cyrilzakka/clinical-trials huggingface dataset:
Autoimmune Protocol Diet and Inflammatory Bowel Disease

There is limited data to guide the use of dietary change in the management of IBD, and it can prove challenging to implement in the setting of altered anatomy, comorbid conditions, and patient compliance. Therefore there is an important need to study diet as a therapy for IBD. Here, the investigators propose a novel study to evaluate the feasibility and efficacy of the autoimmune protocol (AIP) diet in patients with active Crohn's disease (CD) and ulcerative colitis (UC).

The investigators propose a novel study to evaluate the feasibility and efficacy of the autoimmune paleo (AIP) diet in patients with Crohn's disease (CD) and ulcerative colitis (UC).

Specific aims:

1. To evaluate the effect of the AIP diet on clinical and endoscopic disease activity for CD and UC,
2. To examine changes in inflammatory biomarkers during AIP diet
3. To characterize changes in RNA expression from intestinal mucosal biopsy specimens from prior to diet initiation to end of the study.
4. To characterize changes in fecal microbiome during diet intervention

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.
3. Established diagnosis of small bowel CD or colonic CD or ulcerative colitis
4. Confirmation of active CD or UC with recent (within 6 months of consent or prior to study start) objective evidence of endoscopically active disease on colonoscopy or computed tomography/magnetic resonance enterography or video capsule endoscopy
5. Any medications being currently used for IBD must remain stable during the study period with the exception of tapering of corticosteroids.
6. Current disease activity defined as a Harvey Bradshaw index ≥ 5 at baseline for CD or Partial Mayo Score ≥ 3 for UC
7. Established Facebook account
8. Comfortable with internet-based surveys and email

Exclusion Criteria:

1. If female, is pregnant or is breast feeding
2. Known celiac disease or subjects with a positive screen for celiac disease (elevated tissue transglutaminase antibodies)
3. Inability to provide informed consent or unwilling to participate
4. Evidence of untreated infection (e.g. Clostridium difficile)
5. Presence of stoma or J pouch
6. Bowel surgery within 12 weeks prior to enrollment and/or has surgery planned or deemed likely for inflammatory bowel disease during the study period
7. Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 4 weeks prior to study initiation
Treatment Of Bone Cyst With Bone Marrow Mesenchymal Cell Transplantation

There are two types of bone cysts, unicameral and aneurismal. These cysts happen to anyone, but they are most commonly seen in children and young adults while their bones are still growing. Living with a bone cyst and determining treatment options depend on the type of cyst.

Non-surgical treatments for unicameral bone cysts involves repeated X-rays in individuals who do not experience any symptoms.

Surgical removal of a unicameral bone cyst is needed if it becomes especially painful, or the area of the bone starts to thin out. The investigators aim to assess the clinical efficacy and side effects of mesenchymal stem cells seeded on bone matrix in repairing bone cyst.

Bone cysts are benign lesions usually discovered in children from age of 5 to 15 years. Treatment options include observation, corticosteroid injection and surgery. Sometimes the risk of surgery is comparable to the likelihood of fracture without treatment. In orthopedic surgery, bone chips , various types of ceramics, natural and synthetized bone mineral hydroxyapatite and tricalcium phosphate, as well as numerous polymers and co-polymers of alfa-hydroxy acids are used to perform as an osteoconductive and rarely osteoinductive factor to help bone formation.Some evidence demonstrated that bone marrow mesenchymal stem cells deposited on the surface of this constructs enhance its osteogenic differentiation. In this study the investigators seeds cultured bone marrow derived mesenchymal stem cells on bone matrix, to evaluate its therapeutic potential in repairing unicameral or aneurysmal bone cyst.This composite is placed in the bone cyst after its curettage during a surgery.Post-operation assessment is done by X-Ray examination and MRI at 1, 2, 6, and 12 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Bone cyst diagnosed with MRI, CT-scan, or X-Ray
* Intact cyst wall with high risk for fracture
* Cysts with minimum diameter of 6mm
* Diagnostic test performed on cyst fluid
* Provided written consent form

