cyrilzakka/clinical-trials huggingface dataset:
Clinical and Imaging Trial of Uridine for Veterans With Suicidal Ideation

This is a randomized, double-blind, placebo-controlled study of the investigational drug uridine as a treatment for suicidal ideation in veterans.

The investigators hypothesize that the administration of a naturally occurring dietary supplement, uridine, will rapidly reduce suicidal ideation in veterans. The purpose of this study is to determine whether 4 weeks of uridine supplementation is an effective treatment for suicidal ideation in veterans, when compared to a group taking a placebo.

Veteran suicides, attempts and suicidal ideation (SI) remain an urgent concern for the Veterans Health Administration (VHA). Research indicates that approximately half of veteran suicides take place within 1 month of the decedent's final VHA encounter, with one quarter occurring within 1 week. This provides a temporal window of opportunity to intervene, and necessitates development of a rapid-acting treatment for veterans with SI. Uridine shares similar brain mechanisms and neural effects with ketamin and lithium, treatments commonly used to reduce suicidal ideation. This study will test the novel intervention uridine as a rapid-acting oral treatment for veterans with suicidal ideation. The purpose of this study is to investigate whether uridine can decrease suicidal ideation in veterans when taken daily for 4 weeks.

In addition to treatment with the investigational drug versus placebo, the study includes a translational neuroimaging component: magnetic resonance spectroscopy (1H-MRS) brain scans are performed at baseline, and then repeated following 1 week of treatment with uridine or placebo. The scans do not use radiation, and are performed on a 3 Tesla MRI system that is approved for clinical use. The scans allow researchers to measure the concentrations of several chemicals in the brain that are may be involved in suicidal ideation.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to Provide Informed Consent.
* Must be a Veteran of the U.S. Armed Forces.
* Columbia-Suicide Severity Rating Scale Indicates Current Suicidal Ideation
* Beck Scale for Suicide Ideation Score \> 3 (i.e. "Greater Than or Equal to 4").
* History of \> 1 Suicide Attempt or Hospitalization to Prevent Suicide in Past 12 Months; or Functionally Impairing Suicidal Ideation Not Due to a DSM Axis II Diagnosis, in the Past 12 Months.
* Females and Males Ages 18-55 Inclusive.
* Willing and Able to Identify an Alternative Contact Person, e.g. Family Member, Friend or Neighbor.

Exclusion Criteria:

* Schizophrenia or Other Psychotic Disorder.
* Active Substance Use Disorder Requiring Stabilization (N.B. Does Not Include Nicotine).
* Unstable Medical Condition(s).
* Pregnancy or Breastfeeding.
* Contraindication to MRI (e.g. Ferrometallic Implant or Claustrophobic Anxiety).
* Concurrent Enrollment in Another Clinical Trial.
* Significant Risk of Protocol Non-Adherence (e.g. resides \> 50 miles from the hospital, and has no automobile or alternate transportation).
Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study

The purpose of this study is to compare Vanguard High Flex Rotating Platform to Vanguard Complete Knee System in Asian population in terms of early range of motion (ROM), clinical outcomes, and kinetic and kinematic characteristics in relation to healthy knees.

The primary objectives of this clinical study include:

* Evaluate size fit and long term performance of Vanguard Complete Knee ("Fixed") System in Asian and Latino population in comparison to competitor's similar product.
* Evaluate efficacy of Vanguard Complete Knee with Microplasty Tibial Tray.
* Compare Vanguard High Flex Rotating Platform ("High Flex") Knee System to Vanguard Complete Knee System in Asian population in terms of:

  * Early ROM
  * Clinical outcomes
  * Kinetic and Kinematic characteristics in relation to Healthy Knees. o
* Compare current design to new design of Vanguard High Flex Rotating Platform Knee System in terms of :

  * Early ROM
  * Clinical outcomes
  * Kinetic and Kinematic characteristics

Eligibility Criteria:
Inclusion Criteria:

* Painful and disabled knee joint resulting form osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
* Correction of varus, valgus, or posttraumatic deformity.
* Correction or revision of unsuccessful osteotomy, or arthrodesis.
* Need to obtain pain relief and improve function.
* Ability and willingness of the patient to follow instructions, including control of weight and activity level.
* Good nutritional state of the patient.
* Patient must have reached full skeletal maturity.

