cyrilzakka/clinical-trials huggingface dataset:
Fasting-mimicking Diet in Treatment of Depressive Symptoms in IBD

Inflammatory bowel disease (IBD) is a chronic illness characterized by inflammation of the intestine. Many individuals with IBD suffer from depressive symptoms and anxiety which can lead to a decreased quality of life, poor treatment compliance, and higher morbidity and mortality. The object of this clinical trial is to investigate the effects of a fasting mimicking diet in IBD patients who are suffering with symptoms of depression. Participants will carry out 3 cycles of a 5-day period of a plant-based low caloric diet or a plant-based caloric sufficient diet following by 3 weeks of eating normally. Effects of the dietary intervention on microbes in the gut, immune and metabolic function, and depressive symptoms will be measured. The overall goal is to develop a safe and effective treatment to improve mental health in patients with IBD by targeting the gut microbiome through dietary interventions.

The primary objective of this proof of principle study is to investigate the effects of a fasting mimicking diet on depressive symptoms in patients with inflammatory bowel disease.

The specific aims of this project include:

1. Determine whether a fasting-mimicking diet is effective in ameliorating depressive symptoms in patients with Crohn's disease or ulcerative colitis
2. Determine if beneficial effects seen during the interventional period are sustained following cessation of fasting
3. Examine effects of the intervention on the gut microbiome and metabolome

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 65 years at the time of screening
* Diagnosis of Crohn's disease in clinical remission or with mild-moderate disease with Harvey Bradshaw Index (HBI\<8) or diagnosis of ulcerative colitis in clinical remission with partial Mayo (pMayo\<7)
* Suffering from mild-moderate depression with PHQ-9 ≥5 and ≤ 19

Exclusion Criteria:

* Subjects who are reliant on partial or total parenteral nutrition
* Subjects with prior gastrointestinal surgery and consequences such as short bowel syndrome, ostomy of small or large intestine, total colectomy, proctocolectomy, or ileoanal pouch
* Subjects with diabetes or celiac disease
* Subjects with a body mass index (BMI) lower than 18
* Subjects suffering from malnutrition or at high risk of malnutrition assessed by a score of ≥6 on the abridged patient generated subjective global assessment (PGSGA)
* Subjects allergic to nuts
* Subjects currently on a fasting/intermittent type caloric restricted diet
* History of psychotic or bipolar disorders or experiencing suicidal thoughts
* Pregnant women, women who are breast feeding, or women planning on becoming pregnant
* Subjects with immune-compromised condition other than inflammatory bowel disease (e.g. AIDS, lymphoma)
* Subjects with severe uncontrolled cardiovascular or respiratory disease or active malignancy
* Unable to read English or provide informed consent
Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.

Exclusion Criteria:

* Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.
Dairy Choline Bioavailability

The goal of this clinical trial is to find out if dairy is a good source of choline compared to eggs. The main questions it aims to answer are:

* How the body uses choline; and,
* What effect WPPC has on choline metabolism.

Researchers will compare Whey Protein Phospholipid Concentrate (WPPC) to whole egg powder to see if WPPC is as effective as eggs.

Participants will drink a chocolate-flavored drink mixed with either WPPC or whole egg powder.

This study is intended to evaluate the bioavailability and metabolism of choline in WPPC compared to the most commonly -used food for bioavailable choline, whole egg. The intent of the evaluation is to improve the knowledge of how WPPC contributes to the nutritional needs and health of postmenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 51 and 70
* Is currently post-menopausal (Post-menopausal is a term used to describe the time in a woman's life after she has gone through menopause. This usually happens between the ages of 45 and 55. Menopause is when a woman's menstrual periods stop permanently (at least 12 months))
* Not allergic to the intervention foods and allergens that are related to the production of intervention foods (e.g. dairy products, egg, fish, peanut, shellfish, soy, tree nuts, wheat, crustaceans, gluten, mollusks, mustard, sesame seeds.)
* Had stable body weight (± 5%) for the past 6 months
* Free from cancer
* Did not have weight loss surgery, colon surgery
* Do not have chronic kidney diseases
* Do not have malabsorption towards fat and dairy products
* Willing to complete health surveys
* Willing to complete two 4-day food records
* Willing to consume the chocolate-flavored intervention beverages
* Willing to provide blood, urine, fecal samples at baseline and after 10 days of intervention

Exclusion Criteria:

* On weight loss/weight gain diets
* Diagnosed with fat malabsorption
* Undergoing weight loss surgery
* Diagnosed with chronic kidney diseases
* Allergic to the intervention foods and allergens that are related to the production of intervention foods (e.g. dairy products, egg, fish, peanut, shellfish, soy, tree nuts, wheat, crustaceans, gluten, mollusks, mustard, sesame seeds.)
* Regularly using antibiotics or probiotics or prebiotics
* Regularly using Orlistat or Cetilistat
* Regularly using laxatives
* Undergoing hormone replacement therapy, or receiving hormones in any forms
* Unable to avoid strenuous exercise during the study (\>4 h intense exercise per day)
Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF

The primary objective of this study is to compare the Apnea- Hypopnea Index in HF patients with concomitant CSA, after 12 weeks of CRT alone to CRT in combination with one night of overdrive pacing. Secondary objectives are to evaluate the effects of a single night of overdrive pacing applied after 12 weeks of CRT vs. CRT alone on breathing events, sleeping events, and neurohormonal markers. An additional secondary objective of the study is to compare the efficacy of CRT in HF patients with concomitant CSA to HF patients without concomitant CSA.

Sleep apnea is a common and often undiagnosed disorder associated with substantial cardiovascular morbidity and mortality. In recent years studies have been published presenting the relationship between heart failure (HF) and central sleep apnea (CSA). CSA associated with Cheyne-Stokes respiration is a form of periodic breathing in which central apneas and hypopnea alternate with periods of hyperventilation, characterized by a regular crescendo-decrescendo oscillation of tidal volume, which is thought to be caused by dysfunction of central respiratory control. Unlike, obstructive sleep apnea (OSA), CSA likely arises as a consequence of HF.Since 2002, several results have reported on the benefit of atrial overdrive (AOP) pacing in patients suffering from sleep apnea. These results could not be confirmed for obstructive sleep apnea in several subsequent studies. Cardiac resynchronization therapy (CRT) has been proposed as another potential therapeutic pacing approach for CSA by two recently published investigations.The combined therapeutic impact of AOP and CRT (CRT+AOP) so far has not been investigated.We aimed to evaluate the effect of CRT alone and CRT+AOP on CSA in patients with CHF.

Eligibility Criteria:
Inclusion Criteria:

* Patients with documented clinical history of symptomatic but stable congestive heart failure, NYHA III or NYHA IV, of at least six weeks duration.
* Patient has an indication for a CRT device, or patients with previous pacemaker indication, except Sick Sinus Syndrome, and currently in need for an upgrade to a CRT device
* Patient is scheduled for the implantation of a CRT device
* Patient is over 18 years of age
* Patient provides Informed Consent

Exclusion Criteria:

* Inability to complete overnight sleep study as specified by the protocol
* Myocardial infarction or coronary revascularization procedure within 2 calendar months prior to enrollment
* Planned or strong likelihood of cardiac surgery within 4 months following enrollment
* A spirometric confirmation of obstructive lung disease
* Evidence of obstructive sleep apnea at baseline polysomnography
* Body mass index \>30 kg/m²
* Pregnant women
Bipolar Disorder in Late Life

The purpose of this study is to look at certain structural changes in the brain in people with bipolar disorder or those with a history of Bipolar disorder.

Individuals with bipolar disorder or those with a history of bipolar disorder may have certain structural changes in their brain. The purpose of this study is to look at those changes, as well as the assessment of risk factors for bipolar disorders, involving both social and psychological aspects of behavior, age, education, marital relations, nutrition, physical activity, etc., compared with persons not having bipolar disorder. These changes in the brain will be measured by Magnetic Resonance Imaging (MRI).

Eligibility Criteria:
Inclusion Criteria:

1. DSM-IV diagnosis of bipolar Disorder, Manic and mixed episodes.
2. 18 years of age and older, male or female, any race.
3. Capacity to give informed consent and follow study procedures.

Exclusion Criteria:

1. History of alcohol/drug dependence
2. Any metal or pacemaker in the body which precludes MRI
3. Pregnancy
4. Dementia or other primary psychiatric disorders including substance abuse/dependence, anxiety disorders, schizophrenia
5. For controls, numbers one through four above as well as any history of depression or the use of antidepressants
Visual Perception Exploration Using Eye-tracking Technology in a Cannot Intubate/Cannot Oxygenate Simulation

Using eye-tracking technology, the aim of this observational study is to compare the visual interests between attending physicians and residents watching a Cannot Intubate/Cannot Oxygenate (CICO) scripted and simulated scenario

Attending physicians and residents, from the department of Anesthesiology at the Université de Montréal were recruited on a voluntary basis. A 13-minute video based on a suggested CICO algorithm from the Difficult Airway Society to manage unanticipated difficult intubation in adults (3) was produced at the University of Montreal Simulation Centre using high-fidelity settings. The scenario was about a patient, with a cervical collar, in the post-anesthesia care unit. Throughout the video, the patient presents increasing respiratory distress worsening to respiratory failure. The anesthesiologist fails to ventilate, intubate and insert a laryngeal mask leading to a cricothyroidotomy. All participants were looking at a screen on which the scenario was broadcast. The screen was equipped with TobiiEyeX®, an eye-tracking system that automatically aggregates gaze data.