Exclusion Criteria:

* Patients with diagnosis of cancer
* Patients enrolled in other clinical trial
Dexamethasone Administered Via the Epidural Catheter as an Adjunct in Patients Undergoing Cesarean Delivery

This study will evaluate the ability of dexamethasone to enhance labor epidurals when administered as an adjunct to local anesthetics via an epidural catheter. Patients undergoing elective cesarean sections will be randomized into three groups, each receiving the same combined spinal epidural (CSE). At surgical closure, Group 1 will receive 10cc bupivacaine 0.0625%, Group 2 will receive 10cc bupivacaine 0.0625% +4mg dexamethasone, and Group 3 will receive 10cc bupivacaine 0.0625% + 8mg dexamethasone (4mg). VAS, sedation, nausea, and satisfaction scoring will be measured on patient follow-up to compare the outcomes of the different treatment groups.

This study will evaluate the ability of dexamethasone to enhance labor epidurals when administered as an adjunct to local anesthetics via an epidural catheter. Patients undergoing elective cesarean sections will be randomized into three groups using a random allocation table. Group assignment will be performed by opening a previously prepared numbered opaque envelope containing the assignment. Each group will receive the same combined spinal epidural (CSE) containing 10-12mg hyperbaric bupivacaine, 150mcg preservative-free morphine, and 15mcg fentanyl. At surgical closure, Group 1 will receive 10cc bupivacaine 0.0625%, Group 2 will receive 10cc bupivacaine 0.0625% +4mg dexamethasone, and Group 3 will receive 10cc bupivacaine 0.0625% + 8mg dexamethasone (4mg). In order to maintain this as a double-blinded study, the patient will not be told which medication was administered and the drug will be given by one anesthesiologist and the patient follow-up will be performed by a different anesthesiologist. VAS, sedation, nausea, and satisfaction scoring will be measured on patient follow-up to compare how these outcomes compare between the different treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Parturients in their 3rd trimester who are receiving a planned cesarean delivery
* Primiparous and multiparous pregnancies
* American Society of Anesthesia (ASA) classes 1, 2 , and 3

Exclusion Criteria:

* Patients for whom neuraxial anesthesia was either declined, unsuccessful, or contraindicated
* Gestational Diabetics
* Diabetics
* Patients allergic to dexamethasone, local anesthetics, or opioids
* Patients that are immunosuppressed
* Patient who received systemic steroids within the preceding 48 hours
Detection of Staph Colonization in Pre-op Arthroplasty Patients

This study will evaluate which body site(s) provide the best source of possible staph presence in participants undergoing total joint arthroplasty. If the pre-operative cultures indicate staph presence, an Infectious Disease specialist will be consulted for standard of medical care consultation and treatment management. Participants will be followed for 2 years post-implantation of prosthetic joint to monitor development of prosthetic joint infection.

The presence of Staph in/on a patient who will undergo total joint replacement is a risk in that the patient could go on to develop infection at the surgery site after surgery. The purpose of this study is to evaluate if it is beneficial to to administer a questionnaire and obtain cultures from various body sites from patients prior to surgery and also to determine which body site(s) provide the best source of possible staph presence. If the pre operative cultures indicate staph is present, an Infectious Disease specialist will be consulted for standard of medical care consultation and treatment management. All patients scheduled to have total joint arthroplasty are eligible to participate. The research team will follow the study patients for 2 years after they undergo prosthetic joint implantation to monitor for development of prosthetic joint infection.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients undergoing prosthetic joint implantation

Exclusion Criteria:

* None
Virtual Reality Cognitive Training for Older Adults With Mild Cognitive Impairment

This study aims to (1) develop and assess the feasibility of a fi-VRCT program based on IADL for older adults with MCI, (2) implement and evaluate the effectiveness of the fi-VRCT program based on IADL in older adults with MCI, and (3) investigate the potential mechanism of the fi-VRCT program based on IADL for older adults with MCI and refine this intervention accordingly.