Exclusion Criteria:

* Infection, sepsis, osteomyelitis, and failure of previous joint replacement.
* Uncooperative patient or patients with neurologic disorders who are incapable of following directions.
* Osteoporosis
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy, neuromuscular disease
* Incomplete or deficient soft tissue surrounding the knee
Abdominal Aortic Aneurysms and Pseudoexfoliation Syndrome

Conflicting results have been reported concerning the association of pseudoexfoliation syndrome (PXF) and abdominal aortic aneurysms (AAA). Schumacher et al. reported an association between AAA and PXF, with no consideration of grade. However, a later study did not confirm the association between AAA and PXF. The present study aimed at comparing the relative prevalence of PXF in patients suffering from AAA and in age-matched hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* Presence of abdominal aortic aneurism
* Systemic hypertension without abdominal aortic aneurism over 60 years old

Exclusion Criteria:

* Unknown status for abdominal aortic aneurism
Evaluation of Familial Mediterranean Fever Impact on Oral and Dental Health in Children and Adolescents

Aim: It is the clinical and radiological evaluation of oral hygiene, teeth and surrounding tissues in children and adolescents diagnosed with FMF and comparing the results with healthy individuals. Method: Our study included patients aged 6-15, 45 with FMF (study group) and 45 healthy (control group), who were referred from Akdeniz University Faculty of Medicine Pediatric Rheumatology Clinic and evaluated at Akdeniz University Faculty of Dentistry Pedodontics Clinic. MEFV gene mutations were investigated in the study group. After recording the demographic and clinical characteristics of both groups, intraoral examinations were performed and DMFT, dft, bruxism, tooth wear due to bruxism and gingival/plaque indexes were evaluated. Saliva pH, flow rate and buffering capacity were measured. Tooth age was determined by the Cameriere method, The mesio-distal dimensions of the teeth were measured on the plaster model.

In the study, DMFT, dft, bruxism, tooth wear due to bruxism, gingival index (MGI), plaque index (OHI-S), salivary pH, salivary flow rate, salivary buffering capacity, dental age, chronological age difference, mesio-distal dimensions of the teeth, and the presence of aphthous lesions were evaluated and compared between the study group consisting of children with FMF and the control group of healthy children.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with FMF, aged between 6-15 years, who were admitted/referred to the Pediatric Dentistry Department Clinic of Akdeniz University Faculty of Dentistry for oral and dental examination, and who agreed to participate in the study after being thoroughly informed both verbally and in writing.
* Patients with no systemic diseases other than FMF.
* Patients who have not used any systemic antibiotics or similar medications (e.g., antidepressants, psychiatric drugs) within the last 3 months.

Exclusion Criteria:

* Patients diagnosed with FMF, who were admitted/referred to the Pediatric Dentistry Department Clinic of Akdeniz University Faculty of Dentistry for oral-dental examination but declined to participate in the study after being thoroughly informed both verbally and in writing.
* Patients with any systemic disease other than FMF.
* Patients who have used systemic antibiotics or any other medications (e.g., antidepressants, psychiatric drugs) within the last 3 months.
Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.

Provide adefovir dipivoxil (Hepsera) 10 mg once daily to patients with chronic hepatitis B virus (HBV) infection who have completed a Gilead-sponsored study of adefovir dipivoxil and require continued access to adefovir dipivoxil.

The objective of this study is to provide adefovir dipivoxil 10 mg once daily to patients with chronic hepatitis B virus(HBV) infection who have completed a Gilead-sponsored study of adefovir dipivoxil and require continued access to adefovir dipivoxil. The secondary objective of this study is to evaluate the safety of chronic therapy with adefovir dipivoxil 10 mg.

