.
3. Contraindications to regional anesthesia (including patient: refusal, coagulopathy, and local infection).
4. Psychiatric disorders.
5. Significant cognitive dysfunction.
6. American Society of Anesthesiologists (ASA) Physical Status Class III and IV.
7. Daily use of opioids.
8. Obesity (BMI \> 35 kg/m2).
Improved Cognitive Outcomes Associated With Feihe HMO With DHA/ARA in Infant Formula

The goal of this interventional clinical trial is to test the effectiveness of improving cognitive development in newly born infants fed with Feihe investigational formula product containing HMO, and DHA/ARA. The main question it aims to answer is:

- whether the score of Bayley-III cognitive scale (tested at the age of 12 months) of participants in the study product arm is significantly better than participants assigned in the other two arms.

240 qualified participants will be randomized to 3 arms (investigational formula, control formula, and breast-feeding) to consume assigned formula or breast-feeding for 12 months according to protocol. There will be up to 6 site visits arranged for each participant during the study, and all relevant clinical and questionnaire data, including the most important Barley-III cognitive scale data at the age of 12 months, will be captured, recorded and entered to CMTS (Clinical Management Trial System) for statistical analysis and reporting.

Researchers will compare the three arms to validate the assumption that the consumption of Feihe investigational formula product containing HMO, and DHA/ARA will improve cognitive development in newly born infants, along with physical development.


Eligibility Criteria:
Inclusion Criteria:

* Newborn baby, study entry before weaning (within 28 days of birth)
* Exclusively formula for at least 3 days fed prior to onset of study period.
* Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age).
* Birth weight of 2500g (5 lbs. 8 oz.) or more.
* Signed informed consent obtained for infant's participation in the study.
* Parent or guardian of the infant agrees to not enroll the infant in another interventional clinical research study while participating in this study.

Exclusion Criteria:

* History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant.
* Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion).
* Evidence of growth problems or concern for growth.
* Infant was born large for gestational age (LGA) (defined as birth weight-for-age exceeding 90th percentile as plotted on the growth chart provided by Feihe) from mother who was diabetic at childbirth.
* Participant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury.
* Use of probiotics/prebiotics before and during the study.
Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer

The purpose of this study is to explore the clinical outcomes of laparoscopic D1 lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）

Gastrectomy with D2 lymphadenectomy is considered the gold standard treatment for advanced gastric cancer. However, some studies show that age or comorbidities is the relevant predictor of postoperative complications, conditioning the safety of the surgical procedure itself, thus affect the survial. Even with the advances in surgical techniques and care, age still is a significant risk for postoperative morbidity and mortality. Therefore, elderly patients with gastric cancer could receive minimally invasive surgery with reduced nodal dissection, i.e., D1 lymphadenectomy, in order to prevent postoperative complications. Laparoscopic surgery is a minimally invasive operation and is proved to be an acceptable alternative to open surgery. At present, there is no RCTs to confirm the safety and effectiveness of laparoscopic D1 lymphadenectomy for elderly patients with advanced gastric adenocarcinoma. This study is to compare the clinical outcomes of laparoscopic D1 versus D2 lymphadenectomy for elderly patients with advanced gastric adenocarcinoma（cT2-4a, N-/+, M0）to evaluate the safety of laparoscopic D1 lymphadenectomy, and to verify its results in terms of survival in elderly patients with advanced gastric adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. Age over or equal to 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy, including gastric multiple primary carcinoma
3. cT2-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
4. expected to perform distal, total or proximal gastrectomy to obtain R0 resection sugicall results.
5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
6. ASA (American Society of Anesthesiology) class I to III
7. Written informed consent

Exclusion Criteria:

1. Severe mental disorder
2. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
3. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
4. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
5. History of other malignant disease within the past 5 years
6. History of previous neoadjuvant chemotherapy or radiotherapy
7. History of unstable angina or myocardial infarction within the past 6 months
8. History of cerebrovascular accident within the past 6 months
9. History of continuous systematic administration of corticosteroids within 1 month
10. Requirement of simultaneous surgery for other disease
11. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
12. FEV1\<50% of the predicted values