As research on cognitive training methods for older adults with mild cognitive impairment (MCI) progresses, fully immersive virtual reality cognitive training (fi-VRCT) has emerged as a promising approach. While the benefits of fi-VRCT for enhancing cognitive function have been recognized, its potential to improve instrumental activities of daily living (IADL) and promote independence remains uncertain. This study addresses these questions by developing and validating a fi-VRCT program based on IADL to enhance cognitive and IADL performance among older adults with MCI.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 65 or above.
2. MoCA score between 18 and 25.
3. Capability to follow directions and do tasks.

Exclusion Criteria:

1. History of dementia.
2. Previous neurodegenerative illness diagnosis.
3. Severe medical or surgical problems.
4. Major psychological disorders.
5. Inability to use VR system
Support for the Rhabdomyolysis in an Emergency Department

Rhabdomyolysis is a common condition in the UAA. Support is heterogeneous, it is in most cases a mass hyperhydration. The idea is to initially with an EPP simultaneously screened for the most affected by this disease and aggravating factors population, associated comorbidities.

The rhabdomyolysis prognosis depends mainly on the etiology and associated comorbidities.

* Acute renal failure and hyperkalemia are the major complications that worsen the prognosis.
* In most cases, acute renal failure is reversible. Acute renal failure caused by renal vasoconstriction with ischemia, precipitation of myoglobin in the tubules and direct cytotoxic action of myoglobin.

If the prime mover of rhabdomyolysis is ischemia (or hypoxia) cell, we now know that the tissue damage is greatly aggravated during muscle reperfusion, creating ischemia-reperfusion. Reperfusion will not only cause the release into the bloodstream of the cell contents myocytes but also an increase in necrotic areas. Indeed, the massive arrival of oxygen at the myocyte will cause significant production of free radicals, increasing their toxic effects.

Predictive factors of acute renal failure is creatinine and urea. The urine alkalinisation by bicarbonates is questionable oral alkalizing seems to be an alternative when possible (oral alkaline solution) but not used to this day.

The track N-acetyl cysteine as an antioxidant that can possibly have an effect on release of the free radicals during reperfusion by decreasing their toxicity is still not considered clinically.

Main objective / secondary:

Evaluation of current professional practice:

I. Identify the most common etiologies encountered in our SAU. II. Identify the / types of people most affected by this disease III. Detect the most common complications of H0 support and evolution H48 if the patient not transferred IV. Evaluate the emergency treatment at the initial charge.

Methodology :

DESIGN:

It is a non-interventional retrospective single-center study, within the Department of Emergency GHPSJ, to an EPP and output the results regarding the type of population most affected by this disease with the most common etiologies in our support (what we are doing).

Time study:

Study on patient records being passed on to the emergency 12 months out with a diagnosis of rhabdomyolysis.

Eligibility Criteria:
Inclusion Criteria:

* All adults with CPK greater than 5N or 500 IU / L in sera to emergencies

Exclusion Criteria:

* No exclusion criteria
Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters

The Uroshield device is a commercially available device with two parts: a disposable actuator which attaches to the external portion of the catheter and a portable battery. The device sends out low-frequency ultrasound waves which run along the surfaces of the catheter. These acoustic waves prevent bacteria from adhering to the catheter and prevent the formation of biofilm. Our objective is to conduct a pilot study to determine if the UroShield device can reduce bacteriuria and catheter biofilm formation among neurogenic bladder patients with an indwelling catheter, as well as improve urinary quality of life and symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. \>18 years of age
2. Spinal cord injury (\>1 year), multiple sclerosis (\>1 year), spina bifida, parkinsons (\>1 year)
3. Indwelling catheter (urethral or suprapubic) for \>3 months, and used as primary bladder management mechanism
4. \>1 urinary tract infection in the last 12 months

Exclusion Criteria:

1. Intravesical botox in the last 6 months
2. Chronic antibiotic suppressive therapy
3. Active symptomatic UTI on day of randomization
4. Unable to understand written and spoken English
5. Prior/current utilization of the Uroshield device
The Role of Fatty Acids in Vaccine Efficacy

This study intends to use a randomized controlled trial design to vaccinate all participants against rabies and perform ARA interventions during vaccination to test the efficacy, safety, and intestinal flora of each group after immunization.