Eligibility Criteria:
Inclusion Criteria:

* Must have completed one of the following Gilead-sponsored studies as indicated: GS-96-412, GS-98-437, GS-98-438, GS-00-461 and GS-00-481. If the patient has participated in another Gilead-sponsored study, the CRO or Sponsor's Medical Monitor will evaluate for participation in this study on a case by case basis.

Exclusion Criteria:

* Any serious or active medical or psychiatric illness that would interfere with patient treatment, assessment or compliance with the protocol or dosing requirements.
* Currently receiving nephrotoxic drugs such as aminoglycosides (e.g. amikacin, gentamicin, kanamycin, neomycin, netilmicin, streptomycin, tobramycin), amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, or pentamidine OR competitors of renal excretion such as probenecid and sulfinpyrazone. These agents must be discontinued at least 7 days prior to starting treatment with adefovir dipivoxil.
* Currently receiving investigational agents with activity against hepatitis B virus.
* Hypersensitivity to any of the components of the drug product.
* Pregnant or lactating females.
* Inability to comply with study requirements.
* Experienced a treatment limiting toxicity of adefovir dipivoxil that has not yet resolved or resulted in permanent discontinuation of adefovir dipivoxil in the previous study.
LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs

This will be a single-center, prospective, randomized controlled cross-sectional study comparing interscalene brachial plexus block with liposomal bupivacaine versus bupivacaine with epinephrine and PF dexamethasone in patients undergoing primary shoulder arthroplasty. Primary endpoint will be total opioid consumption in the first three post-operative days.


Eligibility Criteria:
Inclusion Criteria:

* Patient age \>18 years;
* Lack of language barrier;
* Informed consent obtained;
* Presenting for primary total shoulder arthroplasty (TSA), both anatomic and reverse, by a specialty-trained surgeon;
* American Society of Anesthesiology (ASA) physical status score I- III

Exclusion Criteria:

* Presence of a language barrier;
* Inability to complete telephone and/or paper questionnaire;
* Lack of consent;
* Allergy to local anesthetic;
* Chronic pain syndrome and/or preoperative opioid use \> 50 MME per day (including extended-release formulations and methadone);
* Preoperative consultation to chronic pain service;
* History of (\<3 months) or current substance abuse, including any illicit drugs or excessive alcohol consumption as defined by the Office of Disease Prevention and Health Promotion (4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men);
* Baseline peripheral neuropathy of the brachial plexus;
* Contraindication to receiving single shot peripheral nerve blockade; including antithrombotic medications as per most recent American Society of Regional - - -Anesthesiology (ASRA) guidelines 17 , coagulopathy or coagulation disorder, or infection at injection site;
* Severe chronic obstructive pulmonary disease (COPD) or other significant pulmonary disease where interscalene nerve block would be contraindicated due to concern for respiratory failure from phrenic nerve palsy;
* Weight \< 45 kg, given concern for local anesthetic toxicity at dosages given for the study; ASA score IV-V;
* Revision arthroplasty;
* Anatomic abnormality that limits or prevents the patient from receiving an interscalene nerve block;
* Pregnant, nursing, or planning to become pregnant during the study or within 1 month after the shoulder replacement surgery
Healthy Transitions: Menopause Effect on Obesity, Energy Balance, and Insulin

The purpose of this study is to determine the effect of menopause on obesity, energy balance, and insulin in postmenopausal, obese women.

The effect of menopause on body composition and cardiovascular risk in healthy caucasian women has been the subject of much study. In contrast, there are few data available on menopause in African-American women. Since menopause is associated with potentially preventable health risks in women, this proposal is aimed at characterizing the perimenopausal period in terms of body fat, energy balance, and insulin action in both caucasian and African-American women.