Eligibility Criteria:
Inclusion Criteria:

* Residents and attending physicians from University of Montreal Anesthesia Department

Exclusion Criteria:

* None
Aquatic and Land Exercises for Chronic Low Back Pain

This study aims to learn about the effects of aquatic and land exercises on managing chronic low back pain in adults aged 18-65. The participants engage in a 12-week supervised land and water-based exercise program.

The main questions this study aims to answer are:

* How effective are aquatic exercises on low back pain, functional disability, Kinesiophobia, sleep quality, and overall quality of life?
* Is aquatic therapy more effective than land exercises for treating LBP or vice versa?


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65
* Both Genders
* Literate in the English language to understand instructions/ to complete a self-report questionnaire.
* Having non-specific Chronic low back pain (≥12 weeks)
* Patient willingness to be a part of any randomly selected treatment groups.

Exclusion Criteria:

* Pregnant Females
* If they had low back pain as the result of diagnosis of severe osteoporosis, spinal bone disorders such as spondylosis and spondylolisthesis, fractures, lumbar spine stenosis, lower limb joint replacement surgery, hip orthosis, ankylosing spondylitis, rheumatoid arthritis, infective or inflammatory disease, compression of the radial nerve, meningitis, arthrosis, lumbar region tumours, Leg length discrepancy, previous back surgery.
* Uncontrolled hypertension, Severe postural hypotension, any heart disease like Left heart failure or exercise-induced angina. Medical illnesses without a medical managing plan in place, e.g., uncontrolled epilepsy, diabetes mellitus. Neurologic deficit, open wounds, current or recurrent radiation treatment.
* Patients with severe depression and psychosis
* People who are already participating in an individually-prescribed exercise programme for LBP.

Aquatic exercises /Pool specific:

* Individuals with hydrophobia/ water-related anxiety, or inability to adapt to an aquatic environment.
* Allergy to chlorine, Severe limiting airway disease
* Faecal or urinary incontinence, diarrhoea, and vomiting.
* Weight more than the emergency evacuation manual handling risk assessment.
Pilot 99mTechnetium-MIBI Single Photon Emission Computed Tomography - Computed Tomography (SPECT-CT) in Papillary Carcinoma (CA) Thyroid

The purpose of this trial is to see if the 99mTechnetium-MIBI SPECT-CT can be a tool for preoperative evaluation of cervical node metastasis in papillary thyroid cancer.


Eligibility Criteria:
Inclusion Criteria:

* papillary thyroid cancer

Exclusion Criteria:

* pregnancy
* Bleeding abnormality
* Prior history of head and neck cancer
* can not perform 99mTechnetium-MIBI SPECT-CT
* can not perform 131I remnant Ablation
* Prior any head and neck surgery within 3 months
* Prior deep neck infection within 3 months
Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease

Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease with meibomian gland dysfunction.

Methods: We enrolled 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months.OSDI score, TBUT, Schirmer I, tCFS, MGD score, and psychological status to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>=18 and Age \<=75.
2. Clinical diagnosis of dry eye disease.

Exclusion Criteria:

1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
2. History of phthalmology surgery.
3. Pregnant or lactating women.
Barriers and Facilitators in Access to OT/PT in Pediatric Cancer Survivors

This study aims to identify the modifiable facilitators and barriers to occupational and physical therapy care for children during and after cancer treatment that may be contributing to disparities in health outcomes. The investigators will identify these facilitators and barriers by surveying and interviewing healthcare administrators at MD Anderson Cancer center. The investigators will also survey and interview physicians, advanced practice providers, and occupational and physical therapists to obtain their feedback on these issues.


Eligibility Criteria:
Aim 1 Inclusion Criteria:

* Employed as an administrator at MD Anderson Cancer Center and the sister institutions and working in the areas of pediatrics, survivorship, cancer control, health policy, and rehabilitation services.

Aim 2 Inclusion Criteria:

* Employed as a referring provider (e.g., oncologist, surgeon, advanced care practitioner), or an OT/PT therapist at MD Anderson Cancer Center and the sister institutions.