Rabies is an acute zoonotic infectious disease caused by central nervous system invasion by rabies virus. At present, there is still a lack of effective treatment, and once clinical symptoms appear, it is almost 100% fatal. Rabies vaccination within 24 hours of exposure may reduce the incidence of rabies. Pre-exposure prophylaxis is also effective, and the current recommended pre-exposure vaccination program in China is 0 days, 7th day, 21st days.

The health of the human body is inseparable from various nutrients. There are studies suggesting that arachidonic acid(ARA) has an immunomodulatory effect, but there is limited evidence for its effect on vaccines. Therefore, this study will explore the effects of nutritional supplements on the effectiveness of rabies vaccination.

Eligibility Criteria:
Inclusion Criteria:

* 1）18-45 years old;
* 2）BMI 18.5-24.9 kg/m2;
* 3）Have not received rabies vaccination.

Exclusion Criteria:

* 1) Those who have severe disorders of abnormal lipid metabolism;
* 2) Those who have used lipid-lowering drugs, weight loss drugs, and insulin drugs in the past three months;
* 3) Those who have received other vaccines in the past three months;
* 4) Those who have used probiotics or prebiotics in the past three months;
* 5) Those who have used steroids and immunosuppressants, other hormonal drugs in the past year;
* 6) Those with immunodeficiency diseases;
* 7) Those with a history of severe vaccine allergies;
* 8) Those who have disorders of liver and kidney metabolism;
* 9) Those who have had fever, cold, severe diarrhea and other diseases in the past month.
* 10) Smokers in the last year.
Heart Rate Changes During Normal Activity, Exercise, and Seizures in Subjects With Epilepsy

Characterization of the cardiac response (ECG) preceding an epileptic seizure.

Characterization of the cardiac response (ECG) to physiologic events and comparison to changes in heart rate that precede an epileptic seizure.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has a clinical diagnosis of epilepsy requiring additional evaluation in an epilepsy monitoring unit (EMU).
2. Patient likely requires an EMU evaluation for a period of at least 3 days.
3. In the opinion of the Principal Investigator, the Patient is likely to have 3 - 5 seizures during the EMU stay.
4. Patient is currently taking at least one antiepileptic medication.
5. Patients must be 18 years or older and may be of either sex and of any race.
6. Patient must be in good general health, fully ambulatory, and able to complete the physical aspects of testing requirements.
7. Patient must be willing and able to complete informed consent and HIPAA authorization.
8. Patient is diagnosed with epilepsy but may also experience pseudo seizures or psychogenic seizures.

Exclusion Criteria:

1. Patients with severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study.
2. Patients experiencing status epileptic within the last 6 months.
3. Patients with cardiovascular, respiratory, neuromuscular or gait disorders that in the investigator's judgment would cause unnecessary risk.
4. Patients prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response. Drugs with secondary cardiac or autonomic actions are allowed.
5. Patients with cardiovascular arrhythmias or cardiac disease that would preclude the ability to detect intrinsic changes in heart rate due to exercise, stress, or seizure. This would include but not be limited to chronic atrial fibrillation and permanent cardiac pacemaker implantation.
6. Patients currently dependent on alcohol or narcotic drugs as defined by DSM IV-R.
7. Patients with a history of only psychogenic seizures or pseudo seizures.
8. Women who are pregnant. Women of childbearing age must take a pregnancy test.
The Hemophilia Inhibitor Eradication Trial

This is a multi-center randomized phase III clinical trial, the Inhibitor Eradication Trial, in which Eloctate ITI plus Emicizumab will be compared with Eloctate ITI alone to eradicate inhibitors in severe hemophilia A.