The study will address 4 general hypotheses:

* Menopause increases both total and visceral abdominal fat
* Changes in body composition and body weight at menopause are mediated, at least in part by changes in 24-hour energy expenditure and/or food intake
* Menopause results in decreased insulin sensitivity that may predispose certain women to develop diabetes later in life
* African-American women may respond to the shifts in reproductive hormones at menopause differently than caucasian women.

Eligibility Criteria:
Inclusion Criteria:

* Age 47-52 yr, at time of enrollment
* Body Mass Index 25-40
* Normal oral glucose tolerance test by National Diabetes Data Group criteria
* Premenopausal, defined by FSH levels \<30mIU/ml and at least 5 menstrual periods in the last 6 months
* Able to confirm ethnic heritage of past 2 generations in family

Exclusion Criteria:

* hypertension or hypercholesterolemia requiring medication
* regular use of medications that influence glucose tolerance
* use of oral contraceptives within the past 6 months
* history of myocardial infarction or significant coronary vascular disease or stroke
* history of endocrine, kidney, or liver disease or malignancy
* any psychopathology, including eating disorders, substance abuse, and major depression
* unable to complete longitudinal study commitment, including anticipating moving out of the area within the next 5 years.
Breast Density Change Predicting Response to Adjuvant Aromatase Inhibitor

Breast density change after short term use of aromatase inhibitor in postmenopausal ER positive breast cancer would predict endocrine responsiveness

Inclusion criteria ER positive breast cancer Postmenopause women Older than 60yr S/P bilateral salphingo-oophorectomy No menstruation history within 1yr and FSH\>30mIU/mL Ipsilateral invasive breast cancer Undergone curative resection No evidence of distant metastasis Capable of breast MRI

Eligibility Criteria:
Inclusion Criteria:

* ER positive invasive breast cancer Postmenopause women age 60yrs or older s/p bilateral salphingo-oophorectomy No history of menstruation and FSH\>30mIU Planned for aromatase inhibitor Unilateral breast cancer Curative resection No evidence of distant metastasis

Exclusion Criteria:

* Bilateral breast cancer Male breast cancer Acceptable for breast MRI Pregnancy or lactation
PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

Eligible patients with stage 2 and 3 triple negative breast cancer will be treated with 4 cycles of neoadjuvant paclitaxel/carboplatin/pembrolizumab. A PET scan will be performed at baseline and after 1 cycle of therapy. A breast MRI will be performed after treatment completion. Patients with complete clinical response will proceed to surgery. Patients with clinical residual disease will complete neoadjuvant rescue with 4 cycles of doxorubicin/cyclophosphamide prior to surgery. If residual disease identified after surgery, adjuvant therapy to be determined by the treating oncologist (may include doxorubicin/cyclophosphamide/pembrolizumab, capecitabine etc).

Eligible participants will undergo baseline procedures including research bloodwork, MRI and PET scan. Participants will then be treated with one cycle of paclitaxel, carboplatin and pembrolizumab (TCarbo/pembro). At the end of Cycle one patients will undergo repeat procedures (bloodwork and PET scan), and then continue with treatment for an additional three cycles. ctDNA will be collected on day 1 of each cycle. At the end of treatment patients will undergo repeat MRI.

Patients achieving a clinical complete response (CR) on MRI will proceed with surgery. Patients with clinical residual disease (RD) on MRI will be recommended a biopsy, and be recommended "rescue" neoadjuvant doxorubicin and cyclophosphamide with pembrolizumab (AC/pembro) for four additional cycles, and then proceed with surgery. Note: patients/treating physician may opt to proceed with surgery.

Archival tissue will be collected from the surgical product. Patients achieving a pathologic CR (pCR) may proceed with adjuvant pembrolizumab per standard of care, and treating physician's discretion. Patients with pathological RD may proceed with "rescue" adjuvant AC/pembrolizumab for four additional cycles (if not given neoadjuvantly), per treating physician discretion. The participants may also receive Aadjuvant capecitabine or olaparib as indicated and per treating physician's discretion.