Exclusion Criteria:

* Inability to provide informed consent
Cardiovascular Disease in Patients With Diabetes: The Silesia Diabetes-Heart Project

The project is an observational one which undertakes different, easy to obtain in everyday clinical practice, demographical, laboratory and clinical parameters of patients with diabetes in Silesian Region in Poland to predict cardiovascular disease, cardiovascular events and neuropathy using machine learning approach.

The study is a prospective, observational one in which it is planned to obtain demographical, laboratory and clinical parameters of patients who are hospitalized in one the the main diabetology sites in Silesia region in Poland and to follow them prospectively for 10 years in order to collect information related to new cardiovascular events. Telephone contact will be performed every 12 months following hospital discharge. Any procedures related to the patients hospitalized in the diabetology ward will be the routine ones and the bioethics committee of Medical University of Silesia gave the permission for the study but waved the necessity of informed consent to be signed.Moreover there will be subgroup analysis of patients recruited from the outpatient diabetology clinics in Silesia region in order to participate in the observational study collecting data related to to vitamin D concentration, densitometry, fibroscan, carotid ultrasound examination, vascular stiffness, electrocardiography, peripheral and cardiovascular autonomic neuropathy and fundus imaging. Patients who are treated in outpatient diabetology clinics in Silesia region and are included into the study must have the informed consent signed and bioethics committee agreement has been obtained.

Machine learning approach will be implemented to discover the association between easy to obtain in everyday practice parameters, namely clinical, biochemical, and demographical ones to identify patients at the highest risk of cardiovascular disease.

The secondary aim of the study is to utilize fundus imaging, electrocardiography, alongside demographic and clinical data in order to potentially diagnose neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* For the group of hospitalized patients: diabetes type 1 or type 2
* For the subgroup of patients treated in outpatient diabetology clinics in Silesia region: diabetes type 1 or type 2

Exclusion Criteria:

1. For the group of hospitalized patients:

   * Types of diabetes other than type 1 and type 2 diabetes
   * Death during hospital stay
   * Terminal stage of cancer.
2. For the subgroup of patients recruited form outpatient diabetology clinics:

   * Lack of an informed consent
   * Types of diabetes other than type 1 and type 2 diabetes
   * Malignant neoplasms
   * Terminal stage of neoplasm
   * End-stage renal disease
   * Malabsorption syndrome
   * Active infection
   * Primary hyperparathyroidism
ALateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer

Researchers have developed a new test to measure a protein QSOX1 that is found to be elevated in subjects with pancreas cancer. Researchers are looking to use this test to compare subjects with pancreas cancer and subjects without pancreas cancer to see if this test could be used to diagnosis pancreas cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with biopsy-proven adenocarcinoma prior to receiving any therapy such as surgery, radiation or chemotherapy.
* Patients without pancreas cancer.
* Adult patients with benign pancreas disorders such as pancreatitis with imaging within 12 months (CT, MRI, EUS) documenting no cancer.
* Healthy adults with blood specimens in an existing biobank.
* Patients with pancreatic cystic lesions.
* Adult patients undergoing clinically indicated EUS-guided FNA biopsy of pancreatic cystic lesions.

Exclusion Criteria:

* Prior treatment for pancreas cancer.
* Unable or unwilling to give consent.
Long Term Follow-up Study for Subjects Administered CLBR001

The goal of this Long Term Follow-Up observational study is to monitor subjects who have received CLBR001, a lentiviral vector based chimeric antigen receptor, for delayed adverse events that may be associated with human gene therapies.

Participants will be followed for 15 years post-gene therapy administration date for safety and efficacy.

In line with FDA guidance on Long Term Follow-Up (LTFU) after administration of human gene therapy products, any subject who receives CLBR001 on any Calibr treatment study will participate in LTFU on this study. Subjects will be enrolled following completion on the applicable treatment study and followed for 15 years post-CLBR001 administration in order to assess the long term safety of CLBR001.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who received at least one CLBR001 cell dose.

Exclusion Criteria:

* None
Treatment of Age-Related Macular Degeneration With Anecortave Acetate

The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control classic neovascularization following failure of treatment with photodynamic therapy using Visudyne.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of patients that previously had a failure of treatment with photodynamic therapy using Visudyne.
2. Patients must be at least 50 years of age.
3. Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
4. Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart

Exclusion Criteria:

1. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
2. Patients who have undergone intraocular surgery within the last 2 months.
3. Patient participating in any other investigational drug study.
4. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
5. Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access).
6. Patient with significant liver disease or uremia.
7. Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
8. Patient has a history of any medical condition which would preclude scheduled visits or completion of study
9. Patient has had insertion of scleral buckle in the study eye
10. Patient has received radiation treatment
11. Patient is on anticoagulant therapy with the exception of aspirin
12. Patient is pregnant or nursing.