This is a multi-center randomized phase III clinical trial, the Inhibitor Eradication Trial, in which Eloctate ITI plus Emicizumab will be compared with Eloctate ITI alone to eradicate inhibitors in patients with severe hemophilia A This adaptive design is necessary as randomized trials in rare diseases are often not possible. The INHIBIT Clinical Trials Platform includes two linked trials, the Inhibitor Prevention Trial (Prevention Trial) and the Inhibitor Eradication Trial (Eradication Trial) that will be conducted at up to 41 U.S. hemophilia treatment centers (HTCs) affiliated with universities. The Inhibitor Eradication Trial is a 48-week randomized phase III trial, in which 90 previously treated patients (PTPs) with severe hemophilia A and high-responding inhibitors (anti-VIII \> 0.6 B.U.), will be enrolled. Subjects will include individuals with severe hemophilia A who develop inhibitors during the linked Inhibitor Prevention Trial and adults or children at the same HTCs refractory to or never undergoing immune tolerance induction (ITI). Once enrolled, subjects who meet all the inclusion and none of the exclusion criteria, will be randomized to weekly Eloctate ITI plus weekly Emicizumab vs. weekly Eloctate ITI alone to eradicate inhibitor formation, defined as anti-FVIII\<0.6 B.U. Blood draws will be minimized to 6 timepoints, pre, 4, 12, 24, 36, and 48 weeks, and validated for small volumes, 3.8 cc (¾ tsp) each. The Inhibitor Eradication Trial is considered greater than minimal risk as study drug is given before the first bleed and special inhibitor studies are obtained. (NB: The Inhibitor Eradication Trial (PRO19070080) is linked to the Inhibitor Prevention Trial (PRO19040140), as part of the INHIBIT Clinical Trials Platform, and both trials will be conducted efficiently in the same hemophilia treatment centers (HTCs), with the same MDs, coordinators, visit frequency, blood sampling, and assays.

Eligibility Criteria:
Inclusion Criteria:

1. Male adults or children \> 4 months of age.
2. Severe hemophilia A (FVIII \< 0.01 U/ml).
3. Current or past high-responding inhibitor, anti-FVIII \>= 5.0 B.U., ITI-refractory or ITI-naive.

Exclusion Criteria:

1. Acquired hemophilia or any bleeding disorder other than hemophilia A.
2. Current use of Emicizumab, or if used, \> 8 weeks since last treatment.
3. Use of an experimental drug(s).
4. Surgery anticipated in the next 48 weeks.
5. Life expectancy less than 5 years.
6. Patient/parent/caretaker unable or unwilling to keep a personal diary of bleeding frequency and study drug treatment, make monthly visits and blood draws at weeks 4, 8, 12, 24, 36, and 48.
7. Other illness, condition, or reason in the opinion of the investigator that would make the patient unsuitable for the trial.
Nutrition, Diabetes and Pulmonary TB/HIV

We propose a randomised trial among pulmonary TB patients, examined and treated as part of the national TB control programme (WHO, 2003). The aim is to improve TB treatment outcome in high TB and HIV burden countries. The overall objective of the proposed trial is to assess the effect of nutritional support on TB treatment outcomes, and to assess the role of diabetes on risk and severity of TB, and TB treatment outcomes. The study will be conducted in Mwanza Tanzania. All patients will initially be examined for HIV and diabetes. A total of 500 found pulmonary TB smear-positive (PTB+) and HIV positive (HIV+) will be randomised to a daily supplement of 1 versus 6 energy-protein bars throughout treatment, both with full multi-micronutrient (MN) content. A total of 1500 found pulmonary TB smear-negative (PTB-, irrespective of HIV status) and PTB+ and HIV negative (HIV-) will be randomised to 1 daily energy-protein bar containing either low or high MN content.


Eligibility Criteria:
Inclusion Criteria:

* New sputum smear positive or negative pulmonary TB patients

Exclusion Criteria:

* pregnant, terminally ill, other serious diseases (except HIV and diabetes), non-residents