Eligibility Criteria:
Inclusion Criteria:

1. Stage II-III TNBC - estrogen receptor (ER) and progesterone receptor (PR) up to and including 10% is eligible
2. Age ≥ 18 years
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
4. Eligible for standard chemo-immunotherapy as determined by treating physician, including consideration of:

   1. Adequate marrow and organ function
   2. Co-morbid conditions do not preclude the use of chemo-immunotherapy (such as uncontrolled autoimmune disease, or the use of immunosuppressive medications)
5. Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria:

1. Patients unable to undergo PET or MRI
2. Evidence of metastatic disease or loco-regional recurrence (i.e. distant or chest wall recurrence)
3. Inflammatory breast cancer
4. Previous treatment with paclitaxel, carboplatin, or immune checkpoint inhibitors
Prevention Program Promoting Self Resilience, Positive Self-Image and Body Image Among Adolescents

The study is a group randomized controlled trial. High school classes were allocated by randomization to the intervention or control group by a Randomization function in Excel computer program. Outcomes were measured by questionnaire at pre-intervention, post-intervention and 3-months follow-up. The study protocol was approved by Tel Hai College institutional review board. Parents of all participants, in the intervention and in the control group, received information about the program and the study and were asked to provide informed consent.

The study is a group randomized controlled trial. High school classes were allocated by randomization to the intervention or control group by a Randomization function in Excel computer program. Outcomes were measured by questionnaire at pre-intervention, post-intervention and 3-month follow-up. The study protocol was approved by Tel Hai College institutional review board. Parents of all participants, in the intervention and in the control group, shall receive information about the program and the study and shall be asked to provide informed consent.

Participants and setting: A high school in the northern region of Israel was recruited for the study. 9th and 10th grade classes were chosen to participate in the study, all mixed gender classes. All data will be collected within the school setting.

Program description: "In Favor of a Resilient Self" is an interactive, cognitive behavior program aiming to address low resilience, low self-esteem and body dissatisfaction. This program is part of a series of intervention programs named "In Favor of Myself" which has been in development since 2008. This resilience-based program contains a range of coping strategies to help adolescents improve resilience, self-esteem and body image. The program consists of nine 90-min sessions delivered by one group leader in the presence of the classes' teachers. Participants in the control group shall receive one session of 90 minutes of health nutrition education.

Eligibility Criteria:
Inclusion Criteria:

• Participants who filled out the questionnaires before and after the program, and whose parents signed a letter of informed consent.

Exclusion Criteria:

• Participants who do not complete the questionnaires at least twice
Comparison of Salivary pH After Consuming Milk of Origin Vegetable vs Cow's Milk in Children

The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female. They were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk)

* The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female.
* The group was given a brushing technique using a model and 2 videos were shown to reinforce the brushing technique and explanation of what was going to be done in the study.
* Supervised tooth brushing was performed in a group of 5 people.
* They were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk).
* Each child was given 7 plastic cups each day and asked to pour their saliva into the cup when instructed.
* The samples were taken with pH indicator strips and the result was recorded in personalized tables.

Eligibility Criteria:
Inclusion Criteria:

* Boys and girls from 3 to 6 years

Exclusion Criteria

* Boys and girls with allergies
* Children with lactose intolerance

Elimination criteria:

- Boys and girls who do not want to participate at the time of the study
Assessment of Retinal Nerve Fibre Layer by Optical Coherence Tomography in Uveitis Patients With Papilloedema

Assessment of optic disc morphology can be difficult in patients with uveitis and papilloedema. Therefore different optical coherence tomography (OCT) and laser scanning techniques may help to detect damage to the retinal nerve fibre layer.


Eligibility Criteria:
Inclusion Criteria:

* anterior or intermediate uveitis
* papilloedema
* glaucoma

Exclusion Criteria:

* dense cataract
* dense vitreous opacification
* circular posterior synechiae